Tenn. Comp. R. & Regs. 1140 — Pharmacy

Chapter 1140-01 Introductory Rules

Tenn. Comp. R. & Regs. 1140-01-.01 DEFINITIONS

(1) “ACPE” means the Accreditation Council for Pharmacy Education.

(2) “Alternate or alternative infusion pharmacy practice site” means a pharmacy practice site where parenteral, enteral or respiratory therapies, and ancillary supplies, medications and equipment are provided to patients in a non-institutional setting.

(3) “Accreditation Council for Pharmacy Education (ACPE)” means the national organization for accreditation of professional degree programs in pharmacy and for accreditation of providers of continuing pharmacy education.

(4) “Automated dispensing system” means a mechanical or electronic system outside the premises of an institutional or long-term care pharmacy that performs operations or activities, other than compounding or administration, relating to pharmacy services, including the storage, dispensing, or distribution of drugs and the collection, control, and maintenance of all transaction information, to provide security and accountability for such drugs.

(5) “Blood” means whole blood collected from a single donor and processed either for transfusion or further manufacturing.

(6) “Blood fraction/component” means that part of blood separated by physical or mechanical means.

(7) “Centralized prescription processing” is the filling or refilling of a lawful prescription order written by the patient’s authorized prescriber by one (1) pharmacy licensed by the State of Tennessee at the request of another pharmacy licensed by the State of Tennessee for the delivery of the prescription drugs to the patient or patient’s agent.

(8) “Certified pharmacy technician” means an individual who is certified by a national or state agency that offers a certification program that is recognized by the board.

(9) “Commercially available” means any marketed FDA-approved drug or biologic product not currently listed on any official shortage list recognized by the Board of Pharmacy.

(10) “Common carrier” means any person or entity who undertakes, whether directly or by any other arrangement, to transport property including prescription drugs and/or devices for compensation. A common carrier is only responsible for transportation. A common carrier has no responsibility to direct the sale or disposition of property.

(11) “Component” means any active ingredient, or any added substance, inactive ingredient, excipient or pharmaceutic ingredient, intended for use in the compounding of a drug product, including those that may not appear on the product label.

(12) “Consultant pharmacist” means a pharmacist retained on a routine basis to consult with organizations, institutional facilities or patients in areas that pertain to the practice of pharmacy.

(13) “Contact hour” means any hour of completed continuing pharmaceutical education programming which is:

(a) Accredited by ACPE (including, but not limited to, live programs, independent study courses, home correspondence courses, and audio or video cassettes); or (b) Approved by the board (including, but not limited to, attendance at state, district, or local pharmacy association meetings).

(14) “Continuing education unit” means ten (10) hours of participation in an ACPE approved or board-approved continuing pharmaceutical education program under responsible sponsorship, capable direction, and qualified instruction.

(15) “Drug sample” means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the prescription drug.

(16) “Electronic medical or prescription order” means a medical or prescription order which is transmitted by computer technology other than by electronic image transmission.

(17) “Facsimile (FAX) medical or prescription order” means a medical or prescription order which is transmitted by an electronic image transmission.

(18) “Foreign pharmacy graduate” means a person whose undergraduate pharmacy degree was conferred by any college or school of pharmacy not accredited by the ACPE but which is listed in the World Health Organization World Directory of Colleges and Schools of Pharmacy, or otherwise approved by the Foreign Pharmacy Graduate Examination Committee (FPGEC) certification program as established by the National Association of Boards of Pharmacy.

(19) “Hazardous product” means any substance that may be cytotoxic, genotoxic, oncogenic, mutagenic, teratogenic, or otherwise pose a potential health hazard.

(20) “Institutional facility” means any organization whose primary purpose is to provide a physical environment for patients to obtain acute or short-term health care services, including but not limited to a(n):

(a) Hospital and associated clinics;

(b) Developmental disability center;

(d) Sub-acute care facility; and (e) University health center.

(21) “Institutional pharmacy practice site” means a pharmacy practice site serving patients within an institutional facility.

(22) “Long term care pharmacy practice site” means a pharmacy practice site serving patients within a long term care facility.

(23) “Long term care facility” means any organization whose primary purpose is to provide a physical environment for patients to obtain healthcare services, and where patients spend a majority of their time within the facility, including, but not limited to a(n):

(a) Nursing home;

(b) Hospice or residential hospice; and (c) Assisted living facility.

(24) “Medication assessment” means a consultation between a pharmacist and a patient undertaken for the specific purpose of managing or discussing a course of drug therapy or treatment. Counseling as required by Board Rule 1140-03-.01 shall not be considered a medication assessment for the purposes of this part.

(25) “Medication order” means a prescription order for any prescription drug or device or related material issued by an authorized prescriber to authorized healthcare personnel in an institutional facility or institutional pharmacy practice site.

(26) “National Association of Boards of Pharmacy (NABP)” means the professional organization that represents the individual state boards of pharmacy.

(27) “Nuclear pharmacy practice site” means a pharmacy practice site providing radiopharmaceutical services.

(28) “Outsourcing facility” means a facility engaged in the compounding of sterile drugs which has elected to register as an outsourcing facility with the U.S. Food and Drug Administration and which complies with all relevant federal laws and regulations.

(29) “Oxygen supplier” means any person who sells, delivers, distributes or wholesales medical gases which require a prescription or medical order prior to administration, dispensing or delivery and which are considered legend drugs pursuant to the federal Food, Drug, and Cosmetic Act to any person residing in this state.

(30) “Patient counseling” means communication by the pharmacist of information to the patient or caregiver in order to improve therapeutic outcome.

(31) “Pharmaceutical care” is the responsible provision of drug therapy through, among other things, pharmacists identifying potential and actual drug-related problems and resolving and preventing drug-related problems, for the purpose of achieving definite outcomes that improve a patient’s quality of life. The outcomes include but are not limited to cure of a disease, elimination or reduction of a patient’s symptomatology, arresting or slowing of a disease process and the preventing of a disease or symptomatology.

(32) “Pharmacy internship” is a period of practical pharmacy experience under the direct supervision of a licensed pharmacist and pursuant to the rules of the board.

(33) “Pharmacy practice site” means any place within this state where prescription drugs or prescription devices are dispensed and where pharmaceutical care is provided, and any place outside of the state where prescription drugs or prescription devices are dispensed and pharmaceutical care is provided to persons residing in this state.

(34) “Preceptor” means an individual who is currently licensed as a pharmacist and who meets the qualifications of a preceptor under the rules of the board and participates in the education of pharmacy interns.

(35) “Prescription department” means the area of a pharmacy practice site in which prescription drugs and devices and related materials are stocked and medical and prescription orders are compounded and dispensed.

(36) “Quality assurance” means a system for identifying problems in patient care that are resolved via administrative, clinical, or educational actions to ensure that final products and outcomes meet applicable specifications.

(37) “Radiopharmaceutical service” means, but is not limited to:

(a) The compounding, dispensing, labeling, and delivering of radiopharmaceuticals;

(b) The participation in radiopharmaceutical selection and radiopharmaceutical utilization reviews;

(d) The maintenance of radiopharmaceutical quality assurance;

(e) The responsibility for advising, where necessary or where regulated, of the diagnostic and therapeutic value, hazards, and use of radiopharmaceuticals; and (f) The offering or performing of those acts, services, operations, or transactions necessary in the conduct, operation, management, and control of a nuclear pharmacy practice site.

(38) “Reciprocity” means to issue a license to an applicant who furnishes satisfactory proof of licensing by examination in another state or territory pursuant to the rules of the board.

(39) “Shall” means that compliance is mandatory.

(40) “Sterile product” means any dosage form, drug product, or biological product devoid from all living microorganisms, including but not limited to bacteria and fungus.

(41) “Sterile manufacturing” means the production, propagation, processing, pooling, or repackaging of sterile products for wholesale or any other form of distribution, not pursuant to a prescription or medical order.

(42) “Third-party logistics provider (3PL)” means a person who provides or coordinates warehousing or other logistics services of a drug or device on behalf of a manufacturer, wholesale distributor, or dispenser of the drug or device, but does not take ownership of the drug or device, nor has responsibility to direct the sale or disposition of the drug or device.

(43) “Third-party pharmacy program” means any system of providing for the reimbursement of medical or prescription orders and/or pharmaceutical care services under a contractual arrangement or agreement between a provider of such services and the third-party program administrator who is not the consumer of those services.

(44) “Third-party pharmacy program administrator” means, but is not limited to, insurance companies, managed care organizations, health maintenance organizations, preferred provider organizations, pharmacy benefit managers, and pharmacy services administrative organizations.

(45) “Unit dose packaging” means that packaging which is designed to hold a quantity of a drug product intended for administration as a single dose.

(46) “USP” means the United States Pharmacopeia.

(47) “USP standards” means any applicable standard or standards published in the most current version of United States Pharmacopeia National Formulary guidelines, to the extent that such guidelines do not conflict with state law, rules, or Board Policy Statements and as those guidelines may, from time to time, be amended.

History

Authority: T.C.A. §§ 63-10-101, 63-10-102, 63-10-204, 63-10-214, 63-10-216, 63-10-301, 63-10-304, 63-10-304(b)(1), 63-10-306, 63-10-404(5), (6), (14), (22), (26), (28), and (29), 63-10-504(b)(1), and Chapter 966 of the Public Acts of 2008, § 1.
Administrative History: Original rule certified June 7, 1974. Repeal and new rule filed February 7, 1983; effective March 9, 1983. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendment filed November 24, 2008; effective February 7, 2009. Amendment filed December 23, 2009; effective March 23, 2010. Emergency rule filed January 31, 2014; effective through July 30, 2014. Emergency rule expired effective July 31, 2014, and the rule reverted to its previous status. Amendment filed July 11, 2014; effective October 9, 2014. Amendment filed March 24, 2015; effective June 22, 2015. Amendments filed November 22, 2016; effective February 20, 2017. Amendments filed September 12, 2018; effective December 11, 2018.

Tenn. Comp. R. & Regs. 1140-01-.02 VIOLATIONS CONSTITUTE UNPROFESSIONAL CONDUCT

(1) Any person who violates any rule of the board may be deemed guilty of dishonorable, immoral, unethical or unprofessional conduct within the meaning of T.C.A. § 63-10-305(6).

History

Authority: T.C.A. §§ 63-10-301, 63-10-304, and 63-10-305.
Administrative History: Original rule certified June 7, 1974. Amendment filed August 14, 1974; effective September 13, 1974. Repeal filed January 11, 1977; effective February 10, 1974. Repeal and new rule filed February 7, 1983; effective March 9, 1983. Amendment filed January 19, 1988; effective April 27, 1988. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Emergency rule filed January 31, 2014; effective through July 30, 2014. Emergency rule expired effective July 31, 2014, and the rule reverted to its previous status. Repeal and new rule filed July 11, 2014; effective October 9, 2014.

Tenn. Comp. R. & Regs. 1140-01-.03 APPLICATION FOR A PHARMACIST LICENSE

(1) An applicant for a license to engage in the practice of pharmacy shall submit the following to the Board office at time of application:

(a) A completed application on a form approved by the Board;

(b) Application and registration fees established in rule 1140-01-.10; and (c) The result of a criminal background check, which the applicant shall pay for and cause to be submitted to the Board’s administrative office directly from the vendor identified in the Board’s licensure application materials.

(d) Any application submitted which lacks required information or reflects a failure to meet any of the requirements for licensure will be returned to the applicant with written notification of the information that is lacking or the reason(s) the application does not meet the requirements for licensure and will be held in “pending” status until (Rule 1140-01-.03 continued) satisfactorily completed within a reasonable period of time, not to exceed sixty (60) days from date of written notification.

(2) For the purpose of T.C.A. § 63-10-306(d), a “recognized” college or school of pharmacy is a college or school of pharmacy which meets the minimum standards of the ACPE and appears in the ACPE annual “Directory of Accredited Professional Programs of Colleges and Schools of Pharmacy.”

(3) No applicant shall be eligible for a license if the applicant has engaged in conduct or suffers a condition which would constitute grounds for revocation or suspension of a license under T.C.A. § 63-10-305, unless the applicant can show cause why a license should be issued.

(4) No license shall be issued to a reciprocal applicant from a state which denies reciprocal privileges to a pharmacist currently licensed and in good standing in Tennessee.

(5) It shall be unlawful for any person to procure or attempt to procure a license or certificate of registration for such person or for any other person by making any false representations.

(6) An applicant initially licensed in another state and who wishes to obtain a Tennessee license may, in the discretion of the board, transfer to Tennessee the applicant’s score on NAPLEX taken in another state. Provided, however, if the applicant has been licensed for twelve (12) or more months in another state, then the applicant shall apply for a license in Tennessee by reciprocity. No license shall be issued to a score transfer applicant from a state which denies score transfer privileges to a pharmacist currently licensed and in good standing in Tennessee.

(7) Upon request, the Board may waive selected portions of these requirements so long as any waiver granted is consistent with the Board’s authority under Tenn. Code Ann. Title 63, Chapters 1 and 10, and Tenn. Code Ann. Title 4, Chapter 5.

History

Authority: T.C.A. §§ 63-1-116, 63-10-101, 63-10-102(a), 63-10-202, 63-10-204, 63-10-304, 63-10-306, 63-10-308, 63-10-404(2), (13), (17), and (26), 63-10-404(2), (13), (17), and (26), 63-10-504(b)(1), 63-10- 506, and 63-10-508.
Administrative History: Original rule certified June 7, 1974. Repeal and new rule filed February 7, 1983; effective March 9, 1983. Amendment filed December 17, 1984; effective March 16, 1985. Amendment filed October 30, 1991; effective December 14, 1991. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendment filed January 4, 2012; effective April 3, 2012. Amendments filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-01-.04 PHARMACY INTERNSHIP

(1) An applicant for an initial pharmacist license by examination must show, on affidavit forms prescribed by the board, that the applicant has acquired a minimum of one thousand seven hundred (1,700) hours of pharmacy internship (practical pharmacy experience) under the instruction of a pharmacist in good standing, subject to all of the following conditions.

(a) The one thousand seven hundred (1,700) hours must be acquired after enrollment in a recognized college or school of pharmacy; one thousand seven hundred (1,700) of these hours must be acquired in pharmacy programs or demonstration projects structured by the college or school of pharmacy.

(b) Pharmacy internship may be acquired in another state, provided that the preceptor’s qualifications are certified by the appropriate authorities of such state.

(c) Foreign pharmacy graduates shall complete five hundred (500) hours of pharmacy internship in Tennessee within a period of six (6) consecutive months.

(d) Upon request, the Board may waive selected portions of these requirements so long as any waiver granted is consistent with the Board’s authority under Tenn. Code Ann. Title 63, Chapters 1 and 10, and Tenn. Code Ann. Title 4, Chapter 5.

History

Authority: T.C.A. §§ 63-10-101, 63-10-102, 63-10-202, 63-10-204, 63-10-304, and 63-10-306.
Administrative History: Original rule filed June 7, 1974; effective July 7, 1974. Amendment filed September 23, 1975; effective October 23, 1975. Amendment filed January 11, 1977; effective February 10, 1977. Repeal and new rule filed February 7, 1983; effective March 9, 1983. Amendment filed December 17, 1984; effective March 16, 1985. Amendment filed January 19, 1988; effective April 27, 1988. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Repeal and new rule filed March 24, 2015; effective June 22, 2015. Amendments filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-01-.05 LICENSING EXAMINATIONS

(1) An applicant for an initial license to engage in the practice of pharmacy in the State of Tennessee shall take the National Association of Boards of Pharmacy (NABP) Multistate Pharmacy Jurisprudence Examination (MPJE®) and the NABP North American Pharmacy Licensing Examination (NAPLEX®), which shall be administered on the dates scheduled by the NABP. An applicant shall also meet the minimum acceptable passing scores on the NAPLEX® and MPJE® as established and nationally accepted.

(2) An applicant to obtain a pharmacy license by reciprocity shall successfully complete the MPJE® by achieving (at least) the designated passing score on the exam.

(3) In addition to completing the requirements in paragraph (1) of this rule, a pharmacy foreign graduate shall successfully complete the foreign pharmacy equivalency examination, the Test of Spoken English (TSE®) examination and any other requirements established by the NABP.

(4) Any applicant who fails either the NAPLEX® or MPJE® may retake the examinations at any of the next examination dates scheduled by the NABP. If an applicant fails the NAPLEX® or MPJE® three (3) consecutive times, then the Board may require that applicant to take review courses prior to any following reexamination.

(5) Upon request, the Board may waive selected portions of these requirements so long as any waiver granted is consistent with the Board’s authority under Tenn. Code Ann. Title 63, Chapters 1 and 10, and Tenn. Code Ann. Title 4, Chapter 5.

History

Authority: T.C.A. §§ 63-10-304 and 63-10-306.
Administrative History: Original rule certified June 7, 1974. Repeal and new rule filed February 7, 1983; effective March 9, 1983. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendment filed November 24, 2008; effective February 7, 2009. Amendments filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-01-.06 SUMMARY SUSPENSION OF LICENSE

Pursuant to T.C.A. § 4-5-320, if the board finds that public health, safety or welfare imperatively requires emergency action and incorporates a finding to that effect in its order, summary suspension of a license may be ordered pending proceedings for revocation or other action.

History

Authority: T.C.A. §§ 4-5-320, 63-10-101, 63-10-102, 63-10-504(b)(1), 63-10-504(b)(2), and 63-10-505.
Administrative History: Original rule certified June 7, 1974. Repeal and new rule filed February 7, 1983; effective March 9, 1983. Amendment filed November 15, 1989; effective December 30, 1989. Repeal and new rule filed May 11, 1998; effective July 25, 1998.

Tenn. Comp. R. & Regs. 1140-01-.07 INACTIVE LICENSES AND LICENSE REINSTATEMENT

(1) A pharmacist may apply for an inactive license by:

(a) Completing the biennial license renewal application form; and (b) Paying the biennial renewal fee for an inactive license.

(2) A pharmacist maintaining an active license to practice pharmacy in another state or jurisdiction is ineligible for inactive license status in Tennessee.

(3) A pharmacist seeking active status for an inactive, delinquent, suspended or revoked license must fulfill the following minimum requirements.

(a) If the license has been inactive, delinquent, suspended or revoked for less than one (1) year, the pharmacist shall:

Provide written notice to the board requesting an active license;
Satisfy all past due continuing pharmaceutical education as required by the board; and 3. Pay all cumulative license renewal fees and any applicable penalty fees for the period during which the license was inactive, delinquent, suspended or revoked.

(b) If the license has been inactive, delinquent, suspended or revoked from one (1) year to not more than five (5) consecutive years, the pharmacist shall:

Provide written notice to the board requesting an active license;
Satisfy all past due continuing pharmaceutical education as required by the board;
Successfully complete the jurisprudence examination;
Pay all cumulative license renewal fees and any applicable penalty fees for the period during which the license was inactive, delinquent, suspended or revoked; and 5. Complete a period of pharmacy internship in Tennessee as follows:

(i) If the license has been inactive, delinquent, suspended or revoked from one (1) year to not more than three (3) consecutive years, one hundred sixty (160) hours within ninety (90) consecutive days.

(ii) If the license has been inactive, delinquent, suspended or revoked for more than three (3) consecutive years but not more than five (5) consecutive years, three hundred twenty (320) hours within one hundred eighty (180) consecutive days.

(c) If the license has been inactive, delinquent, suspended or revoked for more than five (5) consecutive years, the pharmacist shall:

Provide written notice to the board requesting an active license;
Satisfy all past due continuing pharmaceutical education as required by the board;
Successfully complete the NAPLEX and jurisprudence examinations;
Pay all cumulative license renewal fees and any applicable penalty fees for the period during which the license was inactive, delinquent, suspended or revoked; and 5. Complete a period of pharmacy internship of three hundred twenty (320) hours within one hundred eighty (180) consecutive days.

(d) Fulfill any other requirements which may be contained in any order of the board suspending or revoking the applicant’s license.

(e) The board shall consider a written notice requesting reinstatement of an inactive, delinquent, suspended or revoked license within six (6) months of the notice being received by the director.

(f) Upon request, the Board may waive selected portions of these requirements so long as any waiver granted is consistent with the Board’s authority under Tenn. Code Ann. Title 63, Chapters 1 and 10, and Tenn. Code Ann. Title 4, Chapter 5.

History

Authority: T.C.A. §§ 63-10-308 and 63-10-310.
Administrative History: Original rule certified June 7, 1974. Amendment filed June 7, 1974; effective July 7, 1974. Amendment filed September 23, 1975; effective October 23, 1975. Amendment filed January 11, 1977; effective February 10, 1977. Amendment filed April 11, 1979; effective July 30, 1979. Repeal and new rule filed February 7, 1983; effective March 9, 1983. Amendment filed January 26, 1987; effective April 29, 1987. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendments filed November 22, 2016; effective February 20, 2017. Amendments filed July 18, 2025; effective October 16, 2025.

Tenn. Comp. R. & Regs. 1140-01-.08 APPLICATION FOR PHARMACY PRACTICE SITE, MANUFACTURER, OUTSOURCING

FACILITY, OXYGEN SUPPLIER AND WHOLESALER/DISTRIBUTOR LICENSES.

(1) Application for a license to operate as a pharmacy practice site, manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor within the state of Tennessee shall be submitted to the office of the board at least thirty (30) days prior to the scheduled opening date. No pharmacy practice site, manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor may open within the state of Tennessee until a license has been obtained; and such license will not be issued until an inspection by an authorized representative of the board has been made.

(2) An application for an existing pharmacy practice site, manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor physically located within the state of Tennessee must be filed when the pharmacy practice site, manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor changes name, location or ownership.

(a) Transactions constituting a change of ownership include, but are not limited to, the following:

A sole proprietor becomes a member of a partnership or corporation, which succeeds him as the new operator;
A partnership dissolves;
One partnership is replaced by another through the removal, addition or substitution of a partner;
Two (2) or more corporations merge and the originally licensed corporation does not survive; and 5. Transfers between levels of government.

(b) Transactions which do not constitute a change of ownership include, but are not limited to, the following:

Changes in the membership of a corporate board of directors or board of trustees;
Two (2) or more corporations merge and the originally licensed corporation survives; and 3. Corporate stock transfers or sales, even when a controlling interest.

(3) No out-of-state pharmacy practice site, manufacturer outsourcing facility, oxygen supplier or wholesaler/distributor shall conduct business in the state of Tennessee until such pharmacy practice site, manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor obtains the required license from the board. In order to obtain a license for a pharmacy practice site, manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor physically located out-of-state the following standards must be met.

(a) Pharmacy practice site.

Submit an application for a license, which shall include the address of the pharmacy practice site, name of owner if a sole proprietorship, names of partners if a partnership or names and titles of all officers if a corporation and names of all pharmacists who practice at the site, together with the appropriate application fee. The director shall be notified in writing within thirty (30) days of any change in the information contained on the original application for a license, including names of pharmacists practicing at the site.
Comply with all statutorily authorized directions and requests for information from the board.
Maintain at all times a current permit, license or registration to conduct the pharmacy practice site in compliance with the laws of the state in which the site is physically located.
Submit a copy of the most recent inspection report resulting from an inspection conducted by the regulatory or licensing agency of the state in which the pharmacy practice site is physically located. Thereafter, the pharmacy practice site shall submit to the director a copy of any subsequent inspection report conducted by the regulatory or licensing agency of the state in which the site is physically located.

(i) An out-of-state pharmacy practice site engaged in compounding must provide an inspection performed within the previous twelve (12) months.

(ii) An inspection completed by the United States Food and Drug Administration, or an inspection performed by the National Association of Boards of Pharmacy in lieu of an inspection by the regulatory or licensing agency of the state in which the pharmacy practice site is physically located is acceptable.

Maintain records of prescription orders dispensed to and/or of medication assessments provided to persons residing in Tennessee.
All records of prescription orders prepared and dispensed to persons residing in Tennessee shall be readily retrievable from other records.
During regular hours of operation, but not less than six (6) days per week nor for a minimum of forty (40) hours per week provide access to a pharmacist by a tollfree telephone service. A toll-free number shall be placed on the label affixed to the dispensing container for each prescription dispensed to a person residing in Tennessee.
Designate a pharmacist in charge who shall be responsible for compliance with the provisions in this section, and who shall hold a current Tennessee pharmacist license.
All out-of-state pharmacy practice sites shall comply with the requirements for patient counseling, patient profiling, drug regimen review and pharmaceutical care as set forth at 1140-03-.01.
The Board may require additional information before issuing or renewing a pharmacy license to ensure compliance with applicable laws of this state and rules of the Board.

(b) Manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor.

Submit an application for a license, which shall include the address of the manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor, name of owner if a sole proprietorship, names of partners if a partnership or names and titles of all officers if a corporation, together with the appropriate application fee. The director shall be notified in writing within thirty (30) days of any change in the information contained on the original application for a license.
Submit a copy of the most recent inspection report resulting from an inspection conducted by the regulatory or licensing agency of the state in which the manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor is physically located, or by the Food & Drug Administration. Thereafter, the manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor shall submit to the director a copy of any subsequent inspection report conducted by the regulatory or licensing agency of the state in which the manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor is physically located, or by the FDA.
Comply with the requirements contained in Chapter 1140-09 of the rules of the Board of Pharmacy.

(4) Representatives of a manufacturer, outsourcing facility or wholesaler/distributor conducting business in the state of Tennessee and who possesses and distributes controlled substances shall obtain a controlled substance registration from the Board of Pharmacy.

(5) Any entity licensed as or applying for licensure as manufacturer or outsourcing facility conducting business in the state of Tennessee and who manufactures, prepares, propagates, repackages, or processes sterile drug products or biological products using aseptic processing must register and possess a modifier as a sterile manufacturer with the Board of Pharmacy in accordance with this chapter. This section shall not apply to wholesalers/distributors of sterile products.

(6) It shall be unlawful for any person to procure or attempt to procure a license or certificate of registration for such person or for any other person by making any false representations.

(7) In determining whether to grant a license under this rule, the board shall require from the applicant proof satisfactory to the board that the:

(a) Applicant is of good moral character, or, if the applicant is a partnership or corporation, that the managing officers are of good moral character; and (b) That the applicant is equipped as to land, buildings and equipment necessary to conduct the business for which the application has been submitted.

(8) Upon request, the Board may waive selected portions of these requirements so long as any waiver granted is consistent with the Board’s authority under Tenn. Code Ann. Title 63, Chapters 1 and 10, and Tenn. Code Ann. Title 4, Chapter 5.

History

Authority: T.C.A. §§ 53-11-301, 53-11-302, 53-14-104, 53-14-107, 63-10-203, 63-10-204, 63-10-210, 63-10-216, 63-10-301, 63-10-308, 63-10-310, and 63-10-312.
Administrative History: Original rule certified June 7, 1974. Repeal and new rule filed February 7, 1983; effective March 9, 1983. Amendment filed September 30, 1985; effective October 30, 1985. Amendment filed January 19, 1988; effective April 27, 1988. Amendment filed August 25, 1989; effective October 9, 1989. Amendment filed October 30, 1991; effective December 14, 1991. Amendment filed November 17, 1994; effective March 30, 1995. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Emergency rule filed January 31, 2014; effective through July 30, 2014. Emergency rule expired effective July 31, 2014, and the rule reverted to its previous status. Amendments filed July 11, 2014; effective October 9, 2014. Amendments filed March 24, 2015; effective June 22, 2015. Amendments filed November 22, 2016; effective February 20, 2017. Amendments filed December 15, 2023; effective March 14, 2024.

Tenn. Comp. R. & Regs. 1140-01-.09 RENEWAL OF LICENSES

(1) All licenses and certificates of registration granted by the board shall be for a two (2) year period beginning on the date the license is initially granted. All licenses and certificates of registration shall be renewed on or before the last day of the two (2) year license cycle.

(2) A pharmacist or pharmacy technician serving in the uniformed services of the United States shall not be required to pay license or registration renewal fees during the period of active duty and the pharmacist shall not be required to complete continuing pharmacy education requirements during the period of active duty.

(3) Prior to renewal of its license in this state, an out-of-state pharmacy practice site engaged in compounding must provide to the Board the most recent inspection by the regulatory or licensing agency of the state in which the pharmacy practice site is physically located, an inspection performed by the United States Food and Drug Administration, or an inspection performed by the National Association of Boards of Pharmacy, that must have been within the previous twelve (12) months.

(4) Upon request, the Board may waive selected portions of these requirements so long as any waiver granted is consistent with the Board’s authority under Tenn. Code Ann. Title 63, Chapters 1 and 10, and Tenn. Code Ann. Title 4, Chapter 5.

History

Authority: T.C.A. §§ 53-11-301, 53-11-302, 63-10-204, 63-10-210, 63-10-216, 63-10-308, 63-10-310, and 63-10-312.
Administrative History: Original rule certified June 7, 1974. Repeal and new rule filed February 7, 1983; effective March 9, 1983. Amendment filed April 12, 1990; effective July 29, 1990. Amendment filed November 17, 1994; effective March 30, 1995. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendment filed December 23, 2009; effective March 23, 2010. Amendments filed November 22, 2016; effective February 20, 2017. Amendments filed December 15, 2023; effective March 14, 2024.

Tenn. Comp. R. & Regs. 1140-01-.10 FEES

(1) An applicant for examination for a license as a pharmacist shall pay a fee of fifty dollars ($50.00) plus cost of the examination and materials.

(2) An applicant for a reciprocal license or NAPLEX score transfer shall pay a fee of three hundred dollars ($300.00).

(3) Each person becoming licensed as a pharmacist shall pay a registration fee of one-hundred twenty-five dollars ($125.00). Each person licensed as a pharmacist who desires to continue in the practice of pharmacy shall biennially, on or before the last day of the month that the person’s license shall expire, pay a renewal fee of one-hundred twenty-five dollars ($125.00).

Each person licensed as a pharmacist and who wishes to obtain an inactive license shall biennially, on or before the last day of the month that the person’s license shall expire, pay a renewal fee of sixty-three dollars ($63.00).

(4) Each person becoming registered as a pharmacy technician shall pay a registration fee of fifty-five dollars ($55.00). Each person who desires to continue to practice as a pharmacy technician shall biennially, on or before the last day of the month that the person’s registration shall expire, pay a renewal fee of seventy-five dollars ($75.00).

(5) Any person, partnership, firm, corporation or agency owning or operating a pharmacy practice site or any establishment or institution where prescription drugs and devices and related materials are kept for the purpose of the compounding and dispensing of medical and prescription orders shall pay a registration fee of three-hundred dollars ($300.00) biennially.

Any new pharmacy practice site to be opened or established, or any change in location, name or ownership of any existing pharmacy practice site, shall before active operation obtain a license from the Board of Pharmacy and shall pay a fee of three-hundred dollars ($300.00)

(6) All manufacturers, outsourcing facilities, oxygen suppliers, wholesalers/distributors, and 3PLs of prescription drugs and/or devices and related materials doing business in the state of Tennessee must be licensed by the Board of Pharmacy by paying a registration fee of fivehundred twenty-five dollars ($525.00), and thereafter a biennial renewal fee of five-hundred twenty-five dollars ($525.00).

(7) The fee for the Board of Pharmacy’s publication of Pharmacy Drug Laws, Rules and Regulations shall be an amount which covers the cost of publication and shipping, as determined by the Board of Pharmacy. The Board may also publish Pharmacy Drug Laws, Rules and Regulations electronically, and may make an electronic publication freely available on the Board’s website.

(8) The charge for a roster of Tennessee pharmacies, pharmacists and printing of mailing labels of Tennessee pharmacies and pharmacists shall be determined by the administration of the Department of Health.

(9) The fee for certification of license examination grades shall be twenty five dollars ($25.00).

(10) The fee for any duplicate or revised license, registration, modifier or license wall certificate shall be twenty five dollars ($25.00).

(11) If any person fails to renew a license, such license may be reinstated upon complying with

rule 1140-01-.07 and upon the payment of the appropriate renewal fee plus a penalty fee of ten dollars ($10.00) for each month or fraction thereof that payment for renewal is delinquent.

In the event such renewal is not procured within six (6) months from the date on which the last renewal became delinquent, the board may refuse to issue the renewal.

(12) If any person fails to renew a license or registration certificate, such license or registration certificate may be reinstated upon complying with rule 1140-01-.07 and upon the payment of the appropriate renewal fee plus a penalty fee of ten dollars ($10.00) for each month or fraction thereof that payment for renewal is delinquent. In the event such renewal is not procured within six (6) months from the date on which the last renewal became delinquent, the board may refuse to issue the renewal.

(13) A penalty of fifty dollars ($50.00) may, in the discretion of the board, attach to each failure of a licensee or registration certificate holder to provide any required notice to the director as may be required by the rules of the board.

(14) Any licensee who wishes to modify the terms or conditions of a license to manufacture, obtain, possess, administer or dispense a prescription drug or device or controlled substance for the purpose of scientific research, chemical analysis, instruction or training of detection animals shall file those modifications with a non-refundable fee of five dollars ($5.00).

(15) Any person who holds a license to manufacture, obtain, possess, administer or dispense a prescription drug or device or controlled substance for the purpose of scientific research, chemical analysis, instruction or training of detection animals shall pay a renewal fee of onehundred dollars ($100.00) biennially from the date of issuance.

(16) Any person, partnership, firm, corporation or agency owning or operating a pharmacy practice site or any other establishment licensed pursuant to this chapter, where sterile products are compounded, manufactured, prepared, propagated, repackaged, processed, stored, or distributed shall pay a registration fee of two-hundred and fifty dollars ($250.00), and thereafter a biennial renewal fee of two-hundred and fifty dollars ($250.00).

(17) Each automated dispensing system becoming registered with the Board shall pay a registration fee of three-hundred dollars ($300.00), and thereafter a biennial renewal fee of three-hundred dollars ($300.00).

(18) Each licensed practitioner, including pharmacy technicians, shall pay a fee of ten dollars ($10.00) in addition to any initial licensure or renewal fee. All fees collected pursuant to this paragraph shall be for the purpose of funding a peer assistance program.

(19) Upon request, the Board may waive selected portions of these requirements so long as any waiver granted is consistent with the Board’s authority under Tenn. Code Ann. Title 63, Chapters 1 and 10, and Tenn. Code Ann. Title 4, Chapter 5. .

History

Authority: T.C.A. §§ 63-10-308, 63-10-310 and 63-10-312.
Administrative History: Original rule certified June 7, 1974. Amendment filed June 7, 1974; effective July 7, 1974. Amendment filed December 15, 1977; effective January 16, 1978. Amendment filed September 26, 1978; effective December 29, 1978. Repeal and new rule filed February 7, 1983; effective March 9, 1983. Amendment filed May 23, 1986; effective August 12, 1986. Amendment filed January 26, 1987; effective April 29, 1987. Amendment filed October 1, 1987; effective January 27, 1988. Amendment filed November 18, 1988; effective February 28, 1989. Amendment filed October 18, 1990; effective January 29, 1991. Amendment filed May 3, 1991; effective August 28, 1991. Amendment filed December 22, 1992; effective March 31, 1993. Amendment filed June 25, 1993; effective September 28, 1993. Amendment filed October 19, 1996; effective February 28, 1996. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendment filed August 19, 2002; effective November 2, 2002. Emergency rule filed January 31, 2014; effective through July 30, 2014. Emergency rule expired effective July 31, 2014, and the rule reverted to its previous status. Amendments filed July 11, 2014; effective October 9, 2014. Amendments filed March 24, 2015; effective June 22, 2015. Amendments filed November 22, 2016; effective February 20, 2017. Amendments filed September 12, 2018; effective December 11, 2018. Amendments filed December 15, 2023; effective March 14, 2024.

Tenn. Comp. R. & Regs. 1140-01-.11 CONTROLLED SUBSTANCE REGISTRATION

No licensee may obtain, possess, administer, dispense, distribute, or manufacture any controlled substance in this state, and no representative of a manufacturer or wholesaler/distributor may distribute any controlled substance in this state, without obtaining a controlled substance registration from the board. Application for such registration shall be submitted on a form prescribed by the board, and shall be accompanied by a fee of forty dollars ($40.00) and thereafter a biennial renewal fee of forty dollars ($40.00).

History

Authority: T.C.A. §§ 53-10-303, 63-10-102, 63-10-102(a), 63-10-404, 63-10-404(6), 63-10-504, 63-10- 504(b)(1) and (2), and 63-10-508.
Administrative History: Original rule filed October 30, 1991; effective December 14, 1991. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendment filed July 11, 2014; effective October 9, 2014.

Tenn. Comp. R. & Regs. 1140-01-.12 STERILE PRODUCT REGISTRATION

(1) No licensee may compound, manufacture, prepare, propagate, or process any sterile product to be dispensed, sold, traded, or otherwise distributed in or from this state without first obtaining a sterile compounding modifier registration from the Board of Pharmacy.

(2) A registration modifier to compound and dispense sterile products into or from this state may be suspended by the Board of Pharmacy, upon information that the registrant has:

(a) Knowingly furnished false or fraudulent material information in any application filed before the Board of Pharmacy; or (b) Been convicted of a felony under any state or federal law relating to drugs or to the practice of pharmacy; or (c) Had any of its licenses, permits, or registrations granted by the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), the Department of Health and Human Services (DHHS), or any other federal agency or subdivision thereof, suspended, revoked, or voluntarily surrendered; or (d) Been enjoined from operation by the court of any state or a federal court; or (e) Been identified by the Commissioner of Health or the Commissioner’s designee, the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), or an investigator of the Board of Pharmacy as a source of adulterated, misbranded, or otherwise unsafe sterile products which have been, or pose an imminent risk of being dispensed, sold, traded, or otherwise distributed.

(3) An order of suspension issued by the Board of Pharmacy may contain additional directives or requirements necessary to protect public health, safety and welfare, including but not limited to:

(a) The quarantine or disposal of any sterile product compounded, manufactured, prepared, propagated or processed at the facility.

(b) The initiation of a recall of any sterile product compounded, manufactured, prepared, propagated or processed at the facility where such products or any label, container, packaging, or dosage form associated with such products may be adulterated, misbranded, contaminated, or otherwise unsafe.

(c) An order of suspension issued by the Board of Pharmacy may contain exceptions or allowances necessary to protect individual patients or the public health.

(4) Any order of suspension issued by the Board of Pharmacy pursuant to this chapter shall follow the procedures required by the Uniform Administrative Procedures Act, including those procedures required by T.C.A. § 4-5-320(d) where appropriate.

History

Authority: T.C.A. §§ 63-10-301, 63-10-304, 63-10-305, and 63-10-306.
Administrative History: Original rule filed July 11, 2014; effective October 9, 2014.

Tenn. Comp. R. & Regs. 1140-01-.13 STANDARDS FOR PHARMACIES AND PRESCRIPTION DEPARTMENT SECURITY

A license to operate a new or remodeled pharmacy practice site, or an existing pharmacy practice site which changes location or ownership, will not be issued unless the pharmacy practice site meets the following standards.

(1) The pharmacy practice site and equipment therein shall be maintained in a clean, sanitary, orderly and well-lighted condition, and all persons working in the pharmacy practice site shall be required to keep themselves and their apparel in a clean and sanitary condition.

(2) All new or relocated pharmacies opening after July 1, 1998 shall provide a consultation area which offers sufficient privacy to the patient before a license will be issued. All existing pharmacies shall be in compliance with this requirement on or before January 1, 2000.

(3) If the practice site is a dispensing pharmacy, the prescription department at the pharmacy practice site shall meet the following standards.

(a) The department shall have necessary counters and storage space.

(b) The department shall have a representative stock of prescription drugs and devices and related materials sufficient to compound and dispense medical and prescription orders as indicated by experience.

(c) The department shall have the apparatus and equipment needed to compound and dispense medical and prescription orders properly.

(d) The department shall occupy a space of not less than one hundred eighty (180) square feet.

(e) The department shall have hot and cold running water and immediate area refrigeration.

(f) The department shall have a physical barrier sufficient to protect against unauthorized entry and pilferage of prescription drugs and devices and related materials.

(g) Keys or other access devices to the physical barriers shall be subject to the following standards.

Only pharmacists practicing at the pharmacy and pharmacists authorized by the pharmacist in charge shall be in possession of any keys or other access devices.
The pharmacist in charge shall place a key or other access device in a sealed device or vault in a secured place outside of the department, unless the pharmacy practice utilizes an electronic access device which is capable of restricting and preventing unauthorized access into the pharmacy. The key or access device may be used to allow emergency entrance to the department. A written or electronic record of persons accessing the pharmacy department using the key or other access device must be maintained on the premises of that pharmacy practice site for a period of 2 years.

(h) Access to the department is restricted to pharmacists, pharmacy interns and pharmacy technicians who are practicing at the pharmacy. Other persons designated by the pharmacist in charge may be allowed access but only during hours that a pharmacist is on duty.

(i) Notwithstanding any rule or regulation to the contrary, a pharmacy which was established before June 6, 1945, and which serves food, and which has continuously had a soda fountain, may allow a customer to go through the pharmacy area to the restroom, and not be required to have a gate or door to separate the pharmacy from the restroom or other parts of the establishment.

(4) All licenses and certificates of registration for a pharmacy practice site shall at all times be conspicuously displayed at the practice site.

(5) If a pharmacy practice site is located in a mercantile establishment (such as a discount store, grocery store, department store, or other similar establishment), then such pharmacy practice site shall be:

(a) Open for business during the same hours as the mercantile establishment, unless the pharmacy practice site is capable of being closed-off by physical barrier from floor to ceiling; and (b) Under the supervision of a pharmacist at all times; except as provided in rule 1140-03- .07.

(6) The pharmacist shall not at any time be denied access to the prescription department of a pharmacy practice site located in a mercantile establishment; provided, however, that entry of the pharmacist at times when the pharmacy is closed to the public may be subject to reasonable and prudent conditions.

(7) A pharmacy practice site where prescription drugs and devices and related materials are received, stored, compounded and dispensed shall not be opened for business or any other reason unless a licensed pharmacist is present. Furthermore, no medical or prescription order shall be dispensed except during the presence and under the direct supervision of a pharmacist.

(8) Nothing in this rule applies to a pharmacy practice site or prescription department operating in an institutional facility.

(9) In cases of practical difficulty or undue hardship, the board may permit exceptions to the standards specified in this rule.

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-404(28), and 63-10-504(b)(1) and (2).
Administrative History: Original rule filed May 11, 1998; effective July 25, 1998. Emergency rule filed January 31, 2014; effective through July 30, 2014. Emergency rule expired effective July 31, 2014, and the rule reverted to its previous status. Rule was previously numbered 1140-01-.12 but was renumbered 1140-01-.13 with the introduction of new rule 1140-01-.12 filed July 11, 2014; effective October 9, 2014. Amendments filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-01-.14 STANDARDS FOR MANUFACTURERS, OUTSOURCING FACILITIES, OXYGEN

SUPPLIERS AND WHOLESALERS/DISTRIBUTORS.

No license to operate a new or remodeled manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor location within the state of Tennessee, or an existing manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor location which changes location or ownership, will be issued unless the manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor meets the standards set forth in Chapter 1140-09 of the rules of the Board of Pharmacy.

History

Authority: T.C.A. §§ 63-10-301, 63-10-304, and 63-10-306.
Administrative History: Original rule filed May 11, 1998; effective July 25, 1998. Emergency rule filed January 31, 2014; effective through July 30, 2014. Emergency rule expired effective July 31, 2014, and the rule reverted to its previous status. Rule was previously numbered 1140-01-.13 but was renumbered 1140-01-.14 with the introduction of new rule

Tenn. Comp. R. & Regs. 1140-01-.15 REPEALED

History

Authority: T.C.A. §§ 63-10-204, 63-10-205, 63-10-304, 63-10-304(b)(1), 63-10-404(14), 63-10-405, 63- 10-504(b), 63-10-504(b)(1), and 63-10-504(b)(2).
Administrative History: Original rule filed May 11, 1998; effective July 25, 1998. Amendment filed August 19, 2002; effective November 2, 2002. Amendment filed November 24, 2008; effective February 7, 2009. Amendment filed December 23, 2009; effective March 23, 2010. Emergency rule filed January 31, 2014; effective through July 30, 2014. Emergency rule expired effective July 31, 2014, and the rule reverted to reserved status. Rule was previously numbered 1140-01-.14 but was renumbered 1140-01-.15 with the introduction of new rule

Tenn. Comp. R. & Regs. 1140-01-.16 PILOT PROGRAMS

A licensee of the Board who wishes to undertake a temporary pilot program for the purpose of studying or investigating the impact of a public health initiative, or who wishes to address a recognized health emergency or crisis in the State shall submit a written application for such program to the executive director on a form approved by the Board, who may present such application to the Board for approval.

The Board may authorize such a program to take place for a predetermined, temporary amount of time. A program authorized pursuant to this part may deviate from the board’s rules if the Board determines such deviation is crucial to the proposed program and in the best interest of the public health, safety and welfare.

History

Authority: T.C.A. §§ 63-10-301, 63-10-304, 63-10-305, and 63-10-308.
Administrative History: New rule filed November 22, 2016; effective February 20, 2017.

Chapter 1140-02 Professional Conduct and Responsibilities

Tenn. Comp. R. & Regs. 1140-02-.01 PHARMACISTS AND PHARMACY INTERNS

(1) A pharmacist shall hold the health and safety of patients to be the first consideration and shall render to each patient the full measure of the pharmacist’s ability as an essential health practitioner.

(2) A pharmacist shall not knowingly condone or assist in the dispensing, promoting, or distributing of drugs or devices which are not of good quality, which do not meet standards by law, or which lack therapeutic value for the patient.

(3) A pharmacist shall always strive to perfect and enlarge the pharmacist’s professional knowledge and shall utilize and make available this knowledge as may be required in accordance with the pharmacist’s best professional judgment.

(4) A pharmacist shall observe the law, uphold the dignity and honor of the profession, and accept its ethical principles. A pharmacist shall not engage in any activity that will bring discredit to the profession, and shall expose, without fear or favor, illegal or unethical conduct in the profession.

(5) A pharmacist shall seek at all times only fair and reasonable remuneration for the pharmacist’s services. A pharmacist shall never agree to or participate in transactions with practitioners of other health professions or any other person under which fees are divided, or which may cause financial or other exploitation in connection with the rendering of the pharmacist’s professional services.

(6) A pharmacist shall respect the confidential and personal nature of professional and patient records. Except where the best interest of a patient requires or the law demands, a pharmacist shall not disclose such information to anyone without proper patient authorization.

(7) A pharmacist shall not agree to practice under terms or conditions which tend to interfere with or impair the proper exercise of professional judgment and skill, which tend to cause a deterioration of the quality of professional service and patient care, or which require the pharmacist to consent to unethical conduct.

(8) A pharmacist shall not make publication or circulation of any statement tending to deceive, misrepresent, or mislead anyone, nor be a party or accessory to any fraudulent or deceptive practice or transaction in pharmacy.

(9) A pharmacist shall not enter into any agreement with anyone for the compounding of secret formula or coded medical or prescription orders.

(10) A pharmacist shall, by utilizing education, skill, experience, and professional judgment, make every reasonable effort to prevent the abuse of drugs which the pharmacist dispenses.

(11) A pharmacist shall provide pharmaceutical service:

(a) Which is as complete as the public may reasonably expect;

(b) Without discriminating in any manner between patients or groups of patients; and (c) Without compromising the kind or extent of services or facilities made available.

(12) A pharmacist shall recognize the Tennessee Board of Pharmacy as the governing body of the practice of pharmacy in the State of Tennessee, and report to the board any violations of pharmacy laws or rules which may come to the pharmacist’s attention. The pharmacist at all times shall refrain from discussing these matters with nonmembers of the profession.

(13) The following functions must be performed personally by a pharmacist or by a pharmacy intern under the personal supervision and in the presence of a pharmacist:

(a) Certification of medical and prescription orders;

(b) Performance of final verification of the product prior to dispensing;

(d) Providing patient counseling;

(e) Providing direct patient care services;

(f) Providing drug information to patients, care givers, and health care providers;

(g) Supervision of compounding;

(h) Evaluation and establishment of criteria for selection of drug product(s) and supplier(s); and (i) Daily opening and closing of a pharmacy practice site.

(14) A pharmacist and pharmacy intern shall wear appropriate identification showing name and appropriate title.

(15) A pharmacist shall immediately notify the board office in writing of a change in location of primary practice site and permanent residence.

(16) A pharmacist shall conspicuously display the pharmacist’s license and certificate of registration at the pharmacist’s primary practice site, unless it is an institutional pharmacy practice site, in which case, the pharmacist’s license and certificate of registration shall be maintained at the site.

(17) A pharmacist convicted of any crime, including driving under the influence of alcohol or controlled substances, shall report such conviction to the board within ten (10) days of the conviction becoming final. For purposes of this reporting requirement, a conviction includes pretrial or judicial diversion.

(18) A pharmacist shall not incent or induce the transfer of a prescription absent the exercise of professional judgment.

(19) A pharmacist shall comply with lawful order(s) of the board.

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-404(26), (27), and (29), 63-10-304(b)(1) and (c), 63- 10-504(b)(1), and 63-10-504(b)(1)(C).
Administrative History: Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendment filed December 23, 2009; effective March 23, 2010. Amendments filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-02-.02 PHARMACY TECHNICIANS

(1) Any person acting as a pharmacy technician shall register with the Board by submitting a complete application on a form prescribed by the Board accompanied by the following:

(a) An affidavit signed by both the applicant and employer attesting that the applicant has read and understands the laws and rules relative to pharmacy technicians and the practice of pharmacy in Tennessee. (A copy of this affidavit shall be retained at the applicant’s place of employment);

(b) Registration fee established in Rule 1140-01-.10; and (c) The result of a criminal background check, which the applicant shall pay for and cause to be submitted to the Board’s administrative office directly from the vendor identified in the Board’s registration application materials.

(d) Any application submitted which lacks required information or reflects a failure to meet any of the requirements for registration will be returned to the applicant with written notification of the information that is lacking or the reason(s) the application does not meet the requirements for registration and will be held in “pending” status until satisfactorily completed within a reasonable period of time, not to exceed one (1) year from date of initial application.

(2) The following individuals are exempt from registration as a pharmacy technician:

(a) Any individual performing tasks that may be performed by a pharmacy technician who is classified by the employer as a probationary employee. The exemption shall not exceed ninety (90) days from the date of employment.

(b) A student enrolled in a formal pharmacy technician training program while performing experiential rotations as a part of the academic curriculum. The student shall wear a school-issued identification badge.

(3) The pharmacist in charge at each pharmacy practice site is responsible for compliance with the provisions of this chapter by pharmacy technicians at that pharmacy practice site.

(4) A registered pharmacy technician may, under the supervision of a pharmacist, perform those tasks associated with the preparation and dispensing process except those tasks identified in

Rule 1140-02-.01(13) that must be personally performed by a pharmacist or pharmacy intern under the personal supervision and in the presence of a pharmacist, and those tasks identified in 1140-02-.02(5).

(5) Certified pharmacy technicians may also:

(a) Receive new or transferred oral medical and prescription orders;

(b) Receive and transfer copies of oral medical and prescription orders between pharmacy practice sites;

(c) Verify the contents of unit dose carts/automated dispensing systems prepared by other registered technicians when an additional verification by use of bar code technology or a licensed health care professional is performed prior to administration to the patient;

(d) Under the supervision of a pharmacist licensed by the Board who has authorized the administration of a vaccine, administer United States Food and Drug Administration (“FDA”) authorized or FDA-licensed vaccines to patients pursuant to a valid medical or prescription order after the following qualifications are met by the certified pharmacy technician:

Complete a practical training program that is ACPE-approved or approved by the Board. This training program must include hands-on injection technique and the recognition and treatment of emergency reactions to vaccines;
Possess a current certificate in cardiopulmonary resuscitation; and 3. Complete a minimum of two (2) hours of ACPE-approved or Board-approved immunization-related continuing pharmacy education during each Board registration renewal cycle; and (e) Administer tests cleared by the FDA for home use or those tests approved for a waiver under the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) to patients at a pharmacy practice site and under the supervision of a pharmacist pursuant to a medical or prescription order, when required, after completion of the following qualifications by the certified pharmacy technician;
Complete a practical training program that is ACPE-approved or approved by the Board. This training must include hands-on training in point-of-care testing, including the following types of specimen collection: oral swab, nasal swab, throat swab, and finger stick; and 2. Complete a minimum of two (2) hours of ACPE-approved or Board-approved point-of-care testing related continuing education during each Board registration renewal cycle.

(f) The supervising pharmacist at the pharmacy practice site where the vaccination is administered shall be readily and immediately available to the certified pharmacy technician who is administering the vaccine.

(6) No prescription drugs and devices and related materials may be released to a patient unless all of the functions performed by a pharmacy technician are verified by a pharmacist.

(7) Pharmacy Technician to Pharmacist Ratio (a) The pharmacy technician to pharmacist ratio shall not exceed 6:1; however the ratio may be removed if the additional pharmacy technicians beyond the 6:1 ratio are certified pharmacy technicians. However, the pharmacist in charge may request a modification of the ratio from the Board in writing which addresses:

The pharmacy technician’s experience, skill, knowledge and training; and 2. The workload at the practice site; and 3. Detailed information regarding the numbers of pharmacy technicians and the specific duties and responsibilities of each of the pharmacy technicians; and 4. Justification that patient safety and quality of pharmacy services and care can be maintained at the pharmacy.

(b) Requested modifications of the established ratios may not be implemented until the written request is considered and approved by the Board.

(8) Pharmacy technicians must wear appropriate identification showing name and appropriate title (e.g. pharmacy technician, certified pharmacy technician).

(9) All pharmacy technician functions shall be performed under the supervision of a pharmacist, who shall direct and verify the accuracy of all pharmacy technician functions.

(10) A registered technician shall maintain his or her registration certificate at the pharmacy practice site; additionally, all certified technicians shall display in like manner evidence of certification. Pharmacy technicians shall possess at all times, while on duty, proof of registration and proof of certification, if applicable.

(11) All registered technicians shall immediately notify the board in writing of any change of address or employer.

(12) For purposes of this rule, a pharmacy intern is not considered to be a pharmacy technician.

(13) Upon request, the Board may waive selected portions of these requirements so long as any waiver granted is consistent with the Board’s authority under Tenn. Code Ann. Title 63, Chapters 1 and 10, and Tenn. Code Ann. Title 4, Chapter 5.

History

Authority: T.C.A. §§ 63-1-116, 63-10-204, 63-10-308, and 63-10-310.
Administrative History: Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendment filed August 19, 2002; effective November 2, 2002. Amendment filed December 23, 2009; effective March 23, 2010. Amendment filed January 4, 2012; effective April 3, 2012. Amendments filed November 22, 2016; effective February 20, 2017. Amendments filed December 15, 2023; effective March 14, 2024. Amendments filed July 18, 2025; effective October 16, 2025.

Chapter 1140-03 Standards of Practice

Tenn. Comp. R. & Regs. 1140-03-.01 RESPONSIBILITIES FOR PHARMACEUTICAL CARE

(1) Patient Counseling.

(a) Upon the receipt of a medical or prescription order and following a review of the patient’s record, a pharmacist shall personally counsel the patient or caregiver “face-toface” if the patient or caregiver is present. If the patient or caregiver is not present, a pharmacist shall make a reasonable effort to counsel through alternative means.

(b) Alternative forms of patient information may be used to supplement, but not replace, face-to-face patient counseling.

(c) Patient counseling, as described herein, shall also be required for outpatients of hospitals or other institutional facilities dispensing medical and prescription orders and for patients when medications are dispensed on discharge from the hospital or other institutional facility.

(d) Patient counseling as described in this rule shall not be required for inpatients of an institutional or long-term care facility.

(e) Patient counseling shall cover matters, which in the exercise of the pharmacist’s professional judgement, the pharmacist deems significant including:

The name and description of the medication;
The dosage form, dose, route of administration, and duration of drug therapy;
Special directions and precautions for preparation, administration, and use by the patient;
Common side effects or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur;
Techniques for self-monitoring drug therapy;
Proper storage;
Prescription refill information; and 8. Action to be taken in the event of a missed dose.

(f) Upon the receipt of a request for a refill of a medical or prescription order, a pharmacist or a person designated by the pharmacist shall offer for the pharmacist to personally counsel the patient or caregiver. Counseling as described in (e) above is not required unless requested by the patient or deemed necessary in the professional judgment of the pharmacist.

(g) A pharmacist shall not be required to counsel a patient or caregiver when the patient or caregiver refuses such counseling.

(2) Patient Profiling.

(a) A patient’s record system shall be maintained by all pharmacy practice sites for patients for whom medical and prescription orders are dispensed. The patient’s record system shall provide for the immediate retrieval of information necessary for the pharmacist to identify previously dispensed medical and prescription orders at the time a medical or prescription order is presented.

(b) In order to effectively counsel patients, the pharmacist or a person designated by the pharmacist shall, through communication with the patient, caregiver, or agent make a reasonable effort to obtain, record, and maintain the following information for each patient of the individual pharmacy practice site.

Name, address, telephone number.
Date of birth (age), gender.
An individual history where significant, including disease state or states, known allergies and drug reactions, and a comprehensive list of medications and relevant devices.
Pharmacist’s comments as deemed relevant. This may be done manually or by computer.

(3) Drug Regimen Review.

(a) A pharmacist shall be responsible for a reasonable review of a patient’s record prior to dispensing each medical or prescription order. The review shall include evaluating the medical and prescription order for:

Over-utilization or under-utilization;
Therapeutic duplication;
Drug-disease contraindication;
Drug-drug interactions;
Incorrect drug dosage or duration of drug treatment;
Drug-allergy interactions;
Clinical abuse/misuse.

(b) Upon recognizing any of the above, the pharmacist shall take appropriate steps to avoid or resolve the problem.

(4) Implementation of Pharmaceutical Care.

(a) As a necessary health care provider, pharmacists shall carry out, in addition to the responsibilities in paragraphs (1) through (3) of this rule, those professional acts, professional decisions and professional services necessary to maintain a patient’s pharmacy-related care and to implement and accomplish the medical and prescription orders of licensed practitioners, including but not limited to:

Developing a working and collaborative relationship with licensed practitioners to enable the pharmacist to accomplish comprehensive management of a patient’s pharmacy-related care and to enhance a patient’s wellness, quality of life and optimize outcomes; and 2. Communicating to the health care provider any knowledge of unexpected or adverse response to drug therapy, or resolving unexpected or adverse response; and 3. Having a pharmacist accessible at all times to patients and healthcare providers to respond to their questions and needs.
Where formally defined, providing patient care services consistent with a collaborative pharmacy practice agreement.

History

Authority: T.C.A. §§ 63-10-204, 63-10-217, 63-10-304, 63-10-404(19), (22), (23), (26), and (34), 63-10- 504(b)(1) and (2), 63-10-504(c), and 63-10-504(j).
Administrative History: Original rule filed February 7, 1983; effective March 9, 1983. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendments filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-03-.02 LOCATION OF PRACTICE

A pharmacist may compound and dispense prescription drugs and devices and related materials only in a pharmacy practice site which is duly licensed by the Board and which operates in compliance with Tennessee and federal laws and rules governing the practice of pharmacy. The practice of the knowledge skills of pharmacy is not pharmacy practice site dependent. However, any person practicing any aspect of the art and science of pharmacy must be licensed by the Board. Upon request, the Board may waive selected portions of these requirements so long as any waiver granted is consistent with the Board’s

authority under Tenn. Code Ann. Title 63, Chapters 1 and 10, and Tenn. Code Ann. Title 4, Chapter 5.

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-404(4), (8), (11), (14), (26), and (28), 63-10-504(b)(1) and (2).
Administrative History: Original rule filed February 7, 1983; effective March 9, 1983. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendments filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-03-.03 MEDICAL AND PRESCRIPTION ORDERS

(1) To the extent that a medical order contains an order for the compounding, dispensing or administration of a prescription drug or device or related material, the medical order shall be treated as a prescription order. Written medical and prescription orders must be signed by the prescriber. Verbal medical and prescription orders must be immediately reduced to writing (by hand or other means), dated, and initialed by the authorized individual accepting the medical and prescription orders.

(2) Each medical and prescription order when dispensed shall be serially numbered, filed numerically and maintained so as to be readily retrievable at the pharmacy practice site for at least two (2) years from the date the medical and prescription order was last dispensed.

Institutional pharmacies shall not be required to serially number medical and prescription orders dispensed for administration to inpatients of that institution.

(3) A pharmacist upon initial dispensing of a medical or prescription order shall record on that medical or prescription order: the date such medical or prescription order was dispensed, the pharmacist’s initials, and the amount of any product dispensed. If the pharmacist merely initials and dates a medical or prescription order the pharmacist shall be deemed to have dispensed the full face amount of the medical or prescription order.

(4) A pharmacist upon refilling a medical or prescription order shall enter on the back of that medical or prescription order: the date such medical or prescription order was refilled, the pharmacist’s initials, and the amount of any product dispensed on such refill. If the pharmacist merely initials and dates the back of the medical or prescription order the pharmacist shall be deemed to have dispensed a refill for the full face amount of the medical or prescription order. As an alternative to recording refill information on the back of medical and prescription orders, an automated data processing system may be used for the storage and retrieval of refill information for medical and prescription orders, subject to the following conditions:

(a) Any such computerized system must provide on-line retrieval (via CRT display or hardcopy printout) of the original medical or prescription order information and the complete refill history of all medical and prescription orders which are currently authorized for refilling. This shall include all the information contained in and required to be entered on each such medical or prescription order. This data must include at least the medical or prescription order serial number; date of issuance of the medical or prescription order; patient’s name (and address on controlled substance medical and prescription orders); prescriber’s name (and address and DEA registration number on controlled substance medical and prescription orders); product name, strength, dosage form, and quantity prescribed; directions for use, and labeling instructions; refill instructions; and the date of dispensing, quantity dispensed, and identity (name, initials, or identification code) of the dispensing pharmacist for the original dispensing and each refill.

(b) Each individual pharmacist using a computerized system in the refilling of a medical or prescription order shall certify that the information entered into the computer for such a refill is correct by verifying, dating, and signing a hard-copy printout of each day’s medical or prescription order refill data, or in lieu of such a printout, by signing a statement in a book or file each day attesting that the refill information entered that day has been reviewed by the pharmacist and is correct as shown. Such documentation shall be separately maintained at the pharmacy practice site for at least two (2) years from the date of the last dispensing.

(c) Any such computerized system shall have the capability of producing a hard-copy printout of any medical or prescription order refill data which the pharmacy practice site is responsible for maintaining under the laws and/or regulations of this state and/or the federal government. (This would, for example, furnish a medical or prescription orderby-medical or prescription order, refill-by-refill audit trail for any specified strength and dosage form of any prescription drug and device, by either brand or generic name or both.) Such a printout must include: the medical or prescription order serial number; patient’s name (and address on controlled substance medical and prescription orders); name of prescriber; name, strength, and dosage form of the product; and the date of each refill, quantity dispensed on each refill, and the name or identification code of the dispensing pharmacist. Controlled substance data contained on such a printout must be separated, asterisked, or in some other manner visually identifiable apart from other items appearing on the printout. Any computerized system employed by a pharmacy practice site must, upon the request of an authorized representative of the board, send or provide such a printout to the pharmacy practice site within forty-eight (48) hours excluding weekends (Saturdays and Sundays) and legal holidays.

(d) In the event that a pharmacy practice site which utilizes such a computerized system experiences system down-time, the pharmacy practice site must have a written or readily retrievable auxiliary policy and procedure which will be used for documentation of refills of all medical and prescription orders. This auxiliary procedure must ensure that each refill is authorized, and that all appropriate data is retained for on-line data entry as soon as the computer system is available for use again.

(e) Each pharmacy practice site and pharmacist using such a computerized system must comply with the provisions of paragraphs one (1) and two (2) of this rule. In addition, the requirements of paragraph three (3) of this rule shall apply, unless this initial dispensing data is included on the printout required by subparagraph four (4)(b) of this

rule, and is identified as pertaining to the initial dispensing.

(5) A pharmacist may dispense an appropriately authorized refill of a medical or prescription order by referral to a patient profile (medication record) instead of the original medical or prescription order on file at that pharmacy practice site, subject to the following conditions:

(a) The patient profile must contain all the information contained in and required to be entered on the original medical or prescription order, including the complete refill

history of that medical or prescription order. This data includes the medical or prescription order serial number; date of issuance of the medical or prescription order; name of patient; name of the prescriber; product name; strength; dosage form, and quantity prescribed; directions for use, and labeling instructions; refill instructions; and the date of dispensing, quantity dispensed, and initials of the dispensing pharmacist for the original dispensing and each refill. Dispensing data must be identified as to whether it pertains to the original dispensing or to a refill.

(b) Controlled substance data contained on the patient profile must be asterisked, redlined, or in some other manner visually identifiable apart from other items appearing on the profile.

history of all medical and prescription orders dispensed at the pharmacy practice site.

(This record will constitute compliance with the provisions of paragraph four (4) of this

rule.)

(d) Each such profile must be maintained so as to be readily retrievable at the pharmacy practice site for at least two (2) years from the date of the last dispensing recorded on the profile.

(e) A pharmacist dispensing a medical or prescription order by referral to a patient profile in so doing certifies as to the accuracy and validity of the information contained on the patient profile.

(f) Each pharmacy practice site and pharmacist using such a patient profile system must comply with the provisions of paragraphs one (1) and two (2) of this rule. In addition, the requirements of paragraph three (3) of this rule shall obtain, unless the patient profile system contains a record of this initial dispensing information for all medical and prescription orders dispensed at the pharmacy practice site.

(6) No pharmacist, or pharmacy intern or pharmacy technician under the supervision of a pharmacist, shall compound or dispense any medical or prescription order except upon the following conditions:

(a) All medical and prescription orders shall be compounded and dispensed in strict conformity with any directions of the prescriber. Nothing in this rule shall prohibit a pharmacist from substituting a therapeutically equivalent prescription drug or device or related material containing the same active ingredient or ingredients, dosage form and strength;

(b) No medical or prescription order shall be refilled if it contains a statement over the signature of the prescriber that it is not to be refilled, and a medical or prescription order shall not be refilled unless so authorized by the prescriber;

(c) If any medical or prescription order contains a statement that it may be refilled a specified number of times within or during any particular period, such order shall be refilled in strict conformity with such statement; and (d) If a prescription contains a statement that during any particular time it may be refilled at will, the order shall be refilled in strict conformity to dosage directions, with the exception that it may not be refilled after the expiration of the time specified or one (1) year from the date the order was originally issued or dispensed, whichever comes first.

(e) At a rate, based on the actual number of medical and prescription orders compounded and dispensed per hour or per day, that does not pose a danger to the public health, safety or welfare.

(7) Copies of Medical and Prescription Orders.

(a) Copies of medical and prescription orders issued directly to the patient by the pharmacy practice site where the order was originally compounded and dispensed pursuant to the receipt of the order shall bear on the face thereof, in letters red in color and equal in size to those describing the prescription drug or device or related material, the statement: “Copy for Information Only.” Presentation of an informational written copy or label of a dispensing container shall be for information purposes only and have no legal status as a valid medical or prescription order. The recipient pharmacist of such copy or label shall contact the prescriber or transferor pharmacy practice site and obtain all information required by this rule, which is the same as obtaining an original medical or prescription order;

(b) Medical and prescription orders shall be transferred between pharmacy practice sites for the purpose of compounding and dispensing provided that the transferee, upon receiving such order directly from the transferor, records the following:

The name, address and original medical or prescription order serial number at the pharmacy practice site from which the order was transferred;
The name of the transferor; and 3. All information constituting a medical or prescription order including the following:

(i) Date the order was originally issued and dispensed;

(ii) Original number of refills authorized on the original order;

(iii) Date of last dispensing; and (iv) Number of valid refills remaining.

(c) The transferee informs the patient that the original medical or prescription order has been canceled at the pharmacy practice site from which it was obtained.

(d) Computerized systems must satisfy all information requirements.

(e) The transfer of schedule III, IV, V, controlled substances are subject to the conditions set forth in 21 C.F.R. 1306.25.

(8) It is permissible for any pharmacy practice site, pharmacist, or pharmacy intern or pharmacy technician under the supervision of a pharmacist, or any other place of business engaged in compounding and dispensing prescription drugs and devices and related materials for human consumption to receive from any patient or other person the return of any portion of an order that has been taken from the premises of the pharmacy practice site or other place of business, only if authorized:

(a) Pursuant to Tennessee Board of Pharmacy rule 1140-04-.10; or (b) For the purpose of collection for disposal or destruction of any prescription drug; provided that participation in the program shall be voluntary, and such collection and destruction shall be conducted in accordance with the provisions of 21 CFR § 1317.

(9) Medical and prescription orders cannot be accepted, solicited, collected or advertised at any location other than a pharmacy practice site for which a license has been issued by the Board, and such pharmacy practice site shall be actively engaged in compounding and dispensing medical and prescription orders. An entity or other non-licensed site which does not dispense drugs directly to patients may accept, solicit, and collect prescriptions for the

purpose of medication therapy management or other consultative services related to drug therapy and patient care.

(10) Medical and prescription orders typed or printed must be signed by the prescriber. Oral medical and prescription orders shall be initialed by the authorized individual accepting the order.

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-404(4), (11), (14), (19), (26), (29), (30), and (34), 63- 10-504(b)(1) and (2), 63-10-504(j), and 2015 Acts, Pub. Chap. 40.
Administrative History: Original rule filed February 7, 1983; effective March 9, 1983. Amendment filed November 16, 1992; effective January 8, 1993. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendment filed September 15, 2015; effective December 14, 2015. Amendments filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-03-.04 FACSIMILE AND ELECTRONIC MEDICAL AND PRESCRIPTION ORDERS

(1) Facsimile Orders.

(a) The transmission of a facsimile medical or prescription order shall be to a pharmacy practice site of the patient’s choice and shall occur only at the option of the patient.

(b) Medical and prescription orders may be transmitted to a pharmacy practice site by a facsimile device. Medical and prescription orders for controlled substances may be transmitted by facsimile devices in compliance with 21 C.F.R. 21306.11, 1306.21 and 1306.31.

(c) A pharmacist may dispense medical and prescription orders transmitted by facsimile devices only when transmitted by an authorized prescriber or the prescriber’s designated agent.

(d) A facsimile medical or prescription order which meets the requirements of this rule shall be deemed the original medical or prescription order for purposes of filing. The facsimile medical or prescription order must either be photocopied or the original medical or prescription order should be of such quality to not fade within the legal requirements of medical or prescription order record keeping.

(e) Wholesalers, manufacturers, pharmacists and pharmacy practice sites are prohibited from supplying facsimile devices or supplies to any authorized prescriber under any conditions.

(f) An original medical or prescription order that indicates that it has been faxed to a pharmacy practice site, consistent with the provisions of this rule, may only be dispensed as an original medical or prescription order by the pharmacy practice site to which it was faxed, consistent with the notation on the medical or prescription order to be made in accordance with the requirements contained in this rule.

(2) Electronic Orders.

(a) Prescription or medical orders transmitted electronically shall meet the following criteria:

All prescription or medical orders shall be transmitted directly from an authorized prescriber or prescriber’s agent to a licensed pharmacist or to an area in a licensed pharmacy of the patient’s choice that is under the direct supervision of a licensed pharmacist, with no intervening person or entity having access to the order for purposes other than transmission of the order. Subject to the provisions of this rule, a prescriber or prescriber’s agent may electronically transmit medical or prescription orders to a pharmacist within an institutional facility for inpatients and/or outpatients currently under treatment at that facility. Nothing in this subsection shall apply to distributors of medical gases.
The transmission shall include:

(i) The telephone number of the authorized prescriber to allow verbal confirmation of the validity and accuracy of the order;

(ii) The correct time and date of the transmission;

(iii) The name of the pharmacy to which the order is being transmitted; and (iv) The prescribing practitioner’s electronic signature or other secure method of validation. “Electronic Signature” is defined as the process that secures the user authentication (proof of claimed identify, such as by biometrics, fingerprints, retinal scans, hand written signature verification, etc.) at the time the signature is generated and creates the logical manifestation of a signature.

(v) If the transmission is delegated by the prescriber to an agent of the prescriber, the identity of the agent shall be included in the transmission.

(b) Electronic data related to the transmitted order shall be maintained in the pharmacy and shall be deemed the original prescription or medical order meeting all requirements of rule 1140-03-.03 of the rules of the Board.

(c) The pharmacist receiving any transmitted order shall not knowingly participate in any system that restricts the patient’s choice of pharmacy.

(d) The pharmacist may not provide financial or other remuneration to the prescriber for any prescription transmitted to the dispensing pharmacy. No person or entity, including but not limited to wholesalers, distributors, manufacturers, pharmacists, and pharmacies, shall supply electronic equipment, software, devices, or modems to any prescriber in exchange for transmitting orders.

(e) The pharmacist shall not use the electronic transmission of orders to circumvent or violate any provision of state or federal drug laws, or the Tennessee Pharmacy Practice Act, or the regulations of the board.

(f) This rule shall not apply to medical or prescription orders electronically transmitted between pharmacies or medical or prescription orders transmitted by facsimile.

(g) Upon request, the Board may waive selected portions of these requirements so long as any waiver granted is consistent with the Board’s authority under Tenn. Code Ann. Title 63, Chapters 1 and 10, and Tenn. Code Ann. Title 4, Chapter 5.

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-404(19), (26), (29), (30), and (34), 63-10-504, 63-10- 504(b)(1) and (2), and 63-10-504(j).
Administrative History: Original rule filed February 7, 1983; effective March 9, 1983. Amendment filed March 30, 1994; effective June 13, 1994. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendment filed August 19, 2002; effective November 2, 2002. Amendments filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-03-.05 AREAS OF RECEIPT AND DISPENSING

All medical and prescription orders shall be received or accepted and compounded and dispensed from a pharmacy practice site which is in a building permanently located and non-mobile in nature. In case of emergency, the board may waive this rule upon request.

History

Authority: T.C.A. §§ 63-10-404(4), (11), (19), (28), and (34), 63-10-504(b)(1) and (2), and 63-10-504(j).
Administrative History: Original rule filed February 7, 1983; effective March 9, 1983. Amendment filed March 30, 1994; effective June 13, 1994. Repeal and new rule filed May 11, 1998; effective July 25, 1998.

Tenn. Comp. R. & Regs. 1140-03-.06 LABELING REQUIREMENTS

The dispensing label for a medical or prescription order shall bear at least the following information: name and address and telephone number of pharmacy practice site; the medical or prescription order serial number; name of prescriber; name of patient; directions for use; date medical or prescription order originally dispensed, and/or refill date; “poison”, “shake”, “caution”, or other appropriate advisory label; name of product (unless otherwise required by the prescriber); and expiration date of the product (if applicable). All reasonable accommodations for individuals who are blind, visually impaired, or otherwise print-disabled shall be made. This rule shall not apply to medical and prescription orders dispensed by an institutional pharmacy or long-term care pharmacy for administration to inpatients of that institutional facility or long-term care facility, except when medications are dispensed to patients residing in assistedcare living facilities. Upon request, the Board may waive selected portions of these requirements so long as any waiver granted is consistent with the Board’s authority under Tenn. Code Ann. Title 63, Chapters 1 and 10, and Tenn. Code Ann. Title 4, Chapter 5.

History

Authority: T.C.A. § 63-10-308.
Administrative History: Original rule filed February 7, 1983; effective March 9, 1983. Amendment filed October 30, 1991; effective December 14, 1991. Amendment filed November 16, 1992; effective January 8, 1993. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendments filed November 22, 2016; effective February 20, 2017. Amendments filed December 15, 2023; effective March 14, 2024.

Tenn. Comp. R. & Regs. 1140-03-.07 TEMPORARY ABSENCE OF PHARMACIST

A pharmacist is permitted one (1) temporary absence for a period not exceeding one (1) hour per day.

During the absence of a pharmacist from the pharmacy practice site, a sign containing the words “pharmacist not on duty” must be conspicuously displayed in the pharmacy practice site. It shall be unlawful to fail or refuse to display the required sign in a conspicuous place when a pharmacist is absent.

No medical or prescription order may be compounded or dispensed during the absence of a pharmacist.

Additionally, during the absence of the pharmacist the prescription department shall be closed off by physical barrier from floor to ceiling.

History

Authority: T.C.A. §§ 63-10-404(4), (11), (19), (26), (28), and (34), 63-10-504(b)(1) and (2), and 63-10- 504(j).
Administrative History: Original rule filed February 7, 1983; effective March 9, 1983. Repeal and new rule filed May 11, 1998; effective July 25, 1998.

Tenn. Comp. R. & Regs. 1140-03-.08 REPACKAGING

(1) Any repackaging of prescription drugs and devices and related materials must be supervised and controlled by a pharmacist with in-process and end-process verification and documentation.

(2) Prescription drugs and devices and related materials which are repackaged by an institutional pharmacy practice site for subsequent dispensing and use within the institution shall be labeled to include:

(a) The name, strength, and quantity of prescription drug or device or related material, if larger than one (1), in the container;

(b) The manufacturer’s name, and lot or control number;

(c) The expiration date of the prescription drug or device or related material being repackaged; and (d) Cautionary notations (e.g., refrigerate, shake well, not for injection), if applicable.

(3) A batch number assigned by the pharmacy practice site may be placed on the label in lieu of the manufacturer’s name and lot number, provided that the pharmacy practice site maintains a readily retrievable record which identifies, by batch number, the manufacturer and lot number of the prescription drug or device or related material.

(4) The pharmacy practice site shall have proper facilities, qualified personnel, effectual operational practices, suitable packaging material, and adequate control procedures to assure that the purity, integrity, safety, and effectiveness of the prescription drug or device or related material are not affected by such repackaging. All repackaging must be performed by a pharmacist or by a pharmacy intern or pharmacy technician under the supervision of a pharmacist.

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-404(8), (14), (26), and (28), and 63-10-504(b)(1) and (2).
Administrative History: Original rule filed February 7, 1983; effective March 9, 1983. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendments filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-03-.09 LOSS OF PRESCRIPTION DRUGS, DEVICES AND RELATED MATERIALS

The pharmacist in charge shall immediately report to the board any robbery, embezzlement, theft, burglary, or fire or disaster resulting in a loss of prescription drugs, or controlled substances or medical devices or related materials. The report shall include a list, including amounts, of such prescription drugs or controlled substances or medical devices or related materials lost or damaged.

History

Authority: T.C.A. §§ 63-10-404(6), (8), (14), and (27), 63-10-504(b)(1) and (2).
Administrative History: Original rule filed February 7, 1983; effective March 9, 1983. Repeal and new rule filed May 11, 1998; effective July 25, 1998.

Tenn. Comp. R. & Regs. 1140-03-.10 CONDITIONS FOR DELIVERY OR SALE

(1) No package containing any prescription drug or device or related material damaged by fire, heat, smoke, water, or other causes shall be placed in stock, offered for sale or dispensed or otherwise sold. Any repossession proceedings must be performed with the approval of the board.

(2) Under no circumstances shall any prescription drug or device or related material damaged by fire, heat, smoke, water, or other causes be delivered or handed over to any insurance company, adjustor, salvage company, or other person unless approved by the board prior to delivery.

(3) Medications may be returned to, and received by, the pharmacy/pharmacist if received expressly for the purpose of destruction of the returned medication, provided the pharmacy is equipped for doing so with a policy for complete and timely destruction of medications and in strict accordance with 1140-03-.03(8).

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-404(8), (11), and (14), 63-10-504(b)(1) and (2), 63-10- 703, and 63-10-706.
Administrative History: Original rule filed February 7, 1983; effective March 9, 1983. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendments filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-03-.11 OUTDATED AND DETERIORATED DRUGS

The owner or pharmacist in charge of a pharmacy practice site shall immediately return or destroy all outdated, defective, or deteriorated prescription drugs and devices and related materials; except that the destruction of controlled substances listed in any schedule shall be performed by a Board approved agent or vendor. Upon request, the Board may waive selected portions of these requirements so long as any waiver granted is consistent with the Board’s authority under Tenn. Code Ann. Title 63, Chapters 1 and 10, and Tenn. Code Ann. Title 4, Chapter 5.

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-404(6), (8), (14), (27), and (28), and 63-10-504(b)(1) and (2).
Administrative History: Original rule filed February 7, 1983; effective March 9, 1983. Amendment filed November 25, 1985; effective February 12, 1986. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendments filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-03-.12 STORAGE, SALE AND DELIVERY

(1) All prescription drugs and controlled substances and devices and related materials shall be stored in an area not accessible to the public.

(2) A controlled substance which is not a prescription drug under the Federal Food, Drug, and Cosmetic Act may be dispensed by a pharmacist without a prescription to a patient provided the pharmacist complies with the provisions of 21 CFR § 1306.32 and any other applicable law.

(3) Instruments and/or devices intended for the injection of any substance through the skin shall be stored in an area not accessible to the public, and shall be sold only on proof of medical need by a pharmacist or a pharmacy intern or pharmacy technician under the direct supervision of a pharmacist.

(4) All insulin preparations must be stored in an area not accessible to the public, and shall be sold only by a pharmacist or a pharmacy intern or pharmacy technician under the direct supervision of a pharmacist.

(5) Nothing in this section prohibits delivery of a prescription to a patient’s home or business by an agent of the pharmacy practice site.

History

Authority: T.C.A. §§ 63-10-404(6), (8), (14), (26), and (28), and 63-10-504(b)(1) and (2).
Administrative History: Original rule filed February 7, 1983; effective March 9, 1983. Repeal and new rule filed May 11, 1998; effective July 25, 1998.

Tenn. Comp. R. & Regs. 1140-03-.13 AUTOMATED DISPENSING DEVICES FOR AMBULATORY PHARMACY PRACTICE

The following procedures shall be observed in the use and operation of automated dispensing devices used for storing and dispensing capsules or tablets:

(1) The lot number of each drug contained therein must be listed or posted on the device.

(2) After each lot number is used, the portion of the device where the drug was contained must be thoroughly cleaned to remove all residue before refilling.

(3) Lot numbers may not be mixed.

(4) The device may be loaded by a pharmacist; or a pharmacy intern or a pharmacy technician under the supervision of a pharmacist.

History

Authority: T.C.A. §§ 63-10-404(8), (14), (26), (29), and (30), and 63-10-504(b)(1) and (2).
Administrative History: Original rule filed February 7, 1983; effective March 9, 1983. Repeal and new rule filed May 11, 1998; effective July 25, 1998.

Tenn. Comp. R. & Regs. 1140-03-.14 PHARMACIST IN CHARGE

(1) The board shall maintain a current record of all pharmacists who have been designated “pharmacist in charge” of a pharmacy practice site in the state of Tennessee.

(2) It shall be the responsibility of the person, partnership, firm, or corporation holding a pharmacy practice site license issued pursuant to T.C.A. § 63-10-306 to notify the Board immediately of:

(a) The resignation, removal, or death of the pharmacist in charge named in the application for license (or successor pharmacist in charge); or (b) The disability for a period exceeding thirty (30) days of the pharmacist in charge named in the application for license (or successor pharmacist in charge).

(3) The notice required by paragraph two (2) of this rule shall contain:

(a) The name and (except in the case of death or disability) signature of the outgoing pharmacist in charge;

(b) The effective date of the appointment (whether temporary or permanent) of the new pharmacist in charge;

(4) Except in case of death or incapacity, the outgoing pharmacist in charge shall, prior to departure, conduct with the successor pharmacist in charge a joint inventory of all controlled substances. In case of failure of the outgoing pharmacist in charge to comply with this requirement, the successor pharmacist in charge shall conduct such inventory alone.

(5) In the event of death of a pharmacist in charge, the successor pharmacist in charge shall, immediately upon assuming the appointment as pharmacist in charge, conduct an inventory of all controlled substances.

(6) In the event of disability for a period exceeding thirty (30) days of a pharmacist in charge, the successor pharmacist in charge (temporary or permanent) shall conduct an inventory of all controlled substances. Should the disabled pharmacist in charge return, the disabled pharmacist in charge and successor pharmacist in charge shall immediately conduct a joint inventory of all controlled substances.

(7) A record of any inventory required by this rule shall be signed by the pharmacist(s) in charge conducting it and maintained at the pharmacy practice site with other controlled substance records for at least two (2) years. The inventory record shall indicate:

(a) The name and address of the pharmacy practice site;

(b) The name, strength, dosage form, and quantity of each controlled substance on hand;

(8) The pharmacist in charge shall immediately notify the board in writing in the event of termination of business by the pharmacy practice site at which the pharmacist in charge practices. Such notice shall include a complete statement concerning the disposition by the pharmacy practice site of controlled substances and all prescription drugs and devices and related materials, invoices, records, and files.

(9) In a transaction involving the purchase of a pharmacy practice site or its stock of prescription drugs and devices and related materials, both the pharmacist in charge, except in case of death or incapacity, of the pharmacy practice site selling and the pharmacist in charge of the pharmacy practice site buying the stock, or the new owner of the pharmacy practice site if no pharmacist in charge has been appointed, shall jointly inventory all controlled substances and both shall sign and date that inventory and mail a copy of that inventory to the board within thirty (30) days of the completion of the sale.

(10) The pharmacist in charge shall maintain a current registry of individuals employed at the pharmacy practice site performing the functions of a pharmacy technician.

(11) This rule does not relieve other pharmacists or persons from their responsibility to comply with state laws and regulations.

(12) No pharmacist shall be designated pharmacist in charge of more than one (1) pharmacy practice site except where the board determines that such is in the best interest of the public health.

(13) The designated pharmacist in charge at a particular pharmacy practice site shall be on duty a minimum of fifty percent (50%) of the hours that the pharmacy is in operation. Except, in any event, the pharmacist in charge shall not be required to be on duty more than an average of forty (40) hours per week.

(14) The designated pharmacist in charge shall report to the board any situation in which a medical or prescription order has caused serious personal injury or death.

(15) Upon request, the Board may waive selected portions of these requirements so long as any waiver granted is consistent with the Board’s authority under Tenn. Code Ann. Title 63, Chapters 1 and 10, and Tenn. Code Ann. Title 4, Chapter 5.

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-404(2), (25), (26), (27), and (28), and 63-10-504(b)(1) and (2).
Administrative History: Original rule filed February 7, 1983; effective March 9 1983. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendment filed August 19, 2002; effective November 2, 2002. Amendments filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-03-.15 REFERENCE BOOKS

Each pharmacy practice site shall maintain an adequate reference library (printed or electronic) consistent with its scope of practice. The reference library shall include a current edition of the Tennessee Pharmacy Laws issued by the Tennessee Board of Pharmacy and may include current material regarding the technical, clinical, and professional components of the practice of pharmacy, with particular emphasis in the area in which the pharmacy specializes. Upon request, the Board may waive selected portions of these requirements so long as any waiver granted is consistent with the Board’s authority under Tenn.

Code Ann. Title 63, Chapters 1 and 10, and Tenn. Code Ann. Title 4, Chapter 5.

History

Authority: T.C.A. § 63-10-304.
Administrative History: Original rule filed February 7, 1983; effective March 9, 1983. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendment filed November 24, 2008; effective February 7, 2009. Amendments filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-03-.16 CENTRALIZED PRESCRIPTION PROCESSING

Centralized Prescription Processing:

(1) A pharmacy may perform or outsource centralized prescription processing services to another pharmacy, provided that the following criteria are satisfied:

(a) Both pharmacies shall be licensed by the State of Tennessee;

(b) Both pharmacies shall share a common electronic file or both shall have the appropriate technology to allow each other access to information that is necessary to fill or refill a prescription order; and (c) Both pharmacies shall have the same owner or in the event that the pharmacies do not have the same owner, then the pharmacies shall enter a written contract stating the services that will be provided by each pharmacy as well as the responsibilities of each pharmacy in fulfilling the terms of the contract and in complying with federal and state laws and rules.

(2) The pharmacy performing or contracting for centralized prescription processing services shall maintain a policy and procedures manual stating how prescription orders will be filled or refilled through centralized prescription processing. The pharmacies shall provide the Board with a copy of the manual and appropriate documentation of the processes for the Board’s review, upon the Board’s request. The pharmacies shall ensure that the manual includes, but is not limited to the following:

(a) A description of how the pharmacies will comply with federal and state law and rules;

(b) The maintenance of records to identify the responsible pharmacist(s) in the dispensing process;

The maintenance of a mechanism to identify all of the pharmacies involved in dispensing the prescription order on the prescription label;
Adequate security measures to protect the confidentiality and integrity of the patient information; and 3. The maintenance of a quality assurance program for pharmacy services designed to objectively and systematically monitor and evaluate the quality of patient care, the identification of problems with patient care and the resolution of any identified problems with patient care.

(d) The pharmacies that are not physically located in the State of Tennessee shall comply with Tenn. Code Ann Title 63, Chapter 10 and the rules of the State of Tennessee Board of Pharmacy.

History

Authority: T.C.A. § 63-10-304 and Chapter 966 of the Public Acts of 2008, § 1.
Administrative History: New rule filed November 24, 2008; effective February 7, 2009. Amendments filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-03-.17 COLLABORATIVE PHARMACY PRACTICE

(1) Definitions—In addition to the definitions contained in Tenn. Code Ann. Title 63, Chapter 10,

Part 2, the following definitions are applicable to collaborative pharmacy practice:

(a) “Active practice”, for purposes of the qualifications of a pharmacist under (4)(b) of this

rule, means engagement in paid, unpaid, or volunteer activity which requires a pharmacist’s license under Tennessee law, for at least 2,000 hours within the 24-month period immediately preceding the date of the agreement. “Active practice” is not limited to direct patient care and includes supervisory, educational or consultative activities or responsibilities for the delivery of such services.

(b) “Agreement” means the collaborative pharmacy practice agreement.

(c) “Authorizing physician” means a medical doctor or osteopathic physician with an unencumbered Tennessee license who has a direct provider/patient relationship with the patients served under a collaborative pharmacy practice agreement or who is the supervising physician of an advanced practice nurse or physician assistant who has such direct relationship or who, in the case of a multi-specialty practice, is the representative or chief responsible for particular specialty care within that multispecialty practice recognized and certified by the American Board of Medical Specialties (hereinafter “ABMS”) or the American Osteopathic Association Bureau of Osteopathic Specialists (hereinafter “AOABOS”).

(d) “Collaborating prescriber” means the physician, advanced practice nurse or physician assistant who is a party to a collaborative pharmacy practice agreement, who has a direct provider/patient relationship with the patient served by the agreement and who has prepared the patient specific, drug specific, disease or condition specific plan of care based on a physical examination of the patient where required under these rules.

(e) “Hospice patient” means an individual who has been diagnosed as terminally ill, has been certified in writing by a physician to have an anticipated life expectancy of six (6) months or less and who has voluntarily requested admission to, and been accepted by, a licensed hospice as defined in T.C.A. § 68-11-201.

(f) “Institutional-based pharmacy setting” means any institutional facility or long-term care facility, as defined in 1140-01-.01, or an academic health care institution, and where the pharmacist is responsible for the care of patients within that facility, including prescriptive practices, under the terms of a collaborative agreement.

(g) “Patient care services” means services rendered by physicians and members of the healthcare profession under their supervision, including advanced practice nurses, physician assistants and pharmacists for the benefit of the patient and which must be within the professional training and experience of the healthcare practitioner and be covered by the collaborative pharmacy practice agreement.

(h) “Routine scope of practice and services” means any patient care service provided by the authorizing physician and their practice in compliance with the respective applicable licensing board’s laws, rules, policies and procedures. In addition, the services to be provided by the pharmacist shall be services that the authorizing physician generally provides to his or her patients in the normal course of his or her clinical medical practice. The pharmacist should only provide services to the patients whom the authorizing physician or collaborating prescriber routinely treats in the course of his or her clinical medical practice.

(i) “Unencumbered”, for the purpose of this rule, means an active license that is not revoked, suspended or on probation at the time and is not subject to any conditions, restrictions, or limitations imposed by the applicable licensing board, which relate directly to the delivery of health care services. A condition, restriction or limitation directly relates to the delivery of health care services when it prevents a provider from treating certain types of patients or certain types of ailments or injuries, or otherwise limits a provider from fully engaging in the practice which would otherwise be authorized pursuant to his or her license.

(2) Physicians, advanced practice nurses and physician assistants may only engage in collaborative pharmacy practice agreements with pharmacists when an appropriately executed collaborative pharmacy practice agreement has been executed and a written attestation has been filed with the licensing boards for all practitioners participating in the agreement notifying those boards of the existence of such agreement; and when the patient or the patient’s authorized representative has signed a general consent that the patient is to receive services from a healthcare team, including a pharmacist. However, no such general consent shall be required in an institutional based pharmacy setting where consent to treatment has already been given. All consent given related to treatment at an institutional facility or to treatment under a collaborative pharmacy practice agreement is to be made part of the patient record.

(a) Any pharmacist who is a participant in a collaborative pharmacy practice agreement must be provided a copy of said agreement by the director of pharmacy, pharmacist in charge, or designated pharmacist in a group.

(b) The written attestation shall include the names of all signatories and practitioners participating in the collaborative pharmacy practice agreement, the date of the Agreement and a description of the scope of the services covered by the Agreement.

(c) In the event that an advanced practice nurse or physician assistant is a party to a collaborative pharmacy practice agreement, the physician with responsibility for supervision and control of that advanced practice nurse or physician assistant must approve and sign the Agreement.

(d) In addition, for those Agreements not involving the institutional-based pharmacy setting, the written attestation shall include a formulary of the categories of drugs and services authorized by the Agreement.

(e) The written attestation must be provided to the appropriate licensing boards of the signatories no later than thirty (30) days following the effective date of the Agreement.

(3) No physician, advanced practice nurse, physician assistant or pharmacist may engage in a collaborative pharmacy practice agreement unless each collaborating provider holds an active, unencumbered license in Tennessee and possesses at least one million dollars ($1,000,000) in professional liability insurance coverage per occurrence.

(4) In addition to the other requirements of these rules, a pharmacist must meet one of the following qualifications in order to engage in a collaborative pharmacy practice agreement:

(a) Has been awarded a doctor of pharmacy degree from a program accredited by the Accreditation Council for Pharmacy Education; or (b) Has been awarded a bachelor of science in pharmacy and been in the active practice of pharmacy.

(5) Each collaborative pharmacy practice agreement (“Agreement”) shall contain the following elements, at a minimum:

(a) Names and Titles of Collaborating Providers. The agreement must contain identification of all pharmacists and all physicians and other prescribers (collectively, “collaborating providers”) who are parties to the Agreement. The Agreement shall state the procedure to be followed to indicate changes in the members of the group(s) participating in the Agreement. Unless expressly stated in the Agreement, changes to the list of collaborating providers bound by the Agreement shall not automatically void the Agreement. When the Agreement involves a group or groups of practitioners, the chief medical officer or medical director, where applicable, and the director of pharmacy or pharmacist in charge shall sign the Agreement, and the Agreement shall identify all collaborating providers in one or more addendums. In the case of a healthcare institution with an organized medical staff or a multi-specialty group with more than one ABMS or AOABOS recognized physician specialty, the signature of the authorizing physician representing or responsible for that specialty unit will suffice.

Nevertheless, each collaborating provider must affirm understanding and acceptance of the terms of the Agreement by signing an addendum to the Agreement within thirty (30) days of the effective date of the agreement (or within thirty days of employment or association with such multi-specialty group) and all members of the medical staff or group must be provided a copy of the collaborative agreement within fifteen (15) days of execution, with a copy also made available via online access. Signatures may be handwritten, electronic, or any other method authorized by the Board of Pharmacy and the respective licensing board of the signatory.

(b) Authorized Care and Services. The Agreement must contain a provision defining the nature and scope of patient care services and activities, including screening, prevention, assessment, management, and care, authorized or restricted to be provided by the pharmacist(s) under the collaborative pharmacy practice agreement.

All care and services authorized to be provided shall be within the routine scope of practice and services delivered by the authorizing physician and the advanced practice nurse or physician assistant, where applicable. All care and services provided, except immunizations, opioid antagonists, ivermectin, and preventive care, must be pursuant to a diagnosis appropriately made and documented by the physician, advanced practice nurse or physician assistant. An Agreement which grants the collaborating pharmacist prescriptive authority, including authority for initiation and discontinuance of drug therapy, must be specifically authorized in the authorized care and services portion of the Agreement and must contain a listing of the drugs or categories of drugs that may be prescribed by the collaborating pharmacist under the terms of the Agreement.

(c) Documentation and Communication. Any patient care services provided by a pharmacist or pharmacists pursuant to a collaborative pharmacy practice agreement shall be documented in a patient record accessible by the pharmacist(s) and the collaborating prescriber(s) or communicated in writing to the collaborating prescriber or prescribers within three (3) business days of the service. The Agreement shall describe the methods for maintenance and access to the records by the pharmacist(s) and the prescriber(s), for documentation of services performed pursuant to the Agreement and for communication and feedback between the pharmacist(s) and the collaborating prescriber(s). All such records shall be maintained by the collaborating prescriber(s) and pharmacist(s) for a period of not less than ten (10) years from the date of the last patient contact.

(d) Override Clause. A provision must be included in the Agreement allowing the collaborating prescriber to override the actions taken by the collaborating pharmacist specific to services provided under the Agreement if he or she determines that the override is essential to the optimal health outcomes of the patient, and stating how such overrides shall be documented and communicated to the collaborating pharmacist and the patient in a timely manner, as defined in the agreement.

(e) Expiration, Modification and Termination. The effective date of the Agreement shall be stated in the Agreement. Each agreement must contain a term or expiration date, upon which the agreement will expire if not renewed; however, in any event, all Agreements must be reviewed and updated at least every two (2) years as evidenced by signatures of the parties. Every Agreement must contain a provision stating the process for modification or termination of the agreement by either party. This process shall include written notification to all affected parties when modification or termination is sought. An Agreement may be amended upon mutual approval by the collaborating prescriber, authorizing physician (where applicable) and pharmacist who have been duly authorized to execute, modify, or change the Agreement. Such amendments shall include, at a minimum, a description of the desired change and the effective date of the change. Additional prescriber(s) and additional pharmacist(s) may be added to an existing participating group through an addendum without affecting the effective date of the agreement. Any amendment executed shall not automatically void the terms and conditions of the existing Agreement unless expressly stated. Amendments to the authorized care and services not involving an institutional-based pharmacy setting which institute substantive additions or reductions to the scope of patient care services provided under the agreement including new therapeutic classes of drugs to the authorized formulary must be provided to the appropriate licensing boards no later than thirty (30) days from the effective date of the amendment.

(f) Automatic Exclusions. A provision must be included in the Agreement which identifies any terms under which a provider will be automatically excluded from participation in the Agreement, which may include but need not be limited to death, suspension, surrender, revocation, or retirement of license; loss or restriction of prescriptive

authority; the suspension or revocation of a Drug Enforcement Administration registration; exclusion from any federally funded health programs, or the formal termination of the supervising relationship between an advanced nurse practitioner or physician assistant and his or her supervising physician. Any Agreement involving an advanced practice nurse or physician assistant participating in a collaborative pharmacy practice agreement shall contain a procedure for immediate notification to the collaborating pharmacist(s) if that supervisory relationship is terminated for any reason.

(g) Quality Assessment. The authorizing physician(s) and pharmacist(s) shall create written measurable and objective performance goals for evaluating the quality of care provided for the patients treated pursuant to the Agreement. The Agreement must provide for such goals and data as identified by the collaborating providers, to be aggregated and reviewed by the participants to the Agreement at least quarterly. Such quarterly review shall include consideration of any changes necessary to the Agreement, authorized formulary, and patient orders, in addition to strategies regarding patient education and medication adherence, increased or improved monitoring of side effects and the need for further screening/testing. The Agreement shall also provide at a minimum for monthly patient record review by the authorizing physician(s) of at least five percent (5%) of the patients treated pursuant to the Agreement. The quality assessment review shall be properly documented, retained by the participating parties of the Agreement, and available for review by representatives of the various licensing boards for at least ten (10) years.

(6) The scope of a collaborative pharmacy practice agreement shall NOT include:

(a) Any patient of the collaborating prescriber for whom such collaborating prescriber has not prepared a patient-specific, drug-specific, disease- or condition-specific plan of care based on a physical examination of the patient by the collaborating prescriber, with the exception of immunizations, dispensing of ivermectin, and screening/testing which do not require such patient-specific plans, as well as the dispensing of opioid antagonists as defined in T.C.A. § 63-1-152, which require neither a physical examination nor a patient-specific plan;

(b) The prescribing of controlled substances, except by a pharmacist practicing within an institutional-based pharmacy setting or for hospice patients.

(7) A copy of the Agreement, including any addendum, modification or termination shall be accessible at each practice site and shall be made available to the applicable regulatory board for review upon request.

(8) Pharmacists engaging in the collaborative pharmacy practice must utilize an area for inperson, telephonic or other approved consultations with patients that ensures the confidentiality of the communication.

(9) Physicians, advanced practice nurses and physician assistants engaged in a collaborative pharmacy practice agreement shall:

(a) Retain professional responsibility to his/her patients for the management of their drug therapy;

(b) Establish and maintain a physician-patient relationship with each patient subject to the collaborative pharmacy practice agreement;

(c) Be available at all times through direct telecommunication for consultation, assistance and direction, or shall make arrangements for a substitute physician to be available.

(10) Any pharmacist issuing a prescription order, as defined in T.C.A. § 63-10-204, or medical order, as defined in T.C.A. § 63-10-204, pursuant to an Agreement shall issue the prescription order or medical order in accordance with the requirements set forth in Tenn.

Comp. Rules and Regs. 1140-03-.03 and within the terms set forth in the collaborative pharmacy practice agreement.

(11) All collaborative pharmacy practice agreements authorizing pharmacists to provide services and activities shall include language that ensures compliance with all applicable by-laws, policies, and procedures of that facility.

(12) For patient care services performed by a pharmacist and authorized only pursuant to a collaborative pharmacy practice agreement, the Board of Pharmacy expressly adopts the guidelines, rules, and standards of practice of the Board of Medical Examiners, Board of Osteopathic Examiners, or other Tennessee Health Related Boards, as applicable.

(13) Pharmacists engaged in the collaborative pharmacy practice are strongly encouraged to complete ten (10) hours of the biennially required thirty (30) hours of continuing education in topics related to the clinical practice of pharmacy.

(14) All signatories and other parties engaging in a collaborative pharmacy practice shall be subject to disciplinary action by their licensing boards if the licensee violates the terms of these rules or the terms of the collaborative pharmacy practice agreement. Each board with jurisdiction over any of the signatories to the agreement shall report to the other appropriate board any conduct which it believes to be in violation of any such agreement.

(15) Pharmacists who hold a current federal drug enforcement administration (“DEA”) license must complete a minimum of two (2) hours biennially of continuing education related to controlled substance prescribing, which must include instruction in the Department’s treatment guidelines on opioids and chronic pain and may include such other topics as medicine addiction, risk management tools, and other topics as approved by the Board of Pharmacy. Such continuing education hours shall be counted toward the pharmacist’s mandatory continuing education requirement.

History

Authority: T.C.A. §§ 63-10-217, 63-10-224, and 63-10-308.
Administrative History: New rule filed November 22, 2016; effective February 20, 2017. Amendments filed December 15, 2023; effective March 14, 2024.

Tenn. Comp. R. & Regs. 1140-03-.18 PROVISION OF IVERMECTIN

(1) A pharmacist may provide ivermectin under this rule to eligible individuals as identified in T.C.A. § 63-10-224 through a valid collaborative pharmacy practice agreement containing a non-patient-specific prescriptive order and standardized procedures developed and executed by one (1) or more authorized prescriber(s).

(a) The pharmacist shall maintain the collaborative pharmacy practice agreement in accordance with § 63-10-217 and shall comply with all requirements of Tenn. Comp. R. & Regs. 1140-03-.17 except for patient-specificity.

(b) Within 30 days from the effective date of a collaborative pharmacy practice agreement, the prescribing pharmacist shall submit written attestation to the Board for the purpose of notifying the Board of the collaborative agreement.

(2) A pharmacist who is participating in a collaborative pharmacy practice agreement for the provision of ivermectin shall provide the patient with and review a screening risk assessment tool that screens for the following elements:

(a) Comorbidities;

(b) Contraindications; and (c) Pregnancy.

(3) A pharmacist who is participating in a collaborative pharmacy practice agreement for the provision of ivermectin shall provide the patient with a standardized factsheet that includes at minimum the following elements:

(a) The statement “Off-label use is not prohibited by state or federal law. The FDA has not authorized or approved ivermectin for the treatment or prevention of COVID-19 in people or animals. Ivermectin has not gone through the new drug application process with the FDA for COVID-19.”

(b) FDA factsheet or at least the following elements:

Approved indications, dosage and administration as listed in the FDA factsheet;
Contraindications, warnings, and precautions as listed in the FDA factsheet; and 3. Adverse reactions as listed in the FDA factsheet.

(4) A pharmacist who is participating in a collaborative pharmacy practice agreement for the provision of ivermectin shall counsel the patient on matters contained in Tenn. Comp. R. & Regs. 1140-03-.01(1)(e)1. through 1140-03-.01(1)(e)8. at the time ivermectin is prescribed and dispensed.

(5) A pharmacist who is participating in a collaborative pharmacy practice agreement for the provision of ivermectin shall advise the patient to consult with the patient’s primary care practitioner if their symptoms seem to be worsening.

(6) A pharmacist who is participating in a collaborative pharmacy practice agreement for the provision of ivermectin shall document, at a minimum, the completed self-screening risk assessment and the medication and dosage prescribed to the patient by the pharmacist.

While not required by this rule, the pharmacist is authorized to include additional information related to the patient encounter. These records shall be maintained by the pharmacy practice site for a period of ten (10) years. Records regarding the dispensed ivermectin shall be maintained in accordance with Tenn. Comp. R. & Regs. 1140-03-.03.

(7) If the pharmacist who is participating in a collaborative pharmacy practice agreement for the provision of ivermectin determines that the patient is eligible to receive ivermectin, then, as soon as it is practicable, the collaborating pharmacist shall dispense ivermectin to the patient or refer the patient to another pharmacy that may dispense ivermectin.

History

Authority: T.C.A. §§ 63-10-217, 63-10-224, and 63-10-308.
Administrative History: New rule filed December 15, 2023; effective March 14, 2024.

Chapter 1140-04 Institutional and Alternate or Alternative Infusion Pharmacy Practice Sites

Tenn. Comp. R. & Regs. 1140-04-.01 APPLICABILITY

A pharmacy providing products and services to any institutional facility, and alternate or alternative infusion pharmacy practice site, shall be subject to all rules of the board dependent upon services provided.

History

Authority: T.C.A. §§ 63-10-404(2), (28), 63-10-504(b)(1), and (2).
Administrative History: Original rule filed February 7, 1983; effective March 9, 1983.

Tenn. Comp. R. & Regs. 1140-04-.02 PERSONNEL

(1) Pharmacist in charge. The practice of pharmacy and the performance of supportive pharmacy personnel associated with any institutional facility shall be under the direction, supervision and responsibility of the pharmacist in charge. The pharmacist in charge shall also be responsible for the dispensing, distribution, compounding, storage and the procurement of prescription and nonprescription drugs used throughout the institutional facility. Policies and procedures defining the scope of pharmacy practice, collaborative working relationships, the responsibilities of the pharmacists and supportive personnel, and the safe use and management of drugs, devices and related materials shall be established by the pharmacist in charge. The pharmacist in charge or designee shall participate in the institution’s drug policy committees which serve to ensure rational drug use, patient care evaluation processes relating to drug utilization and effectiveness, drug delivery device selection and evaluation systems, and educational activities for the safe and appropriate use of drugs which will assess the quality of services and products provided and document actions taken. Policies and procedures as indicated in this chapter shall be written and shall be made available to the Board.

(2) Pharmacists. The pharmacist in charge shall be supported by a sufficient number of pharmacists to provide appropriate practice of pharmacy for the patients served by the institutional facility. Employment of pharmacists by the institutional facility shall be determined by the pharmacist in charge.

(3) Institutional consultant pharmacist. An institutional facility may utilize a consultant pharmacist who may or may not be independent of the pharmacy practice site, who shall provide patient care service which includes, but is not limited to:

(a) Development, interpretation, and communication of drug, device and related materials orders and health information;

(b) Providing consultation on matters pertaining to efficient drug distribution systems, proper drug selection, rational and safe drug use, and drug therapy assessment;

(c) Evaluation of a patient’s drug therapy to maximize outcome(s), including effective communication with prescribing practitioners and other healthcare professionals;

(d) Effective counseling of a patient or a patient’s attorney for healthcare or other caregiver;

(e) Service on committees or governing bodies; and (f) Providing in service educational programs for members of the healthcare team.

(4) Supportive personnel. The pharmacist in charge shall be assisted by a sufficient number of pharmacy technicians, as defined in 1140-02-.02 pharmacy interns, and other supportive personnel as may be required to operate the pharmacy competently, safely, and adequately to meet the needs of the patients served by the institution.

(5) Supervision. All of the activities associated with the practice of pharmacy and the operations of the pharmacy at a specific institutional pharmacy practice site shall be supervised by a sufficient number of pharmacists to ensure that all functions and activities are performed competently, safely and without risk of harm to patients.

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-404(4), (8), (11), (14), (21), (26), (27), (28), and (30), and 63-10-504(b)(1) and (2).
Administrative History: Original rule filed February 7, 1983; effective March 9, 1983. Amendments filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-04-.03 PHYSICAL REQUIREMENTS

(1) Area. An institutional or alternative infusion pharmacy practice site shall have sufficient floor space allocated to it to ensure that medical and prescription orders are prepared and dispensed in sanitary, well lighted, and enclosed spaces. The institutional pharmacy shall also have sufficient counter space or other suitable work module to ensure that medical and prescription orders are prepared and dispensed in an orderly manner.

(2) Equipment and Materials. The pharmacy practice site shall have sufficient equipment and physical facilities for the practice of pharmacy. This shall include but not be limited to:

(a) Hot and cold running water;

(b) Refrigerated storage space;

(3) Storage. All prescription drugs and devices and related materials shall be stored in designated areas within the pharmacy practice site which are sufficient to ensure proper sanitation, temperature, light, ventilation, moisture control, segregation, and security.

(4) Alcohol and Flammables. Alcohol and flammables shall be stored in an area that shall, at a minimum, meet basic local building code requirements for the storage of volatiles, and such other laws, ordinances, or regulations that may apply.

(5) Security. A pharmacy practice site shall be capable of being locked to prevent access by unauthorized personnel. A pharmacist must be accessible within the institutional facility where an institutional pharmacy practice site is located; and when no pharmacist is present at the institution, the pharmacy practice site must be kept closed and securely locked except as provided in 1140-04-.14.

(6) Upon request, the Board may waive selected portions of these requirements so long as any waiver granted is consistent with the Board’s authority under Tenn. Code Ann. Title 63, Chapters 1 and 10, and Tenn. Code Ann. Title 4, Chapter 5.

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-404(8), (14), (28), 63-10-504(b)(1), and (2).
Administrative History: Original rule filed February 7, 1983; effective March 7, 1983. Amendments filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-04-.04 PRESCRIPTION ORDERS

(1) A pharmacist shall review all prescription orders before the drug is first dispensed. In the event that medications available in the institutional facility are ordered and administered before the pharmacist’s review, the order shall be reviewed by a pharmacist in a timely manner. The pharmacist shall have access to the patient’s medical record. The original order must be maintained in a readily retrievable manner according to the pharmacy practice site policy for at least two (2) years from the date of its issuance.

(2) Upon request, the Board may waive selected portions of these requirements so long as any waiver granted is consistent with the Board’s authority under Tenn. Code Ann. Title 63, Chapters 1 and 10, and Tenn. Code Ann. Title 4, Chapter 5.

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-404(1), (11), (14), (26), and (28), and 63-10-504(b)(1) and (2).
Administrative History: Original rule filed February 7, 1983; effective March 9, 1983. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendments filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-04-.05 DISTRIBUTION AND CONTROL OF DRUGS

The pharmacist in charge or designee, in conjunction with appropriate committees of the facility, shall be responsible for approving policies for the distribution and control of drugs within the facility. The process shall be established to provide for the safe and efficient distribution of drugs and for the provision of pharmaceutical care, and shall include but not be limited to:

(1) A drug dispensed from the pharmacy for subsequent administration to a patient shall be appropriately identified with the name and location of the patient and the name and strength of the drug.

(2) The pharmacist in charge is responsible for the development and maintenance of an audit trail on drugs dispensed.

(3) The prescription order shall be recorded on a patient medication profile that will be maintained during the patient’s treatment. This profile shall include the date of the prescription order, the name and dosage form of the drug and the dose and administration frequency.

(4) The facility distribution system may be based on a combination of processes that will ensure compliance with federal and state guidelines such as emergency kits/crash carts, floorstock systems, automated dispensing devices, medication carts, and/or after-hours procedures for pharmacy site access.

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-404(11), (14), and (27), and 63-10-504(b)(1) and (2).
Administrative History: Original rule filed February 7, 1983; effective March 9, 1983. Amendment to rule filed November 16, 1992; effective January 8, 1993. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendments filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-04-.06 MEDICATION CARTS

(1) Drugs distributed from the pharmacy to other areas of the institutional facility may be stored in medicine cabinets or drug carts which shall be kept secured unless in use by the nursing staff or other authorized personnel. Access to the medication cart shall be defined by facility policies. It is recommended that drugs be dispensed in unit dose packaging and medications for each patient shall be distributed and stored in separate trays, drawers, compartments, or containers assigned to that resident and bearing the resident’s name and location.

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-404(11), (14), and (28), and 63-10-504(b)(1) and (2).
Administrative History: Original rule filed February 7, 1983; effective March 9, 1983. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendments filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-04-.07 FLOORSTOCK DRUGS

(1) The pharmacist in charge or designee, in conjunction with appropriate committees, shall be responsible for approving policies and procedures for floorstock at the institutional facility.

The policies shall include specific drugs, quantities, prescription order review, storage requirements, and replenishment of drugs, devices, or related materials which are supplied to the institutional facility as floorstock.

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-404(8), (14), and (27), and 63-10-504(b)(1) and (2).
Administrative History: Original rule filed February 7, 1983; effective March 9, 1983. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendments filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-04-.08 CONTROLLED DRUGS

(1) Controlled substances (and those drugs deemed by the pharmacist in charge to have a potential for abuse) which are issued as floorstock shall be accounted for by providing documentation of:

(a) The drug name, strength, and dosage form;

(b) The date and time of administration;

(d) Identification of the patient;

(e) Identification of the prescriber; and (f) Identification of the authorized personnel administering the controlled substance.

(2) A record of the destruction of controlled substances previously dispensed to or for patients shall be maintained so as to be readily retrievable for at least two (2) years, and such records shall include:

(a) The identification of patient;

(b) Drug name, strength, dosage form, and quantity;

(c) The date and method of destruction; and (d) The identification of authorized personnel witnessing the destruction and its record.

(3) Schedule II controlled substances which are kept within a pharmacy practice site shall be stored in a secured, substantially constructed cabinet, safe, or other structure which provides a double locked secured system.

(4) Nothing in this rule shall be interpreted to authorize the destruction of controlled substance floorstock or pharmacy stock. Such drugs shall upon request, be destroyed or returned to the pharmacy for destruction by a board approved agent or vendor.

History

Authority: T.C.A. §§ 53-11-302, 63-10-204, 63-10-304, 63-10-404(11), (14), (27), and (28), and 63-10- 504(b)(1) and (2)(j).
Administrative History: Original rule filed February 7, 1983; effective March 9, 1983. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendments filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-04-.09 EMERGENCY AND HOME CARE KITS

Drugs and devices and related materials may be provided by emergency kits as defined by policies and procedures provided that such kits meet the following requirements:

(1) Emergency Kits.

(a) Drugs and devices and related materials may be provided by emergency kits as defined by policies and procedures, provided that such kits meet the following requirements:

Emergency kit drugs are those drugs which may be required to meet the immediate therapeutic needs of patients and which are not available from any other authorized source in sufficient time to prevent risk of harm to patients.

Drugs in this kit are to be used only for emergency orders.

The policies and procedures to implement the requirements of this subsection and to approve the contents of the emergency kit will be determined by a committee composed of representatives of the medical and nursing staff and the pharmacist in charge or his/her designee.
The emergency kit shall be provided sealed or electronically secured by authorized personnel in accordance with established policies. The expiration date of the kit shall be clearly marked on the exterior of the kit to represent the earliest expiration date of any drug, device, or related materials contained in the kits.
Emergency kits shall be stored in a secured area at the institutional facility or patient care site to prevent unauthorized access. To ensure a proper environment for preservation of the drugs contained therein, appropriate policies and procedures shall be written to include storage at the site of patient care.
Only authorized individuals may obtain drugs, devices or related materials from the emergency kit in accordance with established policies and state and federal laws and regulations.
A list of the emergency kit contents shall be readily accessible and it shall include the drugs, devices, and related materials contained therein and include the name (trade and/or generic), strength, and quantity of the products contained therein.
A mechanism must be in place to ensure that the emergency kits are not in use after the expiration date.
Drugs contained within the emergency kit shall be properly labeled according to the United States Food and Drug Administration (FDA) labeling requirements for the drug or device and with additional information that may be required by the staff to prevent misunderstanding or risk of harm to the patients.
Removal of any drug, device, or related material from the emergency kit shall be pursuant to a valid medical or prescription order and must be documented by established policy which may include patients identification, name of the drug, strength, amount, date, time, and identification of the authorized individual removing the drug.
When an emergency kit is opened for any reason, the pharmacy practice site shall be notified, and the kit shall be restocked and resealed within a reasonable time so as to prevent risk of harm to patients.

(2) Home Care Kits.

(a) A home care kit is a kit containing certain drugs, as determined by the board, to be kept in the home of the patient for use by a healthcare professional engaged in home healthcare of a patient as necessary to meet the therapeutic needs of patients and which are not available from any other source in sufficient time to prevent risk of harm to patients.

A home care kit may contain:

(i) Sodium Chloride for Injection 0.9% Bacteriostatic (ii) Sterile Water for injection Bacteriostatic or Preservative Free (iii) Epinephrine injection 1mg/ml (iv) Diphenhydramine (v) Heparin Flush <or = 100units/ml (vi) Naloxone (vii) Sodium Chloride for Irrigation (viii) Sterile Water for Irrigation (ix) Dextrose 50% (x) Urokinase 5000units (xi) Any other legend drug as approved by the board.

(b) Drugs contained in home care kits are to be used for emergencies only. Maintenance of a central venous catheter is considered an emergency if confirmed with the patient’s physician or his/her designee.

(c) Policies and procedures for the dispensing, use, storage at the patient care site, security and expiration date review, and reconciliation of drug contents shall be determined as in section (1)(a)2 of this rule. Additional policies or protocols for treating anaphylactic reaction, maintaining patency of intravenous or central venous catheters, or flushing of intravenous devices shall be established, in the same manner.

(d) Removal of any drug from the Home Care Kit shall be pursuant to a valid medical or prescription order and/or protocol and must be documented in the patient’s medical record.

(e) When a home care kit is opened for any reason, the pharmacy practice site shall be notified and the kit shall be restocked and resealed within a reasonable time so as to prevent risk of harm to patients.

(3) Upon request, the Board may waive selected portions of these requirements so long as any waiver granted is consistent with the Board’s authority under Tenn. Code Ann. Title 63, Chapters 1 and 10, and Tenn. Code Ann. Title 4, Chapter 5.

History

Authority: T.C.A. §§ 63-10-304, 63-10-504, and 63-10-504(b)(1) and (2).
Administrative History: Original rule filed February 7, 1983; effective March 9, 1983. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendment filed August 19, 2002; effective November 2, 2002. Amendments filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-04-.10 UNUSED DRUGS, DEVICES, AND RELATED MATERIALS

(1) Discontinued, outdated, defective, or deteriorated drugs, devices, or related materials and containers with worn, illegible, or missing labels shall be returned to the pharmacy practice site for proper disposition. All such drugs, devices or related materials returned to the pharmacy practice site must be destroyed unless in unit dose packaging, unopened commercially prepackaged containers and in the professional judgment of the pharmacist in charge or designee, the medications or related materials meet all federal and state board standards for product integrity.

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-404(8), (14), (16), (28), and 63-10-504(b)(1) and (2).
Administrative History: Original rule filed February 7, 1983; effective March 9, 1983; effective March 9, 1983. Repeal and rule filed May 11, 1998; effective July 25, 1998. Amendments filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-04-.11 TAKE-HOME AND LEAVE OF ABSENCE DRUGS, DEVICES, AND RELATED

MATERIALS.

(1) All prescription drugs prescribed for and dispensed to patients who are on leave of absence from the institutional facility must be dispensed in accordance with the institution’s policies and procedures.

(2) All prescription drugs prescribed for and dispensed to patients who are being discharged from the institutional facility must be dispensed with labeling in accordance with 1140-3-.06.

(3) The pharmacist in charge in coordination with the medical and nursing staff committees of the facility shall establish policies and procedures to assure that this process meets state and federal guidelines appropriate for the facility.

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-404(11), (14), (16), and (27), and 63-10-504(b)(1) and (2).
Administrative History: Original rule filed February 7, 1983; effective March 9, 1983. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendments filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-04-.12 DRUGS BROUGHT INTO THE FACILITY

(1) The pharmacist in charge shall establish policies to control any drugs brought into the institutional facility.

(2) Administration of these drugs shall be pursuant to a medical or prescription order.

(3) Drugs brought into the facility shall not be administered until properly identified.

(4) Drugs which are not to be administered shall be packaged, sealed, and returned to an adult member of the patient’s family for removal from the institutional facility or the drugs shall be securely stored and returned to the patient at discharge per facility policy.

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-404(14), (19), (27), and (34), and 63-10-504(b)(1) and (2).
Administrative History: Original rule filed February 7, 1983; effective March 9, 1983. Amendment filed December 17, 1984; effective March 16, 1985. Amendment filed August 30, 1991; effective November 27, 1991. Amendments filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-04-.13 RECALLS

The recall procedure shall be readily activated to ensure that all prescription drugs and devices and related materials included on the recall are returned to the pharmacy practice site for proper disposition.

The pharmacist in charge shall develop and implement policies and procedures for recalls.

History

Authority: T.C.A. §§ 63-10-404(8), (14), (27), and (28) and 63-10-504(b)(1) and (2).
Administrative History: Original rule filed February 7, 1983; effective March 9, 1983. Amendment filed August 30, 1991; effective November 27, 1991. Repeal and new rule filed May 11, 1998; effective July 25, 1998.

Tenn. Comp. R. & Regs. 1140-04-.14 ABSENCE OF PHARMACIST

(1) Institutional pharmacy practice site.

(a) General. During such times as an institutional pharmacy practice site is closed, facility policy as approved by the pharmacist in charge shall provide a process for authorized personnel to obtain drugs necessary for the provision of patient care. This function may also be accomplished as outlined in the After Hours Drug Provision of this section.

A pharmacist must be “on call” twenty four (24) hours per day, seven (7) days per week.

(b) After Hours Drug Provision. When an institutional pharmacy practice site is closed, access to prescription drugs shall be by locked cabinet(s), automated dispensing machines or other enclosure(s) constructed and located outside of the pharmacy practice site, to which only personnel authorized by the pharmacist in charge may obtain access. Access should be sufficiently secured to deny entry to unauthorized persons by force or otherwise. Those practice sites utilizing automated dispensing devices for after hours drug provision shall meet the requirements of rule 1140-04-.15.

The pharmacist in charge shall develop an inventory listing of those drugs to be included in such after hours storage, and shall ensure that:

Such prescription drugs are available therein, properly labeled;
Such prescription drugs are prepackaged in amounts not to exceed a seventytwo (72) hour medication period; unless available in a commercially prepared package dictating multiple dose therapy (e.g., ophthalmic products, topical products, otic products);
All prescription drugs therein are inventoried at least once a month;
A record shall be made at the after hours storage location including the following elements:

(i) The date and time of removal of a drug;

(ii) The patient’s name and location;

(iii) The name, strength, dosage form, and quantity of the prescription drug; and (iv) The identification of the authorized personnel removing the drug.

The prescription order shall be verified by a pharmacist or designee in a timely manner.
The above record shall be used by authorized pharmacy personnel to replenish the after hours storage location, and this record shall be kept at the institutional pharmacy practice site so as to be readily retrievable for at least two (2) years;
Policies and procedures shall be established to implement the requirements of this section.

(c) Access to the Pharmacy Practice Site within an Institutional Facility. Whenever any prescription drug is not available from floor supplies, emergency kits, or other approved distribution system for the facility, and such prescription drug or device or related material is required to treat the immediate needs of a patient whose health would otherwise be jeopardized, such prescription drug, device or related material may be obtained from the pharmacy practice site in accordance with the requirements of this paragraph. Only authorized personnel, accompanied by a security guard or other authorized employee of the institution may have access to the pharmacy practice site and may remove the required drug, device or related material. Such person(s) shall be designated through policies of the facility and shall receive appropriate education and training in the proper methods of access and removal of prescription drugs, records and procedures required prior to such person(s) being permitted to obtain access to the pharmacy practice site. Such education and training shall be conducted by the pharmacist in charge or designee, who shall require, at a minimum, the following records and procedures;

Removal of any prescription drug, device or related material from the pharmacy practice site by an authorized person(s) must be recorded in a suitable form at the pharmacy practice site showing:

(i) The date and time of removal of the drug;

(ii) Patient identification and location;

(iii) The name, strength, dosage form, and quantity of the drug, device or related material removed; and (iv) The signatures of the authorized personnel and the accompanying witness;

The above record shall be maintained at least two (2) years at the pharmacy practice site electronically, or in a separate file or log book;
The medication or prescription order shall be verified by a pharmacist or authorized personnel; and 4. The quantity of drug removed shall not exceed the amount needed plus one (1) dose until the pharmacy practice site reopens; unless available in a commercially prepared package dictating multiple dose therapy (e.g., ophthalmic products, topical products, otic products).

(2) Alternate or Alternative Infusion pharmacy practice site.

(a) During such times as an alternate or alternative infusion pharmacy practice site is closed, policies and procedures shall be established by the pharmacist in charge for the provision of prescription drugs, devices and related materials to patients on a twenty four (24) hours per day seven (7) days per week basis.

(b) A pharmacist must be “on call” during all absences.

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-404(11), (14), (15), (19), (26), (27), (28), and (34) and 63-10-504(b)(1) and (2).
Administrative History: Original rule filed February 7, 1983; effective March 9, 1983. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendments filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-04-.15 AUTOMATED DISPENSING SYSTEMS

No prescription drug or device or related material shall be distributed or issued by the use of any automated dispensing device unless the device and the method of operation have been found by the board to ensure the purity, potency, and integrity of the prescription drug or device or related material, and to protect the prescription drug or device or related material from diversion.

(1) A pharmacist shall be designated to be accountable for this automated dispensing system.

(a) Individuals authorized by the facility policies and the pharmacist in charge will stock this device under the supervision of a pharmacist, if a pharmacist is not stocking the device.

(b) The pharmacist will work collaboratively with healthcare professionals to ensure that appropriate controls and monitors are utilized to provide information that drugs dispensed were for the correct patient and that pilferage is identified and resolved.

(2) All persons authorized to have access to these automated devices shall have documentation that they have successfully completed a training program that teaches them to perform the functions they perform with the automated device.

(3) Automated dispensing systems shall be used only for the furnishing of drugs and devices and related materials or other products related to the care of patients of that institution or facility; and (4) At the time of removal of any drug or device or related material from the device, it shall automatically make a record, to be retained by the pharmacy for a minimum of two (2) years, indicating:

(a) The date and time of removal of the drug or device or related material;

(b) The name, strength, dosage form, and quantity of drugs or devices or related material removed;

(c) The identification of the patient for whom the drug or device or related material was ordered; and (d) The identification of the person authorized to remove the drug or device or related material from the device.

(5) The pharmacist in charge or designee is responsible for determining how access codes or other methods of access to automated devices are assigned.

(6) The facility shall have policies and procedures approved by the pharmacist in charge in coordination with members of the nursing and medical staff for the points outlined in this

section for automated dispensing devices.

(7) The facility may provide off-campus automated dispensing systems for care provided by the institution when the following conditions are met:

(a) Each pharmacy holding an active license with the Tennessee Board of Pharmacy and using automated dispensing systems shall register each automated dispensing system with the Tennessee Board of Pharmacy. Each pharmacy shall maintain a list of the physical locations of all automated dispensing machines in its systems, whether such systems are located in the same facility as the licensed pharmacy, or not, and shall be responsible to pay a registration fee, as defined in 1140-01-.10 (for each automated dispensing system, which the licensed pharmacy is responsible for and which is located in an institutional facility.)

(b) The pharmacist in charge of the institutional pharmacy practice site shall be designated to be accountable for this automated dispensing system.

The filling/stocking of all medications in the automated dispensing system shall be completed by a pharmacist or pharmacy technician under the direct supervision of a pharmacist, except as provided below:

(i) If the automated dispensing system uses removable cartridges or containers to hold drugs, the prepackaging of the cartridges or containers shall occur at the provider pharmacy unless provided by an FDA approved repackager.

(ii) The prepackaged cartridges, unit dose packages or containers may be sent to the off-campus site to be loaded into the machine by personnel designated by the pharmacist-in-charge provided:

(I) A pharmacist verifies the cartridge or container has been properly filled and labeled;

(II) The individual cartridges, unit dose packages or containers are transported to the off-campus site in a secure, tamper-evident container;

(III) The automated dispensing system uses bar-coding, microchip, or other technologies to ensure that the containers are accurately loaded in the automated dispensing system;

(IV) All drugs to be stocked in the automated dispensing system shall be delivered to the off-campus site by the institutional pharmacy.

A record of medications filled/stocked into an automated dispensing system shall be maintained and shall include identification of the persons filling/stocking and checking for accuracy.
All containers of medications stored in the automated dispensing system shall be packaged and labeled in accordance with federal and state laws and regulations.
All aspects of handling controlled substances shall meet the requirements of all state and federal laws and regulations.
The automated dispensing system shall provide a mechanism for securing and accounting for medications removed from and subsequently returned to the automated dispensing system, all in accordance with existing state and federal law.
The automated dispensing system shall provide a mechanism for securing and accounting for wasted medications or discarded medications in accordance with existing state and federal law.

(c) Nothing in this section shall be interpreted to authorize the stocking of controlled substances in automated dispensing systems, except when done in a manner consistent with federal controlled substance rules and regulations.

(d) The registration fee for each automated dispensing system shall be determined by the Tennessee Board of Pharmacy and listed in 1140-01-.10. The Board shall maintain a list of registered automated dispensing systems, including physical address and number of devices located at each physical address. Registrations for automated dispensing systems must be renewed every two (2) years.

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-404(8), (11), (14), (26), and (27), and 63-10-504(b)(1) and (2).
Administrative History: Original rule filed February 7, 1983; effective March 9, 1983. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendments filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-04-.16 EMERGENCY ROOMS

(1) If prescription drugs, devices and related materials in an emergency room are to be dispensed (other than by pharmacy staff) rather than administered, the drugs, devices or related materials must be dispensed by the physician or an emergency room nurse or certified physician assistant at the direction of a physician. If the physician in an emergency room does not personally dispense, then prescription drugs, devices and related materials for outpatient use must be packaged in containers from the pharmacy practice site in amounts not to exceed a twelve (12) hour period or with products commercially prepared for multiple dose therapy (e.g., ophthalmic products, topical products, otic drops) in the smallest available package. These prescription drugs, devices or related materials shall be dispensed only after a medical or prescription order has been issued and recorded in the emergency room and shall be labeled with appropriate labeling.

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-404(1), (8), (11), (15), (19), (28), and (34), and 63-10- 504(b)(1) and (2).
Administrative History: Original rule filed February 7, 1983; effective March 9, 1983. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendments filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-04-.17 INVESTIGATIONAL DRUGS

(1) The pharmacist in charge in coordination with the institutional facility, medical and nursing staff and, if appropriate, the pharmaceutical manufacturer, shall develop policies and procedures for the approval, management, distribution and control of investigational drug studies. The process shall ensure that such studies contain safeguards for the patient, for the institution and for the scientific integrity of the study. Each patient or the patient’s legal guardian must freely consent, in writing, to treatment with the drugs, unless otherwise not required by federal law. The pharmacist is responsible to the institution and to the principal investigator for seeing that procedures for the control of investigational drugs are developed and implemented when needed.

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-404(14) and (26), and 63-10-504(b)(1) and (2).
Administrative History: Original rule filed February 7, 1983; effective March 9, 1983. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendments filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-04-.18 MONTHLY INSPECTIONS

The pharmacist in charge shall be responsible (personally or by qualified designee) for documented monthly inspections of all drugs, devices and related materials kept at nursing stations, surgery, delivery rooms, emergency rooms, clinics, and any other area of the facility. Records of such inspections shall be dated, signed and maintained so as to be readily retrievable at the pharmacy practice site for at least two (2) years. These inspections must assure the following:

(1) Test reagents, germicides, and disinfectants are stored separately from drugs, devices and related materials;

(2) External drugs, devices and related materials are stored separately from internal drugs, devices and related materials;

(3) Thermolabile drugs are stored at the proper temperature;

(4) Drugs, devices and related materials requiring special storage conditions to ensure their stability are properly stored;

(5) There are no outdated or deteriorated drugs, devices or related materials;

(6) All drugs, devices and related materials are properly labeled;

(7) Emergency drugs, devices and related materials are stored in accordance with rule 1140-04- .10;

(8) Medicine cabinets, carts and storage areas are accessible to authorized personnel only;

(9) Dispensing of controlled substances is properly and adequately documented;

(10) Telephone numbers of regional poison control centers and other emergency assistance organizations are posted;

(11) Metric-apothecaries’ weight and measure conversion tables and charts are available; and (12) Adequate pharmaceutical references for the drugs administered in that location are available.

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-404(8), (14), and (28), and 63-10-504(b)(1) and (2).
Administrative History: Original rule filed February 7, 1983; effective March 9, 1983. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendments filed November 22, 2016; effective February 20, 2017.

Chapter 1140-05 Continuing Education

Tenn. Comp. R. & Regs. 1140-05-.01 REQUIREMENTS FOR PHARMACIST LICENSE RENEWAL

(1) Every person licensed as a pharmacist shall complete at least thirty (30) hours of continuing pharmaceutical education during each two (2) year license cycle. The required thirty (30) hours shall consist of at least fifteen (15) hours obtained through live contract programs. In order to fulfill the fifteen (15) live contact hour requirement, a pharmacist shall obtain the hours from a program designated as “live” by the ACPE-approved provider, from a program that is approved by the Board prior to the expiration of the pharmacist’s license or from an out-of-state program that is approved by the board of pharmacy in the state where the program was presented.

(2) Notwithstanding paragraph one (1) of this rule, no pharmacist shall be required to complete any continuing pharmaceutical education during a two (2) year license cycle if that pharmacist presents proof that during all or part of the license cycle the pharmacist was enrolled in a recognized academic program pursuing a pharmacy degree, a doctor of medicine degree, a doctor of osteopathic medicine degree, a doctor of dental surgery degree, or an advanced or graduate degree in a health-related science; or participating in a pharmacy residency or fellowship program; or engaged in a course of study leading to certification as a nurse practitioner or a physician assistant.

(3) The board may waive the requirements of this rule upon a showing of emergency, illness, or other good cause.

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-306, 63-10-404(5) and (26), 63-10-504(b)(1), and 63- 10-506(g).
Administrative History: Original rule filed December 5, 1984; effective January 4, 1985. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendment filed November 24, 2008; effective February 7, 2009.

Tenn. Comp. R. & Regs. 1140-05-.02 REPORTING SYSTEM

(1) Each pharmacist shall submit to the board with the license renewal form, and on a form provided by the Tennessee Board of Pharmacy, a sworn statement indicating that the pharmacist has completed the required number of continuing pharmaceutical education hours.

(2) The board shall not renew the license of any pharmacist until the applicant has submitted the required sworn statement indicating that the pharmacist has completed the required number of continuing pharmaceutical education contact hours during the previous license cycle.

(3) The licensee shall produce proof of the completion of the required number of continuing pharmaceutical education hours upon the request of the board or its designee.

(4) Falsification of the continuing pharmaceutical education sworn statement may result in the probation, suspension or revocation of the pharmacist’s license and/or the imposition of a civil penalty not to exceed one thousand dollars ($1,000.00) with the imposition of a requirement for additional continuing education if appropriate.

History

Authority: T.C.A. §§ 56-1-308, 63-10-304, 63-10-306, 63-10-504(b)(1), and 63-10-506.
Administrative History: Original rule filed December 5, 1984; effective January 4, 1985. Amendment filed November 17, 1994; effective March 30, 1995. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendment filed August 19, 2002; effective November 2, 2002. Amendments filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-05-.03 RECOGNITION OF PROGRAMS

The board will recognize any continuing pharmaceutical education hours obtained from an ACPEapproved provider.

History

Authority: T.C.A. §§ 63-10-404(5) and 63-10-504(b)(1).
Administrative History: Original rule filed December 5, 1984; effective January 4, 1985. Amendment filed November 17, 1994; effective March 30, 1995. Repeal and new rule filed May 11, 1998; effective July 25, 1998.

Tenn. Comp. R. & Regs. 1140-05-.04 FALSIFICATION OF RECORDS

Any pharmacist who alters, forges, or falsifies, or causes to be altered, forged, or falsified any information, documents, or records required to be kept or submitted by this Chapter shall be subject to disciplinary action by the Board under T.C.A. § 63-10-305(6).

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-404(2) and (26), and 63-10-504(b)(1).
Administrative History: Original rule filed December 5, 1984; effective January 4, 1985. Amendment filed November 17, 1994; effective March 30, 1995. Repeal and new rule filed May 11, 1998, effective July 25, 1998. Amendments filed November 22, 2016; effective February 20, 2017.

Chapter 1140-06 Nuclear Pharmacy Practice Sites

Tenn. Comp. R. & Regs. 1140-06-.01 APPLICABILITY

The provisions of this Chapter are in addition to, and not in substitution for, other applicable laws and rules administered by the board, the State Board of Radiological Health.

History

Authority: T.C.A. §§ 63-10-304 and 63-10-504(b)(1).
Administrative History: Original chapter filed January 26, 1987; effective April 29, 1987. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Administrative changes made to the authority of this chapter on February 20, 2017.

Tenn. Comp. R. & Regs. 1140-06-.02 GENERAL REQUIREMENTS

(1) A nuclear pharmacy practice site shall contain adequate space, commensurate with the scope of services required and provided. The board may, upon request, exempt a nuclear pharmacy practice site handling radioactive drugs exclusively from the minimum space requirements for pharmacy practice sites.

(2) The compounding and dispensing area for radioactive drugs shall be separate from the compounding and dispensing area for non-radioactive drugs, and shall be secured from unauthorized personnel.

(3) All pharmacy practice sites handling radiopharmaceuticals shall provide adequate radioactive storage and product decay area, preferably separate from and exclusive of the hot laboratory and the compounding, dispensing, quality assurance, and office areas.

A nuclear pharmacy practice site shall only dispense radiopharmaceuticals which comply with acceptable professional standards of radiopharmaceutical quality assurance.

(5) A pharmacist may transfer to authorized persons radioactive materials not intended for drug use, in accordance with T.C.A. § 68-202-206. A nuclear pharmacy practice site may also furnish radiopharmaceuticals for office use to authorized practitioners for individual patient use.

(6) In addition to any labeling requirements of the board for non-radioactive drugs, the immediate outer container of a radioactive drug to be dispensed shall also be labeled with:

(a) The standard radiation symbol;

(b) The words "Caution - Radioactive Material";

(d) The chemical form;

(e) The amount of radioactive material contained, in millicuries or microcuries;

(f) If a liquid, the volume;

(g) The calibration time for the amount of radioactivity contained;

(h) The expiration time; and (i) The name, address, and telephone number of the nuclear pharmacy practice site.

(7) The immediate container shall be labeled with:

(a) The standard radiation symbol;

(b) The words "Caution - Radioactive Material";

(8) The amount of radioactivity shall be determined by radiometric methods for each product immediately prior to dispensing.

(9) A nuclear pharmacy practice site shall conduct and keep proper records of appropriate internal test assessments on all radiopharmaceuticals, with interpretation of the resulting data to determine suitability for use in humans.

(10) A nuclear pharmacy practice site shall conduct authentication of product history by identifying and keeping proper records of the purchasing source, the ultimate fate, and any intermediate handling of any component of a radiopharmaceutical.

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-404(4),(11),(16),(28), 63-10-504(b)(1), 63-10- 504(b)(1),(2), and 63-10-504(j).
Administrative History: Original chapter filed January 26, 1987; effective April 29, 1987. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Administrative changes made to the authority of this chapter on February 20, 2017.

Tenn. Comp. R. & Regs. 1140-06-.03 LIBRARY

Each nuclear pharmacy practice site shall maintain an adequate reference library (printed or electronic) consistent with its scope of practice. The reference library shall include a current edition of the Tennessee Pharmacy Laws issued by the Tennessee Board of Pharmacy and may include current material regarding the technical, clinical, and professional components of the practice of pharmacy, with particular emphasis in the area in which the pharmacy specializes.

History

Authority: T.C.A. § 63-10-304.
Administrative History: Original chapter filed January 26, 1987; effective April 29, 1987. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendment filed November 24, 2008; effective February 7, 2009.

Tenn. Comp. R. & Regs. 1140-06-.04 EQUIPMENT

Each nuclear pharmacy practice site shall contain at least the following equipment:

(1) Vertical laminar flow hood;

(2) Dose calibrator;

(3) Refrigerator;

(4) Room monitor;

(5) Portable survey meter;

(6) Single or multiple channel scintillation counter;

(7) Microscope;

(8) Radio chemical exhaust hood and filter system, only if required for licensing by the State Board of Radiological Health.

(9) Such other equipment as may be required by the State Board of Radiological Health.

History

Authority: T.C.A. §§ 63-10-304 and 63-10-504(b)(1),(2).
Administrative History: Original chapter filed January 26, 1987; effective April 29, 1987. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Administrative changes made to the authority of this chapter on February 20, 2017.

Chapter 1140-07 Sterile Product Preparation in Pharmacy Practice

Tenn. Comp. R. & Regs. 1140-07-.01 APPLICABILITY

The provisions of this Chapter shall apply to all pharmacy practice sites and pharmacists, pharmacy interns, pharmacy technicians and supportive personnel involved in the compounding and dispensing of sterile products.

History

Authority: T.C.A. §§ 63-10-404(4), (11), (26), (28), (29), and (30) and 63-10-504(b)(1), (2). Administrative History Original rule filed October 1, 1987; effective November 15, 1987. Amendment filed March 30, 1994; effective June 13, 1994. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendments filed December 15, 2023; effective March 14, 2024. Amendments expired pursuant to Chapter 827, § 1 of the 2024 Public Acts, effective May 1, 2024, and the rules reverted to their previous statuses.

Tenn. Comp. R. & Regs. 1140-07-.02 STANDARDS

(1) All sterile products shall be prepared in compliance with applicable USP standards for pharmaceutical compounding.

(2) The Board of Pharmacy, upon a showing of good cause and in the best interest of the public health, safety and welfare, may waive the requirements of any applicable portion of USP standards.

(a) All waiver requests submitted pursuant to this part shall be submitted in writing.

(b) The Board of Pharmacy may authorize the Executive Director to exercise some, or all, of its waiver authority under this part.

(3) Noncompliance by a licensee with applicable standards and guidelines, or any other violation of the provisions of this rule shall be considered unprofessional conduct within the meaning of T.C.A. § 63-10-305 and a violation of a duly promulgated rule of the Board of Pharmacy.

(4) Any licensed pharmacy which compounds sterile products, except hospital pharmacies compounding for inpatients of a hospital, shall submit to the Board of Pharmacy, on a quarterly basis, a report listing the quantity of high risk or batch sterile products, as defined by USP standards, compounded and dispensed during the previous quarterly period and any other information as required by USP standards.

(a) Quarterly reports submitted pursuant to this paragraph shall be submitted by the 15th day of the month following the end of each calendar quarter.

(b) In any calendar year where any one of the above dates fall on a weekend or official state holiday, all quarterly reports due on that date shall be submitted on the following business day.

(c) The format for reports submitted pursuant to this paragraph shall be determined by the Board of Pharmacy through policy and made available to the public on the Board of Pharmacy’s website.

(5) Any licensed pharmacy which compounds and dispenses sterile products shall provide at a minimum upon request of the Board of Pharmacy the following information for any sterile drug product compounded, dispensed, traded, sold, or otherwise distributed:

(a) Name, strength, and dosage form;

(b) Quantity compounded, dispensed, traded, sold, or otherwise distributed during the preceding quarterly period;

(d) The beyond-use date;

(e) Storage requirements;

(f) Labels and labeling with appropriate beyond-use date and instructions for storage and use.

(6) Any licensed pharmacy which compounds and dispenses sterile products must ensure that the following information is on file at the practice site and readily accessible for sterile products:

(a) Documentation of the name and strength of all drug products compounded over the past two (2) years;

(b) The sources and lot numbers of the components used in those drug products;

(d) The name of the person who prepared the drug product;

(e) The name of the pharmacist who approved the drug product;

(f) The name of the practitioner or the name of the patient or healthcare entity who received the compounded drug product;

(g) The results of any sampling, testing or other quantitative evaluation conducted for the purposes of quality control for any sterile compounded products, as defined by chapter 1140-01, compounded over the past two (2) years.

History

Authority: T.C.A. §§ 63-10-204, 63-10-216, 63-10-301, 63-10-304, and 63-10-306.
Administrative History: Original rule filed July 11, 2014; effective October 9, 2014. Amendments filed November 22, 2016; effective February 20, 2017. Amendments filed December 15, 2023; effective March 14, 2024. Amendments expired pursuant to Chapter 827, § 1 of the 2024 Public Acts, effective May 1, 2024, and the rules reverted to their previous statuses.

Tenn. Comp. R. & Regs. 1140-07-.03 PERSONNEL

(1) The pharmacist in charge or pharmacist designee shall be responsible for, at a minimum, the following:

(a) Procurement, storage, compounding, labeling, repackaging, dispensing, and distribution of all prescription drugs and devices and related materials necessary in compounding and dispensing sterile products;

(b) Establishment of policies and procedures for the compounding and dispensing of sterile products;

(c) Documentation of competency in aseptic techniques of all pharmacists, pharmacy interns and pharmacy technicians. The aseptic technique of each person compounding and dispensing sterile products shall be observed and evaluated as satisfactory during orientation and training and at least on an annual basis or whenever unacceptable techniques are observed or detected;

(d) Establishment of a quality assurance program;

(e) Reviewing and updating annually all policies and procedures; and (f) Provision of sterile products on a twenty four (24) hour a day basis.

(2) All pharmacists, pharmacy interns and pharmacy technicians as defined in 1140-02-.02 responsible for compounding or dispensing sterile products shall:

(a) Obtain practical and/or academic training in the compounding and dispensing of sterile products;

(b) Complete annual continuing education related to sterile product compounding and dispensing and utilization; and (c) Maintain, in the pharmacy practice site, documentation of completion of the required training and continuing education.

(d) Use proper aseptic technique in all sterile product compounding as defined by the pharmacy practice site’s policies and procedures.

(3) A pharmacist shall be available to respond to patients' and other health care practitioners' information needs on a twenty four (24) hour a day basis.

(4) The pharmacist in charge shall be assisted by such additional pharmacists, pharmacy interns, pharmacy technicians as defined by 1140-02-.02 and supportive personnel necessary to operate the pharmacy practice site competently and safely and to provide services in a timely and appropriate manner.

(5) All pharmacists, pharmacy interns and pharmacy technicians must be qualified through an appropriate combination of specific training and experience to operate or manipulate any item of equipment, apparatus, or device to which such pharmacists, interns and technicians will be assigned to use to compound and dispense sterile products.

(6) A written record of initial and subsequent training and competency evaluations shall be maintained in the pharmacy practice site and contain the following information:

(a) Name of the person receiving the training or evaluation;

(b) Date(s) of the training or evaluation;

(c) General description of the topics covered; and (d) Signature of the person receiving the training or evaluation and the pharmacist in charge or pharmacist designee of the pharmacist in charge.

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-404(4), (5), (8), (11), (14), (16), (26), (27), (29), and (30), and 63-10-504(b)(1), (2).
Administrative History: Original rule filed October 1, 1987; effective November 15, 1987. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Rule was previously numbered 1140-07-.02, but was renumbered to 1140-07-.03 with the addition of a new 1140- 07-.02 filed July 11, 2014; effective October 9, 2014. Amendments filed November 22, 2016; effective February 20, 2017. Amendments filed December 15, 2023; effective March 14, 2024. Amendments expired pursuant to Chapter 827, § 1 of the 2024 Public Acts, effective May 1, 2024, and the rules reverted to their previous statuses.

Tenn. Comp. R. & Regs. 1140-07-.04 with the addition of a new 1140-07-.02 filed July 11, 2014; effective October 9, 2014.

Amendments filed July 11, 2014; effective October 9, 2014. Amendments filed November 22, 2016; effective February 20, 2017. Amendments filed December 15, 2023; effective March 14, 2024.

Amendments expired pursuant to Chapter 827, § 1 of the 2024 Public Acts, effective May 1, 2024, and the rules reverted to their previous statuses.

Tenn. Comp. R. & Regs. 1140-07-.05 POLICY AND PROCEDURE MANUAL

(1) A policy and procedure manual related to sterile product compounding shall be available for inspection at the pharmacy practice site. The manual shall include policies and procedures for sterile compounding pursuant to USP standards, and shall, at a minimum, include:

(a) Security;

(b) Equipment;

(d) Reference materials;

(e) Prescription drug and device and related material storage;

(f) Prescription drug and device and related material compounding and dispensing;

(g) Prescription drug and device and related material labeling and relabeling;

(h) Prescription drug and device and related material destruction and returns;

(i) Dispensing of sterile products;

(j) Record keeping;

(k) Quality assurance;

(l) Quality control;

(m) Duties for pharmacist(s), pharmacy intern(s), pharmacy technician(s) and supportive personnel;

(n) Public safety relative to harmful sterile products, including the active notification of patients if they may be affected by a product found to have a defect or an out-ofspecification result including any recall policy and procedures;

(o) Attire;

(p) Pharmacist, pharmacy intern, and pharmacy technician training;

(q) Compliance with all applicable USP standards; and (r) Response to adverse events, outbreaks, and other public health threats associated with products compounded, dispensed, manufactured, propagated, distributed, or otherwise processed at the facility, including procedures for the rapid compilation and dissemination of records to appropriate authorities.

(2) Any licensed facility which engages in sterile compounding shall conduct an annual review of its policy and procedure manual, and shall update its policy and procedure manual as necessary.

(3) Failure by any licensee or registrant to comply with its policy and procedure manual, or any

part of this rule shall be considered a violation of a duly promulgated rule of the Board of Pharmacy and may be considered dishonorable, immoral, unethical or unprofessional conduct within the meaning of T.C.A. § 63-10-305(6).

History

Authority: T.C.A. §§ 63-10-204, 63-10-216, 63-10-301, 63-10-304, 63-10-306, 63-10-404(4), (8), (14), (26), (29), and (30), and 63-10-504(b)(1), (2).
Administrative History: Original rule filed October 1, 1987; effective November 15, 1987. Amendment filed November 16, 1992; effective January 8, 1993. Amendment filed March 30, 1994; effective June 13, 1994. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Emergency rules filed January 31, 2014; effective through July 30, 2014. Emergency rules expired effective July 31, 2014, and the rules reverted to their previous statuses. Amendments filed July 11, 2014; effective October 9, 2014. Rule was previously numbered 1140-07-.04, but was renumbered to 1140-07-.05 with the addition of a new 1140-07-.02 filed July 11, 2014; effective October 9, 2014. Amendments filed July 11, 2014; effective October 9, 2014. Amendments filed December 15, 2023; effective March 14, 2024. Amendments expired pursuant to Chapter 827, § 1 of the 2024 Public Acts, effective May 1, 2024, and the rules reverted to their previous statuses.

Tenn. Comp. R. & Regs. 1140-07-.06 , but was renumbered to 1140-07-.07 with the addition of a new 1140-07-.02 filed July 11, 2014; effective October 9, 2014. Amendments filed December 15, 2023; effective March 14, 2024.

Amendments expired pursuant to Chapter 827, § 1 of the 2024 Public Acts, effective May 1, 2024, and the rules reverted to their previous statuses.

Tenn. Comp. R. & Regs. 1140-07-.07 HAZARDOUS PRODUCTS

(1) Physical Requirements.

(a) If the pharmacy practice site is engaged in the compounding of hazardous sterile products, a suitable facility to prepare such products and minimize the risk associated with such products shall be provided.

(b) Such pharmacy practice site shall be designed and equipped for storage and have a procedure for disposal of materials containing hazardous residues in accordance with state and federal laws.

(1) A dedicated Class II, Type A contained vertical flow biohazard cabinet is the minimally acceptable compounding site for the routine compounding of hazardous sterile products.

(2) Hazardous sterile products shall be segregated within the pharmacy practice site and storage areas so identified.

(2) Dispensing.

(a) Prepared doses of hazardous sterile products for patients shall be placed in an appropriate outer wrap to minimize the risk exposure in case of accidental rupture of the primary container.

(b) Reasonable effort shall be made to assure that all hazardous sterile product primary containers and waste are removed from the site of use and disposed of as hazardous waste in accordance with applicable state and federal laws.

(3) Training.

(a) As part of the training for all pharmacists, pharmacy interns and pharmacy technicians involved in compounding of hazardous sterile products, an annual certification must be made by each pharmacist, pharmacy intern and pharmacy technician and the pharmacist in charge that each has read and understands the latest editions of:

Work Practice Guidelines for Personnel Dealing with Cytotoxic (Antineoplastic)

Drugs (Occupational); and 2. The American Society of Health-System Pharmacists (ASHP) technical assistance bulletin on handling cytotoxic and hazardous substances.

(4) Hazardous sterile products dispensed shall bear a distinctive warning label with an appropriate caution statement thereon.

(5) Gloving and gowning shall be required in the compounding of hazardous sterile products.

Gloves should be rinsed frequently with a sanitizing agent (e.g., seventy percent (70%) isopropyl alcohol) and shall be changed when the integrity of the gloves is compromised.

(6) In the compounding of hazardous sterile products, a protective disposable gown made of lint-free low permeability fabric with a closed front, long sleeves and elastic or knit closed cuffs with cuffs tucked under the gloves shall be worn. Gowns and gloves used in the compounding of hazardous sterile products shall not be worn outside the sterile product compounding area.

History

Authority: T.C.A. §§ 63-10-404(4), (11), (26), (27), (28), (29), and (30), and 63-10-504(b)(1), (2).
Administrative History: Original rule filed October 1, 1987; effective November 15, 1987. Amendment filed March 30, 1994; effective June 13, 1994. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Emergency rules filed January 31, 2014; effective through July 30, 2014. Emergency rules expired effective July 31, 2014, and the rules reverted to their previous statuses. Rule was previously numbered

Tenn. Comp. R. & Regs. 1140-07-.08 with the addition of a new 1140-07-.02 filed July 11, 2014; effective October 9, 2014.

Amendments filed July 11, 2014; effective October 9, 2014. Amendments filed December 15, 2023; effective March 14, 2024. Amendments expired pursuant to Chapter 827, § 1 of the 2024 Public Acts, effective May 1, 2024, and the rules reverted to their previous statuses.

Tenn. Comp. R. & Regs. 1140-07-.09 QUALITY ASSURANCE

(1) There shall be a documented, ongoing quality assurance program that monitors process validation; pharmacist(s), pharmacy intern(s), and pharmacy technician(s) performance; equipment; and environment.

(2) The program shall be designed to assure that the pharmacy practice site is capable of consistently compounding quality sterile products.

(3) All quality assurance programs shall follow applicable USP standards.

(4) As part of its quality assurance program, any licensed facility which engages in sterile compounding shall perform a gap analysis pursuant to guidelines adopted by the Board of Pharmacy. Any exceptions or serious deficiencies noted in this analysis shall be reported to the Board of Pharmacy.

(5) Failure by any licensee or registrant to comply with its quality assurance program shall be considered a violation of a duly promulgated rule of the Board of Pharmacy and may be considered dishonorable, immoral, unethical or unprofessional conduct within the meaning of T.C.A. § 63-10-305(6).

History

Authority: T. C.A. §§ 63-10-204, 63-10-216, 63-10-301, 63-10-304, 63-10-306, 63-10-404(26), (28), (29), and (30), and 63-10-504(b)(1), (2).
Administrative History: Original rule filed March 30, 1994; effective June 13, 1994. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Emergency rules filed January 31, 2014; effective through July 30, 2014. Emergency rules expired effective July 31, 2014, and the rules reverted to their previous statuses. Rule was previously numbered 1140-07-.08, but was renumbered to 1140-07-.09 with the addition of a new 1140-07-.02 filed July 11, 2014; effective October 9, 2014. Amendments filed July 11, 2014; effective October 9, 2014. Amendments filed December 15, 2023; effective March 14, 2024. Amendments expired pursuant to Chapter 827, § 1 of the 2024 Public Acts, effective May 1, 2024, and the rules reverted to their previous statuses.

Tenn. Comp. R. & Regs. 1140-07-.10 with the addition of a new 1140-07-.02 filed July 11, 2014; effective October 9, 2014.

Amendments filed December 15, 2023; effective March 14, 2024. Amendments expired pursuant to

Chapter 827, § 1 of the 2024 Public Acts, effective May 1, 2024, and the rules reverted to their previous statuses.

Chapter 1140-08 Civil Penalties

Tenn. Comp. R. & Regs. 1140-08-.01 CIVIL PENALTIES

(1) The Board may, in a lawful proceeding respecting licensing (as defined in the Uniform Administrative Procedures Act), in addition to or in lieu of any other lawful disciplinary action, assess civil penalties for violations of statutes, rules or orders enforceable by the Board in accordance with the following schedule:

Violation Penalty T.C.A. Section 63-10-305(1) $0 - $1000 T.C.A. Section 63-10-305(2) $0 - $1000 T.C.A. Section 63-10-305(3) $0 - $1000 T.C.A. Section 63-10-305(4) $0 - $1000 T.C.A. Section 63-10-305(5) $0 - $1000 T.C.A. Section 63-10-305(6) $0 - $1000 T.C.A. Section 63-10-305(7) $0 - $1000 T.C.A. Section 63-10-305(8) $0 - $1000 In determining the amount of any civil penalty to be assessed pursuant to this rule the board may consider such factors as the following:

(a) Willfulness of the violation.

(b) Repetitions of the violation.

(2) Each violation of any statute, rule or order enforceable by the board shall constitute a separate and distinct offense and render the person committing the offense subject to a separate fine for each violation.

(3) Each day any person, partnership, firm, or corporation or agency causes or permits a pharmacy practice site to be conducted in violation of any statutes, rules or orders enforceable by the board constitutes a separate and distinct offense and renders such person, partnership, firm, or corporation or agency subject to a separate fine for each day.

History

Authority: T.C.A. §§ 63-10-304, 63-10-305, 63-10-504(b)(1), and 63-10-505.
Administrative History: Original rule filed November 15, 1989; effective December 30, 1989. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendments filed November 22, 2016; effective February 20, 2017.

Chapter 1140-09 Manufacturers, Outsourcing Facilities, Oxygen Suppliers and Wholesalers/Distributors

Tenn. Comp. R. & Regs. 1140-09-.01 MANUFACTURER, OUTSOURCING FACILITY, OXYGEN SUPPLIER AND

WHOLESALER/DISTRIBUTOR LICENSING.

(1) Every manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor, before engaging in the manufacture, sale or distribution of prescription drugs and prescription devices in this state, must be licensed by the Board in accordance with this chapter.

(2) An applicant with physical facilities in this state must obtain and display prominently a separate license for each principal place of business where the applicant manufactures or distributes prescription drugs and prescription devices.

(3) The requirement of a license shall not apply to the following types of distributions:

(a) Intracompany sales;

(b) The purchase or other acquisition by a hospital or other health care entity that is a member of a group purchasing organization of a prescription drug for its own use from the group purchasing organization or from other hospitals or health care entities that are members of such organizations;

(c) The sale, purchase or trade of a prescription drug or an offer to sell, purchase, or trade a prescription drug by a charitable organization described in section 501(c)(3) of the Internal Revenue Code of 1954 to a nonprofit affiliate of the organization to the extent otherwise permitted by law;

(d) The sale, purchase, or trade of a prescription drug or an offer to sell, purchase, or trade a prescription drug among hospitals or other health care entities that are under common control; for purposes of this subparagraph, “common control” means the power to direct or cause the direction of the management and policies of a person or an organization whether by ownership of stock, voting rights, by contract or otherwise;

(e) The sale, purchase, or trade of a prescription drug or an offer to sell, purchase, or trade a prescription drug for emergency medical reasons; for purpose of this subparagraph, “emergency medical reasons” includes transfers of prescription drugs by a retail pharmacy practice site to alleviate a temporary shortage;

(f) The sale, purchase, or trade of a prescription drug, an offer to sell, purchase or trade a prescription drug, or the dispensing of a prescription drug pursuant to a medical or prescription order;

(g) The distribution of prescription drug samples by manufacturers’ representatives; or (h) The sale, purchase, or trade of blood and blood components intended for transfusion.

(i) The sale, purchase, or trade of a prescription drug, or an offer to sell, purchase or trade of a prescription drug by a pharmacy practice site to another pharmacy practice site or to authorized prescribing practitioners, except that the total gross dollar volume of such transfers shall not exceed five percent (5%) of the total medical and prescription orders sales revenue of either the transferor or transferee pharmacy during any twelve (12) consecutive month period.

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-305, 63-10-306, 63-10-404(2), (8), (14), (18), (37), 63- 10-504(b)(1), and 63-10-506(f).
Administrative History: Original rule filed January 7, 1992; effective February 21, 1992. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Emergency rules filed January 31, 2014; effective through July 30, 2014. Emergency rules expired effective July 31, 2014, and the rules reverted to their previous statuses. Amendment filed July 11, 2014; effective October 9, 2014. Amendments filed March 24, 2015; effective June 22, 2015. Amendments filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-09-.02 MINIMUM INFORMATION REQUIRED

(1) The board shall require the following minimum information from each manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor applying for a license or any renewal of such license:

(a) The name, full business address, and telephone number of the manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor;

(b) All trade or business names used by the manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor;

(c) Addresses, telephone numbers, and the names of contact persons for all facilities used by the manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor for storage, handling, and distribution;

(d) The type of ownership or operation (i.e., partnership, corporation, or sole proprietorship); and (e) The name(s) of the owner and/or operator of the manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor, including:

If a person, the name of the person;
If a partnership, the name of each partner, and the name of the partnership;
If a corporation, the name and title of each corporate officer and director, the corporate names, and the name of the state of incorporation;
If a sole proprietorship, the full name of the sole proprietor and the name of the business entity;
DEA registration number if applicable; and 6. The results of a criminal background check for the owner or manager of the facility seeking licensure, submitted directly to the Board of Pharmacy by the vendor identified in the Board of Pharmacy’s licensure application materials.

(2) Applicants seeking to register as manufacturers or outsourcing facilities shall provide the following materials to the Board of Pharmacy:

(a) Proof of registration with the Food and Drug Administration as a manufacturer or outsourcing facility and the most current inspection by that agency, or correspondence or other written proof from the Food and Drug Administration which states that registration with that agency is unnecessary;

(b) The name and contact information of the owner, the owner’s agent, or another such individual employed at or contracted by the applicant that can be reached at any time by the Board of Pharmacy, the Department of Health or any agents thereof in the event of a potential or actual public health threat related to the sterility or potency of any drug or biologic product manufactured, wholesaled or distributed by the applicant.

(3) Applicants seeking to obtain a sterile compounding modifier registration shall provide the following materials to the Board of Pharmacy:

(a) Upon request by the Board of Pharmacy or the executive director, a list of sterile products currently being manufactured, wholesaled and distributed;

(b) The name and contact information for any laboratory, corporation, or other organization that may perform sterility and potency testing, or similar procedures for the purposes of quality assurance on any drug or biologic product produced by the applicant;

(4) Changes in any information in paragraphs (1), (2), or (3) of this rule shall be submitted in writing to the Board of Pharmacy immediately.

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-305, and 63-10-306.
Administrative History: Original rule filed January 7, 1992; effective February 21, 1992. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Emergency rules filed January 31, 2014; effective through July 30, 2014. Emergency rules expired effective July 31, 2014, and the rules reverted to their previous statuses. Amendments filed July 11, 2014; effective October 9, 2014. Repeal and new rule filed March 24, 2015; effective June 22, 2015. Amendments filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-09-.03 MINIMUM QUALIFICATIONS

(1) The board shall consider, at a minimum, the following factors in reviewing an application for a license as a manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor:

(a) Any convictions of the applicant under any federal, state, or local laws relating to drug samples or distribution of controlled substances;

(b) Any felony convictions of the applicant under federal, state, or local laws;

(c) The applicant’s past experience in the manufacturing or distribution of prescription drugs and prescription devices, including controlled substances;

(d) The furnishing by the applicant of false or fraudulent material in any application made in connection with manufacturing or distribution;

(e) Suspension or revocation by federal, state, or local government of any license currently or previously held by the applicant for the manufacture or distribution of any drugs, including controlled substances, prescription drugs and prescription devices;

(f) Compliance with licensing requirements under previously granted licenses, if any;

(g) Compliance with requirements to maintain and/or make available to the board or to federal, state, or local law enforcement officials those records required by federal, state or local laws; and (h) Any other factors or qualifications the board considers relevant to and consistent with the public health and safety.

(2) The board shall have the right to deny a license to an applicant if it determines that the granting of such a license would not be in the public interest.

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-305, 63-10-306, 63-10-404, 63-10-404(2), (6), (8), (14), (18), (37), 63-10-504, and 63-10-504(b)(1).
Administrative History: Original rule filed January 7, 1992; effective February 21, 1992. Repeal and new rule filed May 11, 1998, effective July 25, 1998. Emergency rules filed January 31, 2014; effective through July 30, 2014. Emergency rules expired effective July 31, 2014, and the rules reverted to their previous statuses. Amendment filed July 11, 2014; effective October 9, 2014. Amendment filed March 24, 2015; effective June 22, 2015. Amendments filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-09-.04 PERSONNEL

The board shall require that personnel employed by a manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor have appropriate education and/or experience to assume positions of responsibility for compliance with board requirements.

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-305, and 63-10-306.
Administrative History: Original rule filed January 7, 1992; effective February 21, 1992. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Emergency rules filed January 31, 2014; effective through July 30, 2014. Emergency rules expired effective July 31, 2014, and the rules reverted to their previous statuses. Amendment filed July 11, 2014; effective October 9, 2014. Repeal and new rule filed March 24, 2015; effective June 22, 2015.

Tenn. Comp. R. & Regs. 1140-09-.07 INSPECTIONS OF MANUFACTURERS AND WHOLESALERS/DISTRIBUTORS OF

MEDICAL DEVICES.

(1) Between December 1 and December 31 of each calendar year, manufacturers and wholesalers/distributors of a medical device shall submit any of the documents referenced in paragraphs (1)(a)–(c), below, which shall demonstrate immediate and continuous compliance with any and all federal and state laws and regulations and shall serve in lieu of a physical, on-site inspection conducted by the Board, subject to paragraph (3), below:

(a) A Form 482 issued by the United States Food and Drug Administration (“FDA”) as evidence of a facility inspection, and, if applicable, a response letter, as documented on a Form 483, from the FDA that indicates responses to the most recent inspection findings and demonstrates no further action is warranted by the manufacturer, wholesaler/distributor or FDA; or (b) Documented evidence, such as International Organization for Standardization (“ISO”) 13485 certification number, date of visit and expiration date of certificate, from a Notified Body that the firm is in good standing and their ISO 13485 certification is valid.

Responses may include dates of Phase 1 and Phase 2 assessments from a Notified Body/Registrar in the certification process; or (c) Evidence of successful Medical Device Single Audit Program certification. Alternatively, a report including corrective action plans for a Medical Device Single Audit Program certification and approval.

(2) Failure to submit documents referenced in subparagraphs 1(a)–(c), above, or submission of a self-audit which does not demonstrate immediate and continuous compliance with any and all federal and state laws and regulations may result in a request from the Board for the production of any and all corresponding documents related to any mandatory reporting or compliance requirements directed by the federal government or its agencies, the International Standards Organization or the Medical Device Single Audit Program.

(3) Notwithstanding any rule provision to the contrary, the Board retains authority to conduct any inspection or investigation of a manufacturer or wholesalers/distributors of a medical device when, in the Board’s sole determination, public health, safety, and welfare necessitates such an inspection or investigation.

History

Authority: T.C.A. §§ 63-10-304, 63-10-306, and 63-10-311.
Administrative History: New rule filed February 1, 2022; effective May 2, 2022.

Tenn. Comp. R. & Regs. 1140-09-.05 MINIMUM REQUIREMENTS FOR GENERAL OPERATION

The following shall be the minimum requirements for the storage and handling of prescription drugs and prescription devices and for the establishment and maintenance of prescription drug and prescription device distribution records by manufacturers, outsourcing facilities, oxygen suppliers and wholesalers/distributors:

(1) Facilities. All facilities at which prescription drugs and prescription devices are stored, warehoused, handled, held, offered, marketed, or displayed shall:

(a) Be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;

(b) Have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions;

(c) Have a quarantine area for storage of prescription drugs and prescription devices that are outdated, damaged, deteriorated, misbranded, or adulterated, or that are in immediate or sealed, secondary containers that have been opened;

(d) Be maintained in a clean and orderly condition, and (e) Be free from infestation by insects, rodents, birds, or vermin of any kind.

(2) Security.

(a) All facilities shall be secure from unauthorized entry.

Access from outside the premises shall be kept to a minimum and be wellcontrolled.
The outside perimeter of the premises shall be well-lighted.
Entry into areas where prescription drugs and prescription devices are held shall be limited to authorized personnel.

(b) All facilities shall be equipped with an alarm system to detect entry after hours.

(c) All facilities shall be equipped with a security system that will provide suitable protection against theft and diversion. When appropriate, the security system shall provide protection against theft or diversion that is facilitated or hidden by tampering with computers or electronic records.

(3) Storage. All prescription drugs and prescription devices shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such drugs and devices, or with requirements in the current edition of an official compendium, such as the United States Pharmacopeia/National Formulary (USP/NF).

(a) If no storage requirements are established for a prescription drug or prescription device it may be held at “controlled” room temperature, as defined in an official compendium, to help ensure that identity, strength, quality, and purity are not adversely affected.

(b) Appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, devices, and/or logs shall be utilized to document proper storage of prescription drugs and prescription devices.

(c) The record keeping requirements in paragraph (6) of this section shall be followed for all prescription drugs and prescription devices.

(4) Examination of materials.

(a) Upon receipt, each outside shipping container shall be visually examined for identity and to prevent the acceptance of contaminated prescription drugs that are otherwise unfit for distribution. This examination shall be adequate to reveal container damage that would suggest possible contamination or other damage to the contents.

(b) Each outgoing shipment shall be carefully inspected for identity of the prescription drug products and to ensure that there is no delivery of prescription drugs that have been damaged in storage or held under improper conditions.

(c) The record keeping requirements in paragraph (6) of this section shall be followed for all incoming and outgoing prescription drugs.

(5) Returned, damaged, and outdated prescription drugs and prescription devices.

(a) Prescription drugs and prescription devices that are outside, damaged, deteriorated, misbranded, or adulterated shall be quarantined and physically separated from other prescription drugs and prescription devices until destroyed or returned.

(b) Any prescription drugs and prescription devices whose immediate or sealed outer or sealed secondary containers have been opened or used shall be quarantined and physically separated from other prescription drugs and prescription devices until either destroyed or returned.

(c) If the conditions under which a prescription drug or prescription device has been returned cast doubt on safety, identity, strength, quality, or purity, then the prescription drug or prescription device shall be destroyed, or returned, unless examination, testing, or other investigation proves that the prescription drug or prescription device meets appropriate standards of safety, identity, strength, quality and purity. In determining whether the conditions under which a prescription drug or prescription device has been returned cast doubt on safety, identity, strength, quality, or purity, the manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor shall consider, among other things, the conditions under which the prescription drug or prescription device has been held, stored or shipped before or during return and the condition of the prescription drug or device or related material and its container, carton, or labeling, as a result of storage or shipping.

(d) The record keeping requirements in paragraph (6) of this section shall be followed for all outdated, damaged, deteriorated, misbranded, or adulterated prescription drugs and prescription devices.

(6) Record keeping.

(a) Manufacturers, outsourcing facilities, oxygen suppliers and wholesalers/distributors shall establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of prescription drugs and prescription devices. These records shall include the following information:

The source of the prescription drugs and prescription devices including the name and principal address of the seller or transferor, and the address of the location from which the prescription drugs and prescription devices were shipped;
The identity and quantity of the prescription drugs and prescription devices received and distributed or disposed of; and 3. The dates of receipt and distribution or other disposition of the prescription drugs and prescription devices.

(b) Inventories and records shall be made available for inspection and photocopying by authorized federal, state, or local law enforcement agency officials for a period of two (2) years following disposition of the prescription drugs and prescription devices.

(c) Records described in this paragraph that are kept at the inspection site or that can be immediately retrieved by computer or other electronic means shall be readily available for authorized inspection during the retention period. Records kept at a central location apart from the inspection site and not electronically retrievable shall be made available for inspection within two (2) working days of a request by an authorized official of a federal, state, or local law enforcement agency.

(7) Written policies and procedures. Manufacturers, outsourcing facilities, oxygen suppliers and wholesalers/distributors shall establish, maintain, and adhere to written policies and procedures, which shall be followed for the receipt, security, storage, inventory, and distribution of prescription drugs and prescription devices; including policies and procedures for identifying, recording, and reporting losses or thefts, and for correcting all errors and inaccuracies in inventories. Manufacturers, outsourcing facilities, oxygen suppliers and wholesalers/distributors shall include in written policies and procedures the following:

(a) A procedure whereby the older approved stock of a prescription drug or prescription device is distributed first. The procedure may permit deviation from this requirement, if such deviation is temporary and appropriate.

(b) A procedure to be followed for handling recalls and withdrawals of prescription drugs and prescription devices. Such procedures shall be adequate to respond to recalls and withdrawals due to:

Any action initiated at the request of the United States Food and Drug Administration or other federal, state, or local law enforcement or other government agency, including the board;
Any voluntary action by the manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor to remove defective or potentially defective prescription drugs and prescription devices from the market; or 3. Any action undertaken to promote public health and safety by replacing of an existing product with an improved product or new package design.

(c) A procedure to ensure that manufacturers, outsourcing facilities, oxygen suppliers and wholesalers/distributors prepare for, protect against, and respond to any crisis that affects security or operation of any facility in the event of strike, fire, flood, or other natural disaster, or other situations of local, state, or national emergency.

(d) A procedure to ensure that any outdated prescription drugs and prescription devices shall be segregated from other prescription drugs and prescription devices and either returned to the manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor or destroyed. This procedure shall provide for written documentation of the disposition of outdated prescription drugs and prescription devices. This documentation shall be maintained for two (2) years after disposition of the outdated prescription drugs and prescription devices.

(8) Responsible persons. Manufacturers, outsourcing facilities, oxygen suppliers and wholesalers/distributors shall establish and maintain lists of officers, directors, managers, and other persons in charge of distribution, storage, and handling, including a description of such persons’ duties and a summary of such persons’ qualifications.

(9) Compliance with federal, state, and local law. Manufacturers, outsourcing facilities, oxygen suppliers and wholesalers/distributors shall operate in compliance with applicable federal, state, and local laws and regulations.

(a) Manufacturers, outsourcing facilities, oxygen suppliers and wholesalers/distributors shall permit the board and authorized federal, state, and local law enforcement officials to enter and inspect premises and delivery vehicles, and to audit records and written operating procedures, at reasonable times and in a reasonable manner, to the extent authorized by law.

(b) Manufacturers, outsourcing facilities, oxygen suppliers and wholesalers/distributors that handle controlled substances shall register with the board and with the United States Drug Enforcement Administration (DEA) and shall comply with applicable state, local and DEA regulations.

(10) Salvaging and reprocessing. Manufacturers, outsourcing facilities, oxygen suppliers and wholesalers/distributors shall be subject to the provisions of any applicable federal, state, and local laws or regulations that relate to salvaging or reprocessing of prescription drugs and prescription devices.

(11) Upon request, the Board may waive selected portions of these requirements so long as any waiver granted is consistent with the Board’s authority under Tenn. Code Ann. Title 63, Chapters 1 and 10, and Tenn. Code Ann. Title 4, Chapter 5.

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-305, 63-10-306, 63-10-404(8), (18), (33), (37), and 63- 10-504(b)(1).
Administrative History: Original rule filed January 7, 1992; effective February 21, 1992. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Emergency rules filed January 31, 2014; effective through July 30, 2014. Emergency rules expired effective July 31, 2014, and the rules reverted to their previous statuses. Amendment filed July 11, 2014; effective October 9, 2014. Amendments filed March 24, 2015; effective June 22, 2015. Amendments filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-09-.06 MINIMUM REQUIREMENTS FOR STERILE PRODUCT OPERATION

(1) Any manufacturer, outsourcing facility or wholesaler/distributor licensed pursuant to this

chapter that also holds an active sterile compounding registration from the Board of Pharmacy and that holds a license or registration from the Federal Food and Drug Administration, shall comply with all applicable federal laws, regulations, and guidelines including, but not limited to:

(a) FDA Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs 21 CFR § 210;

(b) FDA Current Good Manufacturing Practice for Finished Pharmaceuticals 21 CFR § 211;

(2) Any manufacturer, outsourcing facility or wholesaler/distributor licensed pursuant to this

chapter who also holds an active sterile compounding registration from the Board of Pharmacy and who does not hold a license or registration from the federal Food and Drug Administration shall comply with all applicable USP standards.

(3) Any manufacturer, outsourcing facility or wholesaler/distributor licensed pursuant to this

chapter who also holds an active sterile compounding registration from the Board of Pharmacy shall comply with all other applicable Board of Pharmacy rules and all other applicable laws of this State.

(4) The Board of Pharmacy may waive any applicable USP standards upon a showing by the applicant that good cause exists and that a waiver would better promote public health, safety, and welfare.

History

Authority: T.C.A. §§ 63-10-204, 63-10-216, 63-10-304, 63-10-305, and 63-10-306.
Administrative History: Emergency rule filed January 31, 2014; effective through July 30, 2014. Emergency rule expired effective July 31, 2014, and the rule reverted to reserved status. Original rule filed July 11, 2014; effective October 9, 2014. Repeal and new rule filed March 24, 2015; effective June 22, 2015.

Chapter 1140-10 Rules of Procedure for Hearing Contested Cases

Tenn. Comp. R. & Regs. 1140-10 Rules of Procedure for Hearing Contested Cases

RULES

OF THE TENNESSEE BOARD OF PHARMACY

For Rules of Procedure for Hearing Contested Cases see Rules of the Secretary of State.

Authority: T.C.A. §§ 4-5-301, 63-10-304, and 63-10-504(b)(1). Administrative History: Administrative changes made to the authority of this chapter on February 20, 2017. -- 1 of 1 --

Chapter 1140-11 Controlled Substance Monitoring Database

Tenn. Comp. R. & Regs. 1140-11-.01 DEFINITIONS

(1) “ARCOS” (the “Automation of Reports and Consolidated Orders System”) is an automated, comprehensive drug reporting system, created pursuant to 21 U.S.C. § 827 and administered by the United States Drug Enforcement Administration, which monitors the flow of controlled substances from the point of manufacture, through commercial distribution channels, to the point of distribution or sale at the dispensing or retail level;

(2) “Board” means the Board of Pharmacy created by T.C.A., Titl e 63, Chapter 10, part 3;

(3) “Committee” means the Controlled Substance Database Committee created by T.C.A., Title 53, Chapter 10, part 3;

(4) “Controlled substance(s)” means a drug, substance, or immediate precursor in Schedules I through VI as defin ed or listed in the Tennessee Drug Control Act, compiled in T.C.A., Title 39, Chapter 17, part 4;

(5) “Database” means the controlled substance database created by T.C.A., Title 53, Chapter 10, part 3;

(6) “Dispense” means to physically deliver a controlled substance covered by this chapter to any person, institution or entity with the intent that it be consumed away from the premises in which it is dispensed. It does not include the act of writing a prescription by a practitioner to be filled at a pharmacy. For purposes of this part, physical delivery includes mailing controlled substances into this state;

(7) “Dispenser” means any health care practitioner who is licensed and has current authority to dispense controlled substances;

(8) “Healthcare practitioner” means:

(a) A physician, dentist, optometrist, veterinarian, or other person licensed, registered, or otherwise permitted to prescribe, distribute, dispense or administer a controlled substance in the course of professional practice; or (b) A pharmacy, hospital or other institution licensed, registered, or otherwise permitted to distribute, dispense, or administer a controlled substance in the course of professional practice;

(9) “Healthcare practitioner delegate” means any person designated by a healthcare practitioner, who acts as an agent of the healthcare practitioner. A healthcare practitioner shall have the ability to authorize a healthcare practitioner delegate to check the controlled substance database as set forth in the Prescription Safety Act of 2016, Tenn. Code Ann. §§ 53-10-301, et seq. The healthcare practitioner shall be responsible for all actions taken by his or her agent, pursuant to this part;

(10) “Law enforcement personnel” means agents of the Tennessee Bureau of Investigation, agents of a judicial district drug task force, federal law enforcement officers commissioned by a federal government entity, certified law enforcement officers certified pursuant to T.C.A. § 38-8-107, and certified law enforcement officers in other states;

(11) “Patient” means a person or an animal who is receiving medical treatment from a prescriber;

(12) “Patient identifier” means the patient’s full name; address including zip code; date of birth; and social security number or an alternative identific ation number as defined by this rule;

(13) “Person” means any individual, partnership, association, corporation and the state of Tennessee, its departments, agencies and employees, and the political subdivisions of Tennessee and their departments, agencies and employees; and (14) “Prescriber” means an individual licensed as a medical doctor, podiatrist, dentist, optometrist, veterinarian, osteopathic physician, a physician assistant who has authority to issue prescriptions for controlled substances, or an advanced practice nurse with a certificate of fitness to prescribe.

History

Authority: T.C.A. §§ 53-10-303(f), 53-10-305(e), and 53-10-311(b).
Administrative History: Original rule filed December 22, 2005; effective March 7, 2006. Emergency rule filed January 4, 2013; effective through July 3, 2013. Repeal and new rule filed April 2, 2013; effective July 1, 2013. Amendment filed December 16, 2013; effective March 16, 2014. Amendments filed November 22, 2016; effective February 20, 2017. Amendments filed October 28, 2021; effective January 26, 2022.

Tenn. Comp. R. & Regs. 1140-11-.02 DRUGS OF ABUSE

The Committee has found that Schedule V controlled substances demonstrate a potential for abuse and should be reported to the CSMD as authorized by T.C.A. § 53-10-304. However, Schedule V controlled substances which may be dispensed without a prescription, as set forth in 21 C.F.R. §§ 1306, et seq, do not have to be reported to the database.

History

Authority: T.C.A. §§ 53-10-303(f), 53-10-304(c), 53-10-305(e), 53-10-310(e), and 53-10-311(b).
Administrative History: Original rule filed December 22, 2005; effective March 7, 2006. Emergency rule filed January 4, 2013; effective through July 3, 2013. Repeal and new rule filed April 2, 2013; effective July 1, 2013. Amendment filed August 29, 2014; effective November 27, 2014. Amendments filed October 28, 2021; effective January 26, 2022.

Tenn. Comp. R. & Regs. 1140-11-.03 FEES

(1) A fee of twenty-two dollars and fifty cents ($22.50) shall be paid to the Board for each request from law enforcement processed by Committee staff, unless an alternative arrangement has been agreed to.

(2) A fee of twenty-two dollars and fifty cents ($22.50) shall be paid to the Board for each request from any judge of a participating drug court pursuant to T.C.A. § 53-10-306 processed by Committee staff, unless an alternative arrangement has been agreed to.

History

Authority: T.C.A. §§ 53-10-303 and 53-10-306.
Administrative History: New rule filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-11-.04 ALTERNATIVE IDENTIFICATION OF PATIENTS

(1) If a patient does not have a social security number or refuses to provide his or her social security number to be used as a patient identifier, then the board shall use the patient’s driver’s license number or telephone number as the patient identifier in the database.

(2) If a patient does not have a social security number, a driver’s license number or a telephone number, then the board shall use the number “000-00-0000” as the patient identifier in the database.

(3) If a patient or a patient’s agent refuses to provide his or her social security number, driver’s license number or telephone number to his or her prescriber or dispenser, then the board shall use the number “999-99-9999” as the patient identifier in the database.

(4) If a patient’s social security number is not available, then the board shall use the social security number, driver’s license number or telephone number of the person obtaining the controlled substance on behalf of the patient as the patient identifier in the database or the numbers “000-00-0000” (does not have the data) or “999-99-9999” (refusal to provide data), as applicable.

(5) If a patient is a child who does not have a social security number, then the board shall use the parent’s or guardian’s social security number, driver’s license number, telephone number, or number “000-00-0000” (does not have data) or number “999-99-9999” (refusal to provide data) as the patient identifier in the database.

(6) If a patient is an animal, then the board shall use the owner’s social security, driver’s license number, telephone number, or number “000-00-0000” (does not have data) or number “999- 99-9999” (refusal to provide data) as the patient identifier in the database.

History

Authority: T.C.A. §§ 53-10-303(f) and 53-10-305.
Administrative History: Original rule filed December 22, 2005; effective March 7, 2006. Rule was previously numbered 1140-11-.03 but was renumbered

Tenn. Comp. R. & Regs. 1140-11-.05 MINIMUM REPORTING REQUIREMENTS FOR WHOLESALERS AND

MANUFACTURERS.

(1) Wholesalers and manufacturers, as defined in T.C.A. § 63-10-204, shall submit a report of all wholesales and distributions of controlled substances at least once every month and no later than 45 days after the earliest transaction being reported.

(a) Any report submitted pursuant to this rule shall be in the ARCOS format, as specified in the most current version of the “Instructions for Reporting Wholesale Transactions” document, which will be made freely available on the Board of Pharmacy’s website or the Controlled Substance Monitoring Database’s website.

(b) Any report submitted pursuant to this rule shall be sent to the database or email address specified in the “Instructions for Reporting Wholesale Transactions” document.

(c) Any entity exempt from reporting to the Drug Enforcement Administration pursuant to 21 C.F.R. § 1304.33 shall not be required to submit reports of wholesales and distributions of controlled substances pursuant to this rule.

History

Authority: T. C.A. § 53-10-312.
Administrative History: New rule filed November 22, 2016; effective February 20, 2017. Rule was previously numbered 1140-11-.08 but was renumbered 1140-11-.05 with the deletion of rules 1140-11-.05 through 1140-11-.07 filed October 28, 2021; effective January 26, 2022.

Chapter 1140-12 Repealed

Tenn. Comp. R. & Regs. 1140-12-.01 REPEALED

History

Authority: Chapter 919 of the Public Acts of 2006, § 1; and T.C.A. §§ 63-10-501 through 63-10-505.
Administrative History: Public Necessity rule filed February 16, 2007; effective through July 31, 2007. Original rule filed June 19, 2007; effective September 2, 2007. Repeal filed June 5, 2024; effective September 3, 2024.

Tenn. Comp. R. & Regs. 1140-12-.09 REPEALED

History

Authority: Chapter 919 of the Public Acts of 2006, § 1; and T.C.A. §§ 56-1-308 and 63-10-505(g)(4)(A).
Administrative History: Public Necessity rule filed February 16, 2007; effective through July 31, 2007. Original rule filed June 19, 2007; effective September 2, 2007. Repeal filed June 5, 2024; effective September 3, 2024.

Tenn. Comp. R. & Regs. 1140-12-.02 REPEALED

History

Authority: Chapter 919 of the Public Acts of 2006, § 1; and T.C.A. § 63-10-505(g).
Administrative History: Public Necessity rule filed February 16, 2007; effective through July 31, 2007. Original rule filed June 19, 2007; effective September 2, 2007. Repeal filed June 5, 2024; effective September 3, 2024.

Tenn. Comp. R. & Regs. 1140-12-.03 REPEALED

History

Authority: Chapter 919 of the Public Acts of 2006, § 1; and T.C.A. §§ 63-10-502(2) and 63-10- 505(g)(4)(A).
Administrative History: Public Necessity rule filed February 16, 2007; effective through July 31, 2007. Original rule filed June 19, 2007; effective September 2, 2007. Repeal filed June 5, 2024; effective September 3, 2024.

Tenn. Comp. R. & Regs. 1140-12-.04 REPEALED

History

Authority: Chapter 919 of the Public Acts of 2006, § 1; and T.C.A. §§ 63-10-502(2) and 63-10- 505(g)(4)(A).
Administrative History: Public Necessity rule filed February 16, 2007; effective through July 31, 2007. Original rule filed June 19, 2007; effective September 2, 2007. Repeal filed June 5, 2024; effective September 3, 2024.

Tenn. Comp. R. & Regs. 1140-12-.05 REPEALED

History

Authority: Chapter 919 of the Public Acts of 2006, § 1; and T.C.A. §§ 63-10-505(c)(1) and 63-10- 505(g)(4)(A).
Administrative History: Public Necessity rule filed February 16, 2007; effective through July 31, 2007. Original rule filed June 19, 2007; effective September 2, 2007. Repeal filed June 5, 2024; effective September 3, 2024.

Tenn. Comp. R. & Regs. 1140-12-.06 REPEALED

History

Authority: Chapter 919 of the Public Acts of 2006, § 1; and T. C.A. §§ 63-10-505(b)(3) and 63-10- 505(g)(4)(A).
Administrative History: Public Necessity rule filed February 16, 2007; effective through July 31, 2007. Original rule filed June 19, 2007; effective September 2, 2007. Repeal filed June 5, 2024; effective September 3, 2024.

Tenn. Comp. R. & Regs. 1140-12-.07 REPEALED

History

Authority: Chapter 919 of the Public Acts of 2006, § 1; and T.C.A. §§ 63-10-505(c)(5)(A) and 63-10- 505(g)(2).
Administrative History: Public Necessity rule filed February 16, 2007; effective through July 31, 2007. Original rule filed June 19, 2007; effective September 2, 2007. Repeal filed June 5, 2024; effective September 3, 2024.

Tenn. Comp. R. & Regs. 1140-12-.08 REPEALED

History

Authority: Chapter 919 of the Public Acts of 2006, § 1; and T.C.A. §§ 63-10-505(f) and 63-10-505(g)(3).
Administrative History: Public Necessity rule filed February 16, 2007; effective through July 31, 2007. Original rule filed June 19, 2007; effective September 2, 2007. Repeal filed June 5, 2024; effective September 3, 2024.

Chapter 1140-13 Pharmacy Practice in Federally Qualified Health Centers

Tenn. Comp. R. & Regs. 1140-13-.01 PURPOSE

The rules in this chapter implement a pilot program for the dispensing of prescription medications from federally qualified health centers through the use of telepharmacy pursuant to T.C.A. §§ 63-10-601, et seq.

History

Authority: Chapter 1028 of the Public Acts of 2008, § 2; and T.C.A. §§ 63-10-601 through 63-10-602 [effective July 1, 2008].
Administrative History: Public necessity rule filed November 25, 2008; effective through May 9, 2009. New rule filed February 24, 2009; effective May 10, 2009.

Tenn. Comp. R. & Regs. 1140-13-.02 DEFINITIONS

In addition to the definitions contained in T.C.A. § 63-10-601, the following definitions are applicable to this chapter:

(1) “Board” means the Tennessee Board of Pharmacy;

(2) “Central pharmacy” means the central pharmacy practice site licensed by the Tennessee Board of Pharmacy located within a federally qualified health center that is connected through computer link, videolink, and audiolink to one (1) or more satellite clinics;

(3) “Dispense” shall have the same meaning as set forth in Tenn. Code Ann. § 63-10-204(12);

(4) “Issue” means the delivery of drugs from the pharmacy technician employed by the federally qualified health center participating in this program to the patient or patient’s agent;

(5) “Person” means any individual, partnership, association, corporation, or entity;

(6) “Pharmacist” shall have the same meaning as set forth in Tenn. Code Ann. § 63-10-204(30) and who is an employee of a federally qualified health center participating in this program;

(7) “Pharmacist-in-charge” shall have the same meaning as set forth in Tenn. Code Ann. § 63- 10-204(31) and who is an employee of a federally qualified health center participating in this program;

(8) “Pharmacy practice site” shall have the same meaning as set forth in Tenn. Comp. R. & Regs. Rule 1140-01-.01(23);

(9) “Pharmacy technician” means an individual registered by the Board as a pharmacy technician who is an employee of a federally qualified health center participating in this program and is being supervised by a pharmacist at the central pharmacy;

(10) “Program” means the pilot program established in T.C.A. § 63-10-601 for the dispensing of medications (with the exception of controlled substances schedules I, II, III, and IV) from federally qualified health centers through the use of telepharmacy;

(11) “Satellite clinic” means a clinic location located within federally qualified health center where any prescription dispensed at the central pharmacy shall be issued to the patient or patient’s agent through telepharmacy;

(12) “Telepharmacy” means the method of providing pharmaceutical services through a remote site connection between a central pharmacy and a satellite clinic.

History

Authority: Chapter 1028 of the Public Acts of 2008, § 2; and T.C.A. §§ 63-10-601 through 63-10-602 [effective July 1, 2008].
Administrative History: Public necessity rule filed November 25, 2008; effective through May 9, 2009. New rule filed February 24, 2009; effective May 10, 2009.

Tenn. Comp. R. & Regs. 1140-13-.03 LICENSING AND RENEWAL

(1) Licensing.

(a) Beginning July 1, 2008, the central pharmacy that desires to participate in this pilot program shall obtain a pharmacy license for the central pharmacy to be issued by the Board by submitting an application to the Board, along with the required license fee, and shall comply with the pharmacy practice site licensure requirements established in Tenn. Comp. R. & Regs. Rule 1140-01-.08(1) and Rule 1140-01-.12.

(b) As a condition for licensure, the central pharmacy participating in this program shall meet all of the standards established in Tenn. Comp. R. & Regs. Rule 1140-01-.12(1), (2), and (3) and shall also meet the following minimal operating requirements:

Shall be connected to the satellite clinic through computer link, videolink, and audiolink;
Shall have a computer system that is connected to the satellite clinic’s computer system that shares common electronic files;
Shall have its own computer(s) that is/are not accessed by others employed by the federally qualified health center, scanner(s), printer(s), and fax machine(s); and 4. Shall have a licensed pharmacist at the central pharmacy location.

(2) The central pharmacy license shall expire two (2) years from the date of issuance. All licenses shall be renewed on or before the last day of the two (2)-year license cycle.

(3) The central pharmacy may renew its license within six (6) months after the license expiration date with payment of the renewal fee and late renewal penalty fee. After the six (6) month grace period, the licensee may reapply for licensure.

History

Authority: Chapter 1028 of the Public Acts of 2008, § 2; and T.C.A. §§ 63-10-601 and 63-10-602 [effective July 1, 2008].
Administrative History: Public necessity rule filed November 25, 2008; effective through May 9, 2009. New rule filed February 24, 2009; effective May 10, 2009. Amendments filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-13-.04 REPEALED

History

Authority: Chapter 1028 of the Public Acts of 2008, § 2; and T.C.A. §§ 63-10-601 through 63-10-602 [effective July 1, 2008].
Administrative History: Public necessity rule filed November 25, 2008; effective through May 9, 2009. New rule filed February 24, 2009; effective May 10, 2009. Repeal filed June 5, 2024; effective September 3, 2024.

Tenn. Comp. R. & Regs. 1140-13-.05 REPEALED

History

Authority: Chapter 1028 of the Public Acts of 2008, § 2; and T.C.A. §§ 63-10-601 through 63-10-602 [effective July 1, 2008].
Administrative History: Public necessity rule filed November 25, 2008; effective through May 9, 2009. New rule filed February 24, 2009; effective May 10, 2009. Repeal filed June 5, 2024; effective September 3, 2024.

Tenn. Comp. R. & Regs. 1140-13-.06 PHARMACIST RESPONSIBILITIES

(1) Pharmacy Operations and Security.

(a) The pharmacist-in-charge shall ensure that the central pharmacy’s connection with the satellite clinic through computer, videolink, and audiolink is operational at all times that the satellite clinic is open.

(b) In the event that the computer, videolink, or audiolink connection is not operational, the pharmacist-in-charge shall ensure that the satellite clinic shall cease to operate relative to the issuance of prescriptions supplied by the central pharmacy until the links are reconnected. Whenever an interruption of data, video, or audiolink occurs between the central pharmacy and the satellite clinic, no prescription shall be dispensed, and a sign shall be posted noting the closure with an estimated time until a resumption of services can be expected.

(c) The pharmacist-in-charge shall ensure that prescriptions for controlled substances schedules I, II, III, or IV are not issued from the satellite clinic.

(d) The pharmacist-in-charge shall ensure that only the pharmacists and pharmacy technicians employed by the federally qualified health center and working in the satellite clinic shall have keys to the satellite clinic.

(e) The pharmacist-in-charge shall ensure that the security at the central pharmacy shall be performed in accordance with Tenn. Comp. R. & Regs. Rule 1140-01-.12.

(f) The pharmacist-in-charge shall ensure the security of the storage of drugs at the central pharmacy and the satellite clinic.

(g) The pharmacist-in-charge shall ensure that the prescriptions filled at the central pharmacy and stored in the satellite clinic to be issued to patients and caregivers by means of telepharmacy shall be segregated in a secure area in the pharmacy room from other medications stored in the pharmacy room that have not been filled and will not be issued through the telepharmacy program.

(h) The pharmacist-in-charge shall ensure that pharmacy technicians working at the central pharmacy are supervised by a pharmacist in accordance with Rule 1140-02- .02(8).

(i) The pharmacist-in-charge shall ensure that pharmacy technicians working at the satellite clinic shall be supervised by a pharmacist without a pharmacist being physically present.

(j) The pharmacist-in-charge may request a waiver of Tenn. Comp. R. & Regs. Rule 1140- 03-.14(12) upon a showing of good cause.

(2) Verification.

(a) The pharmacist shall perform all in-process and end-process verification of the pharmacy technician’s activities, including, but not limited to: checking the contents of the prescription bottle; checking the bottle label; checking the prescription; performing a drug utilization review in accordance with Tenn. Comp. R. & Regs. Rule 1140-03- .01(3); and performing patient counseling.

(3) Patient Counseling.

(a) If a pharmacist is not physically present at the satellite clinic and the patient or patient’s agent is being issued a new prescription, then the pharmacist shall counsel the patient or patient’s caregiver by means of telepharmacy before the prescription is issued.

(b) If a pharmacist is not physically present at the satellite clinic and the patient or patient’s agent is being issued a refilled prescription, then the pharmacy technician shall offer counseling to the patient or patient’s caregiver by means of telepharmacy before the prescription is issued.

(c) Pharmacists shall counsel patients in accordance with Board of Pharmacy rules whether the medication is issued from the central pharmacy or the satellite clinic.

(4) Supervision.

(a) The pharmacist-in-charge shall ensure that each individual operating as a pharmacy technician while employed by a federally qualified health center at a central pharmacy or satellite clinic is properly registered with the Board at all times.

(b) The pharmacist-in-charge or a designee of the pharmacist-in-charge shall complete an in-person inspection twice a month of the satellite clinics to ensure compliance with all applicable laws and rules relative to drugs and the practice of pharmacy outlined in the central pharmacy’s policies and procedures.

(c) The pharmacists working at the federally qualified health center are not required to be physically present to verify the accuracy of all pharmacy technician functions performed at the satellite clinic while participating in this program; verification may be conducted by means of the computer link, videolink, and audiolink.

(5) Policies and Procedures.

(a) The pharmacist-in-charge shall ensure that the central pharmacy and satellite clinic have policies and procedures including, but not limited to the following:

When and how a pharmacy technician should contact a pharmacist to perform the issuing process;
How the pharmacy technician is to use the computer, videolink, and audiolink technology to communicate with the pharmacist;
Delivery of the filled prescriptions to the satellite clinic to be issued to the patient or the patient’s caregiver;
Recordkeeping process to track the prescriptions dispensed from the central pharmacy and issued from the satellite clinic;
Recordkeeping process to track the filled prescriptions received by the satellite clinic from the central pharmacy;
How to securely transport the filled prescriptions from the central pharmacy to the satellite clinic;
How to order prescriptions and refills for the central pharmacy;
How to ensure that patient counseling is performed in accordance with this

chapter;

When and how unissued medications will be disposed of or sent back to the central pharmacy.

History

Authority: Chapter 1028 of the Public Acts of 2008, § 2; and T.C.A. §§ 63-10-601 through 63-10-602 [effective July 1, 2008].
Administrative History: Public necessity rule filed November 25, 2008; effective through May 9, 2009. New rule filed February 24, 2009; effective May 10, 2009.

Tenn. Comp. R. & Regs. 1140-13-.07 PHARMACY TECHNICIAN RESPONSIBILITIES

(1) The pharmacy technician shall ensure that the central pharmacy’s connection with the satellite clinic through computer, videolink, and audiolink is operational at all times that the satellite clinic is open.

(2) In the event that the computer, videolink, and audiolink connection is not operational, the pharmacist-in-charge shall ensure that the satellite clinic shall cease to operate relative to the issuance of medications supplied by the central pharmacy until the links are reconnected.

Whenever an interruption of data, video, or audio link occurs between the central pharmacy and the satellite clinic, no prescription shall be issued, and a sign shall be posted noting the closure of the clinic with an estimated time that a resumption of services can be expected.

(3) While working at a satellite clinic, the pharmacy technician shall notify the pharmacist at the central pharmacy prior to any medication being issued in order to ensure that patient counseling is performed or offered.

(4) The pharmacy technician shall only issue prescriptions dispensed by the central pharmacy.

History

Authority: Chapter 1028 of the Public Acts of 2008, § 2; and T.C.A. §§ 63-10-601 through 63-10-602 [effective July 1, 2008].
Administrative History: Public necessity rule filed November 25, 2008; effective through May 9, 2009. New rule filed February 24, 2009; effective May 10, 2009.

Tenn. Comp. R. & Regs. 1140-13-.08 RECORDKEEPING AND INSPECTIONS

(1) The pharmacist-in-charge, pharmacists, and pharmacy technicians employed by the federally qualified health center working at a central pharmacy or satellite clinic shall ensure that a record is maintained at each central pharmacy and satellite clinic containing the prescriptions dispensed or issued from each location, including but not limited to the date dispensed/issued; date dispensed from the central pharmacy; date received by the satellite clinic; the drug name; quantity, dosage; strength; and patient name.

(2) All records of prescriptions dispensed from the central pharmacy and issued from the satellite clinic shall be retained for at least two (2) years from the date dispensed.

(3) Board of Pharmacy investigators shall be able to inspect the central pharmacies and the satellite clinics to ensure compliance with the applicable laws and rules related to drugs and the practice of pharmacy.

History

Authority: Chapter 1028 of the Public Acts of 2008, § 2; and T.C.A. §§ 63-10-307 and 63-10-601 through 63-10-602 [effective July 1, 2008].
Administrative History: Public necessity rule filed November 25, 2008; effective through May 9, 2009. New rule filed February 24, 2009; effective May 10, 2009.

Chapter 1140-14 Long-Term Care Pharmacy Practice Sites

Tenn. Comp. R. & Regs. 1140-14-.01 APPLICABILITY

A long-term care pharmacy practice site providing products and services to any long-term care facility shall be subject to all rules of the board dependent upon services provided.

History

Authority: T.C.A. §§ 63-10-204 and 63-10-304.
Administrative History: New rule filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-14-.02 PERSONNEL

(1) Pharmacist in charge. The practice of pharmacy and the performance of pharmacists and supportive pharmacy personnel associated with any long-term care facility shall be under the direction, supervision and responsibility of the pharmacist in charge. The pharmacist in charge shall also be responsible for the dispensing and storage of prescription and nonprescription drugs used throughout the long-term care facility. Policies and procedures defining the scope of pharmacy practice and the responsibilities of the pharmacists and supportive personnel, and the safe use and management of drugs, devices and related materials shall be established by the pharmacist in charge. The pharmacist in charge or designee shall participate in the long-term care facility’s drug policy committees which serve to ensure rational drug use, patient care evaluation processes relating to drug utilization and effectiveness, drug delivery device selection and evaluation systems, and educational activities for the safe and appropriate use of drugs which will assess the quality of services and products provided and document actions taken. Policies and procedures as indicated in this chapter shall be written and shall be made available to the Board.

(2) Pharmacists. The pharmacist in charge shall be supported by a sufficient number of pharmacists to provide appropriate practice of pharmacy for the patients served by the longterm care facility.

(3) Long-term care consultant pharmacist. A long-term care facility may utilize a consultant pharmacist who may or may not be independent of the pharmacy practice site, who shall provide patient care service which includes, but is not limited to:

(a) Providing consultation on matters pertaining to efficient drug distribution systems, proper drug selection, rational and safe drug use, and drug therapy assessment;

(b) Evaluation of a patient’s drug therapy to maximize outcome(s), including effective communication with prescribing practitioners and other healthcare professionals;

(c) Service on committees or governing bodies; and (d) Providing in service educational programs for members of the healthcare team.

(4) Supportive personnel. The pharmacist in charge shall be assisted by a sufficient number of pharmacy technicians, as defined in 1140-02-.02, pharmacy interns, and other supportive personnel as may be required to operate the pharmacy competently, safely, and adequately to meet the needs of the patients served by the long-term care facility.

(5) Supervision. All of the activities associated with the practice of pharmacy and the operations of the pharmacy at a specific long-term care pharmacy practice site shall be supervised by a sufficient number of pharmacists to ensure that all functions and activities are performed competently, safely and without risk of harm to patients.

History

Authority: T.C.A. § 63-10-304.
Administrative History: New rule filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-14-.03 PHYSICAL REQUIREMENTS

(1) Area. A long-term care pharmacy practice site shall have sufficient floor space allocated to it to ensure that medical and prescription orders are prepared and dispensed in sanitary, well lighted, and enclosed spaces. The long-term care pharmacy shall also have sufficient counter space or other suitable work module to ensure that medical and prescription orders are prepared and dispensed in an orderly manner.

(2) Equipment and Materials. The pharmacy practice site shall have sufficient equipment and physical facilities for the practice of pharmacy. This shall include but not be limited to:

(a) Hot and cold running water;

(b) Refrigerated storage space;

(5) Security. A pharmacy practice site shall be capable of being locked to prevent access by unauthorized personnel. If a long-term care pharmacy practice site is located within a longterm care facility, a pharmacist must be accessible within that long-term care facility; and when no pharmacist is present at the long-term care facility, the pharmacy practice site must be kept closed and securely locked except as provided in 1140-14-.11.

History

Authority: T.C.A. § 63-10-304.
Administrative History: New rule filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-14-.04 PRESCRIPTION ORDERS

A pharmacist shall review all prescription orders before the drug is first dispensed. In the event that medications available in the long-term care facility are ordered and administered before the pharmacist’s review, the order shall be reviewed by a pharmacist in a timely manner. The pharmacist shall have access to the patient’s medical record. The prescription order must be maintained in a readily retrievable manner according to the pharmacy practice site policy.

If a patient residing in a long-term care facility has an existing prescription order for a controlled substance, and a valid prescription is needed from the prescriber to continue that order, a fax or electronic communication containing the required information listed in 1140-03-.03 (4)(a) may be generated by a pharmacist, or pharmacy technician working under the direct supervision of a pharmacist, and communicated to the prescriber. Upon receipt of the communication, the prescriber may complete the prescription order by indicating the name of the patient, name and signature of the prescriber, drug, quantity, and date. The completed prescription order may then be faxed or electronically communicated to the long-term care pharmacy practice site. When received by the long-term care pharmacy practice site, this signed fax or electronic communication shall be considered a valid prescription order.

History

Authority: T.C.A. § 63-10-304.
Administrative History: New rule filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-14-.05 DISTRIBUTION AND CONTROL OF DRUGS

The pharmacist in charge shall be responsible for approving policies for the distribution and control of drugs within the long-term care facility. The process shall be established to provide for the safe and efficient distribution of drugs and for the provision of pharmaceutical care, and shall include but not be limited to:

(1) A drug dispensed from the pharmacy for subsequent administration to a patient shall be appropriately identified with the name and location of the patient and the name and strength of the drug.

(2) The pharmacist in charge is responsible for the development and maintenance of an audit trail on drugs dispensed and delivered.

(4) The long-term care facility distribution system may be based on a combination of processes that will ensure compliance with federal and state guidelines such as, but not limited to, emergency kits/crash carts, automated dispensing devices, and/or after-hours procedures for pharmacy site access.

History

Authority: T.C.A. § 63-10-304.
Administrative History: New rule filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-14-.06 CONTROLLED DRUGS

(1) As permitted by state and federal rules and regulations, controlled substances (and those drugs deemed by the pharmacist in charge to have a potential for abuse) which are issued as floorstock shall be accounted for by providing documentation of:

(a) The drug name, strength, and dosage form;

(b) The date and time of administration;

(d) Identification of the patient;

(e) Identification of the prescriber; and (f) Identification of the authorized personnel administering the controlled substance.

(2) As permitted by state and federal rules and regulations, record of the destruction of controlled substances previously dispensed to or for patients and returned to the dispensing pharmacy for destruction shall be maintained so as to be readily retrievable, and such records shall include:

(a) The identification of the patient;

(b) Drug name, strength, dosage form, and quantity;

(c) The date and method of destruction; and (d) The identification of authorized personnel witnessing the destruction and its record.

(3) Schedule II controlled substances which are kept within a pharmacy practice site shall be stored in a secured, substantially constructed cabinet, safe, or other structure.

(4) Nothing in this rule shall be interpreted to authorize the destruction of controlled substance floorstock or pharmacy stock. Such drugs shall upon request, be destroyed by a board approved agent or vendor.

History

Authority: T.C.A. § 63-10-304.
Administrative History: New rule filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-14-.07 EMERGENCY AND HOME CARE KITS

Drugs and devices and related materials may be provided by emergency kits as defined by policies and procedures provided that such kits meet the following requirements:

(1) Emergency Kits.

(a) Drugs and devices and related materials may be provided by emergency kits as defined by pharmacy policies and procedures, provided that such kits meet the following requirements:

Emergency kit drugs are those drugs which may be required to meet the therapeutic needs of patients and which are not available from any other authorized source in sufficient time to prevent risk of harm to patients.
The policies and procedures to implement the requirements of this subsection and to approve the contents of the emergency kit will be determined by the pharmacist in charge or his/her designee.
The emergency kit shall be sealed or electronically secured by authorized personnel in accordance with established policies. The expiration date of the kit shall be clearly marked on the exterior of the kit or kept electronically to represent the earliest expiration date of any drug, device, or related materials contained in the kits.
Emergency kits shall be stored in a secured area at the long-term care facility or patient care site to prevent unauthorized access. To ensure a proper environment for preservation of the drugs contained therein, appropriate policies and procedures shall be written to include storage at the site of patient care.
Only authorized individuals may obtain drugs, devices or related materials from the emergency kit in accordance with established policies and state and federal laws and regulations.
A list of the emergency kit contents shall be readily accessible and it shall include the drugs, devices, and related materials contained therein and include the name (trade and/or generic), strength, and quantity of the products contained therein.
Drugs contained within the emergency kit shall be properly labeled according to the United States Food and Drug Administration (FDA) labeling requirements for the drug or device and with additional information that may be required by the staff to prevent misunderstanding or risk of harm to the patients.
Removal of any drug, device, or related material from the emergency kit shall be pursuant to a valid medical or prescription order and must be documented by established policy which may include patient’s identification, name of the drug, strength, amount, date, time, and identification of the authorized individual removing the drug.
When an emergency kit is opened for any reason, the pharmacy practice site shall be notified, and the kit shall be restocked and resealed within a reasonable time so as to prevent risk of harm to patients.
A pharmacy technician, holding an active registration with the Tennessee Board of Pharmacy and employed by the pharmacy, may restock and reseal the emergency kit with items prepared and checked by a pharmacist at the pharmacy.

(2) Home Care Kits.

A home care kit may contain:

(d) Removal of any drug from the Home Care Kit shall be pursuant to a valid medical or prescription order and/or protocol and must be documented in the patient’s medical record.

History

Authority: T.C.A. § 63-10-304.
Administrative History: New rule filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-14-.08 UNUSED DRUGS, DEVICES AND RELATED MATERIALS

Discontinued, outdated, defective, or deteriorated drugs, devices, or related materials and containers with worn, illegible, or missing labels shall be returned to the pharmacy practice site for proper disposition. All such drugs, devices or related materials returned to the pharmacy practice site must be destroyed unless in unit dose packaging, unopened commercially prepackaged containers and in the professional judgment of the pharmacist in charge or designee, the medications or related materials meet all federal and state board standards for product integrity.

History

Authority: T.C.A. § 63-10-304.
Administrative History: New rule filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-14-.09 TAKE-HOME AND LEAVE OF ABSENCE DRUGS, DEVICES AND RELATED

MATERIALS.

(1) All prescription drugs prescribed for and released to patients who are on leave of absence from the long-term care facility must be released in accordance with the long-term care facility's policies and procedures.

(2) All prescription drugs prescribed for and dispensed to patients who are being discharged from the long-term care facility must be dispensed with labeling in accordance with 1140-03- .06.

(3) The pharmacist in charge in coordination with the medical and nursing staff of the facility shall establish policies and procedures to assure that this process meets state and federal guidelines appropriate for the facility.

History

Authority: T.C.A. § 63-10-304.
Administrative History: New rule filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-14-.10 RECALLS

The pharmacist in charge shall develop and implement policies and procedures for recalls.

History

Authority: T.C.A. § 63-10-304.
Administrative History: New rule filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-14-.11 ABSENCE OF PHARMACIST

(1) Long-term care pharmacy practice site.

(a) General. During such times as a long-term care pharmacy practice site is closed, facility policy as approved by the pharmacist in charge shall provide a process for authorized personnel to obtain drugs necessary for the provision of patient care. This function may also be accomplished as outlined in the After Hours Drug Provision of this

section. A pharmacist must be “on call” twenty four (24) hours per day, seven (7) days per week.

(b) After Hours Drug Provision. When a long-term care pharmacy practice site is closed, access to prescription drugs shall be by locked cabinet(s), automated dispensing machines or other enclosure(s) constructed and located within the long-term care facility, to which only personnel authorized by the pharmacist in charge, in coordination with the medical and nursing staff, may obtain access. Access should be sufficiently secured to deny entry to unauthorized persons by force or otherwise. Those practice sites utilizing automated dispensing devices for after hours drug provision shall meet the requirements of rule 1140-14-.12.

History

Authority: T.C.A. § 63-10-304.
Administrative History: New rule filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-14-.12 AUTOMATED DISPENSING SYSTEMS IN LONG-TERM CARE PRACTICE SITES

No prescription drug or device or related material shall be distributed or issued by the use of any automated dispensing device unless the method of operation has been approved and each device licensed by the board to ensure the purity, potency, and integrity of the prescription drug or device or related material, and to protect the prescription drug or device or related material from diversion.

(1) Each pharmacy holding an active license with the Tennessee Board of Pharmacy and using automated dispensing systems shall register each automated dispensing system with the Tennessee Board of Pharmacy. Each pharmacy maintain a list of the physical locations of all automated dispensing machines in its systems, whether such systems are located in the same facility as the licensed pharmacy, or not, and shall be responsible to pay a registration fee, as defined in 1140-01-.10, for each automated dispensing system, which the licensed pharmacy is responsible for and which is located in a long-term care facility.

(2) The pharmacist in charge of the long-term care pharmacy practice site shall be designated to be accountable for this automated dispensing system.

(a) The filling/stocking of all medications in the automated dispensing system shall be completed by a pharmacist or pharmacy technician under the direct supervision of a pharmacist, except as provided below:

If the automated dispensing system uses removable cartridges or containers to hold drugs, the prepackaging of the cartridges or containers shall occur at the provider pharmacy unless provided by an FDA approved repackager.
The prepackaged cartridges, unit dose packages or containers may be sent to the remote site to be loaded into the machine by personnel designated by the pharmacist-in-charge provided:

(i) A pharmacist verifies the cartridge or container has been properly filled and labeled;

(ii) The individual cartridges, unit dose packages or containers are transported to the remote site in a secure, tamper-evident container; and (iii) The automated dispensing system uses bar-coding, microchip, or other technologies to ensure that the containers are accurately loaded in the automated dispensing system.

(iv ) All drugs to be stocked in the automated dispensing system shall be delivered to the remote site by the provider pharmacy.

(b) A record of medications filled/stocked into an automated dispensing system shall be maintained and shall include identification of the persons filling/stocking and checking for accuracy.

(c) All containers of medications stored in the automated dispensing system shall be packaged and labeled in accordance with federal and state laws and regulations.

(d) All aspects of handling controlled substances shall meet the requirements of all state and federal laws and regulations.

(e) The automated dispensing system shall provide a mechanism for securing and accounting for medications removed from and subsequently returned to the automated dispensing system, all in accordance with existing state and federal law.

(f) The automated dispensing system shall provide a mechanism for securing and accounting for wasted medications or discarded medications in accordance with existing state and federal law.

(g) The pharmacist in charge will work collaboratively with healthcare professionals to ensure that appropriate controls and monitors are utilized to provide information that drugs dispensed were for the correct patient and that pilferage is identified and resolved.

(3) All persons authorized to have access to these automated systems shall have documentation that they have successfully completed a training program that teaches them to perform the functions they perform with the automated device.

(4) Automated dispensing systems shall be used only for the furnishing of drugs and devices and related materials or other products related to the care of patients of that long-term care facility; and (5) At the time of removal of any drug or device or related material from the system, it shall automatically make a record, to be retained by the pharmacy for a minimum of two (2) years, indicating:

(a) The date and time of removal of the drug or device or related material;

(b) The name, strength, dosage form, and quantity of drugs or devices or related material removed;

(6) The pharmacist in charge or designee is responsible for determining how access codes or other methods of access to automated devices are assigned.

(7) The facility shall have policies and procedures approved by the pharmacist in charge in coordination with members of the nursing and medical staff for the points outlined in this

section for automated dispensing devices.

(8) Nothing in this section shall be interpreted to authorize the stocking of controlled substances in automated dispensing systems, except when done in a manner consistent with federal controlled substance rules and regulations.

(9) The registration fee for each automated dispensing system shall be determined by the Tennessee Board of Pharmacy and listed in 1140-01-.10. The Board shall maintain a list of registered automated dispensing systems, including physical address and number of systems located at each physical address. Registrations for automated dispensing systems must be renewed every two (2) years.

History

Authority: T.C.A. § 63-10-304.
Administrative History: New rule filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-14-.13 INVESTIGATIONAL DRUGS

The pharmacist in charge in coordination with the long-term care facility, medical and nursing staff and, if appropriate, the pharmaceutical manufacturer, shall develop policies and procedures for the approval, management, distribution and control of investigational drug studies. The process shall ensure that such studies contain safeguards for the patient, for the long-term care facility and for the scientific integrity of the study. Each patient or the patient’s legal guardian must freely consent, in writing, to treatment with the drugs, unless otherwise not required by federal law. The pharmacist is responsible to the long-term care facility and to the principal investigator for seeing that procedures for the control of investigational drugs are developed and implemented when needed.

History

Authority: T.C.A. § 63-10-304.
Administrative History: New rule filed November 22, 2016; effective February 20, 2017.

Tenn. Comp. R. & Regs. 1140-14-.14 INSPECTIONS

The pharmacist in charge shall be responsible (personally or by qualified designee) for documented inspections, at minimum quarterly, of all drugs, devices and related materials dispensed by the long-term care pharmacy practice site and delivered to the long-term care facility. Records of such inspections shall be dated, signed and maintained so as to be readily retrievable at the pharmacy practice site for at least two (2) years. These inspections must assure the following:

(1) Thermolabile drugs are stored at the proper temperature;

(2) Drugs, devices and related materials requiring special storage conditions to ensure their stability are properly stored;

(3) There are no outdated or deteriorated drugs, devices or related materials;

(4) All drugs, devices and related materials are properly labeled;

(5) Emergency drugs, devices and related materials are properly stored; and (6) Medicine cabinets, carts and storage areas are accessible to authorized personnel only.

History

Authority: T.C.A. § 63-10-304.
Administrative History: New rule filed November 22, 2016; effective February 20, 2017.

Chapter 1140-15 Prescribing and Dispensing of Hormonal Contraceptives

Tenn. Comp. R. & Regs. 1140-15-.01 PURPOSE

A pharmacist is authorized to prescribe hormonal contraceptives, in good faith, pursuant to a valid collaborative pharmacy practice agreement which contains a nonpatient-specific prescriptive order and standardized procedures developed and executed by one (1) or more authorized prescribers.

History

Authority: T.C.A. § 63-10-219.
Administrative History: Original rules filed April 19, 2018; effective July 18, 2018.

Tenn. Comp. R. & Regs. 1140-15-.02 DEFINITIONS

(1) “Hormonal contraceptive” means a self-administered drug, or a transdermal patch applied to the skin of a patient, by the patient or by a pharmacist, which releases a drug composed of a combination of hormones that are approved by the United States Food and Drug Administration (“FDA”) to prevent pregnancy.

(2) “Total cost” means the specific information regarding the cost of the hormonal contraceptive and the fee charged by the pharmacist for the administration, application, or any other patient care service provided to the patient by the pharmacist.

(3) “Pharmacist’s agent” means an individual, such as a registered pharmacy technician, pharmacy clerk, or pharmacy intern, working under the supervision of a pharmacist who is authorized to assist in tasks and responsibilities related to the delivery of patient care services pursuant to a valid collaborative pharmacy practice agreement.

History

Authority: T.C.A. § 63-10-219.
Administrative History: Original rules filed April 19, 2018; effective July 18, 2018.

Tenn. Comp. R. & Regs. 1140-15-.03 TRAINING

(1) Each pharmacist licensed in the state of Tennessee shall complete educational training pertaining to the prescribing of hormonal contraceptives prior to providing contraceptive therapies to patients pursuant to this rule. This rule does not prohibit pharmacists from providing care and services to patients, including hormonal contraceptives, pursuant to a valid patient-specific collaborative pharmacy practice agreement.

(2) The minimum required educational training shall be approved by the Tennessee Department of Health (“TDH”), listed on the TDH website, and provided by an Accreditation Council for Pharmacy Education (“ACPE”) -approved provider.

(3) The pharmacist shall permanently maintain the certificate of completion of training at their place of practice and shall make the certificate of completion available to the Board of Pharmacy upon request.

July, 2018 2 (4) The training program shall provide, at a minimum, information pertaining to the types and pharmacology of hormonal contraceptives which may be prescribed, the risk and benefits of each hormonal contraceptive, any side effects associated with the hormonal contraceptive, and any contraindications associated with the hormonal contraceptive.

The training program shall provide the prescribing pharmacist with a minimum level of proficiency regarding proper prescribing of hormonal contraceptives.

(5) An equivalent curriculum-based training program completed in or after the year 2017 from a school or college of pharmacy recognized by the Board or a training program recognized by the Board shall satisfy the requirement of training prior to the prescribing of hormonal contraceptives.

(6) It shall be the professional responsibility of each pharmacist engaged in the prescribing of hormonal contraceptives to maintain current knowledge regarding the science and trends of hormonal contraceptives.

History

Authority: T.C.A. § 63-10-219.
Administrative History: Original rules filed April 19, 2018; effective July 18, 2018.

Tenn. Comp. R. & Regs. 1140-15-.04 COLLABORATIVE PHARMACY PRACTICE AGREEMENTS

Within 30 days from the effective date of a collaborative pharmacy practice agreement, the prescribing pharmacist shall submit written attestation to the Board for the purpose of notifying the Board of the collaborative agreement.

History

Authority: T.C.A. §§ 63-10-217 and 63-10-219.
Administrative History: Original rules filed April 19, 2018; effective July 18, 2018.

Tenn. Comp. R. & Regs. 1140-15-.05 DELIVERY OF CARE

A pharmacist may provide hormonal contraceptives under this rule to eligible individuals as identified in T.C.A. § 63-10-219.

History

Authority: T.C.A. §§ 39-11-106 and 63-10-219.
Administrative History: Original rules filed April 19, 2018; effective July 18, 2018.

Tenn. Comp. R. & Regs. 1140-15-.06 PROCEDURAL MANDATES

For each new patient requesting a hormonal contraceptive, and, at a minimum of every twelve months for each returning patient, the prescribing pharmacist shall:

(1) Ask the patient to use and complete the TDH-produced standardized self-screening risk assessment tool. The TDH-produced standardized self-screening risk assessment tool shall be the only self-screening risk assessment tool to be utilized when evaluating a patient’s candidacy for a hormonal contraceptive. The TDH-produced standardized self-screening risk assessment tool shall be made available through the TDH website. The same TDH-approved standardized self-screening risk assessment tool may be incorporated into a pharmacy’s management system’s software.

(2) Review the self-screening risk assessment answers and clarify responses with the patient as needed before using professional judgment regarding whether to prescribe a hormonal contraceptive.

(3) Dispense a hormonal contraceptive to the patient or refer the patient to a pharmacy that may dispense the hormonal contraceptive, if the pharmacist determines the patient is eligible to receive the medication.

Dispensing a hormonal contraceptive or referring the patient to another pharmacy that may dispense a hormonal contraceptive shall occur as soon as practicable after making the determination that the patient is eligible to receive a hormonal contraceptive.

July, 2018 3 (4) Counsel the patient on matters contained in Tenn. Comp. R. & Regs. 1140-03-.01(1)(e)1 through 1140-03-.01(1)(e)8 at the time the hormonal contraceptive is prescribed and dispensed.

(5) Provide the patient with the FDA-required patient product information document that is included with the hormonal contraceptive and a factsheet which includes, but is not limited to, the indications and contraindications for the use of the drug, the appropriate method for using the drug, the importance of a medical follow-up, and other appropriate information.

(6) Advise the patient to consult with the patient’s primary care practitioner or women’s health practitioner.

(7) Provide the patient, at the time the hormonal contraceptive is prescribed, with a list which contains contact information for primary care practitioners or women’s health practitioners. In the event it is not practicable to provide contact information at the time the hormonal contraceptive is prescribed, the prescribing pharmacist shall provide contact information for primary care practitioners or women’s health practitioners within seventy-two (72) hours after the contraceptive is prescribed.

History

Authority: T.C.A. § 63-10-219.
Administrative History: Original rules filed April 19, 2018; effective July 18, 2018.

Tenn. Comp. R. & Regs. 1140-15-.07 PROHIBITED PRACTICES

A prescribing pharmacist shall not require the patient to schedule an appointment with the pharmacist for the purpose of prescribing or dispensing of a hormonal contraceptive. However, nothing in this rule shall prevent a pharmacist from providing services which are incorporated into normal flow of business in order to promote efficiency and to optimize patient care.

History

Authority: T.C.A. § 63-10-219.
Administrative History: Original rules filed April 19, 2018; effective July 18, 2018.

Tenn. Comp. R. & Regs. 1140-15-.08 RECORDS

(1) The prescribing pharmacist shall document, at a minimum, the completed self-screening risk assessment and the medication prescribed to the patient by the pharmacist. While not required by this rule, the pharmacist is authorized to include additional information related to the patient encounter. These records shall be maintained by the pharmacy practice site for a period of ten years.

Records regarding the dispensed hormonal contraceptive shall be maintained in accordance with Tenn. Comp. R. & Regs. 1140-03-.03.

History

Authority: T.C.A. § 63-10-219.
Administrative History: Original rules filed April 19, 2018; effective July 18, 2018.

Tenn. Comp. R. & Regs. 1140-15-.09 FEES

(1) A pharmacist, pharmacist’s employer, or pharmacist’s agent is authorized to charge an annual administrative fee for services provided to patients pursuant to this Chapter in addition to any costs associated with the dispensing of the drug. However, patients who are insured or covered and receive a pharmacy benefit that covers the cost of hormonal contraceptives shall not be required to pay an administrative fee; instead, these patients shall be required to pay co-payments pursuant to the terms and conditions of their coverage.

July, 2018 4 (2) Upon an oral, telephonic, electronic, or written request from a patient or customer, a pharmacist or pharmacist's employee shall disclose the total cost that a consumer would pay for pharmacist-provided hormonal contraceptives.

(3) The “total cost” requirement is not intended to interfere with patients who have active hormonal contraceptive coverage under an insurance plan or pharmacy benefit which has been contractually agreed upon between a pharmacist, a pharmacist’s employer, or a pharmacist’s agent, and a health insurance plan or insurer.

History

Authority: T.C.A. § 63-10-219.
Administrative History: Original rules filed April 19, 2018; effective July 18, 2018.

Chapter 1140-16 Third-Party Logistics Provider

Tenn. Comp. R. & Regs. 1140-16-.01 PURPOSE

Pursuant to 21 U.S.C. § 360eee-4(b)(2) (2013), a Third-Party Logistics Provider (3PL), as defined, shall be licensed separately from a wholesale distributor.

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, and 63-10-306.
Administrative History: Original rules filed September 12, 2018; effective December 11, 2018.

Tenn. Comp. R. & Regs. 1140-16-.02 THIRD-PARTY LOGISTICS PROVIDER LICENSING

(1) Before any 3PL provides or coordinates warehousing or other logistics services within this state for a prescription drug and/or prescription device on behalf of a manufacturer, wholesale distributor, or dispenser the 3PL shall be licensed by the Board in accordance with this Chapter whether physically located within this state or outside this state. Where operations are conducted at more than one location, each such location shall be licensed by the Board. A warehouse provided by a 3PL shall be inspected by the Board’s inspector(s) or inspectors of the state where the warehouse is physically located prior to providing services.

(2) A 3PL that coordinates with facilities that are engaged in the act of wholesale drug distribution and are also located outside of this state, shall provide documentation to the Board within 60 days of issuance of a 3PL license that each facility used by the 3PL has received either:

(a) A Verified-Accredited Wholesale Distributors accreditation from the National Association of Boards of Pharmacy;

(b) A manufacturer, wholesaler, or distributor license issued by the Board, including any license modifiers and/or additional registrations; or (c) A manufacturer, wholesaler, or distributor license issued by the state where the facility is physically located, including any license modifiers and/or additional registrations.

(3) Failure to provide the required documentation within 60 days of the issuance of a 3PL license or within 60 days from any change in status of any previously submitted documentation may result in disciplinary action.

(4) Each manufacturer, wholesaler, or distributor that ships prescription drugs and/or prescription devices into or from the State of Tennessee shall be licensed by the Board accordingly and shall comply with all requirements of Tenn. Comp. R. & Regs. 1140-01-.08 and 1140-09-.01 et. seq.

(5) Each wholesale distributor, who is also engaged in providing 3PL services, as defined in Tenn. Code Ann. § 63-10-204(46), shall obtain a license to operate as a wholesale distributor December, 2018 2 issued by the Board and shall obtain a separate license to operate as a 3PL issued by the Board.

(6) An applicant with physical facilities located in this state must obtain and display prominently a separate license for each principal place of business where the applicant manufactures or distributes prescription drugs and/or prescription devices.

(7) Any 3PL that obtains controlled substances shall obtain the Board’s controlled substance registration in accordance with Tenn. Comp. R. & Regs. 1140-01-11.

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, and 63-10-306.
Administrative History: Original rules filed September 12, 2018; effective December 11, 2018.

Tenn. Comp. R. & Regs. 1140-16-.03 MINIMUM INFORMATION REQUIRED

(1) The Board shall require the following minimum information from an applicant applying for a license to operate as a 3PL or any renewal of such license:

(a) All trade or business names used by the 3PL (includes “is doing business as” and “formerly known as”), full business address, and telephone number of the 3PL;

(b) Addresses, telephone numbers, and the names of contact persons for all facilities used by the 3PL for storage, handling, and distribution;

(c) The name and contact information of the owner, the owner’s agent, or another such individual employed at or contracted by the applicant who can be reached at any time by the Board, the Department of Health or any agents thereof in the event of a potential or actual public health threat related to the sterility or potency of any drug or biologic product manufactured, wholesaled or distributed by the applicant;

(d) A list of all state and federal licenses, registrations, or permits, including the number of each such license, registration, or permit issued to the 3PL by any other state and federal authority authorizing the 3PL to possess and/or distribute prescription drugs, and including any disciplinary action taken against the 3PL and/or its principals, owners, directors, or officers;

(e) The type of ownership or operation (i.e., partnership, corporation, or sole proprietorship); and;

(f) The name(s) of the owner and operator of the 3PL, including:

If a person, the name of the person;
If a partnership, the name of each partner, and the name of the partnership;
If a corporation, the name and title of each corporate officer and director, the corporate names, and the name of the state of incorporation;
If a sole proprietorship, the full name of the sole proprietor and the name of the business entity;
United States Drug Enforcement Administration (DEA) registration number if applicable; and December, 2018 3 6. The results of a criminal background check for the owner and manager of the 3PL seeking licensure, submitted directly to the Board by the vendor identified in the Board’s licensure application materials.

(2) Changes in any information in paragraphs (1)(a) through (f) of this rule shall be submitted in writing to the Board within one business day of the change.

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, and 63-10-306.
Administrative History: Original rules filed September 12, 2018; effective December 11, 2018.

Tenn. Comp. R. & Regs. 1140-16-.04 MINIMUM QUALIFICATIONS

(1) The Board shall consider, at a minimum, the following factors in reviewing an application for a license as a 3PL:

(a) Any convictions of the applicant under any federal, state, or local laws relating to drug samples or distribution of controlled substances;

(b) Any felony convictions of the applicant under federal, state, or local laws;

(c) The applicant's past experience in the distribution of prescription drugs and/or prescription devices, including controlled substances;

(d) The furnishing by the applicant of false or fraudulent material in any application made in connection with distribution;

(e) Suspension or revocation by federal, state, or local government of any license currently or previously held by the applicant for the distribution of any drugs, including controlled substances, prescription drugs and/or prescription devices;

(f) Compliance with licensing requirements under previously granted licenses, if any;

(g) Compliance with requirements to maintain and/or make available to the Board or to federal, state, or local law enforcement officials those records required by federal, state or local laws; and (h) Any other factors or qualifications the Board considers relevant to and consistent with the public health and safety.

(2) The Board shall have the right to deny a license to an applicant if it determines that the granting of such a license would not be in the public interest.

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, and 63-10-306.
Administrative History: Original rules filed September 12, 2018; effective December 11, 2018.

Tenn. Comp. R. & Regs. 1140-16-.05 PERSONNEL

The Board shall require that personnel employed by a 3PL have appropriate education and/or experience to assume positions of responsibility for compliance with Board requirements.

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, and 63-10-306.
Administrative History: Original rules filed September 12, 2018; effective December 11, 2018. December, 2018 4

Tenn. Comp. R. & Regs. 1140-16-.06 MINIMUM REQUIREMENTS FOR GENERAL OPERATION

The following shall be the minimum requirements for the storage and handling of prescription drugs and/or prescription devices and for the establishment and maintenance of prescription drug and/or prescription device distribution records by a 3PL:

(1) Facilities. All facilities at which prescription drugs and/or prescription devices are stored, warehoused, handled, held, offered, marketed, or displayed shall:

(a) Be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;

(b) Have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions;

(c) Have a quarantine area for storage of prescription drugs and/or prescription devices that are outdated, damaged, deteriorated, misbranded, or adulterated, or that are in immediate or sealed, secondary containers that have been opened;

(d) Be maintained in a clean and orderly condition; and (e) Be free from infestation by insects, rodents, birds, or vermin of any kind.

(2) Security.

(a) All facilities at which prescription drugs and/or prescription devices are stored, warehoused, handled, held, offered, marketed, or displayed shall be secure from unauthorized entry.

Access from outside the premises shall be kept to a minimum and be wellcontrolled.
The outside perimeter of the premises shall be well-lit.
Entry into areas where prescription drugs and/or prescription devices are held shall be limited to authorized personnel.

(b) All facilities shall be equipped with an alarm system to detect entry after hours.

(d) All facilities shall be equipped with inventory management and control systems that protect against, detect, and document any instances of theft, diversion, or counterfeiting.

(e) All common carriers used by a 3PL shall ensure security via one of the following:

A verifiable security system; or 2. A Board-approved accreditation or certification program.

(3) Storage. All prescription drugs and/or prescription devices shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in December, 2018 5 the labeling of such drugs and devices, or with requirements in the current edition of an official compendium, such as the United States Pharmacopeia-National Formulary (USP-NF).

(a) If no storage requirements are established for a prescription drug, the prescription drug may be held at “controlled” room temperature, as defined in an official compendium such as USP-NF, to help ensure that its identity, strength, quality, and purity are not adversely affected.

(b) Appropriate manual, electromechanical, or electronic temperature and humidity recording equipment and/or logs shall be utilized to document proper storage of prescription drugs and/or devices.

(c) Packaging of the prescription drugs and/or devices shall be in accordance with an official compendium such as USP-NF and identify any compromise in the integrity of the prescription drugs and/or devices due to tampering or adverse storage conditions.

(d) Controlled substance drugs shall be isolated from non-controlled substance drugs and stored in a secure area in accordance with DEA security requirements and standards.

(e) The record keeping requirements in paragraph (7) of this Rule shall be followed for the distribution of all prescription drugs and/or devices.

(4) Reporting. A 3PL must comply with all reporting requirements and must exchange transaction

history, transaction information, and transaction statements with authorized trading partners in accordance with all applicable state and federal reporting requirements.

(5) Examination of materials.

(a) Upon receipt, each outside shipping container shall be visually examined for identity and to prevent the acceptance of contaminated prescription drugs and/or prescription devices that are otherwise unfit for distribution. This examination shall be adequate to reveal container damage that would suggest possible contamination or other damage to the contents.

(b) Each outgoing shipment shall be carefully inspected for identity of the prescription drug and/or prescription devices products and to ensure that there is no delivery of prescription drugs that have been damaged in storage or held under improper conditions.

(6) Returned, damaged, and outdated prescription drugs and prescription devices.

(a) Prescription drugs prescription devices that are damaged, deteriorated, misbranded, or adulterated shall be quarantined and physically separated from other prescription drugs and/or prescription devices until destroyed or returned.

(b) Any prescription drugs and/or prescription devices whose immediate or sealed outer or sealed secondary containers have been opened or used shall be quarantined and physically separated from other prescription drugs and/or prescription devices until either destroyed or returned.

(c) If the conditions under which a prescription drug and/or prescription device has been returned cast doubt on safety, identity, strength, quality, or purity, then the prescription drug and/or prescription device shall be destroyed, or returned, unless examination, testing, or other investigation proves that the prescription drug and/or prescription device meets appropriate standards of safety, identity, strength, quality, and purity. In determining whether the conditions under which a prescription drug and/or prescription December, 2018 6 device has been returned cast doubt on safety, identity, strength, quality, or purity, the 3PL shall consider, among other things, the conditions under which the prescription drug and/or prescription device has been held, stored or shipped before or during return and the condition of the prescription drug and/or device or related material and its container, carton, or labeling, as a result of storage or shipping.

(d) The record keeping requirements in paragraph (7) of this rule shall be followed for all outdated, damaged, deteriorated, misbranded, or adulterated prescription drugs and/or prescription devices and reported to all applicable state and federal authorities.

(7) Record Keeping.

(a) A 3PL shall establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of prescription drugs and/or devices as outlined in federal law. These records shall include:

Dates of receipt and distribution; or 2. Other disposition of the prescription drugs and/or devices.

(b) Such records shall include the inventories and transaction records and shall be made available for inspection and photocopying for a period of two (2) years following their creation date.

(c) Records described in this section that are kept at the inspection site or that can be immediately retrieved by computer or other electronic means shall be readily available for authorized inspection during the retention period. Records kept at a central location apart from the inspection site and not electronically retrievable shall be made available for inspection within two (2) working days of a request by an authorized official of any state or federal governmental agency charged with enforcement of these rules.

(d) A 3PL shall maintain an ongoing list of persons with whom it provides services.

(e) All facilities shall establish and maintain procedures for reporting counterfeit and contraband or suspected counterfeit and contraband drugs and/or devices, as well as counterfeiting and contraband or suspected counterfeiting and contraband activities, to the Board and United States Food and Drug Administration (FDA).

(8) Written Policies and Procedures (a) A 3PL shall establish, maintain, and adhere to written policies and procedures, which shall be followed for the receipt, security, storage, inventory, transport, and shipping and distribution of prescription drugs and/or prescription devices, including policies and procedures for identifying, recording, and reporting losses or thefts and for correcting all errors and inaccuracies in inventories.

(b) A 3PL shall include in its written policies and procedures the following:

A procedure to be followed for handling recalls and withdrawals of prescription drugs and/or devices. Such procedure shall be adequate to deal with recalls and withdrawals due to any action initiated at the request of the FDA or any other federal, state, or local law enforcement or other government agency, including the Board;
A procedure to ensure that a 3PL prepares for, protects against, and handles any crisis that affects security or operation of any facility in the event of strike, fire, December, 2018 7 flood, or other natural disaster, or other situations of local, state, or national emergency;
A procedure to ensure that any outdated prescription drugs shall be segregated from other prescription drugs and either returned to the manufacturer or destroyed in accordance with federal and state laws, including all necessary documentation and the appropriate witnessing. This procedure shall provide for written documentation of the disposition of outdated prescription drugs;
A procedure for the destruction of outdated prescription drugs in accordance with federal and state laws;
A procedure for the disposal and destruction of containers, labels, and packaging to ensure that the containers, labels, and packaging cannot be used in counterfeiting activities, including all necessary documentation, maintained for a minimum of two (2) years, and the appropriate witnessing of the destruction of any labels, packaging, immediate containers, or containers in accordance with all applicable federal and state requirements;
A procedure for identifying, investigating and reporting significant prescription drug inventory discrepancies involving counterfeit, contraband, or suspected counterfeit or contraband prescription drugs, including reporting of such discrepancies as required by federal and state law to the FDA, Board and/or appropriate federal or state agency upon discovery;
A procedure for reporting criminal or suspected criminal activities involving the inventory of prescription drug(s) and/or device(s) as required to the Board, FDA, and, if applicable, DEA;
A procedure to correct errors and inaccuracies in inventories;
A procedure for maintaining the capability to trace the receipt and outbound distribution of a product, and supplies and records of inventory; and 10. A procedure for verifying security provisions of common carriers.

(c) Responsible persons. A 3PL shall establish and maintain lists of officers, directors, managers, and other persons in charge of distribution, storage, and handling, including a description of such persons’ duties and a summary of such persons’ qualifications.

(d) Compliance with federal, state, and local law. A 3PL shall operate in compliance with applicable federal, state, and local laws and regulations.

A 3PL shall permit the Board and authorized federal, state, and local law enforcement officials to enter and inspect premises and delivery vehicles, if applicable, and to audit records and written operating procedures, at reasonable times and in a reasonable manner, to the extent authorized by law.
A 3PL that handles controlled substances shall register with the Board and with the DEA and shall comply with applicable local, state, and federal laws and DEA regulations.

(9) Salvaging and reprocessing. A 3PL shall be subject to the provisions of any applicable federal, state, and local laws or regulations that relate to salvaging or reprocessing of prescription drugs and/or prescription devices.

December, 2018 8

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, and 63-10-306.
Administrative History: Original rules filed September 12, 2018; effective December 11, 2018.

Tenn. Comp. R. & Regs. 1140-16-.07 Upon request, the Board may waive selected portions of this Chapter so long as any waiver granted is consistent with the Board’s authority under Tenn. Code Ann. Title 63, Chapters 1 and 10, and Tenn. Code Ann. Title 4, Chapter 5.

History

Authority: T.C.A. §§ 63-10-204, 63-10-304, and 63-10-306.
Administrative History: Original rules filed September 12, 2018; effective December 11, 2018.

Chapter 1140-17 Repealed

Tenn. Comp. R. & Regs. 1140-17-.01 REPEALED

History

Authority: T.C.A. §§ 63-10-501 through 63-10-510 and Chapter 392 of the Public Acts of 2017, § 1.
Administrative History: Original rules filed May 31, 2018; effective August 29, 2018. Repeal filed June 5, 2024; effective September 3, 2024.

Tenn. Comp. R. & Regs. 1140-17-.12 REPEALED

History

Authority: T.C.A. §§ 63-10-501 through 63-10-510 and Chapter 392 of the Public Acts of 2017, § 1.
Administrative History: Original rules filed May 31, 2018; effective August 29, 2018. Repeal filed June 5, 2024; effective September 3, 2024.

Tenn. Comp. R. & Regs. 1140-17-.02 REPEALED

History

Authority: T.C.A. §§ 63-10-501 through 63-10-510 and Chapter 392 of the Public Acts of 2017, § 1.
Administrative History: Original rules filed May 31, 2018; effective August 29, 2018. Repeal filed June 5, 2024; effective September 3, 2024.

Tenn. Comp. R. & Regs. 1140-17-.03 REPEALED

History

Authority: T.C.A. §§ 63-10-501 through 63-10-510 and Chapter 392 of the Public Acts of 2017, § 1.
Administrative History: Original rules filed May 31, 2018; effective August 29, 2018. Repeal filed June 5, 2024; effective September 3, 2024.

Tenn. Comp. R. & Regs. 1140-17-.04 REPEALED

History

Authority: T.C.A. §§ 63-10-501 through 63-10-510 and Chapter 392 of the Public Acts of 2017, § 1.
Administrative History: Original rules filed May 31, 2018; effective August 29, 2018. Repeal filed June 5, 2024; effective September 3, 2024.

Tenn. Comp. R. & Regs. 1140-17-.05 REPEALED

History

Authority: T.C.A. §§ 63-10-501 through 63-10-510 and Chapter 392 of the Public Acts of 2017, § 1.
Administrative History: Original rules filed May 31, 2018; effective August 29, 2018. Repeal filed June 5, 2024; effective September 3, 2024.

Tenn. Comp. R. & Regs. 1140-17-.06 REPEALED

History

Authority: T.C.A. §§ 63-10-501 through 63-10-510 and Chapter 392 of the Public Acts of 2017, § 1.
Administrative History: Original rules filed May 31, 2018; effective August 29, 2018. Repeal filed June 5, 2024; effective September 3, 2024.

Tenn. Comp. R. & Regs. 1140-17-.07 REPEALED

History

Authority: T.C.A. §§ 63-10-501 through 63-10-510 and Chapter 392 of the Public Acts of 2017, § 1.
Administrative History: Original rules filed May 31, 2018; effective August 29, 2018. Repeal filed June 5, 2024; effective September 3, 2024.

Tenn. Comp. R. & Regs. 1140-17-.08 REPEALED

History

Authority: T.C.A. §§ 63-10-501 through 63-10-510 and Chapter 392 of the Public Acts of 2017, § 1.
Administrative History: Original rules filed May 31, 2018; effective August 29, 2018. Repeal filed June 5, 2024; effective September 3, 2024.

Tenn. Comp. R. & Regs. 1140-17-.09 REPEALED

History

Authority: T.C.A. §§ 63-10-501 through 63-10-510 and Chapter 392 of the Public Acts of 2017, § 1.
Administrative History: Original rules filed May 31, 2018; effective August 29, 2018. Repeal filed June 5, 2024; effective September 3, 2024.

Tenn. Comp. R. & Regs. 1140-17-.10 REPEALED

History

Authority: T.C.A. §§ 63-10-501 through 63-10-510 and Chapter 392 of the Public Acts of 2017, § 1.
Administrative History: Original rules filed May 31, 2018; effective August 29, 2018. Repeal filed June 5, 2024; effective September 3, 2024.

Tenn. Comp. R. & Regs. 1140-17-.11 REPEALED

History

Authority: T.C.A. §§ 63-10-501 through 63-10-510 and Chapter 392 of the Public Acts of 2017, § 1.
Administrative History: Original rules filed May 31, 2018; effective August 29, 2018. Repeal filed June 5, 2024; effective September 3, 2024.