Wyo. Code R. 059 | Wyoming Administrative Rules 059 — Pharmacy, Board of

346 Commissioner of Drugs & Substances Control

Chapter 1 Authority & Definitions

Wyo. Code R. 059.0002.1.01162014 Authority & Definitions

CHAPTER 1

AUTHORITY AND DEFINITIONS

Section 1. Authority.

These rules and regulations are adopted as authorized by the Wyoming Administrative Procedure Act, W.S. 16-3-101 through 16-3-115; and the Wyoming Controlled Substances Act, W.S. 35-7-1001 through 35-7-1055.

Section 2. Definitions.

As used herein, the following terms shall have the meanings specified:

(a) The term "Act" means the Wyoming Controlled Substances Act.

(b) The term "Bureau" means the Drug Enforcement Administration, United States Department of Justice.

(c) The term "person" includes any individual, corporation, government or governmental subdivision or agency business trust, partnership, association or other legal entity.

(d) The term "pharmacist" means any pharmacist licensed by the Board to dispense controlled substances, and shall include any other person (e.g., a pharmacist intern) authorized by the Board to dispense controlled substances under the immediate supervision of a pharmacist licensed by the Board.

(e) The term "prescription" means an order for medication which is dispensed to or for an ultimate user but does not include an order for medication which is dispensed for immediate administration to the ultimate user. (E.g., an order to dispense a drug to a bed patient for immediate administration in a hospital is not a prescription.)

(f) The term "registrant" means any person who is registered pursuant to either Sections 24 and 25 of the Act or Section 302 of the Federal Act.

Section 3. Principal Reasons for Adoption of Rules.

The adoption of rules requiring registration of persons engaged in the manufacture, distribution or dispensing of controlled substances is deemed to be in the public's interest in the regulation of such activities. To implement such regulation the rules specifically provide for and establish:

(a) Requirements pertaining to registration of persons manufacturing, distributing and dispensing controlled substances, and provide for exemption from registration designated classes.

(b) Requirements relating to maintaining records of inventories and safeguarding inventories.

(d) Procedures for Administrative Inspection of inventories and records.

History

Effective 2014-01-16

Chapter 2 Hearings

Wyo. Code R. 059.0002.2.01162014 Hearings

CHAPTER 2

HEARINGS

Section 1. Hearings Generally.

In any case where the Commissioner, or his designee shall hold a hearing on the issuance, amendment, or repeal of rules pursuant to the Act, the procedures for such hearing and accompanying proceedings shall be governed generally by the rule making procedures set forth in the Wyoming Administrative Procedure Act

Section.2. Burden of Proof.

At any hearing held under the provisions of the Act, the proponent for the issuance, amendment, or repeal of any rule or regulation shall have the burden of proof.

Section.3. Control Required by Statute.

(a) In the event that the Bureau has published in the Federal Register a final order designating, rescheduling, or deleting any substance as a controlled substance under the Federal Controlled Substances Act (21 U. S. C., 811), the Commissioner, pursuant to Section 11(d) of the Act may either:

(i) Within thirty (30) days after the publication of the final order in the Federal Register, object to designating, rescheduling, or deleting the substance in the same manner under the Act, or

(ii) After thirty (30) days following the publication of the final order in the Federal Register, issue a final order designating, rescheduling, or deleting the substance in the same manner without regard to findings required under Section 11(b) of the Act.

(b) In the event that the Commissioner objects to designating, rescheduling, or deleting the substance in the same manner as the Bureau, the Commissioner shall promptly notify all persons who have previously requested in writing, notification of such action. Such notice shall contain the reasons for the objection. Thereafter, the Commissioner shall hold a hearing as required by Section 11(d) of the Act. Such hearing shall conform as nearly as practicable to the provisions of the Wyoming Administrative Procedure Act regulating the adoption, amendment, or repeal of rules.

Section 4. Complaints.

(a) A disciplinary action is initiated against a license holder by submitting a written complaint to the Board office. A complaint concerning an alleged violation of the Act or Board Rules may be submitted by any person or entity, a Board member, or a Board staff member. The written complaint should provide as much of the following information as may be available and applicable:

(i) The name and address of the complainant;

(ii) The name, address, place of employment, and telephone number of the license holder against whom the charges are made;

(iii) The specific conduct alleged to constitute the violation;

(iv) The name and address of any other witnesses; and

(v) The signature of the complainant.

Section 5. Review of Written Complaint.

(a) Written complaints shall be referred to the Board staff Compliance Officer/Investigator or to an Investigative Board Member (IBM) selected by Board staff from a rotating schedule. License holders against whom charges are made will be advised of the investigation and the nature of the complaint.

(i) The IBM shall not take part in the consideration of any contested case.

(ii) The IBM shall not, by this rule, be barred from attending any disciplinary hearing.

Section 6. Investigations and Board Action.

Board staff shall investigate those written complaints received which merit further investigation.

(a) Upon completion of the investigation the Executive Director shall:

(i) Dismiss the complaint if no evidence of violation of the Act or Board rules is found; or

(ii) Prepare an investigative report which shall include:

(A) The findings;

(B) A list of statutes and/or Board rules believed to have been violated; and

(b) The Executive Director shall forward the report and his/her recommendations to the Assistant Attorney General assigned to the Board for prosecution, and consult with the Assistant Attorney General.

(i) Send the notice required by Section 5;

(ii) Prepare and file a formal petition and notice of hearing setting the matter for a contested case hearing before the Board;

(iii) Recommend the Board accept an offer of conditional terms for settlement, which may include educational courses;

(iv) Recommend the Board dismiss the complaint.

(d) The Board may resolve a complaint at any time by:

(i) Accepting a voluntary surrender of a license;

(ii) Accepting conditional terms for settlement;

(iii) Dismissal.

Section 7. Service of Notice and Opportunity to Show Compliance.

Prior to commencement of a formal hearing, the IBM Executive Director shall give notice by mail to the license holder of the facts or conduct which warrant his/her intended action. The notice shall give the license holder an opportunity to show compliance with all lawful requirements for retention of the license within twenty (20) days of the mailing of the notice. Such notice shall be sent to the license holder's last known address both by certified mail with return receipt requested and by first class mail.

Section 8. Formal Hearing Procedures Prerequisites.

(a) Formal proceedings for a hearing before the Board regarding action against a license holder shall be commenced by petition and notice of hearing, served in person, or by both certified mail and first class mail sent to the address last known by the Board at least thirty (30) days prior to the date set for the hearing. The petition and notice shall contain at least:

(i) The name and address of the license holder;

(ii) A statement, in ordinary and concise language, of the nature of the complaint filed with the Board, the facts upon which the complaint is based, as well as the specific statute(s) or Board rules and regulations alleged to have been violated;

(iii) The time, place, and nature of the hearing;

(iv) That the hearing is being held pursuant to the authority provided by W.S. § 33-24-101 through 33-24-301.

(v) The license holder shall file an Answer or Notice of Appearance, which must be received by the Board at least ten (10) working days prior to the date set for hearing, or the license holder will be in default.

Section 9. Default.

The Board may enter an order based on the allegations in a petition in any case where the applicant or license holder has not answered or appeared in writing ten (10) working days before the hearing, or in any case in which the applicant or license holder or his/her representative has not appeared at a scheduled hearing for which they had notice.

Section 10. Contested Case Hearings.

The Office of Administrative Hearings shall act as the hearing officer and shall preside over the formal contested case hearing which shall be conducted pursuant to the Wyoming Administrative Procedure Act and the Office of Administrative Hearings' rules concerning contested case proceedings.

(a) At the Board's discretion, contested case hearings shall either be conducted in the presence of a quorum of Board Members or a committee of one (1) or more Board Members.

(b) During the formal contested case hearing, Board Members may ask questions of the witnesses and/or the parties including their attorneys.

Section 11. Decisions.

(a) Proposed Decisions:

(i) At the discretion and direction of the Board hearing officer, the parties may file proposed findings of fact, conclusions of law, and order after the hearing and before the deadline announced in the hearing's closing announcements.

(ii) At the discretion and direction of the Board, the hearing officer or the Assistant Attorney General assigned to advise the Board shall prepare proposed findings of fact, conclusions of law, and order following deliberations by the Board or its committee.

(b) Final Decisions. Proposed decisions will be given consideration but are not binding upon the Board. All final decisions will be issued by the Board and shall be based exclusively upon the evidence in the record and matters officially noticed. All final decisions issued by the Board shall be served to all parties by first class mail sent to their last known address.

Section 12. Appeals.

A Petition for Judicial Review of the Board decision may be filed in the district court in accordance with the Wyoming Rules of Appellate Procedure.

Section 13. Transcripts.

If a Petition for Judicial Review is filed in the district court, the petitioner shall either arrange the preparation and pay for the transcript of the testimony, or reimburse the Board for the cost of the transcript if previously prepared at Board expense.

History

Effective 2014-01-16

Chapter 3 Fees for Registration and Re-Registration

Wyo. Code R. 059.0002.3.01162014 Fees for Registration and Re-Registration

CHAPTER 3

FEES FOR REGISTRATION AND RE-REGISTRATION

Section 1. Fee Amounts.

(a) For each registration or re-registration to manufacture controlled substances, the registrant shall pay a fee of $250.00.

(b) For each registration or re-registration to distribute controlled substances, the registrant shall pay a fee of $250.00.

(c) For each registration or re-registration to dispense, or to conduct research or instructional activities with controlled substances listed in Schedules II through V, the registrant shall pay a fee of $40.00 per year.

(d) For each registration or re-registration to conduct research or instructional activities with a controlled substance listed in Schedule I, the registrant shall pay a fee of $40.00 per year.

(e) For each registration or re-registration to conduct chemical analysis with controlled substances listed in any schedule, the registrant shall pay a fee of $40.00 per year.

(f) Any Federal, State, or local governmental agency may be exempted in the discretion of the Board from the payment of a registration fee under this section.

Section 2. Time and Method of Payment; Delinquency Fee; Refund.

Registration and re-registration fees shall be paid at the time when the application for registration or re-registration is submitted for filing. Payment shall be made in the form of a personal, certified, or cashier's check or money order, or credit card using the online renewal process, made payable to the Wyoming State Board of Pharmacy. A delinquency fee of $40.00 shall be assessed against any registrant that does not re-register by June 30th of that renewal period. In the event that the application is not accepted for filing or is denied, the payment shall be refunded to the applicant. If the check is returned for any reason, the registration issued to the applicant shall be deemed invalid.

Section 3. Persons Exempt from Fee.

(a) The Board may exempt from payment of a fee for registration or re-registration the following persons:

(i) Any official or agency of the United States Army, Navy, Marine Corps, Air Force, Coast Guard, Veterans' Administration or Public Health Service who or which is authorized to procure or purchase controlled substances for official use; and

(ii) Any official, employee, or other civil officer or agency of the United States, of any State, or any political subdivision or agency thereof, who or which is authorized to purchase controlled substances, to obtain such substances from official stocks, to dispense or administer such substances, to conduct research, instructional activities, or chemical analysis with such substances, or any combination thereof, in the course of his or its official duties or employment.

(b) Exemption from payment of a registration or re-registration fee does not relieve the registrant of any other requirements of duties prescribed by law.

REQUIREMENT OF REGISTRATION

Section 4. Persons Required to Register.

Every person who manufactures, distributes or dispenses any controlled substance or who proposes to engage in the manufacture, distribution or dispensing of any controlled substance shall obtain annually a registration unless exempted by law or by the regulations. Only persons actually engaged in such activities are required to obtain a registration; related or affiliated persons who are not engaged in such activities are not required to be registered. (For example, a stockholder of a parent corporation of a corporation manufacturing controlled substances is not required to obtain a registration.)

Section 5. Separate Registration for Independent Activities.

(a) The following six groups of activities are deemed to be independent of each other:

(i) Manufacturing controlled substances;

(ii) Distributing controlled substances;

(iii) Dispensing, conducting research with (other than research described in subparagraph (4) of this paragraph), and conducting instructional activities with controlled substances listed in Schedules II through V;

(iv) Conducting research with narcotic drugs listed in Schedules II through V for the purpose of continuing the dependence on such drugs of a narcotic drug dependent person in the course of conducting an authorized clinical investigation in the development of a narcotic addict rehabilitation program pursuant to a Notice of Claimed Investigational Exemption for a New Drug approved by the Food and Drug Administration;

(v) Conducting research and instructional activities with controlled substances listed in Schedule I; and

(vi) Conducting chemical analysis with controlled substances listed in any schedule.

(b) Every person who engages in more than one group of independent activities shall obtain a separate registration for each group of activities, except as provided in this paragraph.

(i) A person registered to manufacture any controlled substance or basic class of controlled substance shall be authorized to distribute that substance or class, but no other substance or class which he is not registered to manufacture;

(ii) A person registered to manufacture any controlled substance listed in Schedules II through V shall be authorized to conduct chemical analysis and preclinical research (including quality control analysis) with narcotic and non-narcotic controlled substances listed in those schedules in which he is authorized to manufacture;

(iii) A person registered to conduct research with a basic class of controlled substance listed in Schedule I shall be authorized to manufacture such class if and to the extent that such manufacture is set forth in the research protocol filed with the application for registration and to distribute such class to other persons registered to conduct research with such class or to conduct chemical analysis;

(iv) A person registered to conduct chemical analysis with controlled substance shall be authorized to manufacture such substances for analytical or instructional purposes, to distribute such substances to other persons registered to conduct chemical analysis or instructional activities, to persons registered or authorized to conduct research with such substances, and to conduct instructional activities with controlled substances;

(v) A person registered or authorized to conduct research (other than research described in paragraph (a) (4) of this section) with controlled substances listed in Schedules II through V shall be authorized to conduct chemical analysis with controlled substances listed in those schedules in which he is authorized to conduct research to manufacture is set forth in a statement filed with the application for registration, and to distribute such substances to other persons registered or authorized to conduct chemical analysis, instructional activities, or research with such substances, and to conduct instructional activities with controlled substances;

(vi) A person registered to dispense, or to conduct research (other than research described in paragraph (a) (4) of this section) with controlled substances listed in Schedules II through V shall be authorized to dispense and to conduct such research and to conduct instructional research with those substances.

(c) A single registration to engage in any group of independent activities may include one or more controlled substances listed in the schedules authorized in that group of independent activities. A person registered to conduct research with controlled substances listed in Schedule I may conduct research with any substance listed in Schedule I for which he has filed and had approved a research protocol.

Section 6. Separate Registrations for Separate Locations.

(a) A separate registration is required for each principal place of business or professional practice at one general physical location where controlled substances are manufactured, distributed, or dispensed by a person.

(b) The following locations shall be deemed not to be places where controlled substances are manufactured, distributed, or dispensed:

(i) A warehouse where controlled substances are stored by or on behalf of a registered person, unless such substances are distributed directly from such warehouse to registered locations other than the registered location from which the substances were delivered or to persons not required to register by virtue of subsection 24(c)(ii) of the Act;

(ii) An office used by agents of a registrant where sales of controlled substances are solicited, made, or supervised but which neither contains such substances (other than substances for display purposes of lawful distribution as samples only) nor serves as a distribution point for filling sales orders; and

(iii) An office used by a practitioner (who is registered at another location) where controlled substances are prescribed but neither administered nor otherwise dispensed as a regular part of the professional practice of the practitioner at such office, and where no supplies of controlled substances are maintained.

Section 7. Exemption of Agents and Employees; Affiliated Practitioners.

(a) The requirement of registration is waived for any agent or employee of a person who is registered to engage in any group of independent activities, if such agent or employee is acting in the usual course of his business or employment.

(b) A practitioner (other than an intern, resident, or foreign physician) who is an agent or employee of another practitioner registered to dispense controlled substances may, when acting in the usual course of his employment, administer, and dispense (other than by issuance of prescription) controlled substances if and to the extent that such individual practitioner is authorized or permitted to do so by the jurisdiction in which he practices, under the registration of the employer or principal practitioner in lieu of being registered himself. (For example, a pharmacist employed by a pharmacy need not be registered individually to fill a prescription for controlled substances if a pharmacy is so registered.)

(c) A practitioner who is an intern, resident, or foreign physician may dispense and prescribe controlled substances under the registration of the hospital or other institution which is registered and by whom he is employed provided that:

(i) Such dispensing or prescribing is done in the usual course of his professional practice;

(ii) Such individual practitioner is authorized or permitted to do so by the laws of the State of Wyoming;

(iii) The hospital or other institutions by whom he is employed has determined that the practitioner is so permitted to dispense or prescribe drugs by the State of Wyoming;

(iv) Such practitioner is acting only within the scope of his employment in the hospital or institution;

(v) The hospital or other institution authorizes the intern, resident, or foreign physician to dispense or prescribe under the hospital registration and designates a specific internal code number for each intern, resident, or foreign physician so authorized. The code number shall consist of numbers, letters, or a combination thereof and shall be a suffix to the institution's DEA registration number, preceded by a hyphen (e.g., AP 0123456-10 or AP 0123456-A12;

(vi) A current list of internal codes and the corresponding practitioner is kept by the hospital or other institution and is made available to the public upon request for the purpose of verifying the authority of the prescribing practitioner.

Section 8. Exemption of Certain Military and Other Personnel.

(a) The requirement of registration is waived for any official of the United States Army, Navy, Marine Corps, Air Force, Coast Guard, or Public Health Service who is authorized to prescribe, dispense, or administer, but not to procure or purchase, controlled substances in the course of his official duties. Such officials when issuing a prescription shall state the branch of service or agency (e.g., "U. S. Army" or "Public Health Service") and the service identification number of the issuing official in lieu of the registration number required on prescription forms. The service identification number for a Public Health Service employee is his Social Security identification number.

(b) If any official exempted by this section also engages as a private individual in any activity or group of activities for which registration is required, such official shall obtain a registration for such private activities.

Section 9. Exemption of Law Enforcement Officials.

(a) The requirement of registration is waived for the following persons in the circumstances described in this section:

(i) Any officer or employee of the Drug Enforcement Administration, any officer of the United States Bureau of Customs, any officer or employee of the United States Food and Drug Administration, and any other Federal officer who is lawfully engaged in the enforcement of any Federal law relating to controlled substances, drugs or customs, and is duly authorized to possess controlled substances in the course of his official duties; and

(ii) Any officer or employee of any State, or any political subdivision or agency thereof, who is engaged in the enforcement of any State of local law relating to controlled substances and is duly authorized to possess controlled substances in the course of his official duties.

(b) Any official exempted by this section may, when acting in the course of his official duties, possess any controlled substance and distribute any such substance to any other official who is also exempted by this section and acting in the course of his official duties.

(c) Any official exempted by this section may procure any controlled substance in the course of an inspection, in accordance with Section 46 of the Act, or in the course of any criminal investigation involving the person from whom the substance was procured.

(d) In order to enable law enforcement agency laboratories to obtain and transfer controlled substances for use as standards in chemical analysis, such laboratories must obtain annually a registration to conduct chemical analysis. Laboratory personnel, when acting in the scope of their official duties, are deemed to be officials exempted by this section and within the activity described in Section 50(c) of the Act. (Section 515(d) of the Federal Act.) For purposes of this paragraph, laboratory activities shall not include field or other preliminary chemical tests by officials exempted by this section.

Section 10. Exemption of Civil Defense Officials.

(a) The requirement of registration is waived for any official of a civil defense or disaster relief organization who, in the course of his official duties, is authorized to:

(i) Maintain, and distribute for such maintenance, controlled substances held for emergency use; or

(ii) Procure controlled substances for the purpose of maintaining supplies for emergency use, provided that all of such procurement is from the United States General Services Administration and in accordance with the rules of the United States office of Emergency Preparedness.

(b) The requirement of registration is waived for any official of a civil defense or disaster relief organization during a state of emergency or disaster within his jurisdiction proclaimed by the President or by a concurrent resolution of the Congress, which official, in the course of his official duties during such emergency or disaster, is authorized to:

(i) Dispense controlled substances; or

(ii) Procure or distribute controlled substances, provided that all such procurement is on a special "Civil Defense Emergency Order Form," as described in this section.

(c) Civil Defense Emergency Order Forms shall be furnished by the United States Office of Emergency Preparedness and will contain the name of the civil defense or disaster relief organization. Such forms may be used and are valid only during a state of emergency or disaster proclaimed by the President or by a concurrent resolution of the Congress for the area in which the organization using such forms has civil defense or disaster relief jurisdiction, who shall state his position and the nature and legal designation of the emergency or disaster. Such forms may be filled by any person registered under the Act. The organization shall, upon the execution of a Civil Defense Emergency Order Form, be deemed to be registered under the Act for purposes of recordkeeping pursuant to Chapter 4.

Section 11. Time for Application for Registration; Expiration Date.

(a) Any person who is required to be registered and who is not so registered may apply for registration at any time. No person required to be registered shall engage in any activity for which registration is required until the application for registration is approved. The Board will issue a "Preliminary" approval so that the registrant may become registered with the Drug Enforcement Administration. After receiving the DEA number, the Board will register them.

(b) Any person who is registered may apply to be reregistered not less than thirty (30) days, nor more than sixty (60) days, before the expiration date of his registration.

(d) Any registrant who fails to renew their registration by September 30th of each calendar year shall be penalized in the amount of $40.00. If failure to renew continues past December 31st of the calendar year, the registration shall be cancelled and the Bureau notified for cancellation of the registrants' federal registration.

(e) Any registrant who wishes to reinstate their registration when said registration has lapsed only for failure to pay renewal fees, the registrant shall pay all back renewal fees, including annual fines, up to a maximum of five (5) years.

Section 12. Application Forms; Contents; Signature.

(a) If any person is required to be registered, and is not so registered and is applying for registration, he should obtain the necessary forms from the officer of the Board.

(b) If any person is registered and is applying for re-registration, registration and renewal forms will be mailed approximately sixty (60) days before expiration date, or by May 1st of each renewal year.

(c) Registration information may be obtained at any regional office of the Drug Enforcement Administration or by contacting the Wyoming State Board of Pharmacy.

(d) Each application for registration to handle any basic class of controlled substance listed in Schedule I (except to conduct chemical analysis with such classes), and each application for registration to manufacture a basic class of controlled substances listed in Schedule II, or to conduct research with any narcotic controlled substance listed in Schedule II, shall include the Controlled Substances Code Number for each basic class or substance to be covered by such registration.

(e) Each application shall include all information called for in the form, unless the item is not applicable, in which case this fact shall be indicated.

(f) Each application, attachment, or other document filed as part of an application, shall be signed by the applicant, if an individual; by a partner of the applicant, if a partnership; or by an officer of the applicant, if a corporation, corporate division association trust or other entity.

Section 13. Filing of Application; Joint Filings.

(a) All applications for registration shall be submitted for filing to the Board. The appropriate registration fee and any required attachments must accompany the application.

(b) Any person required to obtain more than one registration may submit all applications in one package. Each application must be complete and should not refer to any accompanying application for required information.

Section 14. Acceptance for Filing, Defective Applications.

(a) Applications submitted for filing are dated upon receipt. If found to be complete, the application will be accepted for filing. Applications failing to comply with the requirements of this part will not generally be accepted for filing. In the case of minor defects as to completeness, the Board may accept the application for filing with a request to the applicant for additional information. A defective application will be returned to the applicant with a statement of the reason for not accepting the application for filing. A defective application may be corrected and resubmitted for filing at any time prior to the expiration date.

(b) Accepting an application for filing does not preclude any subsequent request for additional information pursuant to this chapter and has no bearing on whether the application will be granted.

Section 15. Additional Information.

(a) The Board may require an applicant to submit such documents or written statements of fact relevant to the application as it deems necessary to determine whether the application should be granted. The failure of the applicant to provide such documents or statements within a reasonable time after being requested to do so shall be deemed to be a waiver by the applicant of an opportunity to present such documents or facts for consideration by the Board in granting or denying the application.

Section 16. Amendments to and Withdrawal of Applications.

(a) An application may be amended or withdrawn without permission of the Board at any time before the date on which the applicant receives an order to show cause pursuant to this chapter. An application may be amended or withdrawn with permission of the Board at any time where good cause is shown by the applicant or where the amendment or withdrawal is in the public interest.

(b) After an application has been accepted for filing, the request by the applicant that it be returned or the failure of the applicant to respond to official correspondence regarding the application within ten (10) days, when sent by registered or certified mail, shall be deemed to be a withdrawal of the application.

Section 17. Administrative Review Generally.

The Board may inspect, or cause to be inspected, the establishment of an applicant or registrant, pursuant to Section 46 of the Act. The Board shall review the application for registration and other information regarding an applicant in order to determine whether the applicable standards of Sections 24 and 25 of the Act have been met by the applicant.

Section 18. Certificate of Registration; Denial of Registration.

(a) The Board shall issue a Certificate of Registration to an applicant if the issuance of registration or re-registration is required. In the event that the issuance of registration or re- registration is not in the public interest, the Board shall deny the application. Before denying any application, the Board shall issue an order to show cause and, if requested by the applicant, shall hold a hearing on the application.

(b) The Certificate of Registration shall contain the name, address, and the Drug Enforcement Administration registration number of the registrant, the activity authorized by the registration, the schedules and/or Controlled Substances Code Number of the controlled substances which the registrant is authorized to handle, the amount of fee paid (or exemption), and the expiration date of the registration. The registrant shall prominently display the Certificate of Registration at the registered location.

Section 19. Suspension or Revocation of Registration.

(a) The Board may suspend any registration pursuant to Section 26(a) of the Act for any period of time it determines.

(b) The Board may revoke any registration pursuant to Section 26(a) of the Act.

(c) Before revoking or suspending any registration, the Board shall issue an order to show cause pursuant to this chapter and, if requested by the registrant, shall hold a hearing pursuant to this chapter. Notwithstanding the requirements of this section, however, the Board may suspend any registration pending a final order pursuant to this chapter.

(d) Upon service of the order of the Board suspending or revoking registration, the registrant shall immediately surrender his Certificate of Registration and shall:

(i) Deliver all controlled substances in his possession to the Board or its authorized agents; or

(ii) Place all controlled substances in his possession under seal.

(e) In the event that revocation or suspension is limited to particular controlled substance or substances, the registrant shall be given a new Certificate of Registration for all substances not affected by such revocation or suspension; no fee shall be required to be paid for the new Certificate of Registration. The registrant shall surrender the old Certificate of Registration to the Board. Also, the registrant shall:

(i) Deliver to the Board or its authorized agents all of the particular controlled substance or substances affected by the revocation or suspension which are in his possession; or

(ii) Place all of such substances under seal.

Section 20. Suspension of Registration Pending Final Order.

(a) The Board may suspend any registration simultaneously with or at any time subsequent to the service upon the registrant of an order to show cause why such registration should not be revoked or suspended, in any case where it finds that there is an imminent danger to the public health or safety. If the Board so suspends, it shall serve, together with the order to show cause pursuant to this chapter an order of immediate suspension which shall contain a statement of his findings regarding the danger to public health or safety.

(b) Upon service of the order of immediate suspension, the registrant shall promptly surrender his Certificate of Registration, and shall:

(i) Deliver all affected controlled substances in his possession to the Board or its authorized agents; or

(ii) Place all of such substances under seal.

(c) Any suspensions shall continue in effect until the conclusion of all proceedings upon the revocation or suspension, including any judicial review thereof, unless sooner withdrawn by the Board or dissolved by a court of competent jurisdiction. Any registrant whose registration is suspended under this section may request a hearing on the revocation or suspension of his registration at a time earlier than specified in the order to show cause pursuant to Section 46, which request shall be granted by the Board which shall fix a date for such hearing as early as reasonably possible.

Section 20. Extension of Registration Pending Final Order.

In the event that an applicant for re-registration (who is doing business under a registration previously granted and not revoked or suspended) has applied for re-registration before the date on which the existing registration is due to expire, and the Board has issued no order on the application on the date on which the existing registration is due to expire, the existing registration of the applicant shall automatically be extended and continue in effect until the date on which the Board so issues its order. The Board may extend any other existing registration under the circumstances contemplated in this section even though the registrant failed to apply for re-registration at least thirty (30) days before expiration of the existing registration, with or without request by the registrant, if the Board finds that such extension is not inconsistent with the public health and safety.

Section 21. Order to Show Cause.

(a) If, upon examination of the application for registration from any applicant and other information regarding the applicant, the Board is unable to make the determinations required by the applicable provisions to register the applicant, the Board shall serve upon the applicant an order to show cause why the registration should not be denied.

(b) If, upon information regarding any registrant, the Board determines that the registration of such registrant is subject to suspension or revocation, the Board shall serve upon the registrant an order to show cause why the registration should not be revoked or suspended.

(c) The order to show cause shall call upon the applicant or registrant to appear before the Board at a time and place stated in the order, which shall not be less than thirty (30) days after the date of receipt of the order. The order to show cause shall also contain a statement of the legal basis for such hearing and for the denial, revocation, or suspension of registration and a summary of the matters of fact and law asserted.

(d) Upon receipt of an order to show cause, the applicant or registrant must, if he desires a hearing, file a request for a hearing.. If a hearing is requested, the Board shall hold a hearing at the time and place stated in the order pursuant to this chapter.

(e) When authorized by the Board, any agent of the Board may serve the order to show cause, or the Board may serve such order by mailing the same by registered or certified mail to the last known address of the applicant or registrant.

MODIFICATION OR TERMINATION

Section 22. Modification of Registration.

Any registrant may apply to modify his registration to authorize the handling of additional controlled substances by submitting a letter of request to the Board. The letter shall contain the registrant's name, address, registration number, and the substances and/or schedules to be added to or deleted from his registration and shall be signed by the same person who signed the most recent application for registration or re-registration. If the registrant is seeking to handle additional controlled substances listed in Schedule I for the purpose of research or instructional activities, he shall attach one copy of a Federally approved research protocol describing each research project involving the additional substances, or two copies of a statement describing the nature, extent, and duration of such instructional activities, as appropriate. No fee shall be required to be paid for the modification. The request for modification shall be handled in the same manner as an application for registration.

Section 23. Termination of Registration.

The registration of any person shall terminate if and when such person dies, ceases legal existence, discontinues business or professional practice, or changes his name or address as shown on the Certificate of Registration. Any registrant who ceases legal existence, discontinues business or professional practice, or changes his name or address as shown on the Certificate of Registration shall notify the Board promptly of such fact. In the event of a change in name or address, the person may apply for a new Certificate of Registration in advance of the effective date of such change by filing an application and paying the appropriate fee in the same manner as an application for new registration. The application shall be handled in the same manner as an application for registration.

SECURITY REQUIREMENTS

Section 24. Security Requirements Generally.

(a) All applicants and registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substances. In order to determine whether a registrant has provided effective controls against diversion, the Board shall use the security requirements set forth in standards for the physical security controls and operating procedures necessary to prevent diversion. Materials and construction which will provide a structural equivalent to the physical security controls set forth in this chapter may be used in lieu of the materials and construction described.

(b) Substantial compliance with the standards set forth in this chapter may be deemed sufficient by the Board after evaluation of the overall security system and needs of the applicant or registrant. In evaluating the overall security system of a registrant or applicant, the Board may consider any of the following factors as it may deem relevant to the need for strict compliance with security requirements:

(i) The type of activity conducted (e.g., processing of bulk chemicals, preparing dosage forms, packaging, labeling, cooperative buying, etc.);

(ii) The type and form of controlled substances handled (e.g., bulk liquids or dosage units, usable powders or non-usable powders);

(iii) The quantity of controlled substances handled;

(iv) The location of the premises and the relationship such location bears on security needs;

(v) The type of building construction comprising the facility and the general characteristics of the building or buildings;

(vi) The type of vault, safe, and secure enclosures or other storage system (e.g., automatic storage and retrieval system) used;

(vii) The type of closures on vaults, safes, and secure enclosures;

(viii) The adequacy of electric detection and alarm systems, if any, including use of supervised transmittal lines and stand-by power sources;

(ix) The extent of unsupervised public access to the facility, including the presence and characteristics of perimeter fencing, if any;

(x) The adequacy of supervision over employees having access to manufacturing and storage areas;

(xi) The procedures for handling business guests, visitors, maintenance personnel, and non-employee service personnel;

(xii) The availability of local police protection or of the registrant's or applicant's security personnel, and;

(xiii) The adequacy of the registrant's or applicant's system for monitoring the receipt, manufacture, distribution, and disposition of controlled substances in its operations.

(c) When physical security controls become inadequate as a result of a controlled substance being transferred to a different schedule, or as a result of a non-controlled substance being listed on any schedule, or as a result of a significant increase in the quantity of controlled substances in the possession of the registrant during business operations, the physical security controls shall be expanded and extended accordingly. A registrant may adjust physical security controls within the requirements set forth in this chapter when the need for such controls decreases as a result of a controlled substance being transferred to a different schedule, or a result of a controlled substance being removed from control, or as a result of a significant decrease in the quantity of controlled substances in the possession of the registrant during normal business operations.

(d) Any registrant or applicant desiring to determine whether a proposed security system substantially complies with, or is the structural equivalent of, the requirements set forth in this chapter, may submit any plans, blueprints, sketches or other materials regarding the proposed security system to the Board.

(e) Physical security controls of locations registered under the Harrison Narcotic Act or the Narcotics Manufacturing Act of 1960 on April 20, 1971, shall be deemed to comply substantially with the standards set forth in this chapter. Any new facilities or work or storage areas constructed or utilized for controlled substances, which facilities or work or storage areas have not been previously approved by the Drug Enforcement Administration, shall not necessarily be deemed to comply substantially with the standards set forth in this chapter, notwithstanding that such facilities or work or storage areas have physical security controls similar to those previously approved by the Board.

Section 25. Physical Security Controls for Nonpractitioners; Storage Areas.

(a) Schedules I and II. Raw materials, bulk materials awaiting further processing, and finished products which are controlled substances listed in Schedule I or II shall be stored in one of the following secure storage areas:

(i) Where small quantities permit, a safe:

(A) When the safe has an Underwriters' Laboratories Burglary Rating of T- 20, E or better, or the equivalent of such a safe;

(B) Which safe, if it weighs less than 750 pounds, is bolted, or cemented to the floor or wall in such a way that it cannot be readily removed; and

(C) Which safe, if necessary, depending upon the quantities and type of controlled substances stored, is equipped with an alarm system which, upon unauthorized entry, shall transmit a signal directly to a central protection company or a local or State police agency which has a legal duty to respond, or a 24-hour control station operated by the registrant, or such other protection as the Board may approve.

(ii) A vault constructed before, or under construction on, September 1, 1971, which is of substantial construction with a steel door, combination or key lock, and an alarm system; or

(iii) A vault constructed after September 1, 1971:

(A) The walls, floors, and ceilings of which vault are constructed of at least 8 inches of reinforced concrete or other substantial masonry, reinforced vertically and horizontally with 1/2 inch steel rods tied 6 inches on center, or the structural equivalent to such reinforced walls, floors, and ceilings;

(B) The door of which vault contains a multiple-position combination lock or the equivalent, a relocking device or the equivalent, and steel plate with a thickness of at least 1/2 inch or with a two-hour fire rating or the equivalent;

(C) Which vault, if operations require it to remain open for frequent access, is equipped with a "day gate" which is self-closing and self-locking, or the equivalent, for use during the hours of operation in which the vault door is open;

(D) The walls or perimeter of which vault are equipped with an alarm, which upon unauthorized entry shall transmit a signal directly to a central station, protection company, or a local or State Police agency which has a legal duty to respond, or a 24-hour control station operated by the registrant, or such other protection as the Board may approve, and, if necessary, holdup buttons at strategic points of entry to the perimeter area of the vault;

(E) The door of which vault is equipped with contact switches; and

(F) Which vault has one of the following: complete electrical lacing of the walls, floor and ceilings; sensitive ultrasonic equipment within the vault; a sensitive sound accumulator system; or such other device designed to detect illegal entry as may be approved by the Board.

(b) Schedules III, IV, and V. Raw materials, bulk materials waiting further processing, and finished products which are controlled substances listed in Schedules III, IV, and V shall be stored in one of the following secure storage areas:

(i) Where small quantities permit, a safe which complies with the requirements set forth in paragraph (a) (1) of this section;

(ii) A vault which complies with the requirements set forth in either paragraph (a) (2) or (3) of this section; or

(iii) A building or area located within a building, which building or area:

(A) Has walls or perimeter fences of sufficient height and construction to provide security from burglary;

(B) Has substantial doors which may be securely locked during non- working hours by a multiple-position combination or key lock;

(C) Is equipped with an alarm which, upon unauthorized entry, shall transmit a signal directly to a central station protection company, or local, or State police agency which has a legal duty to respond, or a 24-hour control station operated by the registrant, or such other protection as the Board may approve; and

(D) In which all controlled substances are segregated from all other merchandise and kept under constant surveillance during normal business hours.

Where several types or classes of controlled substances are handled separately by the registrant or applicant for different purposes (e.g., returned goods, or goods in process), the controlled substances may be stored separately, provided that each storage area complies with the requirements set forth in this section.

(d) Accessibility to Storage Areas.

The controlled substances storage areas shall be accessible only to an absolute minimum number of specifically authorized employees. When it is necessary for employee maintenance personnel, non-employee maintenance personnel, business guests, or visitors to be in or pass through controlled substances storage areas, the registrant shall provide for adequate observation of the area by an employee specifically authorized in writing.

Section 26. Physical Security Controls for Nonpractitioners; Manufacturing Areas.

All manufacturing activities (including processing, packaging, and labeling) involving controlled substances listed in any schedule shall be conducted in accordance with the following:

(a) All in-process substances shall be returned to the controlled substances storage area at the termination of the process. If the process is not terminated at the end of a workday (except where a continuous process or other normal manufacturing operation should not be interrupted), the processing area or tanks, vessels, bins, or bulk containers containing such substances shall be securely locked, with adequate security for the area or building. If such security requires an alarm, such alarm, upon unauthorized entry, shall transmit a signal directly to a central station protection company, or local or State police agency which has a legal duty to respond, or a 24-hour control station operated by the registrant.

(b) Manufacturing activities with controlled substances shall be conducted in an area or areas of clearly defined limited access which is under surveillance by an employee or employees designated in writing as responsible for the area. "Limited access" may be provided, in the absence of physical dividers such as walls or partitions, by traffic control lines or restricted space designation. The employee designated as responsible for the area may be engaged in the particular manufacturing operation being conducted: provided that he is able to provide continuous surveillance of the area in order that unauthorized persons may not enter or leave the area without his knowledge.

(c) During the production of controlled substances, the manufacturing areas shall be accessible to only those employees required for efficient operation. When it is necessary for employee maintenance personnel, non-employee maintenance personnel, business guests, or visitors to be present in or pass through manufacturing areas during production of controlled substances, the registrant shall provide for adequate observation of the area by an employee specifically authorized in writing.

Section 27. Other Security Controls for Nonpractitioners.

(a) Before distributing a controlled substance to any person who the registrant does not know to be registered to possess the controlled substance, the registrant shall make a good faith inquiry either with the Drug Enforcement Administration or with the Wyoming State Board of Pharmacy, to determine that the person is registered to possess the controlled substance.

(b) The registrant shall design and operate a system to disclose to the registrant suspicious orders of controlled substances. The registrant shall inform the Board and the Drug Enforcement Administration of suspicious orders when discovered by the registrant. Suspicious orders include orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.

(c) The registrant shall notify the Drug Enforcement Administration and the Board of any theft or significant loss of any controlled substances upon discovery of such theft or loss. The registrant shall also complete an inventory regarding such theft or loss and submit a copy of such inventory to the Board. Thefts must be reported whether or not the controlled substances are subsequently recovered and/or the responsible parties are identified and action taken against them.

(d) Distribution of Controlled Substance Samples.

(i) The registrant shall not distribute any controlled substance listed in Schedule II or III as a complimentary sample to any potential or current customer or patient except in the following manner:

(A) Manufacturers/distributors of samples of controlled substance pharmaceutical products must be registered with the Board of Pharmacy and Drug Enforcement Administration before shipping controlled substances into the State of Wyoming.

(B) Manufacturers/distributors shall send to the Wyoming Board of Pharmacy a record of all such transactions involving the shipment of samples to a Wyoming registrant. The Board shall be notified of any unreasonable order requests or records shall be sent upon request. Records kept and provided by the manufacturer/distributor shall include:

(I) Manufacturer/Distributor name and DEA registration number.

(II) Address of Manufacturer/Distributor.

(III) Name, address and registration (DEA#) number of registrant receiving samples.

(IV) Drug name, strength, quantity/package, quantity/number of packages - total quantity sent to registrant.

(V) Date of shipment or delivery to the registrant.

(ii) Registrants (practitioners) requesting controlled substance samples shall do so in the following manner:

(A) Registrant (or agent) must sign for samples upon receipt.

(B) Retain the invoice of controlled substances samples received.

(C) Records must be kept of all samples dispensed or administered. The registrant's office record shall include: date of dispensing or administering; patient name; drug sample name; strength; quantity given (total number of tablets or volume of liquid); initial of practitioner or agent.

(D) Registrant shall personally sign or initial records of samples dispensed or administered at the bottom of each page on a regular basis.

(E) Make such records available to the Wyoming State Board of Pharmacy inspector or Drug Enforcement Administration agent upon request.

(iii) Samples of controlled substances listed in Schedule IV and V are exempted from requirements further than those imposed by the Drug Enforcement Administration for distribution in the State of Wyoming.

Section 28. Physical Security Controls for Practitioners.

(a) Controlled substances listed in Schedule I and II shall be stored in a securely locked, substantially constructed cabinet. However, pharmacies may disperse such substances throughout the stock of non-controlled substances in such a manner as to obstruct the theft or diversion of the controlled substances.

(b) Controlled substances listed in Schedules III, IV, and V shall be stored in a securely locked, substantially constructed cabinet. However, pharmacies may disperse such substances throughout the stock of non-controlled substances in such a manner as to obstruct the theft or diversion of the controlled substances.

(c) This section shall also apply to non-practitioners authorized to conduct research or chemical analysis under another registration.

Section 29. Other Security Controls for Practitioners.

(a) The registrant shall not employ as an agent or employee any person, who has access to controlled substances, who has had an application for registration denied, or has had his registration revoked, suspended, or limited at any time.

(b) The registrant shall notify the Board and the Drug Enforcement Administration of the theft or significant loss of any controlled substances upon discovery of such loss or theft. The registrant shall also complete an inventory regarding such loss or theft and submit it in writing to the Board.

History

Effective 2014-01-16

Chapter 4 Records and Inventories of Registrants

Wyo. Code R. 059.0002.4.05162017 § 1 Records and Inventories of Registrants

Authority

(a) These regulations are promulgated as authorized by the Wyoming Controlled Substances Act; W.S. 35-7-1001 through -1101.

History

Effective 2017-05-16

Wyo. Code R. 059.0002.4.05162017 § 2 Records and Inventories of Registrants

Purpose

To maintain the records and inventories and file reports as required by W.S. 35-7-1028.

History

Effective 2017-05-16

Wyo. Code R. 059.0002.4.05162017 § 3 Records and Inventories of Registrants

Scope

Applies to all registrants.

History

Effective 2017-05-16

Wyo. Code R. 059.0002.4.05162017 § 4 Records and Inventories of Registrants

Records and Inventory Requirements Generally.

(a) Each registered manufacturer, distributor, importer, and narcotic treatment program shall maintain inventories and records of controlled substances.

(b) Each registered individual practitioner shall keep records with respect to controlled substances which he prescribes or administers. Said practitioner shall keep additional records of such substances which he dispenses.

(i) Schedules I and II shall be maintained separately from all other records of the pharmacy, and prescriptions for such substances shall be maintained in a separate written or electronic prescription file in consecutive numbers or by date.

(ii) Schedules III-V shall be maintained separately from all other records of the pharmacy and prescriptions for such substances shall be maintained in separate written or electronic prescription files for controlled substances in consecutive numbers or by date.

(iii) All written or electronic invoices for controlled substances shall be dated and signed when received by the pharmacist in charge or his/her designated agent. Invoices shall be maintained on file for two years and readily available for inspection by the Board.

(iv) All retail and institutional pharmacies shall maintain a perpetual inventory for all Schedule II controlled substances. This inventory shall be reconciled no less than once a quarter. Discrepancies discovered during reconciliation shall be reported to the Board within ten (10) calendar days of discovery. Only those discrepancies which are considered a significant loss or gain shall be reported. For the purpose of this section, a significant loss or gain shall exist whenever the actual inventory differs from the recorded inventory by more than five percent (5%) for any drug product.

(d) All required records shall be kept by the registrant and be made available for at least two (2) years from the date of record.

History

Effective 2017-05-16

Wyo. Code R. 059.0002.4.05162017 § 5 Records and Inventories of Registrants

Inventory Requirements.

Every registrant required to keep records shall take a physical inventory count of controlled substances during the first seven (7) days of May of each year or other date approved by the Board.

(a) Each inventory shall contain a complete and accurate record of all controlled substances on hand on the date the inventory is taken.

(b) A separate inventory shall be made by a registrant for each registered address. Each inventory shall be kept at the registered location for which it is taken.

(c) A registrant may take an inventory either at the opening or close of business on the inventory date. The registrant shall indicate the time the inventory was taken on the inventory record.

(d) An inventory must be maintained in a legible written or printed form.

(e) Each registered pharmacy shall forward one (1) copy of the annual inventory to the office of the Board of Pharmacy, including the name of the pharmacy, date and time the inventory was taken, and the signature of the responsible person(s).

History

Effective 2017-05-16

Wyo. Code R. 059.0002.4.05162017 § 6 Records and Inventories of Registrants

Drug Enforcement Administration (DEA) Order Form 222.

The order forms may be obtained only by those persons registered to handle controlled substances in Schedules I and II.

(a) An order form may be executed only by or on behalf of the registrant named thereon and only if his registration is current.

(b) Order forms issued by the DEA will be serially numbered and issued with the name, address and registration number of the registrant, the authorized activity and the schedules of the registrant. This information cannot be altered or changed in any manner.

(d) A registrant may authorize another individual to obtain and execute an order form on his behalf by executing a power of attorney. The power of attorney shall be filed with and retained for the same period as any order form bearing the signature of the grantor. The power of attorney shall be available for inspection.

(e) The purchaser registrant shall submit Copy 1 and Copy 2 of the order form to the supplier and retain Copy 3 with his own records. The supplier shall enter the suppliers DEA registration number, number of packages shipped, and the date shipped on Copies 1 and 2. If the supplier is another local registrant (not a registrant manufacturer or distributor), Copy 2 may be forwarded directly to the DEA Regional Office or the office of the Board of Pharmacy.

(f) The purchaser registrant shall record on Copy 3 of the order form the number of containers received on each item of the order form and the date received.

(g) Order forms and attached corresponding invoices shall be maintained separately from all other records of the registrant for a period of two years. Order forms shall be available for inspection during that time.

(h) The Controlled Substance Ordering System (CSOS) is authorized.

History

Effective 2017-05-16

Wyo. Code R. 059.0002.4.05162017 § 7 Records and Inventories of Registrants

Methamphetamine Precursor Records.

(a) The retail sale of non-liquid methamphetamine precursor drugs or liquid products with ephedrine or pseudoephedrine as the sole active ingredient shall be limited to amounts as specified in W.S. § 35-7-1059.

(b) The seller shall maintain a written or electronic list of such sales (logbook) as described in W.S. § 35-7-1059.

(i) The prospective purchaser shall present photo identification in accordance with W.S. § 31-7-111 and W.S. § 8-7-101.

(ii) The prospective purchaser shall sign the logbook and enter in the logbook his or her name, address and the date and time of the sale.

(iii) The seller shall determine that the name entered in the logbook corresponds to the name provided on such identification and that the date and time entered are correct.

(iv) The seller shall enter into the logbook the name of the product and the quantity sold.

(d) The logbook shall contain a notice to purchasers that entering false statements or misrepresentations in the logbook may subject the purchaser to criminal penalties under 18 U.S.C. § 1001 and such notice must specify the maximum fine ($250,000.00) and term of imprisonment (5 years).

History

Effective 2017-05-16

Chapter 7 Administrative Inspections

Wyo. Code R. 059.0002.7.12112018 § 1 Administrative Inspections

Authority.

These rules are pursuant to Title 21 Code of Federal Regulations and by the Wyoming Controlled Substances Act W.S. § 35-7-1001 through -1101.

History

Effective 2018-12-11

Wyo. Code R. 059.0002.7.12112018 § 2 Administrative Inspections

Scope.

Applies to all registrants.

History

Effective 2018-12-11

Wyo. Code R. 059.0002.7.12112018 § 3 Administrative Inspections

Inspections.

(a) In carrying out their functions under the Act, the Board, and the Commissioner of Drugs and Substances Control and their duly authorized agents are authorized in accordance with W.S. § 35-7-1024 to enter controlled premises and conduct administrative inspections thereof.

(b) Inspections shall be done in accordance with Title 21 Code of Federal Regulations process:

(i) Title 21 Chapter II Drug Enforcement Administration, Department of Justice, Part § 1316.01 to 1316.13 as of July 17, 2015.

(ii) The incorporated rule does not include any later amendments or editions;

(iii) The incorporated rule is maintained at the Wyoming State Board of Pharmacy, 1712 Carey Avenue, Suite 200, Cheyenne, WY 82002 and is available for public inspection and copying at cost at the same location.

(iv) The incorporated rule is maintained at https://www.deadiversion.usdoj.gov/21cfr/cfr/2116cfrt.htm.

History

Effective 2018-12-11

Wyo. Code R. 059.0002.7.12112018 § 4 Administrative Inspections

Notice of Inspection.

(a) The notice of inspection form shall contain:

(i) The name and title of the owner, operator, or agent in charge of the controlled premises;

(ii) The controlled premises name;

(iii) The address of the controlled premises to be inspected;

(iv) The date and time of the inspection;

(v) A statement that a notice of inspection is given pursuant to W.S. § 35-7-1024;

(vi) A reproduction of the pertinent parts of W.S. § 35-7-1024; and

(vii) The signature of the authorized agent.

History

Effective 2018-12-11

Chapter 8 Prescription Drug Monitoring Program

Wyo. Code R. 059.0002.8.05242023 Prescription Drug Monitoring Program

PRESCRIPTION DRUG MONITORING PROGRAM

CHAPTER 8

Section 1. Authority.

These regulations are promulgated as authorized by the Wyoming Controlled Substances Act; W.S. 35-7-1001 through -1101.

Section 2. Scope.

This Chapter applies to all Wyoming controlled substance registrants and dispensers licensed by the Board of Pharmacy

Section 3. Definitions.

(a) "Drug of Concern" means any non-controlled substance prescription medication that is required to be reported into the prescription tracking program by the Board of Pharmacy as authorized by W.S. §35-7-1060(b).

(b) "Inpatient" (for the purposes of this chapter) means:

(i) The patient is physically located in a hospital, long term care facility, or correctional facility; or

(ii) The practitioner or his agent is administering a controlled substance directly to the patient as part of a procedure, whether or not the patient is physically located in a facility.

Section 4. Registration Requirements.

(a) Practitioners shall register with the controlled substances prescription tracking program (Wyoming PMP AWARxE) if the practitioner is authorized to dispense any controlled substances in Schedules II through V.

(b) Practitioners shall register online at https://wyoming.pmpaware.net/; and

(d) Each dispenser that dispenses a controlled substance listed in Schedule II, III, IV or V, or drug of concern to a person in this state who is not an inpatient shall register as a dispenser with the Wyoming PMP AWARxE program.

Section 5. Required Reporting.

(a) Dispensers shall transmit the following required information into the PMP Clearinghouse:

(i) Dispenser identification number;

(ii) Patient date of birth;

(iii) Patient gender;

(iv) Date prescription was dispensed;

(v) Prescription number;

(vi) Prescription is new or is a refill. If the prescription was a refill, the date of the original dispensing;

(vii) Quantity dispensed;

(viii) Date the prescription was issued by the prescriber;

(ix) Number of days supply dispensed;

(x) NDC code number for drug dispensed;

(xi) Prescriber identification number;

(xii) Patient last name;

(xiii) Patient first name;

(xiv) If patient is an animal, the animal's name, species and the owner's last name;

(xv) Patient street address;

(xvi) Patient zip code; and

(xvii) Method of third-party liability and/or payment.

(b) Dispensers shall report the information required pursuant to this Chapter for the following non-controlled substances:

(i) Gabapentin; and

(ii) Cyclobenzaprine.

(c) The dispenser shall ensure that, not later than the close of business on the business day immediately following the day the controlled substance, or drug of concern, was dispensed, the information required pursuant to this Chapter is reported into the PMP Clearinghouse.

(d) When a dispenser does not have any dispensations to report, the dispenser shall submit a "zero report" into the PMP Clearinghouse.

(e) Exemptions from reporting include certain inpatient health care settings.

(f) Each dispenser shall ensure that information reported to the PMP Clearinghouse is correct and shall submit corrections when necessary.

(g) Each dispenser shall reverse information for any prescription that was not dispensed.

Section 6. Solicited Patient Profiles.

(a) Occupational licensing boards in Wyoming that regulate practitioners who are authorized to dispense any controlled substances in Schedules II through V or other drugs of concern, may register with Wyoming PMP AWARxE to request licensee profiles from the Board as it relates to their investigation regarding their licensees' practice.

(b) Pharmacists and practitioners shall register as users with Wyoming PMP AWARxE to request patient profiles where a pharmacist/patient, practitioner/patient relationship exists.

(i) Pharmacists or practitioners may appoint delegates to perform patient searches in Wyoming PMP AWARxE on their behalf.

(ii) The pharmacist or practitioner shall be responsible for the actions of their appointed delegates; and

(iii) The pharmacist or practitioner shall terminate the delegate's access in Wyoming PMP AWARxE when the appointment has ended.

(iv) A pharmacist appointed delegate must be a pharmacy technician, pharmacy technician in training, or pharmacy intern, licensed by the Board, who is employed at the pharmacy where the pharmacist is employed.

(v) All practitioners, pharmacists, and delegates shall attest that inappropriate access or disclosure of this information is a violation of Wyoming Law and may result in disciplinary action and/or revocation of access privileges to Wyoming PMP AWARxE.

(vi) The Board staff shall discontinue access to any user whose license, DEA registration or WY Controlled Substance Registration has lapsed or been revoked or suspended.

(vii) The Board staff shall discontinue access to any user who fails to follow these regulations.

(c) Patients, or in the case of a minor, the minor's parent or guardian may request a copy of the patient's profile from the Board office provided:

(i) The requestor shall complete a notarized form provided by the Board; and

(ii) The notarized form may be faxed, emailed, or mailed to the Board office.

(d) Local, State, or Federal law enforcement may register with Wyoming PMP AWARxE to request information that is contained in the PMP as it relates to investigations regarding violations of the Wyoming Controlled Substances Act or the Federal Controlled Substances Act. Requests must contain:

(i) The purpose of the request, the date range requested, and the specific reasons for this request including investigation number, if applicable, must be included; and

(ii) A copy of the warrant or subpoena related to their investigation is uploaded into Wyoming PMP AWARxE as part of their request.

(e) A patient may authorize the release of their Wyoming PMP AWARxE profile to third party provided:

(i) The patient shall complete a notarized form provided by the Board; and

(ii) The notarized form may be faxed, emailed, or mailed to the Board office.

Section 7. Unsolicited Patient Profiles.

Board staff may generate patient profiles based on information showing use of controlled substances, within established parameters. Profiles generated will be emailed to each pharmacy and practitioner where the patient was seen. A letter of explanation will accompany each profile.

Section 8. Reports.

(a) Board staff shall maintain a register for solicited patient profile requests for five (5) years from the date of the request. The register shall include:

(i) Date request received;

(ii) Name of patient, patient's date of birth;

(iii) Name, title, business, and address of the requestor; and

(iv) Date profile was provided to the requestor.

(b) The Board shall maintain a register for five (5) years for any unsolicited patient profile generated by the Board. The register shall include:

(i) Date generated;

(ii) Criteria used for profile generation; and

(iii) The pharmacies and practitioners that the unsolicited report was provided too.

(c) The Board shall maintain the database records for five (5) years and then archive de-identified records for research purposes.

Section 9. Statistical Profiles.

The Board may generate statistical profiles upon request, provided no patient/practitioner/pharmacy specific information is included. The Board shall charge a fee of $500.00 per profile to any non-governmental agency.

History

Effective 2023-05-24

Chapter 9 Opioid Prescription Limits

Wyo. Code R. 059.0002.9.07012020 § 1 Authority

These rules are promulgated as authorized by the Wyoming Controlled Substances Act; Wyoming Statute 35-7-1001 through -1101.

History

Effective 2020-07-01

Wyo. Code R. 059.0002.9.07012020 § 2 Opioid Prescription Limit Exceptions

(a) The prescribing limits imposed by Wyoming Statute 35-7-1030(e) shall not apply if the prescription bears an indication for:

(i) Chronic pain that cannot be managed without opioid treatment;

(ii) Cancer-related pain;

(iii) Palliative care;

(iv) Medication assisted treatment (MAT) for opioid addiction;

(v) To treat a patient:

(A) Who has been admitted, for at least twelve (12) hours to an ambulatory outpatient surgery center or hospital inpatient facility, and

(B) Has been administered an opioid during their stay, and

(C) Their pain management as part of their recovery is expected to be severe enough to require opioid treatment for more than seven (7) days.

History

Effective 2020-07-01

Chapter 10 Issuing and Dispensing Prescriptions for Controlled Substances

Wyo. Code R. 059.0002.10.05242023 § 1 Authority

These rules are promulgated as authorized by the Wyoming Controlled Substances Act; W.S. § 35-7-1001 through 35-7-1063.

History

Effective 2023-05-24

Wyo. Code R. 059.0002.10.05242023 § 2 Definitions

(a) "Electronic prescription" means the computer to computer transmission of prescription data that meets the federal requirements for electronically prescribed controlled substances (EPCS).

(b) "Security paper" means standardized paper used for issuing controlled substance prescriptions to help prevent tampering, counterfeiting, and fraudulent use of controlled substances.

History

Effective 2023-05-24

Wyo. Code R. 059.0002.10.05242023 § 3 General Requirements for all Controlled Substance Prescriptions

(a) A controlled substance prescription shall be issued only by a practitioner who is either registered or exempted from registration.

(b) A practitioner, other than a pharmacy, may directly dispense controlled substances to a patient.

(c) In order for a controlled substance prescription to be effective it must be issued for a legitimate medical purpose by a practitioner acting in the usual course of his/her professional practice. The responsibility for the proper prescribing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who dispenses the prescription.

(d) An individual practitioner may issue multiple controlled substance prescriptions authorizing the patient to receive a total of up to a ninety (90) day supply of a Schedule II controlled substance provided the following conditions are met:

(i) Each individual prescription shall be dated with the date it was issued;

(ii) The practitioner provides instructions on each prescription indicating the earliest date on which a pharmacy may dispense each prescription (other than the first prescription, if the prescribing practitioner intends for that prescription to be filled immediately); and

(iii) The practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse.

(iv) Practitioners shall not issue multiple prescriptions to circumvent the seven (7) day prescribing limits outlined in W.S. 35-7-1030(e).

(e) Practitioners shall not issue controlled substance prescriptions to an individual practitioner for the purpose of general dispensing to patients.

(f) All controlled substance prescriptions shall contain the following:

(i) The patient's full name and address;

(ii) Name and strength of the drug;

(iii) Quantity to be dispensed;

(iv) Directions for using the drug;

(v) Date issued by the practitioner; and

(vi) The practitioner's full name, address, telephone number, and DEA registration.

History

Effective 2023-05-24

Wyo. Code R. 059.0002.10.05242023 § 4 Issuing Electronic Controlled Substance Prescriptions

(a) The practitioner's electronic prescription system and the receiving pharmacy's dispensing system shall comply with federal law and regulation for electronic prescriptions of controlled substances.

(b) Practitioners and practitioner's agents shall transmit EPCS to the pharmacy of the patient's choice.

History

Effective 2023-05-24

Wyo. Code R. 059.0002.10.05242023 § 5 Exemptions to Electronic Prescribing Requirement

(a) A practitioner may authorize a verbal controlled substance prescription in the case of an emergency situation. Emergency situations are those situations in which the prescribing practitioner determines:

(i) That immediate administration of the controlled substance is necessary for the proper treatment of the patient;

(ii) No appropriate alternative treatment is available, including administration of a drug which is not a controlled substance; and

(iii) It is not reasonably possible for the prescribing practitioner to provide an electronic prescription to be transmitted to the pharmacy prior to dispensing.

(b) In the case of an emergency situation, a pharmacist may directly dispense a controlled substance upon receiving verbal authorization from a practitioner, provided that:

(i) The quantity prescribed and dispensed shall be limited to the amount necessary to treat the patient during the emergency period (dispensing beyond the emergency period must be pursuant to a valid controlled substance prescription from the practitioner);

(ii) The emergency verbal prescription shall be immediately reduced to writing by the pharmacist and shall contain all of the information required of a valid prescription;

(iii) If the practitioner is not known to the pharmacist, the pharmacist shall make a reasonable effort to determine that the verbal authorization came from a registered practitioner; and

(iv) The practitioner shall cause a valid controlled substance prescription for the emergency quantity prescribed to be transmitted to the dispensing pharmacy. This valid controlled substance prescription shall include "Authorization for Emergency Dispensing" and the date of the verbal order. Upon receipt, the dispensing pharmacist shall attach this prescription to the verbal emergency prescription which had earlier been reduced to writing. The pharmacist shall notify the DEA if the practitioner fails to deliver the electronic prescription as required by federal regulation.

(i) The patient resides in a nursing home, long-term care facility, correctional facility, or jail;

(ii) The patient is terminally ill. The prescription shall have written on its face "terminally ill," "hospice," or "palliative care;"

(iii) The prescription is to be filled at a pharmacy outside of Wyoming or at a pharmacy within federal jurisdiction. The practitioner shall write on the face of the prescription "Not to be dispensed in Wyoming" or indicate that the prescription shall be dispensed at a pharmacy within a federal jurisdiction

(iv) The prescription is issued by a licensed veterinarian;

(v) The prescription is issued by a practitioner working at a federal facility;

(vi) The prescription is for a compounded preparation containing two or more components; or

(vii) The prescription is for a Schedule II controlled substance that is to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion.

(viii) The practitioner's electronic prescribing system is not functioning. The practitioner shall not prescribe for more than a thirty (30) day supply and shall write on the face of the prescription "E-Prescribing System Not Functioning."

History

Effective 2023-05-24

Wyo. Code R. 059.0002.10.05242023 § 6 Additional Requirements for Non-Electronic Prescriptions for Controlled Substances

(a) All non-electronic controlled substance prescriptions shall meet the following requirements;

(i) The controlled substance prescription shall be issued on security paper. Any controlled substance prescription issued by a Wyoming practitioner that is on non-security paper shall not be dispensed by a pharmacist.

(ii) All non-electronic controlled substance prescriptions issued by a practitioner shall be wet signed.

(iii) All non-electronic controlled substance prescriptions shall be dated and signed with the date they are issued to the patient.

(b) Non-electronic controlled substance prescriptions shall not contain stickers.

History

Effective 2023-05-24

Wyo. Code R. 059.0002.10.05242023 § 7 Dispensing Controlled Substance Prescriptions

(a) The pharmacist or employee under supervision shall verify the identity of the person who presents a non-electronic controlled substance prescription or receives any controlled substance prescription.

(i) Identification may be done by visual recognition.

(ii) Identification may be verified by state or federally issued identification.

(iii) The pharmacist or employee shall record the individual's name, identification, and identification number.

(iv) The recorded information shall be readily retrievable.

(b) If a controlled substance prescription is mailed to a patient, the pharmacist or employee shall record the name, address, and date the prescription was mailed. This information shall be readily retrievable.

(c) No controlled substance prescription shall be valid more than six (6) months after the date it was issued by the practitioner.

(d) The pharmacist, after consultation/approval of the prescribing practitioner, may change or add the following on a controlled substance prescription:

(i) Drug strength;

(ii) Drug quantity;

(iii) Directions for use;

(iv) Dosage form;

(v) Date to be dispensed;

(vi) The patient's address with proper verification without consulting the practitioner.

(vii) The practitioner's DEA registration, address, or telephone number after verifying the information from another reliable source.

(e) A pharmacist shall not change the following on a controlled substance prescription:

(i) Patient's name;

(ii) Controlled substance prescribed;

(iii) Date issued; or

(iv) The prescribing practitioner.

(f) A pharmacist shall document any change or addition made to a controlled substance prescription. The documentation shall include the date, name of person consulted, and initials of the pharmacist making the change.

(i) Pharmacists may make computer generated modifications to the controlled substance prescription.

(ii) Any changes or additions made by the pharmacist may appear on the front or back of the non-electronic controlled substance prescription.

(g) Pharmacies shall label dispensed controlled substance prescriptions according to the requirements in the Wyoming Pharmacy Act Rules Chapter 2.

(h) The pharmacist shall make a reasonable effort to determine that controlled substance prescriptions from out of state practitioners came from a registered practitioner before dispensing the controlled substance.

History

Effective 2023-05-24

Wyo. Code R. 059.0002.10.05242023 § 8 Refilling Prescriptions for Controlled Substances

(a) A Schedule II controlled substance prescription shall not be refilled.

(b) No Schedule III, IV, or V-controlled substance shall have more than five (5) refills authorized.

(c) The pharmacy shall document each refill of Schedule III, IV, and V-controlled substance prescriptions. The documentation shall be readily retrievable and shall include the date, quantity dispensed, and the name of the dispensing pharmacist.

History

Effective 2023-05-24

Wyo. Code R. 059.0002.10.05242023 § 9 Partial Filling of Controlled Substances

(a) A Schedule II controlled substance prescription may be partially filled if:

(i) The patient or practitioner requests a partial fill; or

(ii) The pharmacist is unable to supply the full quantity prescribed; and

(iii) The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed; and

(iv) The remaining portions of the partially filled Schedule II controlled substance prescription is dispensed no later than thirty (30) days, or sixty (60) days for terminally ill or long term care facility patients, after the date on which the prescription is issued.

(b) For each partial filling of a Schedule II controlled substance the dispensing pharmacist shall record:

(i) The date of the partial filling;

(ii) Quantity dispensed;

(iii) Remaining quantity authorized to be dispensed; and

(iv) Identification of the dispensing pharmacist.

(i) Each partial filling is recorded in the same manner as a refilled Schedule III, IV, or V controlled substance prescription;

(ii) The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed; and

(iii) The prescription is not dispensed after six (6) months from the date that the prescription was issued.

(d) Pharmacists and practitioners shall not partially fill opioids or combinations of opioids to circumvent the seven (7) day prescribing limits outlined in W.S. 35-7-1030(e).

History

Effective 2023-05-24

Wyo. Code R. 059.0002.10.05242023 § 10 Transferring Controlled Substance Prescription Orders Between Pharmacies

(a) The transfer of a controlled substance prescription shall be communicated directly between two licensed pharmacists;

(b) The information required to be communicated and recorded for the transfer of non-controlled substance prescriptions between pharmacies in Chapter 2 of the Wyoming Pharmacy Act Rules shall also be communicated and recorded for the transfer of controlled substance prescriptions with the addition that

(i) The DEA registration number of the transferring pharmacy shall be provided to and recorded by the receiving pharmacist and

(ii) The DEA registration number of the receiving pharmacy shall be provided to and recorded by the transferring pharmacist.

(c) A Schedule II controlled substance prescription shall not be transferred, with the exception that an unfilled original EPCS may be transferred from one pharmacy to another pharmacy one time.

(d) Unfilled non-electronic Schedule III, IV, and V controlled substance prescriptions shall not be transferred.

(e) A Schedule III, IV, or V controlled substance prescription may be transferred only one time. Pharmacies sharing a real-time, online database may transfer up to the maximum refills permitted by law and the practitioner's authorization.

History

Effective 2023-05-24

345 Pharmacy, Board of

Chapter 1 Rules of Practice and Procedure

Wyo. Code R. 059.0001.1.12192018 § 1 Rules of Practice and Procedure

Authority.

These rules are promulgated as authorized by the Wyoming Pharmacy Act W.S. § 33-24-101 through -301.

History

Effective 2018-12-19

Wyo. Code R. 059.0001.1.12192018 § 2 Rules of Practice and Procedure

Purpose.

To describe procedures for applications and investigations.

History

Effective 2018-12-19

Wyo. Code R. 059.0001.1.12192018 § 3 Rules of Practice and Procedure

Scope.

Applies to all applicants and licensees.

History

Effective 2018-12-19

Wyo. Code R. 059.0001.1.12192018 § 4 Rules of Practice and Procedure

Definitions.

(a) "Act" means the Wyoming Pharmacy Act, W.S. § 33-24-101 through -301.

(b) "Application Review Committee" (ARC) means the Executive Director, at least one Board member, and a Board Compliance Officer.

(d) "Contestant" means the person, persons, firm or corporations who are licensed under the jurisdiction of the Board against whom a proceeding by petition, verified complaint in writing or formal notice, alleging violation directly or indirectly of any of the terms and provisions of the Act or of the lawful Rules and Regulations of the Board or any related acts and resulting lawful rules and regulations (i.e. Controlled Substances Act, 1971).

(e) "Contested Case" means any proceeding where legal rights, duties or privileges of a party are required by law to be determined by the Board.

(f) "Executive Director" means the Executive Director of the Board.

(g) "License" means the whole or part of any Board permit, certificate, approval, registration or similar form of permission required by law. License does not include a license required solely for revenue purposes.

(h) "Prosecuting Attorney" means the Assistant Attorney General assigned to the Board to represent the Executive Director in contested cases.

(i) "Staff" means the personnel of the Board.

History

Effective 2018-12-19

Wyo. Code R. 059.0001.1.12192018 § 5 Rules of Practice and Procedure

Application Review Process.

(a) Upon receipt of a completed application, the Staff shall review the application and if it is complete and, if there are no grounds for denial, issue the license. If grounds for denial exist, the Staff shall forward the application for review by the Prosecuting Attorney.

(b) The Prosecuting Attorney shall review the application and all other information available and following the review shall:

(i) Recommend approval of the application; or

(ii) Recommend the application be forwarded to the ARC for review.

(i) A preliminary denial letter shall be sent to the applicant. The letter shall:

(A) State the basis for the denial including relevant statutes and rules; and

(B) Advise the applicant of the right to request reconsideration.

(ii) If the applicant fails to request reconsideration in writing within thirty (30) days of the preliminary denial letter, the preliminary denial becomes final.

(iii) If the applicant requests reconsideration within thirty (30) days, an informal reconsideration conference shall be held between the ARC, the Prosecuting Attorney, and the applicant.

(iv) Following the informal reconsideration conference, the ARC shall either approve or deny the application.

(v) If denied, the applicant must submit a request in writing for a hearing within thirty (30) days of the date of the denial letter.

(vi) If the applicant fails to request a hearing in writing within thirty (30) days of the date of the denial letter, the denial becomes final.

(d) Application denial hearings.

(i) An application denial hearing is a formal contested case hearing conducted before the Office of Administrative Hearings (OAH) pursuant to the Wyoming Administrative Procedure Act W.S. § 16-3-107 through -113 and Office of Administration Rules.

(ii) The applicant has the burden of proving that he/she meets all requirements for the license requested.

(e) The ARC may attend hearings, but shall not take part in the consideration of any contested case.

History

Effective 2018-12-19

Wyo. Code R. 059.0001.1.12192018 § 6 Rules of Practice and Procedure

Complaints.

(a) A complaint concerning an alleged violation of the Act must be submitted in writing to the Board. The written complaint shall provide the following information:

(i) The name and address of the complainant;

(ii) The name, address, place of employment, and telephone number of the license holder against whom the charges are made, if available and applicable;

(iii) The specific conduct alleged to constitute the violation;

(iv) The name and address of any witnesses; and

(v) The notarized signature of the complainant.

(b) Written complaints for which there is an alleged violation of the act shall be referred for investigation to the Board Compliance Officer or to an Investigative Board Member (IBM) selected by Staff from a rotating schedule.

(i) The IBM shall not take part in the consideration of any contested case.

(ii) The IBM shall not, by this rule, be barred from attending any disciplinary hearing.

(c) License holders against whom charges of an alleged violation of the act are made shall be advised of the investigation and the nature of the complaint.

History

Effective 2018-12-19

Wyo. Code R. 059.0001.1.12192018 § 7 Rules of Practice and Procedure

Investigations and Board Action.

(a) Upon completion of the investigation, the Executive Director shall:

(i) Dismiss the complaint if no evidence of violation of the Act or Board rules is found; or

(ii) Prepare an investigative report which shall include:

(A) The findings of the investigation;

(B) A list of statutes and/or Board rules violated; and

(b) The Executive Director shall forward the report and recommendations to the Prosecuting Attorney for review.

(i) Send the notice required by Section 6;

(ii) Prepare and file a formal petition and notice of hearing setting the matter for a contested case hearing before the Board;

(iii) Recommend the Board accept an offer of conditional terms for settlement; or

(iv) Recommend the Board dismiss the complaint.

(d) The Board may resolve a complaint at any time prior to a contested case hearing by:

(i) Accepting voluntary surrender of a license;

(ii) Accepting conditional terms for settlement; or

(iii) Dismissing the complaint.

History

Effective 2018-12-19

Wyo. Code R. 059.0001.1.12192018 § 8 Rules of Practice and Procedure

Service of Notice and Opportunity to Show Compliance.

Prior to commencement of a formal hearing, the Executive Director shall notify the licensee by certified mail of the intent to proceed with disciplinary action. The notice shall give the license holder an opportunity to contest the violations referred to in the Notice or to accept the proposed settlement agreement within twenty (20) days of receipt of the notice

History

Effective 2018-12-19

Wyo. Code R. 059.0001.1.12192018 § 9 Rules of Practice and Procedure

Incorporation by reference.

(a) For any code, standard, rule or regulation incorporated by reference in this Chapter:

(i) The Board has determined that incorporation of the full text in these rules would be cumbersome or inefficient given the length or nature of the rules;

(ii) The incorporation by reference does not include any later amendments or editions of the incorporated matter beyond the applicable date identified in subsection (b) of this section; and

(iii) The incorporated code, standard, rule or regulation is maintained at Board's office and is available for public inspection and copying at cost at the same location.

(b) Each code, standard, rule or regulation incorporated by reference in this Chapter is further identified as follows:

(i) Chapter 2 - Uniform Rules for Contested Case Practice and Procedure, adopted by the Office of Administrative Hearings and effective on October 17, 2014, found at: http://soswy.state.wy.us/Rules/RULES/9644.pdf.

(ii) Chapter 2 - Uniform Procedures, Fees, Costs and Charges for Inspecting, Copying and Producing Public Records adopted by the Department of Administration and Information and effective on September 6, 2016, found at pharmacyboard.state.wy.us.

History

Effective 2018-12-19

Chapter 2 General Practice of Pharmacy Regulations

Wyo. Code R. 059.0001.2.05242023 General Practice of Pharmacy Regulations

GENERAL PRACTICE OF PHARMACY REGULATIONS

CHAPTER 2

Section 1. Authority.

These regulations are promulgated pursuant to the Wyoming Pharmacy Act W.S. § 33-24-101 et seq.

Section 2. Scope.

This chapter applies to any person, partnership, corporation, limited liability company, or other entity engaging in the practice of pharmacy within the state.

Section 3. Definitions.

(a) "Collaborative pharmacy practice" is that practice of pharmacy whereby one or more pharmacists have jointly agreed, on a voluntary basis, to work in conjunction with one or more practitioners in collaboration to provide patient care services to achieve optimal medication use and desired patient outcomes.

(b) "Collaborative practice agreement" is a written and signed agreement between one or more pharmacists and one or more practitioners that defines a collaborative practice.

(c) "Compounding" means the preparation, mixing, assembling, altering, packaging, or labeling of a drug, drug-delivery device, or device, unless performed in a Food and Drug Administration (FDA)-registered outsourcing facility in conformance with Federal law, in accordance with a licensed practitioner's prescription, medication order, or initiative based on the practitioner/patient/pharmacist/compounder relationship in the course of professional practice. Compounding includes the following:

(i) Preparation of drug dosage forms for both human and animal patients;

(ii) Preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns; and

(iii) Manipulation of commercial products for patient-specific needs beyond FDA-approved labeling.

(iv) Compounding does not include mixing, reconstituting, adding flavoring or other such acts that are performed in accordance with directions contained in approved labeling provided by the product's manufacturer and other manufacturer directions consistent with the labeling.

(d) "Deliver" or "delivery" means the actual, constructive or attempted transfer from one person to another of a drug or device, whether or not there is an agency relationship.

(e) "Dispense" or "Dispensing" means the interpretation, evaluation, and implementation of a prescription drug order, including the preparation, final verification, and delivery of a drug or device to a patient or patient's agent in a suitable container appropriately labeled for subsequent administration to, or use by, a patient.

(f) "Fill date" means the date that a new or refilled prescription was prepared, verified and labelled. It may or may not be the date the medication was received by the patient.

(g) "Labeling" means the process of preparing and affixing a label to any drug container, exclusive of the labeling by a manufacturer, packager or distributor.

(h) "Medication refill consolidation" means a component of medication therapy management that recognizes the authority of the pharmacist, at the patient's directions, to proactively adjust the medication quantity or refill schedule and to manage a patient's maintenance medications by coordinating the refill schedules, not to exceed the total quantity prescribed, to improve patient outcomes.

(i) "Medication therapy management" (MTM) is a distinct service or group of services that optimize therapeutic outcomes for individual patients. MTM services are independent of, but can occur in conjunction with, the provision of a medication or a medical device. MTM encompasses a broad range of professional activities and responsibilities within the licensed pharmacist's scope of practice.

(j) "Patient counseling" means the verbal communication by the pharmacist of information, to the patient or caregiver, in order to encourage proper use of drugs and devices. Patient counseling may be supplemented with printed materials. For medications provided by delivery, patient counseling may be provided in writing, and shall indicate the manner or method that the patient may use to contact a pharmacist for counseling or to answer questions.

(k) "Pharmacist care" are those patient care activities provided by a pharmacist, with or without the dispensing of drugs or devices, that are intended to achieve positive clinical outcomes and to optimize the patient's health-related quality of life.

(l) "Pharmacist-in-Charge" ("PIC") means a licensed pharmacist has the authority to direct the pharmacy's operations and staff.

(m) "Prescription drug order" means a lawful order of a practitioner for a drug or device for a specific patient.

(n) "Readily retrievable" means records kept in such a manner that they can be separated out from all other records and produced for review within forty-eight (48) hours.

(o) "Reasonable effort" means that degree of effort which a pharmacist of ordinary prudence and accepted professional duty would exercise in similar circumstances.

(p) "Shared pharmacy services" means a pharmacy or pharmacist performing functions at the request of another pharmacy.

(q) "Supervise" means to direct the execution of pharmacy related functions or tasks.

Section 4. Responsibilities of the Pharmacist-in-Charge (PIC).

(a) Every resident pharmacy shall designate one pharmacist, who is licensed by the Board, as the PIC.

(b) Every non-resident pharmacy shall designate one registered pharmacist as the PIC.

(c) A pharmacist may not serve as PIC for more than one pharmacy at a time unless the pharmacist obtains a waiver from the Board.

(d) A PIC shall:

(i) Direct the pharmacy's operations and staff;

(ii) Ensure all pharmacy and professional staff licenses are current and on display;

(iii) Ensure all expired or recalled drug products are removed from active stock and placed in a designated quarantine area for return or destruction;

(iv) Ensure the proper management of drug recalls which may include, where appropriate, contacting patients to whom the recalled drug product(s) have been dispensed; and

(v) Maintain all pharmacy records required by state and federal law in a readily retrievable format.

(e) The PIC shall report to the Board, in writing, the following:

(i) Confirmed diversion, theft or significant loss of prescription drugs or controlled substances from the pharmacy within one business day of discovery. When a DEA Form 106 is submitted to the DEA in instances involving controlled substances, a copy of that completed DEA Form 106, along with a detailed explanation, shall be submitted to the Board within one business day of signing the form;

(ii) Security breaches within the pharmacy or pharmacy area within one business day of discovery;

Section 5. Responsibilities of the Pharmacy License Holder.

(a) The pharmacy license holder shall:

(i) Designate a PIC;

(ii) Notify the Board upon notice of the vacancy of the PIC for a period exceeding thirty (30) days.

(iii) Ensure the pharmacy operates in compliance with all state and federal laws, rules and regulations.

(iv) Ensure the pharmacy has at least one physically present licensed pharmacist on duty at all times the pharmacy is open;

(v) Ensure a sign stating "Pharmacy Closed - No Pharmacist on Duty" is conspicuously posted when there is no pharmacist present in the building;

(vi) Ensure a working environment is provided to staff that protects the health, safety and welfare of patients, which includes, but is not limited to:

(A) Sufficient staffing with pharmacists, pharmacy interns, pharmacy technicians, and/or pharmacy technicians in training as may be required to competently and safely provide pharmacy services.

(B) Appropriate opportunities for meal breaks.

(vii) Notify the Board of any of the following:

(A) Change in ownership of the pharmacy;

(B) Change in address of the pharmacy;

Section 6. Requirements for issuing valid prescriptions

(a) In order for a prescription drug to be valid it must be issued for a legitimate medical purpose by a practitioner acting in the usual course of his or her professional practice. The responsibility for the proper prescribing of the prescription drug is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who dispenses the prescription.

(b) All non-controlled substance prescriptions and refill authorizations shall contain the following:

(i) The patient's full name and date of birth;

(ii) Name and strength of the drug;

(iii) Quantity to be dispensed, including refills, if applicable;

(iv) Directions for use;

(v) Date issued by the practitioner;

(vi) The practitioner's full name, address, telephone number; and

(vii) If a written or faxed prescription, the recognizable signature of the issuing practitioner; or

(viii) If an electronically transmitted prescription, the prescribing practitioner's electronic or digital signature; or

(ix) If a verbal order, the name of the authorized agent providing information, if other than prescriber.

(c) Prescriptions received from out-of-state practitioners are valid only to the extent a practitioner licensed in Wyoming may prescribe that medication in Wyoming.

(d) A prescription may not be dispensed to a practitioner based on an order that is not issued for one specific patient. A prescription order for "office use" is not a valid order.

(e) Upon learning that a practitioner/patient relationship has been terminated for reasons other than discharge of the patient by the practitioner, a pharmacist utilizing his or her professional judgment may honor a patient's request for remaining medication refills, for a period not exceeding twelve (12) months.

(f) The pharmacist shall determine the accuracy and authenticity of all prescriptions received. Pharmacists shall request and document verification when necessary. If verification is refused, the prescription shall not be filled.

(g) All prescription medication shall be dispensed in child-resistant packaging, in accordance with the Poison Prevention Packaging Act.

(i) The patient may request a one-time or a blanket waiver from this requirement.

(ii) The practitioner, at the patient's request, may request a one-time waiver only.

(iii) The pharmacist shall document a one-time request on the prescription or in the patient profile record.

(h) A written or electronic record of a prescription shall be maintained and available for inspection by agents of the Board for a period of two (2) years from the date it is filed, as follows:

(i) The pharmacy system shall be able to reproduce the original prescription information and maintain it in a readily retrievable format;

(ii) A pharmacy shall be authorized to maintain an exact digitized image of the prescription in an electronic record-keeping system;

(iii) A pharmacy may maintain any hard copy prescriptions in numerical or date

order; and

(iv) Disposal of the hard copy must ensure privacy and confidentiality of the contents.

Section 7. Personal Responsibility and Accountability.

(a) Each pharmacist, pharmacy intern, pharmacy technician, and pharmacy technician in training shall be responsible and accountable for their own actions performed in their practice of pharmacy.

(b) If any action of the supervising pharmacist is deemed to contribute to or cause a violation of the Wyoming Pharmacy Act, the Wyoming Controlled Substances Act, or the Board's Rules and Regulations, the supervising pharmacist may be held responsible.

(c) If any action of the pharmacy license holder is deemed to contribute to or cause a violation of the Wyoming Pharmacy Act, the Wyoming Controlled Substances Act, or the Board's Rules and Regulations, the pharmacy license holder may be held responsible.

Section 8. Unprofessional Conduct.

(a) It shall be unprofessional conduct for any licensed pharmacy staff member to practice pharmacy while under the influence of alcohol or drugs.

(b) It shall be unprofessional conduct for any licensed pharmacy staff member in the pharmacy to practice pharmacy with a mental or physical impairment affecting his or her ability to safely and competently practice pharmacy.

(c) It shall be unprofessional conduct for any licensed pharmacy staff member to sexually harass another licensee, employee of the pharmacy, or patient.

(d) It shall be unprofessional conduct for any licensed pharmacy staff member to not report another pharmacy staff member suspected of engaging in unprofessional conduct to the Board.

(e) It shall be unprofessional conduct for a licensed pharmacy or licensed pharmacy staff member to distribute or dispense prescription drug samples.

(f) It shall be unprofessional conduct for a resident or non-resident pharmacy, or pharmacist, to dispense, sell or offer to sell prescription drugs to persons on the basis of a prescription generated solely through an internet practitioner consultation questionnaire. All pharmacies or pharmacists included in this section are prohibited from linking an internet site with or relating a site, to any other site, business or practitioner that provides prescriptions for medications solely on the basis on an internet practitioner consultation questionnaire.

Section 9. Refill Authorization.

(a) If a refill was not authorized on the original prescription or, if no refills remain,

pharmacy staff may contact the prescriber to obtain refill authorization or a new prescription at the request of a patient.

(b) When refill authorization is obtained, the name of the practitioner authorizing

the prescription and, if applicable, the name of the agent transmitting the prescription, must be recorded, as well as the number of refills authorized.

(i) Date refilled;

(ii) Quantity; and

(iii) Pharmacy staff's initials who are involved in dispensing the refill.

Section 10. Labeling Prescription Drug Containers.

(a) All original or refill prescription drug containers dispensed by a pharmacy shall be labeled with the following:

(i) The patient's full name; or

(ii) If the patient is an animal, the animal's name, species and the owner's last name;

(iii) Brand or generic name of the drug product dispensed, unless otherwise specified;

(iv) Drug strength and quantity;

(v) Directions for use;

(vi) The name, address, and telephone number of the pharmacy;

(vii) The practitioner's name;

(viii) The serialized number of the prescription;

(ix) The date the prescription was filled or refilled;

(x) The product's physical description, including any identification code that may appear on the tablets and capsules, and;

(xi) Purpose for use where appropriate

(xii) Accessory cautionary labels for patient safety, where appropriate.

(b) All single unit dose or unit of use packaging shall include the following additional information on the label:

(i) Manufacturer's lot number; and

(ii) Expiration date; which shall be the lesser of the manufacturer's expiration date or twelve (12) months from the date of pre-packaging or repackaging.

Section 11. Patient Records.

(a) A patient profile record shall be maintained by pharmacies for patients for whom prescriptions are dispensed.

(b) The profile record shall provide for the immediate retrieval of information of previously dispensed drugs and devices.

for each new prescription:

(i) Patient's full name;

(ii) Patient's address and telephone number;

(iii) Patient's date of birth;

(iv) Patient's sex; and

(v) A list of all prescription drug orders obtained at the pharmacy during the two years immediately preceding the most recent entry showing the name of the drug or device, prescription number, strength of the drug, quantity, date received and the name of the prescriber;

(d) Pharmacy staff shall make a reasonable effort to obtain, record, and maintain the following information in the patient profile record:

(i) Known allergies;

(ii) Adverse drug reactions; and

(iii) Pharmacist comments relevant to the patient or their drug therapy.

Section 12. Transfer of Non-Controlled Substance Prescription Orders Between Pharmacies.

(a) A pharmacy shall transfer prescription order information for non-controlled substances upon the request of the patient.

(b) Transfer of prescription order information for the purpose of filling or refilling a prescription is subject to the following requirements:

(i) A prescription order for a non-controlled prescription drug may be transferred from one pharmacy to another pharmacy only so long as there are refills remaining.

(ii) Both the original and transferred prescription drug orders shall be maintained and readily retrievable for a period of two years from the date of last refill at the respective pharmacy;

(iii) Pharmacies electronically transferring information must satisfy all information requirements of a transferred prescription including those requirements in W.S. § 33-24-136;

(i) Document that the prescription has been transferred in the data processing system;

(ii) Record his/her name;

(iii) Record the name of the receiving individual;

(iv) Record the name, store number if a chain pharmacy, telephone number, and whether the prescription is a controlled substance; and

(v) Record the date of the transfer.

(d) The individual receiving the transferred prescription order information shall:

(i) Document that the prescription was originated by transfer in the data processing system; and

(ii) Record the original prescription's issued date and prescription number;

(iii) Record the original number of refills authorized by the prescriber;

(iv) Record the date of original dispensing;

(v) Record the number of valid refills remaining;

(vi) Record the name, store number if a chain pharmacy, and whether the prescription is a controlled substance; and

(vii) Record the name of the individual transferring the prescription.

Section 13. Return of Unused Prescription Drugs.

(a) A pharmacist may:

(i) Accept and redistribute an unused prescription drug under the Wyoming Drug Donation Program Act, W.S. § 35-7-1601 et seq or its rules; or

(ii) Accept and redistribute any unused prescription drug, or a part of it, after it has left the premises of the pharmacy if:

(A) The drug was intended for inpatients of an institutional facility and has been maintained in the custody and control of the institutional facility or dispensing pharmacy;

(B) The drug was returned to the original dispensing pharmacy;

(D) In the professional judgment of the PIC of the pharmacy, the safety and efficacy of the drug has not been compromised during transportation and storage;

(E) A system is in place to track the restocked drug for purposes of a recall; and

(F) Accepting and redistributing of the drug complies with state and federal law.

(b) A prescription dispensed by a pharmacy for delivery but not delivered to the ultimate user may be returned to stock for redispensing provided:

(i) The prescription is returned to the original dispensing pharmacy;

(ii) Storage conditions during transport of the prescription to and from the pharmacy do not in any way compromise the integrity or stability of the drug;

(iii) No compounded or flavored prescription may be returned to stock;

(iv) The drugs did not require refrigeration, freezing, or special storage;

(v) The expiration date of the drug is not more than one year from the date it was dispensed, unless it was dispensed in the manufacturer's original sealed container and bears the manufacturer's original label and expiration date.

(c) A pharmacist may accept the return of a prescription for disposal or destruction if the prescription was dispensed by the pharmacy in error, was defective, adulterated, misbranded, expired, or subject to a recall.

Section 14. Therapeutic Equivalents.

(a) Therapeutic equivalents do not include therapeutic substitutions. Therapeutically equivalent is defined in W.S. § 33-24-147(a)(v). Therapeutic substitution is that class of drug having the same or similar action, but not the identical composition.

(b) Pharmaceuticals that are considered to be therapeutic substitution instead of generic substitution shall not be used by retail/non-resident pharmacies. An institutional pharmacy using a formulary may reach a written agreement with members of the medical staff under which therapeutic substitution is permitted for use of formulary drugs.

Section 15. Shared Pharmacy Services

(a) Minimum requirements for shared pharmacy services:

(i) A resident or a non-resident pharmacy may participate in shared pharmacy services by another licensed pharmacy or pharmacist, provided involved parties:

(A) Have entered into a written agreement, specifying the services to be provided and the responsibilities and accountabilities of each party, or are of common ownership;

(B) Have a system in place to identify the parties responsible for each aspect of prescription preparation.

(b) A policy and procedure manual relating to shared pharmacy services shall be maintained by all involved parties and shall be available for inspection by the Board upon request. The manual shall:

(i) Outline the responsibilities of each of the involved parties;

(ii) Acknowledge the originating and sharing pharmacy shall be jointly responsible; and

(iii) Include policies and procedures for:

(A) Notifying patients that their prescription may be outsourced to another party for shared pharmacy services

(B) Protecting the confidentiality and integrity of patient information;

(C) Dispensing prescription drug orders when the filled order is not received or the patient comes in before the order is received;

(D) Operating a quality assurance program for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified problems; and

(E) Provide documentation of annual review of the written policies and procedures.

(c) The dispensing pharmacy, which shall be identified as such in the written agreement between pharmacies participating in shared pharmacy services shall ensure that:

(i) Drugs stored at the pharmacy shall be stored in an area secure from unauthorized personnel;

(ii) Access to the area where drugs are stored at the shared pharmacy services pharmacy must be limited to pharmacists, pharmacy interns, pharmacy technicians, or pharmacy technicians in training, who are employed by the shared pharmacy services pharmacy. Non-pharmacy staff may enter the drug storage area under the direct supervision of a pharmacist;

(iii) The pharmacy maintains and uses storage or shipment containers and shipping processes that ensure drug stability and potency;

(iv) The dispensed prescriptions are shipped in containers sealed in such a manner as to show evidence of opening or tampering;

(v) Records indicate the date the prescription was shipped to the originating retail pharmacy or patient; and

(vi) If the prescription is delivered directly to the patient, the patient shall receive written notice of available counseling. Such notice shall include:

(A) The days and hours when counseling is available,

(B) The location of pharmacy, and

(d) A resident pharmacy requesting shared pharmacy services shall ensure that:

(i) Records are readily retrievable and include:

(A) The date and time the request for processing was transmitted to the central fill pharmacy or remote processing pharmacy or pharmacist; and

(B) The date and time the dispensed prescription was received from the central fill pharmacy or remote processing pharmacy or pharmacist by the originating pharmacy, including the method of delivery and the name of the person accepting delivery unless shipped directly to the patient.

(ii) The original prescription is maintained at the originating pharmacy for a time period not less than two (2) years from the date last filled or refilled.

(iii) Notification is provided to patients that their prescription may be

outsourced to another pharmacy prior to outsourcing the prescription unless the prescription drug is delivered to patients in institutional facilities where a licensed healthcare professional is responsible for administering the prescription drug to the patient.

(iv) The prescription label clearly indicates a pharmacy that has access to the patient's records;

(v) The pharmacy has access to each pharmacy's prescription records and patient profiles and records, as needed to safely and properly perform the shared services activities.

(e) Shared pharmacy services pharmacies shall:

(i) Comply with federal and state laws and regulations; and

(ii) Protect the confidentiality and integrity of protected health information.

(f) Nothing in this Section shall prohibit an individual pharmacist, who is an employee of or under contract with a pharmacy, or a licensed certified pharmacy technician, certified pharmacy technician candidate, or pharmacy intern, working under the supervision of the pharmacist, from accessing that pharmacy's electronic database from inside or outside the pharmacy and performing the prescription drug order processing functions permitted by the Pharmacy Act, if both of the following conditions:

(i) The pharmacy establishes controls to protect the confidentiality and integrity of protected health information; and

(ii) No part of the database is duplicated, downloaded, or removed from the pharmacy's electronic database.

Section 16. Collaborative Pharmacy Practice

(a) Collaborative pharmacy practice is where one (1) or more pharmacists jointly agree to work under a protocol authorized by one (1) or more prescribers to provide patient care and drug therapy management services not otherwise permitted to be performed by a pharmacist under specified conditions.

(b) A collaborative practice agreement must be in place prior to engaging in collaborative pharmacy practice.

(c) The collaborative practice agreement must explain the scope of the pharmacist's practices and shall be updated upon any changes in the scope or agreement of practices.

(d) A copy of the signed agreement and any additional information regarding the agreement must be readily retrievable upon request by the Board.

Section 17. Medication Therapy Management

Medication Therapy Management (MTM) services may be performed without a collaborative practice agreement. These services may include, but are not limited to:

(a) Such other patient care services as may be allowed by law;

(b) Ordering, or performing laboratory assessments; and

(i) The pharmacy or service is certified by the US Department of Health and Human Services, as a clinical laboratory under the Clinical Laboratory Improvement Amendments (CLIA); or

(ii) The tests do not otherwise require a physician's order and the pharmacy or service has obtained a CLIA Certificate of Waiver from the US Department of Health and Human Services; and

(iii) The pharmacist is qualified to direct the laboratory.

Section 18. Ancillary Drug Supply for Nursing Homes, Hospices, Extended Care Facilities or Intermediate Care Facilities.

(a) Nursing homes, hospices, extended care facilities, or intermediate care facilities licensed by the Wyoming Department of Health may be issued a permit by the Board to maintain an ancillary supply of drugs, both scheduled and non-scheduled subject to approval by the Board. The drugs maintained in the ancillary drug supply shall remain the property of the pharmacy to which the permit was jointly issued.

(i) The pharmacy servicing the facility or facilities listed in this chapter shall make application to the Board, on an application form provided by the Board. The Board may issue a permit, if the conditions of this section are met, in the name of the facility and the pharmacy authorizing the storage and use of an ancillary drug supply at the facility. This registration shall be valid until June 30 of each year. The permit must be renewed annually.

(ii) The permit may be revoked by the Board, if conditions as outlined in this Section are not followed, or for other violations of the Wyoming Pharmacy Act or Wyoming Controlled Substances Act or Rules promulgated under said Acts.

(b) The ancillary drug supply shall be kept in a tamper-evident, sealed and secured container or secured automated dispensing device and used for:

(i) An emergency situation;

(ii) To temporarily replace unavailable medications; or

(iii) As a starter dose for the purpose of starting the initial therapy for a patient residing in a facility.

(c) The facility and the pharmacy servicing the facility shall develop and implement written policies and procedures to ensure safety, accuracy, accountability, security, resident confidentiality and maintenance of the quality, potency and purity of the ancillary drug supply, including the formulary.

(i) Copies of the most recent drug supply policy and procedure manual shall be on file at both the facility and the pharmacy servicing the facility.

(ii) The ancillary drug supply policy and procedure manual shall be reviewed and approved annually by the Consultant Pharmacist of the facility and the facility's Director of Nursing.

(d) The ancillary drug supply stored in an automated dispensing device shall only be stocked and restocked by a pharmacist licensed by this Board or a registered pharmacy technician or pharmacy intern under his or her supervision.

(e) Drugs administered from the ancillary drug supply shall be limited to the following:

(i) A legend drug order given by the practitioner to a nurse for administration to a resident of a facility. Enough medication may be taken to cover dosing for ninety-six (96) hours or less, until the next scheduled delivery from the pharmacy. The pharmacist must be notified of the removal of medication within forty-eight (48) hours, to review the practitioner's order and resident's profile for potential contraindications and adverse drug reactions; and

(ii) Removal of any controlled substance can only be done after the pharmacist has received an order from the practitioner or verified that a prescription exists. No controlled substance can be removed from the ancillary box until the pharmacist grants access.

(f) If the pharmacy servicing the facility discontinues its service, the Board must be notified and the permit surrendered. If the new pharmacy provider desires to maintain an ancillary drug supply, the new pharmacy provider must make application to the Board.

(g) Facilities described in this section are if the pharmacy providing their ancillary drug supply is physically located at the same site as the facility and this pharmacy possesses a DEA registration and is licensed by the Board.

History

Effective 2023-05-24

Chapter 3 Pharmacy Internship Regulations

Wyo. Code R. 059.0001.3.08312023 § 1 Authority

These regulations are promulgated as authorized by the Wyoming Pharmacy Act W.S. § 33-24-101 et seq.

History

Effective 2023-08-31

Wyo. Code R. 059.0001.3.08312023 § 2 Definitions

(a) "ACPE" means Accreditation Council for Pharmacy Education its agent, designee or successor.

(b) "FPGEC" means Foreign Pharmacy Graduate Examination Committee or its successor.

(d) "Preceptor" means a pharmacist or other health care professional licensed and in good standing with their respective Boards who supervises the internship training of a pharmacy intern.

History

Effective 2023-08-31

Wyo. Code R. 059.0001.3.08312023 § 3 Qualifications for Pharmacy Interns

(a) Submit a completed application on a form furnished by the Board, including payment of all fees;

(b) Complete a background check through the Wyoming Division of Criminal Investigation (DCI);

(i) Be enrolled and in good standing with an ACPE accredited school or college of pharmacy; or

(ii) Be a graduate from an ACPE accredited school or college of pharmacy; or

(iii) Be a graduate from a foreign school or college of pharmacy who has established education equivalency by obtaining a FPGEC Certification and who is currently licensed by the Board for the purpose of obtaining practical experience as a requirement for licensure as a pharmacist; or

(iv) An applicant awaiting licensure as a pharmacist by reciprocity who cannot provide proof of active practice and must complete an internship in Wyoming approved by the Board of no less than four hundred (400) hours; or

(v) An applicant for reinstatement of their pharmacist license after failure to renew or retuning from inactive status who must demonstrate minimum competency by completing an internship in Wyoming approved by the Board. The internship period may vary depending upon how long the individual was out of practice.

History

Effective 2023-08-31

Wyo. Code R. 059.0001.3.08312023 § 4 Pharmacy Intern Registration; Fees; Licenses

(a) The Board reserves the right to require an interview of the applicant prior to a pharmacy intern license being issued.

(b) Pharmacy intern licenses shall expire annually on September 30.

(d) A pharmacy intern license shall not be renewed beyond twenty-four (24) months from the date of graduation from an ACPE accredited school or college of pharmacy where the initial degree in pharmacy is obtained.

History

Effective 2023-08-31

Wyo. Code R. 059.0001.3.08312023 § 5 Pharmacy Internship Requirements

(a) Graduates of an ACPE accredited school or college of pharmacy shall complete one thousand two hundred (1,200) hours of practical pharmacy experience.

(b) The Board shall annually review and approve the practical pharmacy experience program offered by the University of Wyoming, School of Pharmacy.

History

Effective 2023-08-31

Chapter 4 Code of Ethics

Wyo. Code R. 059.0001.4.01162014 Code of Ethics

CHAPTER 4

CODE OF ETHICS

Section 1. Authority.

These regulations are promulgated as authorized by the Act.

Section 2. Code of Ethics.

(a) A pharmacist has the duty to observe the law, uphold the dignity and honor of the profession and to accept its ethical principles.

(b) A pharmacist shall hold the health and safety of patients to be of first consideration.

(c) A pharmacist shall not condone the dispensing, promoting or distributing of drugs or medical devices which do not meet standards required by law or which lack therapeutic value for the patient.

(d) A pharmacist shall strive to improve and enlarge professional knowledge and shall utilize that knowledge in accordance with professional judgment.

(e) It shall be considered unprofessional conduct for a pharmacist to deliver a prescription drug without having a valid drug order as described in chapter 2 from a practitioner authorized by law to prescribe.

(f) Pharmacists shall not participate in transactions with any person under which fees are divided or may cause financial or other exploitation in connection with the rendering of professional services.

(g) A pharmacist shall respect the confidential and personal nature of patient records and shall not disclose the information without proper patient authorization except when required by law. In an emergency medical situation, the patient's records may be released to another pharmacist or other medical personnel involved in treating the patient.

(h) A pharmacist shall not provide practitioners with pre-printed prescription blanks bearing the pharmacy or pharmacist name or address.

(i) Any behavior by a pharmacist toward a patient, another licensee, or an employee of a pharmacy that exploits the position of trust, knowledge, emotions or influence of the licensee or any behavior by a pharmacist which involves offers to exchange pharmacy services for some form of sexual gratification shall be considered unprofessional conduct.

History

Effective 2014-01-16

Chapter 6 Continuing Professional Education Regulations

Wyo. Code R. 059.0001.6.08312023 § 1 Authority

These regulations are promulgated as authorized by the Wyoming Pharmacy Act W.S. § 33-24-101 et. seq.

History

Effective 2023-08-31

Wyo. Code R. 059.0001.6.08312023 § 2 Definitions

"Previous License Period" means the calendar year (January 1 through December 31) immediately preceding the year for which the pharmacist is seeking a license renewal.

History

Effective 2023-08-31

Wyo. Code R. 059.0001.6.08312023 § 3 Continuing Pharmaceutical Education (CPE) Requirement for Pharmacists

(a) In accordance with W.S. § 33-24-121, all pharmacists must complete and report fifteen (15) hours of approved continuing pharmaceutical education (CPE) obtained during the previous license period in order to renew their license to practice pharmacy.

(b) Pharmacists are exempt from the CPE requirement for their first license renewal period.

(c) At least one and one-half (1.5) of the fifteen (15) hours of CPE obtained in a licensing period must be related to the responsible prescribing of controlled substances, pursuant to W.S. § 33-24-121(d), which may include courses on pain management/opioids.

(d) At least one (1) hour of CPE must be related to immunizations for pharmacists who indicate they intend to administer immunizations on their license renewal application.

(e) Pharmacists must complete CPE programs approved by the Accreditation Council for Pharmacy Education (ACPE);

(f) Pharmacists are required to obtain the required CPE and have it reported into NABP's CPE monitor in order to renew their license. If audited, failure to demonstrate evidence of completing the required CPE constitutes prima facie evidence of knowingly submitting false or misleading information to the Board for the renewal of a license and may subject the pharmacist to disciplinary action by the Board.

(g) CPE credits shall not be carried forward to subsequent years.

(h) A pharmacist who is not engaged in the practice of pharmacy in Wyoming may request inactive license status on their renewal application, and is exempt from the CPE requirements for the license period(s) while remaining inactive.

(i) A pharmacist who is on inactive status may be reactivated upon completing the CPE requirements for each year of inactive status, not to exceed five (5) years.

History

Effective 2023-08-31

Wyo. Code R. 059.0001.6.08312023 § 4 Continuing Pharmaceutical Education (CPE) Requirement for Registered Pharmacy Technicians

(a) All registered pharmacy technicians must complete and report ten (10) hours of approved CPE obtained during the previous license period in order to renew their license to practice pharmacy.

(b) Registered pharmacy technicians are exempt from the CPE requirement for their first license renewal period.

(c) For registered pharmacy technicians who have indicated they provide immunizations on their renewal application, at least one (1) hour of CPE obtained in the previous licensing period must be related to immunizations.

(d) Registered pharmacy technicians must complete CPE programs approved by ACPE.

(e) Registered pharmacy technicians are required to obtain the required CPE and have it reported into NABP's CPE monitor. If audited, failure to demonstrate evidence of completing required CPE constitutes prima facie evidence of knowingly submitting false or misleading information to the Board for the renewal of a license and may subject the registered pharmacy technician to disciplinary action by the Board.

(f) CPE hours shall not be carried forward to the subsequent years.

(g) A registered pharmacy technician who is not engaged in the practice of pharmacy in Wyoming may request inactive license status on their renewal application, and is exempt from the CPE requirements for the license period(s) while remaining inactive.

(h) A registered pharmacy technician who is on inactive status may be reactivated upon completing the CPE requirements for each year of inactive status, not to exceed five (5) years.

History

Effective 2023-08-31

Chapter 8 Wholesale Distributor Regulations

Wyo. Code R. 059.0001.8.08192025 § 1 Wholesale Distributor Regulations

Authority.

These rules are promulgated as authorized by the Wyoming Pharmacy Act W.S. § 33-24-101 through -301.

History

Effective 2025-08-19

Wyo. Code R. 059.0001.8.08192025 § 2 Wholesale Distributor Regulations

Purpose.

The purpose of this rule is to provide for the minimum licensing standards necessary to ensure the safety and efficacy of prescription drugs offered for sale by manufacturers and wholesale distributors.

History

Effective 2025-08-19

Wyo. Code R. 059.0001.8.08192025 § 3 Wholesale Distributor Regulations

Scope.

This Chapter applies to any person, partnership, corporation or business engaging in the wholesale distribution of human prescription drugs either into, out of, or within this State.

History

Effective 2025-08-19

Wyo. Code R. 059.0001.8.08192025 § 4 Wholesale Distributor Regulations

Definitions.

(a) "Authorized Distributor of Record" means a wholesale distributor with whom a manufacturer has established an ongoing relationship to distribute the manufacturer's products.

(b) "Common Carrier" means any person or entity who undertakes directly or indirectly to transport property, including prescription drugs, for compensation.

(c) "Designated Representative" means an individual designated by the wholesale distributor and who is actively involved in and aware of the actual daily operation of the wholesale drug distributor at the wholesaler's licensed location.

(d) "Dispenser" means a retail pharmacy, institutional pharmacy, a group of chain pharmacies under common ownership and control that do not act as a wholesale distributor, or any other person authorized by law to dispense or administer prescription drugs, and the affiliate warehouses or distribution centers of such entities under common ownership and control that do not act as a wholesale distributor; and does not include a person who dispenses only products to be used in animals.

(e) "Distribute" or "Distribution" means the sale, purchase, trade, delivery, handling, storage, or receipt of a product, and does not include the dispensing of a product pursuant to a prescription.

(f) "Drug" means a substance recognized as a drug in any official compendium as listed in W.S. § 33-24-127, designated for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or animals.

(g) "Drug Sample" means a unit of a prescription drug that is not intended to be sold but is intended to promote the sale of the drug.

(h) "Food and Drug Administration" (FDA) means a federal agency within the United States Department of Health.

(i) "Illegitimate product" means a product for which credible evidence shows that the product:

(i) Is counterfeit, diverted or stolen;

(ii) Is intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;

(iii) Is the subject of a fraudulent transaction; or

(iv) Appears otherwise unfit for distribution such that the product would be reasonably likely to result in serious adverse health consequences or death to humans.

(j) "Manufacturer's Exclusive Distributor" means an individual or entity who purchased the product directly from the manufacturer and is the sole distributor of that manufacturer's product to a subsequent repackager, wholesale distributor, or dispenser.

(k) "Misbranded" means a drug whose label is false or misleading or the label does not bear the name and address of the manufacturer, packer or distributor and does not have an accurate statement of the quantities of the active ingredients or:

(i) If the advertising or promotion of a compounded drug is false or misleading in any particular; or

(ii) If it is a drug and it fails to bear the product identifier.

(l) "Outsourcing Facility" means a person who registers with the FDA under section 503B of the federal act to compound sterile drugs for human use under the supervision of a pharmacist but without a prescription from a practitioner for a particular patient.

(m) "Prescription Drug" or "Legend Drug" means a drug which, under federal law, is required to be labeled with one of the following statements:

(i) "Caution: Federal law prohibits dispensing without a prescription";

(ii) "Caution: Federal law restricts this drug to use by, or on the order of, a licensed veterinarian"; or

(iii) "Rx Only."

(n) "Product Identifier" means a standardized graphic that includes in both human-readable form and on a machine readable data carrier that conforms to the standards developed by a widely recognized international standards development organization, the standardized numerical identifier, lot number, and expiration date of the product.

(o) "Product Tracing" means a dispenser shall not accept ownership of a product unless the previous owner prior to, or at the time of, the transaction, provides:

(i) Transaction Information (TI);

(ii) Transaction History (TH); and

(iii) Transaction Statement (TS).

(p) "Reverse Processor" means a person who owns or operates an establishment that dispositions or otherwise processes saleable or nonsaleable product received from an authorized trading partner such that the product may be processed for credit to the purchaser, manufacturer, or seller or disposed of for no further distribution.

(q) "Suspect Product" means there is reason to believe that such product:

(i) Is potentially counterfeit, diverted or stolen;

(ii) Is potentially intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;

(iii) Is potentially the subject of a fraudulent transaction; or

(iv) Appears otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans.

(r) "Third Party Logistics Provider" means an entity that provides or coordinates warehousing, distribution, or other logistics services of a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of a product but does not take ownership of the product, nor have responsibility to direct the sale or disposition of the product.

(s) "Transaction" in general means the transfer of product between persons in which a change of ownership occurs. The term transaction does not include:

(i) Intracompany distribution of any product between members of an affiliate or within a manufacturer;

(ii) The distribution of a product among hospitals or other health care entities that are under common control;

(iii) The distribution of a product for emergency medical reasons including a public health emergency, except that a drug shortage not caused by a public health emergency shall not constitute an emergency medical reason;

(iv) The dispensing of a product pursuant to a prescription;

(v) The distribution of product samples by a manufacturer or a licensed wholesale distributor;

(vi) The distribution of blood or blood components intended for transfusion;

(vii) The distribution of minimal quantities of product by a licensed retail pharmacy to a licensed practitioner for office use;

(viii) The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug by a charitable organization described in section 501(c)(3) of the Internal Revenue Code of 1986 to a nonprofit affiliate of the organization;

(ix) The distribution of a product pursuant to the sale or merger of a pharmacy or pharmacies or a wholesale distributor or wholesale distributors (except that records required to be maintained for the product shall be transferred to the new owner of the pharmacy or pharmacies or wholesale distributor or wholesale distributors); or

(x) The dispensing of a product approved under section 512(c) of the Federal Food, Drug, and Cosmetic Act regarding a new animal drug application.

(t) "Transaction History" means a statement in paper or electronic form that includes the transaction information of each prior transaction going back to the manufacturer of the product.

(u) "Transaction Information" means:

(i) The proprietary or established name or names of the product;

(ii) The strength and dosage form of the product;

(iii) The national drug code number of the product;

(iv) The container size;

(v) The number of containers;

(vi) The lot number of the product;

(vii) The transaction date;

(viii) The shipment date, if more than twenty-four (24) hours after the transaction date;

(ix) The business name and address of the person from whom ownership is being transferred; and

(x) The business name and address of the person to whom ownership is being transferred.

(v) "Transaction Statement" is a statement in paper or electronic form that the entity transferring ownership in a transaction:

(i) Is authorized under federal law;

(ii) Received the product from a person who is authorized as required under federal law;

(iii) Received transaction information and a transaction statement from the prior owner of the product as required by federal law;

(iv) Did not knowingly ship a suspect or illegitimate product;

(v) Had systems and processes in place to comply with verification requirements outlined in federal law;

(vi) Did not knowingly provide false transaction information; and

(vii) Did not knowingly alter the transaction history.

(w) "Wholesale Distribution" means the distribution of a drug to a person other than a consumer or patient, or receipt of a drug subject by a person other than the consumer or patient, but does not include:

(i) The intracompany distribution of any drug between members of an affiliate or with a manufacturer;

(ii) The distribution of a drug or an offer to distribute a drug among hospitals or other health care entities which are under common control;

(iii) The distribution of a drug or an offer to distribute a drug for emergency medical reasons, including a public health emergency declaration except that a drug shortage not caused by a public health emergency shall not constitute an emergency medical reason;

(iv) The dispensing of a drug pursuant to a prescription;

(v) The distribution of minimal quantities of drug by a licensed retail pharmacy to a licensed practitioner for office use;

(vi) The distribution of a drug or an offer to distribute a drug by a charitable organization to a nonprofit affiliate of the organization;

(vii) The purchase or other acquisition by a dispenser, hospital or other health care entity of a drug for use by such dispenser, hospital, or other health care entity;

(viii) The receipt of a drug by an authorized third party logistics provider who does not take ownership of the drug;

(ix) A common carrier that transports a drug who does not take ownership of the drug;

(x) The distribution of an intravenous drug that, by its formulation, is intended for the replenishment of fluids and electrolytes (such as sodium, chloride, and potassium) or calories (such as dextrose and amino acids);

(xi) The distribution of an intravenous drug used to maintain the equilibrium of water and minerals in the body, such as dialysis solutions; or

(xii) Facilitating the distribution of a product by providing solely administrative services, including processing of orders and payments.

History

Effective 2025-08-19

Wyo. Code R. 059.0001.8.08192025 § 5 Wholesale Distributor Regulations

Licensing Requirement.

(a) Every manufacturer, repackager, third party logistics provider, and wholesale distributor of prescription drugs for human use, wherever located, that provides services within this State shall be licensed by the Board and shall annually renew their license using an application provided by the Board. Manufacturers, repackagers, third party logistics providers and wholesale distributors cannot operate from a place of residence. Where wholesale distribution operations are conducted at more than one location, each such location shall be licensed by the Board.

(b) The Board shall require the following minimum information from each manufacturer, repackager, third party-logistics provider, and wholesale drug distributor as part of the initial licensing procedure and as part of any renewal of such license:

(i) All trade or business names used by the licensee (includes "is doing business as" and "formerly known as") which cannot be identical to the name used by another unrelated licensee to purchase/distribute prescription drugs in this State;

(ii) Name(s) of the owner and operator of the licensee (if not the same person), including:

(A) If a person: the name, business address, social security number, and date of birth;

(B) If a partnership: the name, business address, and social security number and date of birth of each partner, and the name of the partnership and federal employer identification number;

(C) If a corporation: the name, business address, social security number, date of birth, and title of each corporate officer and director; the corporate names, state of incorporation, federal employer identification number, and name of the parent company, if any; the name, business address, and social security number of each shareholder owning ten percent (10%) or more of the voting stock of the corporation, including over-the-counter (OTC) stock, unless the stock is traded on a major stock exchange and not OTC:

(D) If a sole proprietorship: the full name, business address, social security number, and date of birth of the sole proprietor and the name and federal employer identification number of the business entity;

(E) If a limited liability company: the name of each member, the name of each manager, the name of the limited liability company and federal employer identification number, and the name of the state in which the limited liability company was organized; and

(F) Any other relevant information the Board requires.

(iii) Name(s), business address(es), and telephone number(s) of the person(s) to serve as the designated representative(s) for each facility of the wholesale distributor that engages in the wholesale distribution of prescription drugs. The Board shall be notified of each change in designated representative within 30 days of the change. Fingerprints and a fifty dollar ($50.00) fee shall be submitted for each designated representative application for a criminal background check and with each application for change in designated representative;

(iv) A list of all state and federal licenses, registrations, or permits, including the license, registration, or permit numbers issued to the wholesale distributor by any other state and federal authority that authorizes the wholesale distributor to purchase, possess, and wholesale distribute prescription drugs;

(v) A list of all disciplinary actions by state and federal agencies against the entity as well as any such actions against principals, owners, directors or officers;

(vi) A full description of each facility and warehouse, including all locations utilized for prescription drug storage or wholesale distribution. The description shall include the following:

(A) Square footage;

(B) A general description of security and alarm systems;

(D) Address; and

(E) Temperature and humidity controls in accordance with this Chapter.

(vii) A copy of the deed for the property on which the entity's establishment is located, if the property is owned by the entity; or a copy of the wholesale distributor's lease for the property on which the establishment is located which has an original term of not less than one (1) calendar year (if the establishment is not owned by the entity);

(viii) Information regarding general and product liability insurance, including copies of relevant policies;

(ix) A description of the entity's drug import and export activities; and

(x) An electronic copy of the entity's written policies and procedures as required by this Chapter.

(c) The information collected pursuant to this Chapter shall be made available only to the Board, a third party recognized by the Board, and to state and federal law enforcement officials. The Board shall make provisions for protecting the confidentiality of the information collected under this section.

(d) All current wholesale distributor licensees and all applicants for licensure as a third party logistics provider or wholesale distributor must submit security in the amount of one hundred thousand dollars ($100,000.00) to the Board. The purpose of these funds will be to secure payment for any administrative penalty assessed by the Board, which remains unpaid thirty (30) days after the liability for the payment is final. A separate bond or other equivalent means of security is not required for each company's separate location or for affiliated companies/groups when such separate location or affiliated companies/groups are required to apply for or renew their wholesale distributor license with the Board. Acceptable forms of security include:

(i) "Surety" bond naming the board as the payee;

(ii) Irrevocable letter of credit naming the board as the payee; or

(iii) Funds deposited in a trust account or financial institution naming the board as the payee.

(e) The Board may waive the security requirement, if the wholesale distributor or third party logistics provider:

(i) Has previously obtained a comparable bond or other comparable security for the purposes of licensure in another state where they possess a valid license in good standing; or

(ii) Is a publicly held company.

(iii) Manufacturers and repackagers shall be exempt from securing a "surety" bond or other equivalent means of security acceptable to the Board or a third party recognized by the Board.

(f) Each facility licensed by the Board and all applicants for licensure must provide evidence of Verified-Accredited Wholesale Distributor (VAWD®) accreditation from the National Association of Boards of Pharmacy or from another third party recognized by the Board and must undergo the re-accreditation process periodically after initial accreditation. Manufacturing facilities are exempt from this requirement provided the manufacturing facilities are currently registered with the FDA in accordance with Section 510 of the Federal Act.

(i) Any applicant that is denied accreditation described under this section shall have the right of review of the accreditation body's decision, by:

(A) The accreditation body; and

(B) The Board.

(ii) The recognized accreditation body shall ensure that the proprietary information obtained during the accreditation process remains confidential and privileged.

(iii) Individual or third party inspectors must demonstrate to the Board that they have received training or demonstrate familiarity with the inspection standards. A letter for certification from a training program, a notice from the inspector's employing third party organization, or other means recognized by the Board shall be accepted as meeting the requirement.

(g) The Board may license by reciprocity a manufacturer, repackager, third party logistics provider or wholesale distributor that is licensed under laws of another state if:

(i) The requirements of that state are deemed by the Board to be substantially equivalent; or

(ii) The applicant is accredited by a third party recognized by the Board. An applicant that is accredited by a third party recognized and approved by the Board shall not be subject to duplicative requirements set by the Board.

(h) Where operations are conducted at more than one location by a single wholesale distributor, each location shall be licensed by the Board.

(i) Changes in any information required by this section shall be submitted to the Board within thirty (30) days after the change.

(j) All wholesale distributors shall publicly display or have readily available all licenses and the most recent inspection report.

(k) Information submitted by the wholesale distributor to the Board or a third party recognized by the Board that is considered trade secret or proprietary information, as defined under the state privacy and trade secret proprietary statutes, shall be maintained by the Board or a third party recognized by the Board as private or trade secret/proprietary information and be exempt from public disclosure.

(l) Any applicant denied licensure by the Board shall have the right of timely review and appeal as authorized by the Wyoming Administrative Procedure Act.

History

Effective 2025-08-19

Wyo. Code R. 059.0001.8.08192025 § 6 Wholesale Distributor Regulations

Medical Oxygen Distributors.

(a) Medical oxygen is a prescription drug and distributors or manufacturers or repackagers shall be licensed by the Board and annually renew their licensure in order to provide medical oxygen in or into this State.

(b) Medical oxygen distributors located in this state may be inspected by the Board.

(c) Medical oxygen distributors shall complete all the requirements in this Chapter with the exception that they do not need VAWD® accreditation.

History

Effective 2025-08-19

Wyo. Code R. 059.0001.8.08192025 § 7 Wholesale Distributor Regulations

Outsourcing Facilities.

(a) Outsourcing facilities shall be licensed by the FDA under section 503(b).

(b) Resident and non-resident outsourcing facilities shall be licensed as such in this State and annually renew their licensure.

(d) Outsourcing facilities shall complete all the requirements in this Chapter with the exception that they do not need VAWD® accreditation.

(e) Outsourcing facilities shall:

(i) Compound drugs by or under the direct supervision of a licensed pharmacist;

(ii) Compound drugs in accordance with current good manufacturing practice (cGMP) as required by federal law;

(iii) Ensure that pharmacists conducting or supervising compounding shall be proficient in the art of compounding and shall acquire the education, training, or experience to maintain that proficiency and become certified by a compounding certification program approved by the Board;

(iv) Label compounded drugs with:

(A) Required drug and ingredient information;

(B) Facility identification;

(v) Only compound using bulk drug substances that meet specified FDA criteria. May also compound drugs that appear on an FDA shortage list if the bulk drug substances used comply with the aforementioned specified criteria.

(f) All licensed outsourcing facilities shall report to the Board the biannual reports they are required to provide to the FDA identifying the drugs compounded in the previous six (6) month period, including the drug's active ingredients, strength and dosage form.

History

Effective 2025-08-19

Wyo. Code R. 059.0001.8.08192025 § 8 Wholesale Distributor Regulations

Third Party Logistics Providers.

(a) Third Party Logistics Providers (3PL) shall be licensed as such in this State and annually renew their licensure.

(b) Third Party Logistics Providers shall complete all the requirements in this Chapter.

History

Effective 2025-08-19

Wyo. Code R. 059.0001.8.08192025 § 9 Wholesale Distributor Regulations

Wholesale Distributors of Prescription Drugs for Non-Human Use.

(a) Veterinary prescription drug wholesale distributors may be licensed as such in this State and annually renew their license.

(b) Veterinary prescription drug wholesale distributors located in this State may be inspected by the Board.

(c) Veterinary prescription drug wholesale distributors applying for or renewing a license in this State shall complete all the requirements of this Chapter with the exception that they do not need VAWD® accreditation and they are not required to provide a designated representative.

(d) Veterinary prescription drug wholesale distributors may sell or deliver to a person responsible for the control of a livestock animal, as defined in Wyo. Stat. § 11-29-101(a)(vi), a non-controlled substance prescription drug intended for veterinary use provided the following conditions are met:

(i) A licensed veterinarian has issued, prior to such sale or delivery, a written prescription order for the non-controlled substance prescription drug in the course of an existing, valid veterinarian-client-patient relationship;

(ii) The original order must be retained on the premises of the veterinary prescription drug wholesale distributor for two years from the date of the last transaction affecting the order;

(iii) The non-controlled substance prescription drug(s) distributed sold or delivered pursuant to the veterinary drug order issued according to (i) of this subdivision are sold in the original, unbroken manufacturer's containers; and

(iv) The non-controlled substance prescription drug(s), once distributed, may not be returned to the veterinary prescription drug wholesale distributor for resale or redistribution.

(e) The prescription order issued by the veterinarian becomes void after two years, unless the veterinarian specifies a shorter expiration date.

(f) The veterinary prescription drug wholesale distributor shall not distribute larger quantities than the order authorizes.

(g) The original order must be retained on the premises of the veterinary prescription drug wholesale distributor filed by client name. The invoices for each distribution authorized by the order must be attached to the order.

(h) A drug distribution log must be retained on the premises of the veterinary prescription drug wholesale distributor. It shall include the following information:

(i) Date sold/delivered;

(ii) Client name;

(iii) Veterinarian name;

(iv) Non-controlled substance prescription drug sold/delivered;

(v) Quantity of non-controlled substance prescription drug sold/delivered;

(vi) Date of issue of order;

(vii) Expiration of order; and

(viii) Invoice number.

History

Effective 2025-08-19

Wyo. Code R. 059.0001.8.08192025 § 10 Wholesale Distributor Regulations

Repackagers.

(a) Repackagers of prescription drugs for human use shall be licensed as such in this State and annually renew their licensure.

(b) Repackagers shall complete all the requirements in this Chapter.

History

Effective 2025-08-19

Wyo. Code R. 059.0001.8.08192025 § 11 Wholesale Distributor Regulations

Minimum Qualifications.

(a) The Board shall consider the following factors in determining eligibility for, and renewal of, licensure:

(i) Any criminal convictions, except minor traffic violations, or civil penalties of the applicant under any federal, state or local laws;

(ii) Any findings by the Board that the applicant has violated, or been disciplined by a regulatory agency in any state for violating any federal, state or local laws;

(iii) The furnishing by the applicant of false or fraudulent material in any application;

(iv) Suspension, sanction, or revocation by federal, state or local government against any license currently or previously held by the applicant or any of its owners for violations of state or federal laws regarding prescription drugs;

(v) Compliance with the requirements to maintain or make available to the Board or to federal, state or local law enforcement officials any required records; and

(vi) Any other factors or qualifications the Board considers relevant to and consistent with public health and safety.

History

Effective 2025-08-19

Wyo. Code R. 059.0001.8.08192025 § 12 Wholesale Distributor Regulations

Personnel.

(a) Each person that is issued an initial or renewal license as a manufacturer, repackager, third party logistics provider or wholesale distributor of prescription drugs for human use, whether in state or out of state, must designate in writing on a form required by the Board, a person for each facility to serve as the designated representative.

(b) To be certified as a designated representative, a person shall:

(i) Submit an application on a form furnished by the Board and provide information that includes:

(A) Fingerprint cards and fee for a criminal background check;

(B) Date and place of birth;

(D) Principal business and address of any business corporation, or other organization in which each such office of the person was held or in which each such occupation or position of employment was carried on;

(E) Whether the person, during the past seven (7) years, has been enjoined, either temporarily or permanently, by a court of competent jurisdiction for violating any federal or state law regulating the possession, control or wholesale distribution of prescription drugs, together with details of such events;

(F) A description of any involvement by the person with any business, including any investments, other than the ownership of stock in a publicly traded company or mutual fund, during the past seven (7) years, which manufactured, administered, prescribed, wholesale distributed, or stored prescription drugs in which such businesses were named as a party in a lawsuit;

(G) A description of any felony criminal offense, or any offense (misdemeanor or felony) involving moral turpitude, or any offense related to the qualifications, functions or duties of that person in connection with the operation of the entity, of which the person, as an adult, was found guilty, regardless of whether adjudication of guilty was withheld or whether the person pled guilty or nolo contendere. If the person indicates that a criminal conviction is under appeal and submits a copy of the notice of appeal of the criminal offense, the applicant must, within thirty (30) days after the disposition of the appeal, submit a copy of the final written order of disposition to the Board; and

(H) A passport type and size of photograph of the person taken within the previous year.

(ii) Have a minimum of two (2) years of verifiable full-time managerial or supervisory experience in a pharmacy or entity or another state where the person's responsibilities included but were not limited to recordkeeping, storage, and shipment of prescription drugs;

(iii) Serve as the designated representative for only one location at any one time, except where more than one licensed entity is co-located in the facility and such entities are members of an affiliated group, as defined in Section 1504 of the Internal Revenue Code;

(iv) Be actively involved in and aware of the actual daily operations of the entity as follows:

(A) Be employed full-time in a managerial position by the entity;

(B) Be physically present at the location during normal business hours, except for time periods when absent due to illness, family illness or death, scheduled vacation, or other authorized absence; and

(c) The information collected pursuant to this Chapter shall be made available only to the Board, a third party recognized by the Board, and to state and federal law enforcement officials. The Board and a third party recognized by the Board shall make provisions for protecting the confidentiality of the information collected under this Section.

History

Effective 2025-08-19

Wyo. Code R. 059.0001.8.08192025 § 13 Wholesale Distributor Regulations

General Minimum Requirements of Facilities Storing and Handling Prescription Drugs.

(a) The following are required for the storage, handling, transport and shipment of prescription drugs and for the establishment and maintenance of records:

(b) All facilities at which prescription drugs are received, stored, warehoused, handled, held, offered, marketed, transported from or displayed shall:

(i) Be of suitable size and construction to facilitate cleaning, maintenance and proper operations to ensure that all prescription drugs in the facilities are maintained in accordance with the product labeling or in compliance with official compendium standards such as the United State Pharmacopeia-USP-NF;

(ii) Have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment and security conditions;

(iii) Have a quarantine area for storage of prescription drugs that are outdated, damaged, deteriorated, misbranded or adulterated, counterfeit, or suspected of being counterfeit, otherwise unfit for distribution or wholesale distribution, or that are in immediate or sealed secondary containers that have been opened prior to receipt by the entity;

(iv) Be maintained in a clean and orderly condition;

(v) Be free from infestation of any kind;

(vi) Be a commercial location and not a personal dwelling or residence;

(vii) Provide for the secure and confidential storage of all information with restricted access and policies and procedures to protect the integrity and confidentiality of the information; and

(viii) Provide and maintain appropriate inventory controls in order to detect and document any theft, counterfeiting, or diversion of prescription drugs.

(c) All entities involved in the wholesale distribution of controlled substances shall be duly registered with the Drug Enforcement Administration (DEA) and the Board and in compliance with all applicable laws and rules for the storage, handling, transport, shipment and distribution of controlled substances.

History

Effective 2025-08-19

Wyo. Code R. 059.0001.8.08192025 § 14 Wholesale Distributor Regulations

Security and Anti-Counterfeiting.

(a) All facilities used for drug distribution shall be secure from unauthorized entry as follows:

(i) Access from outside the premises shall be kept to a minimum and be well controlled;

(ii) The outside perimeter of the premises shall be well lighted;

(iii) Entry into areas where prescription drugs are held shall be limited to authorized personnel;

(iv) All facilities shall be equipped with an alarm system to detect unauthorized entry after hours; and

(v) 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.

(b) All facilities shall be equipped with inventory management and control systems that protect against, detect, and document any instances of theft, diversion, or counterfeiting.

(c) All entities shall be equipped with security measures to protect the integrity of data and documents and make such data and documents readily available to the Board and other state and federal law enforcement officials.

History

Effective 2025-08-19

Wyo. Code R. 059.0001.8.08192025 § 15 Wholesale Distributor Regulations

Examination of Materials.

(a) Upon receipt, each shipping container shall be visually examined for identity and to determine if it may contain suspect products. This examination shall be adequate to reveal container damage that would suggest possible suspect product or other damage to the contents.

(b) The prescription drugs found to be unacceptable under paragraph "a" above shall be quarantined from the rest of the stock.

(c) 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.

(d) All entities shall comply with reporting requirements and exchange transaction history, transaction information, and transaction statements as outlined in federal law.

History

Effective 2025-08-19

Wyo. Code R. 059.0001.8.08192025 § 16 Wholesale Distributor Regulations

Policies and Procedures.

(a) All entities shall establish, maintain and adhere to written policies and procedures, which shall be followed for the receipt, security, storage, inventory, transport, shipping and wholesale distribution of prescription drugs, including policies and procedures for identifying, recording and reporting losses or thefts, and for correcting all errors and inaccuracies in inventories. Policies and procedures shall include the following:

(b) A procedure to be followed for handling recalls and withdrawals of prescription drugs due to:

(i) Any action initiated at the request of the FDA or any other federal, state or local law enforcement or other governmental agency, including the board of pharmacy; or

(ii) Any volunteer action by the manufacturer to remove defective or potentially defective prescription drugs from the market.

(c) A procedure to ensure that all entities prepare for, protect against, and handle any crisis that affects security or operation of any facility in the event of a strike, fire, flood, natural disaster, or other situations of local, state or national emergency;

(d) A procedure to ensure that any outdated prescription drugs shall be segregated from other prescription drugs and either returned to the manufacturer or third party return processor 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. This documentation shall be maintained for two (2) years after disposition of the outdated prescription drugs;

(e) A procedure for the disposing 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;

(f) A procedure for identifying, investigating and reporting significant prescription drug inventory discrepancies involving suspect products, in the inventory and reporting of such discrepancies within ten (10) business days to the Board and appropriate federal or state agency upon discovery of such discrepancies;

(g) A procedure for reporting criminal or suspected criminal activities involving the inventory of prescription drugs to the board, FDA and, if applicable, DEA, within three (3) business days; and

(h) A procedure for verifying security provisions of common carriers.

History

Effective 2025-08-19

Chapter 9 Patient Counseling and Prospective Drug Use Review

Wyo. Code R. 059.0001.9.01162014 Patient Counseling and Prospective Drug Use Review

CHAPTER 9

PATIENT COUNSELING AND PROSPECTIVE DRUG USE REVIEW REGULATIONS

Section 1. Authority.

These regulations are promulgated as authorized by the Act.

Section 2. Definitions.

(a) "Reasonable effort" means that degree of effort which a pharmacist of ordinary prudence and accepted professional duty would exercise in similar circumstances.

Section 3. Patient Profile Records.

(a) A profile record shall be maintained by all pharmacies for patients for whom prescriptions are dispensed. The profile record shall provide for the immediate retrieval of information of previously dispensed drugs and devices. The pharmacist shall be responsible for maintaining the following patient information for each new prescription:

(i) Full name of the patient for whom the drug is intended;

(ii) Address and telephone number of the patient;

(iii) Patient's age or date of birth and gender;

(iv) A list of all prescription drug orders obtained at the pharmacy during the two years immediately preceding the most recent entry showing the name of the drug or device, prescription number, strength of the drug, the quantity, date received and the name of the prescriber;

(v) Pharmacist comments relevant to the individual's drug therapy, including any information peculiar to the specific patient or drug.

(b) Each pharmacist or their agent shall make a reasonable effort to obtain the individual's medical history, any known allergies, drug reactions, idiosyncrasies and chronic conditions or disease states of the patient and the identity of any other medications including over-the-counter drugs or devices currently being used by the patient which may relate to prospective drug review.

Section 4. Prospective Drug Use Review.

(a) A pharmacist shall review the patient record and each prescription drug order presented for dispensing by identifying:

(i) Overutilization or underutilization;

(ii) Therapeutic duplication;

(iii) Drug-disease contraindications;

(iv) Drug-drug contraindications;

(v) Incorrect drug dosage or duration of drug treatment;

(vi) Drug-allergy interactions; and

(vii) Clinical abuse/misuse.

(b) Upon recognizing any of the above, the pharmacist shall take appropriate steps to avoid or resolve the problem which shall, if necessary, include consultation with the prescriber. The pharmacist shall document those steps taken.

Section 5. Patient Counseling.

(a) Upon receipt of a prescription and following a review of the patient's record, a pharmacist or a pharmacy intern shall personally offer to discuss matters which will enhance or optimize drug therapy with each patient or caregiver of the patient. Non-resident pharmacies/pharmacists are not exempt from this regulation Such elements may include the following:

(i) Name and description of the drug;

(ii) Dosage form, dose, route of administration, and duration of drug therapy;

(iii) Intended use of the drug and expected action;

(iv) Special directions and precautions for preparation, administration, and use by the patient;

(v) Common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the actions required if they occur;

(vi) Techniques for self-monitoring drug therapy;

(vii) Proper storage;

(viii) Prescription refill information;

(ix) Action to be taken in the event of a missed dose; and

(x) Comments relevant to the individual's drug therapy, including any other information peculiar to the specific patient or drug or refusal of counseling.

(b) A pharmacist shall not be required to counsel a patient or caregiver when the patient or caregiver refuses consultation. Every refusal shall be documented by the pharmacist.

(c) Information obtained may be recorded in the patient's manual or electronic profile, in the prescription signature log or in any other system of records and may be considered by the pharmacist in the exercise of professional judgment concerning both the offer to counsel and content of counseling. The absence of any record of a failure to accept the offer to counsel shall be presumed to signify that the offer was accepted and that counseling was provided.

Section 6. Retrospective Drug Use Review

(a) "Retrospective drug use review" means the monitoring for:

(i) Therapeutic appropriateness;

(ii) Over-utilization and under-utilization;

(iii) Appropriate use of generic products;

(iv) Therapeutic duplication;

(v) Drug-disease contraindications;

(vi) Drug-drug interactions;

(vii) Incorrect dosage;

(viii) Duration of drug treatment; and

(ix) Clinical abuse/misuse after the drug has been dispensed.

History

Effective 2014-01-16

Chapter 10 Pharmacy Technician Regulations

Wyo. Code R. 059.0001.10.06052024 § 1 Authority

These rules are promulgated as authorized by the Wyoming Pharmacy Act W.S. § 33-24-101 through -301.

History

Effective 2024-06-05

Wyo. Code R. 059.0001.10.06052024 § 2 Definitions

"Pharmacy Technician-in-Training" means an individual who is registered with the Board to receive on-the-job training in preparation for licensure as a pharmacy technician.

History

Effective 2024-06-05

Wyo. Code R. 059.0001.10.06052024 § 3 Qualifications for Pharmacy Technicians and Pharmacy Technician-in-Training

(a) Be at least 18 years of age;

(b) Complete a background check through the Wyoming division of Criminal Investigation (DCI);

(d) Hold a high school diploma or its equivalent; and

(e) Have complete requirements for registration.

History

Effective 2024-06-05

Wyo. Code R. 059.0001.10.06052024 § 4 Requirements for Pharmacy Technicians and Pharmacy Technicians-in-Training

(a) Wear a name badge with the appropriate designation "Pharmacy Technician" or "Pharmacy Technician-in-Training" at all times when in or near the pharmacy area; and

(b) Identify themselves as the appropriate level of technician in all telephone conversations while on duty.

History

Effective 2024-06-05

Wyo. Code R. 059.0001.10.06052024 § 5 Pharmacy Technician-in-Training Registration

(a) A pharmacy technician-in-training shall apply to the Board for a training permit on an application supplied by the Board and shall pay the fee required before starting on-the-job training.

(i) This permit shall be valid for two years from the date of original issuance;

(ii) This permit shall include the sponsoring pharmacy; and

(iii) If the sponsoring pharmacy changes, the technician-in-training shall immediately submit a pharmacy sponsor transfer form.

(b) A pharmacy technician-in-training may only perform pharmacy functions at their sponsoring pharmacy.

History

Effective 2024-06-05

Wyo. Code R. 059.0001.10.06052024 § 6 Pharmacy Functions for Technicians-in-Training

(a) A pharmacy technician-in-training may perform the following functions under the direct supervision of a licensed pharmacist:

(i) Retrieve the product from stock, count, pour, reconstitute, place product in a prescription container, and affix the label;

(ii) Make computer entries for new or refill prescriptions;

(iii) Contact the practitioner's office and obtain refill authorizations for any prescription provided there are no changes; and

(iv) Restock drugs for those sites where the pharmacy has an emergency drug permit.

(v) Stock automated drug dispensing units, floor stock, crash carts, after-hour drug cabinets, sterile solutions and unit dose cart preparation;

(vi) Repackage unit dose and/or unit of issue packaging;

(vii) Conduct inspections; and

(viii) Input practitioner medication orders.

History

Effective 2024-06-05

Wyo. Code R. 059.0001.10.06052024 § 7 Pharmacy Technician Registration; Fees; Licenses

(a) Individuals shall apply for pharmacy technician licensure by completing an application, providing evidence of current certification by the Pharmacy Technician Certification Board (PTCB) or National Healthcareer Association (ExCPT) and paying the required fee. The Board reserves the right to require an interview of the applicant prior to a pharmacy technician license being issued;

(b) A pharmacy technician must apply to renew their license each year on or before December 31 and submit payment of the required renewal fee. The Board shall assess a late payment fee for any renewal application postmarked or filed after December 31;

(c) If the pharmacy technician fails to renew before December 31, the license expires ten (10) days after a written notice to renew is sent to the holder by certified mail, to the address last recorded for the licensee;

(d) An expired license may be restored by the Board upon compliance with this section no later than March 31 following expiration of the license;

(e) A pharmacy technician may petition the Board for reinstatement of an expired license. To be considered for reinstatement, the pharmacy technician must submit the following:

(i) A letter requesting reinstatement;

(ii) Payment of annual fees, including late payment fees, for those years which the license was expired up to a maximum of five (5) years;

(iii) Evidence of current certification by the PTCB or ExCPT; and

(iv) Proof of continuing pharmacy education for those years the license was expired, up to a maximum of five (5) years.

(f) A pharmacy technician who fails to obtain the required number of continuing education credits may be issued an "inactive" license. A pharmacy technician may not practice in Wyoming with an "inactive" license. An "inactive" license may be converted to "active" status by providing the necessary hours of continuing education credits for those years the license has been "inactive" to a maximum of five (5) years;

(g) If change of employment or mailing address occurs, the Board shall be notified within 30 days of date of change by the pharmacy technician; and

(h) A pharmacy technician shall not practice in this state with an expired technician license.

History

Effective 2024-06-05

Wyo. Code R. 059.0001.10.06052024 § 8 Reinstatement of a Revoked or Suspended Pharmacy Technician License

(a) A pharmacy technician whose license has been revoked or suspended by the Board may file an application, on a form supplied by the Board, requesting a hearing to present evidence to show why the license should be reinstated subject to the following:

(i) A pharmacy technician whose license was revoked by the Board may not file an application requesting a hearing until thirty-six (36) months have elapsed from the date the order revoking the pharmacy technician license became final;

(ii) A pharmacy technician whose license was suspended by the Board may not file an application requesting a hearing until one-half (1/2) of the suspension so ordered by the Board has elapsed;

(iii) A pharmacy technician shall submit an application fee of one hundred twenty five dollars ($125.00) and pay for the cost of the hearing, if the Board issues an order denying reinstatement. The application fee is nonrefundable;

(iv) The applicant must complete all questions and provide all information requested on the application;

(v) An incomplete application and the accompanying fee will be returned and a hearing date will not be set by the Board; and

(vi) In In the application, the pharmacy technician shall authorize any health professional who has examined or treated the applicant to disclose a diagnosis and the reasons for it to the Board and the Board staff.

(b) Applications received by the Board will be reviewed by the Executive Director. The Executive Director shall:

(i) Review the application for completeness. If information or attachments are missing, the application and fee will be returned to the applicant with a letter stating the reason(s) for the rejection; and

(ii) If the application is complete, the Executive Director, in consultation with a Compliance Officer, a member of the Board and the Board's Prosecuting Attorney shall make a decision if the evidence submitted supports reinstatement. The Executive Director will notify the applicant whether the Board staff will support or oppose the request for reinstatement. If not, a hearing for reinstatement shall be scheduled by the Executive Director, if requested by the applicant.

(c) The Executive Director may require the applicant to submit to an examination by a health professional chosen by Board staff. The health professional shall report on the examination to Board staff and may testify at a hearing on reinstatement. Cost for the examination shall be the responsibility of the applicant.

(d) To be reinstated, a pharmacy technician must prove that he or she has been rehabilitated so that further violation of Wyoming Statutes and Board rules is not likely to occur, and that he or she is competent to function as a pharmacy technician. The Board, as a condition to establish competency, may require successful completion of the PTCB Pharmacy Technician Certification Examination (PTCE) or ExCPT.

History

Effective 2024-06-05

Wyo. Code R. 059.0001.10.06052024 § 9 Pharmacy Functions for Pharmacy Technicians

(a) A pharmacy technician may perform the pharmacy functions previously mentioned in this chapter for technicians-in-training, as well as the following:

(i) Compounding - Compounded prescription orders shall be reviewed by a pharmacist. The PIC shall certify competency of the pharmacy technician prior to allowing a pharmacy technician to assist the pharmacist in compounding, and annually thereafter. Documentation of the competency shall remain on file at the pharmacy and be available for inspection by the Board for each pharmacy technician, and shall include, but not be limited to, documentation of the following skills:

(A) Knowledge and understanding of FDA's Good Manufacturing Practices;

(B) Weights and measures;

(D) Use of torsion balance or electronic scales'

(E) Knowledge of various techniques utilized to compound products;

(F) Labeling requirements;

(G) Aseptic technique;

(H) Use and maintenance of laminar and/or vertical flow air hood;

(I) Knowledge in handling chemotherapeutic agents;

(J) Dating requirements; and

(K) Record keeping requirements.

(ii) Transfer prescriptions electronically or via facsimile to another pharmacy with consent of the supervising pharmacist.

History

Effective 2024-06-05

Wyo. Code R. 059.0001.10.06052024 § 10 Pharmacy Functions Not Permitted for all Technicians

(a) No pharmacy technician or technician-in-training shall:

(i) Receive a new prescription order verbally from a prescriber or other person authorized by law;

(ii) Perform evaluations and interpretations of a prescription;

(iii) Obtain any needed clinical clarifications prior to filling;

(iv) Review and analyze any clinical data in a patient's medication record or chart;

(v) Perform professional consultation with any prescriber, nurse, other health care professional or any patient/customer;

(vi) Offer to counsel; and

(vii) Counsel.

History

Effective 2024-06-05

Wyo. Code R. 059.0001.10.06052024 § 11 Functions When a Pharmacist is Absent

(a) When no pharmacist is in the pharmacy, but at least one supervising pharmacist remains in the building, the pharmacy technician or pharmacy technician-in-training may perform functions as outlined in this Chapter, provided no prescription product leaves the pharmacy until the pharmacist returns and authorizes the release;

(b) When no supervising pharmacist is in the building, a retail pharmacy may not remain open, and staff may not remain in the pharmacy; and

(c) An institutional pharmacy may not remain open. A pharmacy technician or pharmacy technician-in-training may remain in the pharmacy, but may not perform pharmacy functions. If a drug needs to be removed from the pharmacy, those procedures as outlined in Chapter 12 shall be followed.

History

Effective 2024-06-05

Wyo. Code R. 059.0001.10.06052024 § 12 Legal and Professional Responsibilities

A pharmacy technician or pharmacy technician-in-training shall not violate the Wyoming Pharmacy Act or the Wyoming Controlled Substances Act or their rules or regulations.

History

Effective 2024-06-05

Chapter 12 Institutional Pharmacy Practice Regulations

Wyo. Code R. 059.0001.12.01162014 Institutional Pharmacy Practice Regulations

CHAPTER 12

INSTITUTIONAL PHARMACY PRACTICE REGULATIONS

Section 1. Authority.

These regulations are promulgated as authorized by the Act.

Section 2. Purpose.

The purpose of this chapter is to provide standards for the conduct, practice activities, and operation of a pharmacy located in a hospital or other inpatient facility that is licensed under the Wyoming Department of Health. The intent of these standards is to establish a minimum acceptable level of pharmaceutical care to the patient so that the patient's health is protected while contributing to positive patient outcomes.

Section 3. Scope of Chapter.

This chapter applies to any person, partnership, corporation, limited liability company, or other entity engaging in the practice of pharmacy in an institutional facility, as defined below, within this state.

Section 4. Definitions.

(a) "Automated Dispensing Device" means a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, packaging, dispensing, or distribution of medications, and which collects, controls and maintains all transaction information.

(b) "Beyond-Use Date" means a date placed on a prescription label at the time of dispensing that is intended to indicate to the patient or caregiver a time beyond which the contents of the prescription are not recommended to be used.

(d) "Drug Room" means a secure and lockable location within an inpatient care facility that does not have an institutional pharmacy.

(e) "Emergency Drug Cart (crash cart)" means a cart containing those drugs that may be required to meet the immediate therapeutic needs of patients

(f) "Floor Stock" means prescription drugs not labeled for a specific patient and maintained at a nursing station or other institutional facility department (excluding the institutional pharmacy) for the purpose of administration to a patient of the institutional facility.

(g) "Formulary" means a continually revised compilation of pharmaceuticals that reflects the current clinical judgment of the pharmacy staff and medical staff of the institutional facility.

(h) "Institutional Facility" means a hospital, convalescent home, nursing home, extended care facility, correctional or penal facility, or any other organization, public or private, which provides a physical environment for patients to obtain medical, surgical, and/or nursing services, except those places where physicians, dentists, veterinarians, or other practitioners of the healing arts engage in private office practice.

(i) "Institutional Pharmacy" means a pharmacy where medications are dispensed to other health care professionals for administration to institutionalized patients served by an institutional facility, and which is:

(i) Located within the institutional facility, or

(ii) Located outside the institutional facility but only provides pharmacy services to institutionalized patients.

(j) "Investigational Drug" means:

(i) A substance in a clinical stage of evaluation not released by the Food and Drug Administration (FDA) for general use or for sale in interstate commerce; or

(ii) Commercial drugs that are proposed for a new use, contain a new component, have a new dosage or mode of administration, or are in a new combination or combined in new proportions.

(k) "Medication Order" means a written, electronic, or verbal order from a practitioner (or his/her agent) authorized by law to prescribe medications for administration to a patient.

(l) "Remote Order Processing for Institutional Pharmacies" includes any of the following activities performed for an institutional pharmacy from a remote location:

(i) Receiving, interpreting, or clarifying medication orders;

(ii) Entering or transferring medication order data;

(iii) Performing prospective drug use review;

(iv) Obtaining substitution authorizations;

(v) Interpreting and acting on clinical data;

(vi) Performing therapeutic interventions;

(vii) Providing drug information;

(viii) Authorizing the release of a medication for administration.

Section 5. Licensing.

(a) All institutional pharmacies shall register annually with the Board on a form provided by the Board. Institutional pharmacies that also provide outpatient pharmacy services shall also register as a retail pharmacy.

(b) All institutional pharmacy licenses shall expire on June 30. Renewal notices will be sent by the Board's office at least sixty days prior to June 30.

(c) The fee established in chapter 2, will be charged for issuance of a new license and renewal. The late fee established in chapter 2, will be charged, in addition to the renewal fee, for any license renewal application that is postmarked after June 30 or is hand-delivered to the Board office after June 30.

Section 6. Change of Ownership.

(a) If an institutional pharmacy changes ownership, it must obtain a new and separate registration from the Board. In the case of a corporation, limited liability company, or partnership holding an institutional pharmacy license, the Board shall be notified and a new license applied for any time the majority of stock in the corporation is sold or a majority of the partners of the partnership or members of the limited liability company change.

Section 7. Personnel.

(a) A Pharmacist-in-Charge (PIC), who is licensed to engage in the practice of pharmacy in Wyoming, shall direct each institutional pharmacy.

(b) The storage, compounding, repackaging, dispensing, and distribution of drugs by an institutional pharmacy shall be under the direction, supervision, and responsibility of the PIC. Depending upon the size and needs of the institutional facility, pharmacy service may be provided on a full or part-time basis.

(i) In hospital institutional facilities with fifty (50) or more acute care beds, a pharmacist shall be in the hospital institutional facility during the time the institutional pharmacy is open for pharmacy services, except in case of emergencies. Pharmacy services shall be provided for a minimum of forty (40) hours per week, unless an exception is made upon written request by the institutional facility and with express permission of the Board.

(ii) In hospital institutional facilities with less than fifty (50) acute care beds, a pharmacist shall be in the hospital institutional facility during the time the institutional pharmacy is open for pharmacy services. Upon written request by the hospital institutional facility, and with the express permission of the Board, the services of a pharmacist may be on a part-time basis, according to the needs of the hospital institutional facility. The services of a pharmacist shall be required as follows:

(A) In hospital institutional facilities with one to twenty-five (1- 25) acute care beds, a pharmacist shall be on-site a minimum of five (5) hours per week.

(B) In hospital institutional facilities with twenty-six to forty-nine (26-49) acute care beds, a pharmacist shall be on-site a minimum of twenty (20) hours per week.

(iii) In a non-hospital institutional facility, a pharmacist shall be available commensurate with the needs of the institutional facility. The hours shall be identified on the initial application and provided with each license renewal.

(c) Policies and procedures defining the pharmacy services to be provided and the responsibilities of the institutional pharmacy shall be established. Such policies and procedures shall be made available to the Board upon request.

(d) The responsibilities of the PIC shall include, at a minimum, the following:

(i) Providing the appropriate level of pharmaceutical care services to patients of the institutional facility;

(ii) Ensuring that drugs and/or devices are dispensed and distributed safely and accurately;

(iii) Developing a system for sterile compounding as required in chapter 17.

(iv) Providing guidelines and approval of the procedure to assure that all pharmaceutical requirements are met when any part of preparing, sterilizing, and labeling of sterile pharmaceuticals is not performed under direct institutional pharmacy supervision;

(v) Participating in the development of a formulary for the institutional facility which is approved by the appropriate committee, including the medical staff of the institutional facility;

(vi) Developing a system to assure that drugs to be administered to inpatients are distributed pursuant to of the practitioner's medication order;

(vii) Maintaining records of all transactions of the institutional pharmacy as may be required by applicable state and federal law, and as may be necessary to maintain accurate control over and accountability for all pharmaceutical materials;

(viii) Participating in those aspects of the institutional facility's patient care evaluation program that relate to pharmaceutical utilization and effectiveness as required in chapter 9 for prospective and retrospective drug use review;

(ix) Assuring that a reasonable effort is made to obtain, record, and maintain patient medication records;

(x) Assuring the legal operation of the institutional pharmacy, including meeting all inspection and other requirements of state and federal laws or rules governing the practice of pharmacy; and

(xi) Collaborating with the nursing staff and the medical staff to develop a list of standardized concentrations of medications that will be used in the institutional facility (e.g., therapeutic heparin intravenous infusions). Pediatric formulations will be considered as a separate listing from adult formations.

(e) The PIC shall be assisted by a sufficient number of additional licensed pharmacists as may be required to operate the institutional pharmacy competently, safely, and adequately to meet the needs of the patients. All pharmacists shall assist the PIC in meeting the responsibilities as outlined in this chapter

(f) Pharmacy technicians may assist the PIC, and pharmacists provided the ratio of pharmacy technicians and pharmacy technicians-in-training to licensed pharmacists does not exceed the requirement of chapter 10.

(g) The PIC may be assisted by secretarial and clerical assistance for non- pharmacy functions as defined in chapter 10.

Section 8. Environment.

(a) The institutional pharmacy shall be enclosed and lockable.

(b) The institutional pharmacy shall have adequate space necessary for the storage, compounding, labeling, dispensing, and sterile preparation of drugs prepared in the institutional pharmacy, depending on the size and scope of pharmaceutical services provided.

(d) The institutional pharmacy shall be arranged in an orderly fashion and shall be kept clean. All required equipment shall be clean and in good operating condition.

(e) The institutional pharmacy shall be properly lighted and ventilated.

(f) The temperature of the institutional pharmacy shall be maintained within a range of 59 to 86 degrees Fahrenheit (15 to 30 degrees Centigrade). The temperature of the refrigerator shall be maintained within a range of 36 to 46 degrees Fahrenheit (2 to 8 degrees Centigrade) and the freezer shall be maintained within a range of –13 to +14 degrees Fahrenheit (-25 to –10 degrees Centigrade).

(g) The institutional pharmacy shall store drugs for external use, separately from internal and injectable medications.

(h) If the institutional pharmacy compounds sterile pharmaceuticals, they shall be prepared in accordance with chapter 17.

Section 9. References.

Each institutional pharmacy shall maintain in its library at least one current reference (text or electronic format, including online access or PDA) from each category listed below.

(a) Drug monograph reference:

(b) Stability and incompatibility reference:

(d) Drug interactions:

(e) Reference on pharmacology and therapeutics:

(f) Current copies of the Wyoming Pharmacy Act and Rules and Regulations, and Wyoming Controlled Substances Act and Rules and Regulations, text or electronic format, and including internet access to the Board website.

(g) Wyoming State Board of Pharmacy quarterly newsletter from the Board website.

Section 10. Equipment.

(a) Institutional pharmacies distributing medication orders shall have the following equipment:

(i) Refrigerator, including a system or device to monitor the temperature daily to ensure that proper storage requirements are met;

(ii) Computer and software appropriate for the institutional facility.

(b) If the institutional pharmacy compounds medication orders, that require the use of a balance, a Class A prescription balance or electronic scale with 10 mg sensitivity shall be available. Such balance or electronic scale shall be properly maintained by the PIC and may be inspected by the Board of Pharmacy.

(c) An institutional pharmacy that compounds sterile pharmaceuticals, shall have equipment and supplies listed in chapter 17.

Section 11. Security.

(a) No one shall be permitted in the institutional pharmacy unless the pharmacist is on duty, except as provided in this chapter. If the pharmacist must leave the institutional pharmacy for an emergency or patient care duties, pharmacy technicians may remain to perform duties as authorized by the PIC, provided that the pharmacist remains in the institutional facility.

(b) All institutional pharmacy areas shall be capable of being locked. The PIC shall designate in writing, by title and specific area, those persons who shall have access to specific institutional pharmacy areas.

(d) Pharmacists, technicians, clerical staff, and interns working in the institutional pharmacy shall wear identification badges, including name and position, whenever on duty.

(e) The PIC shall be responsible for policies and procedures for the safe distribution and control of prescription blanks and tamper resistant paper.

Section 12. Absence of Pharmacist.

(a) General. During such times as institutional pharmacy services are not available on-site, arrangements shall be made in advance by the PIC for provision of drugs by use of floor stock, ADD, and/or access to the institutional pharmacy.

(b) If floor stock is used, the following shall prevail:

(i) In the absence of a registered pharmacist, medication for inpatients shall be obtained from a locked cabinet or other enclosure located outside the institutional pharmacy to which only authorized nurses may have access.

(ii) The PIC shall develop inventory listings of those drugs to be included in such floor stock, and shall ensure that:

(A) Such drugs are available, properly labeled;

(B) Such drugs are prepackaged in appropriately small amounts, unless commercially prepared packages, (e.g. ophthalmics, otics, topicals, etc.)

(D) A record shall be maintained, and shall include:

(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 drug removed; and

(IV) The printed name and signature of the nurse removing the drug.

(F) Written policies and procedures are established.

(c) Access to the institutional pharmacy. Whenever any drug is not available from floor stock, only supervisory or charge nurses may have access to the institutional pharmacy and may remove drugs.

(i) Removal of any drug from the institutional pharmacy by an authorized nurse must be recorded showing:

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

(B) The patient's name and location;

(D) The printed name and signature of the nurse.

(ii) The nurse removing the drug shall leave a copy of the physician's order for the new drug with the above record.

(iii) The quantity of drug removed shall not exceed the amount of medication needed until the institutional pharmacy reopens. Drugs that are usually dispensed as a unit of use package, such as inhalers, otics, topicals, insulin, and ophthalmics, are excluded.

(iv) A procedure shall be established to allow verification by the pharmacist of the drug removed (such as by leaving the identifying container or unit- dose sample of the drug with the records).

(d) If off-site pharmaceutical care is provided whenever an institutional pharmacy is closed, then the following requirements must be met:

(i) The institutional pharmacy shall have a pharmacist on duty at the institutional facility the minimum number of hours required in this chapter.

(ii) Any pharmacist providing off-site pharmaceutical care under this section shall be licensed to practice pharmacy in Wyoming.

(iii) The Board shall be notified in writing by the institutional pharmacy of any arrangement whereby pharmaceutical care is provided off-site. This notification shall include the following:

(A) The name, address, and Wyoming license number of each pharmacist who will be providing this service.

(B) The name, address, and Wyoming license number of each pharmacy exchanging information with the institutional facility.

(C) Description of the communication link that will be utilized to exchange information between the institutional facility and the off-site pharmacist.

(D) Description of the scope of work of any pharmacist who provides off-site pharmaceutical care.

(E) Description of patient information that is to be shared between the institutional facility and the off-site pharmacist. At minimum, the off-site pharmacist shall have access to the patient's medical record.

(iv) A pharmacist providing off-site pharmaceutical care may perform remote order processing, if the pharmacist has access to appropriate patient information, including laboratory results.

(v) A pharmacist providing off-site pharmaceutical care shall provide the following services as a minimum:

(A) Review of any new medication order or change in existing medication order prior to administration by the nursing staff at the institutional facility.

(B) Communication with the institutional pharmacy staff on a daily basis or whenever the institutional pharmacy is open for business.

Section 13. Emergency Outpatient Medication.

(a) Institutional facilities which provide for the administration and distribution of emergency pharmaceuticals to outpatients and/or inpatients being discharged during hours when normal community or outpatient Institutional pharmacy services are not available, may:

(i) Allow a designated nurse on the original written or electronic order of a practitioner to administer and distribute medications pursuant to the following requirements:

(A) A written or electronic order of a practitioner authorized to prescribe a drug is presented.

(B) The medication is prepackaged by a pharmacist or a technician under a pharmacist's supervision or is administered and distributed utilizing an automated drug dispensing device;

(C) The quantity of medication administered and distributed is limited to a seventy-two hour (72-hour) supply. Exceptions to the 72-hour supply include: oral pediatric antibiotic preparations, otics, ophthalmics, topicals, inhalers, nitroglycerin tablets, nasal sprays, manufacture packaged courses of therapy such as Z-paks or dosepaks; and

(D) The labeling of the administered and distributed medication includes:

(I) Name, address, and telephone number of the institutional facility;

(II) Name of patient;

(III) Name of drug, strength, and quantity;

(IV) Directions for use;

(V) Date;

(VI) Accessory cautionary information, as required for patient safety;

(VII) Name of practitioner; and

(VIII) Initials of the nurse administering and distributing the medication.

(b) The order may be in the form of a separate written or electronic prescription or a prescription entered in the patient's medical record. A practitioner must sign the order. A copy of the prescription order must be readily available for review by the pharmacist.

(c) A record shall be maintained for all medications administered and distributed from the emergency room. The record shall include the following information:

(i) Name of patient;

(ii) Date of issuance;

(iii) Name of drug;

(iv) Patient's institutional facility record number; and

(v) Initials of the nurse who administered and distributed the drug.

(d) The emergency room log for drugs administered and distributed after hours shall be available for review by the pharmacist. Inventory levels will be compared to drugs administered and distributed. Discrepancies will be reviewed with the emergency room nursing supervisor.

(e) Security of all drugs prepackaged must be maintained in a locked cabinet, ADD or storeroom location in the emergency room area to which only specifically authorized personnel shall have access.

Section 14. Emergency Drug Carts (crash carts).

Emergency drug carts may be used by institutional facilities if:

(a) All drug kits are supplied, and kept up-to-date, under the supervision of a licensed pharmacist;

(b) A committee composed of the PIC, nursing staff, and medical staff of the institutional facility develops a standard drug inventory, including kind and quantity of each drug;

(d) A listing of all drugs, their respective strength, quantity, and location, shall be placed on the cart in a conspicuous location. If the pharmacy which services this emergency drug cart is not located within the institutional facility, the name, address, and telephone number of the pharmacy shall be displayed in a conspicuous location;

(e) All drugs are properly labeled;

(f) The drugs are distributed, pursuant to a valid order, by authorized personnel, and the pharmacist is notified of entry into the emergency drug cart; and

(g) The PIC, nursing staff, and medical staff develop and implement written policies and procedures for using emergency drug carts.

Section 15. Automated Dispensing Devices.

(a) No drug shall be distributed or issued by the use of any automated dispensing device unless the device and method of operation ensure the purity, potency, and integrity of the drug, protect the drug from diversion, and provided that:

(i) The device shall be stocked with drugs only by or under the supervision of a pharmacist;

(ii) The device shall be used only for the furnishing of drugs for administration to patients of that institutional facility; and

(iii) At the time of removal of any drug from the device, it shall automatically make a written or electronic record to be retained by the pharmacist for at least one (1) year, indicating:

(A) The date of removal of the drug;

(B) The name, strength, dosage form, and quantity of drug removed;

(D) The name or identification code of the nurse removing the drug from the device.

Section 16. Parenteral Medications.

(a) The PIC shall be responsible for the preparation, sterilization, labeling, and dispensing of parenteral medications prepared within the institutional facility and shall participate in the education and training, including the provision of appropriate incompatibility information, of all personnel involved in the preparation of parenteral medications.

(b) If intravenous admixtures are prepared within the institutional facility, the institutional pharmacy shall have adequate equipment, personnel, and space for such preparation. The compounding and labeling of intravenous admixtures, including all total parenteral nutrition, shall be performed by, or under, the direct supervision of a pharmacist; however, if twenty-four hour (24-hour) pharmacy service is not provided at the institutional facility, the PIC shall establish written policies and procedures to be followed in the preparation of intravenous admixtures when the institutional pharmacy is closed or in emergency situations.

(c) All admixtures shall be labeled with a distinctive supplementary label, indicating the name and amount of drug added, date and time of addition, beyond use date, and rate of administration, and the name or identification code of the person adding the drug.

(d) The PIC shall be responsible for removing concentrated electrolytes (including, but not limited to: potassium chloride, potassium phosphate, sodium chloride greater than 0.9%) from patient care areas and limiting their access to pharmacists. If twenty-four hour (24-hour) on-call status for pharmacists is not available, the institutional facility must utilize the most trained professional available to process concentrated electrolytes. Training in the safe use of concentrated electrolytes should be conducted by the institutional pharmacy for non-pharmacist staff with access to concentrated electrolytes. Evidence of training will be documented and retrievable, and the institutional facility will have policies and procedures that detail this process. Premixed large volume intravenous solutions containing electrolytes and premixed potassium bolus doses will be used whenever possible.

Section 17. Practitioner's Orders.

(a) All orders for drugs shall be transmitted to the institutional pharmacy by electronic order entry, or by means of an order format that is capable of producing a direct copy or an electronically reproduced facsimile. A pharmacist shall review the practitioner's order before the initial dose of medication is dispensed provided that, in emergencies or when pharmacy services are not available, the medication order shall be reviewed by the pharmacist as soon as possible. Verification of the accuracy of the medication dispensed and of any transcriptions made of that order shall be documented by the initials of the pharmacist so certifying.

(b) Orders for drugs for use by inpatients shall, at a minimum, contain the patient name and location, drug name, strength, directions for use, date, and practitioner's written or electronic signature or written or electronic signature of the practitioner's agent.

Section 18. Dispensing.

(a) If unit-dose packaging is used, medication for each patient, when not supplied by an automated dispensing device, shall be distributed and stored in separate trays, drawers, compartments, or containers assigned to that patient and bearing the patient's name and location.

Section 19. Investigational Drugs and Protocols.

(a) All investigational drugs shall be stored in the institutional pharmacy and distributed only from the institutional pharmacy. Basic information concerning the dosage form, route of administration, strength, actions, uses, side effects, adverse effects, interactions, and symptoms of toxicity of such drugs shall be available in the institutional pharmacy. investigational drugs shall be properly labeled and shall be administered only under the personal and direct supervision of the principal physician-investigator or his or her authorized clinician(s) with prior approval of the appropriate committee(s) of the institutional facility and with verifications that the patient (or his or her legal designee) has signed the informed consent form.

(b) A copy of all investigational drug protocols shall be on file in the institutional pharmacy.

Section 20. Inspections.

The PIC or his/her designee shall document on at least a quarterly basis an inspection of all drug storage areas in the institutional facility. Records of such inspections shall be dated, signed, and maintained so as to be readily retrievable at the institutional pharmacy for at least two (2) years. These inspections must ascertain that:

(a) Test reagents, germicides, and disinfectants are stored separately from medications;

(b) External medications are stored separately from internal medications;

(d) There are no outdated or deteriorated drugs;

(e) All drugs are properly labeled;

(f) Emergency drug carts (crash carts) are adequate and in proper supply;

(g) Medication storage areas are locked when not in use, and only authorized individuals have access to these areas;

(h) Distribution and administration of controlled substances are properly and adequately documented;

(i) Telephone numbers of the regional poison control center and other emergency assistance organizations are posted;

(j) Metric-apothecaries' weight and measure conversion tables and charts are available; and

(k) Adequate pharmaceutical references are available at these areas.

Section 21. Medications brought into the institution by patients.

Whenever patients bring drugs into an institutional facility, such drugs shall not be administered unless they can be precisely identified; administration shall be pursuant to a practitioner's order. If such drugs are not to be administered, they shall be delivered to the institutional pharmacy, packaged, sealed, and returned to an adult (18 years or older) member of the patient's immediate family (spouse, unless legally separated; adult child; parent; grandparent; adult brother or sister; adult grandchild), the patient's legal guardian or conservator, or the patient's designated agent, or they shall be stored and returned to the patient upon discharge, only after advice is provided regarding continuing the returned medication.

Section 22. Controlled Drugs.

(a) All controlled substances issued by the institutional pharmacy to any institutional facility department, excluding those controlled substances for which the dispensing and record-keeping are maintained utilizing an automated drug dispensing device, shall be labeled and accompanied with control sheets (proof of use forms) that provide space for recording:

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

(ii) The date and time of administration;

(iii) The quantity administered;

(iv) Name of patient;

(v) The signature of the nurse who administered the medication, when issued to nursing units; and

(vi) The signature of the practitioner who administered the medication and a witness, when issued to surgery or other specialized areas such as endoscopy labs.

(b) Such drugs shall be limited both in kind and quantity commensurate with the needs of the area to which they are distributed; the institutional pharmacy shall maintain a record of such distribution. The PIC, in consultation with the director of nursing or other appropriate hospital staff, shall establish written requirements for the frequency of controlled substance inventories in drug storage areas outside of the institutional pharmacy.

(c) All control sheets must be returned to the institutional pharmacy upon completion. The pharmacist shall verify the returned sheets for accountability and control prior to drug reissuance. These control sheets, as well as any records generated, must be maintained so as to be readily retrievable at the institutional pharmacy for two (2) years. Records of controlled substance, which are dispensed utilizing an automated dispensing device, shall be maintained at the institutional pharmacy for two (2) years.

(d) All controlled substances that must be wasted shall be destroyed by a method approved by the PIC. Documentation of all destruction must occur on the control sheet, in the patient's medical record, or utilizing the format available with an automated drug dispensing device, and be signed (written or electronically) by the nurse/physician destroying and one witness who observed the destruction.

(e) Transdermal patches containing controlled substances shall be handled in the following manner:

(i) The PIC, in coordination with the director of nursing, will implement a policy requiring all nursing personnel applying a transdermal patch containing a controlled substance to write the date on the patch when it is first applied to a patient.

(ii) All used transdermal patches containing a controlled substance shall be destroyed in front of a witness, and documented. The destruction will be done in a manner currently recommended by the FDA.

History

Effective 2014-01-16

Chapter 14 Telepharmacy

Wyo. Code R. 059.0001.14.10312017 Telepharmacy

First Draft, Wyoming Rules and Regulations - Garbing

TELEPHARMACY

CHAPTER 14

Section 1. Authority.

These rules are promulgated as authorized by the Wyoming Pharmacy Act, W.S. § 33-24-101 through -301.

Section 2. Purpose.

To describe procedures for operating a telepharmacy.

Section 3. Scope.

Applies to parent pharmacies and telepharmacies licensed in Wyoming.

Section 4. Definitions.

(a) "Adequate Supervision" means oversight by the parent pharmacy by which they maintain visual supervision and auditory communication with the telepharmacy and full supervisory control of the automated system, if applicable, and shall not be delegated to another person or entity.

(b) "Automated Dispensing Device" means a mechanical system which performs operations relative to distributing individual unit of issue packages, and which collects, controls, and maintains all transaction information.

(c) "Parent Pharmacy" means a pharmacy licensed by the Board which is authorized by the Board to operate a telepharmacy site via real-time data, video, and audio links.

(d) "Real-time" means that the transmission of information through data, video and audio links is so rapid that the information is available to the parent pharmacy and telepharmacy sites simultaneously.

(e) "Telepharmacy" means a site where prescription drugs are stored and dispensed that is remote from but under the active control and supervision of a parent pharmacy and a licensed pharmacist, and that is subject to the requirements of W.S. § 33-24-156.

(f) "Single Unit Dose" means a package that contains one unit of medication.

(g) "Traditional Dispensing" means a drug package system in which individual doses are not packaged in single unit dose packages or unit of use packages.

(h) "Unit of Use package" means a package that provides multiple units of doses separated in a medication card or other similarly designed container.

Section 5. Licensing of Facilities.

(a) An application for licensure to establish, operate or maintain a telepharmacy shall be made on an application provided by the Board and submitted to the Board no less than sixty (60) days prior to opening the telepharmacy.

(b) A set of blueprints shall be provided to the Board with the initial application for licensure.

(c) Prior to opening a telepharmacy site, the Board shall inspect the telepharmacy for minimum standards of this Chapter.

(d) The Board shall be notified with every change of pharmacist-in-charge (PIC).

(e) Every telepharmacy license shall expire on June thirty (30) of each year and shall be renewed annually by filing an application provided by the Board together with a fee set by the Board, postmarked no later than June thirty (30).

(f) Initial and renewal telepharmacy license fee shall be $150.00. Any application for renewal postmarked after June thirty (30) shall be subject to a late fee of $200.00 in addition to the renewal fee.

(g) A telepharmacy license shall not be renewed by the Board if a retail pharmacy opens for business within ten (10) miles of the telepharmacy site. A telepharmacy may continue to operate until the end of the current licensure year. The Board shall notify the telepharmacy's parent pharmacy when a retail pharmacy license has been issued to a site within ten (10) miles of the licensed telepharmacy, and shall include the last date the telepharmacy may remain open for business. This ten (10) mile restriction does not apply:

(i) In counties with a city of fifty thousand (50,000) or more persons as shown in the most recent federal census; or

(ii) To any facility owned or leased by the state or any subdivision of the state; or

(iii) To any facility located in a hospital or clinic setting.

Section 6. Minimum Structural, Security and Equipment Requirements to Operate a Telepharmacy.

(a) All telepharmacies operating in Wyoming shall meet the following structural requirements:

(i) Shall consist of an area of no less than 150 square feet exclusive of the patient consulting room;

(ii) Shall have a means of delivering a private, secure consultation;

(iii) Shall include a sink with a hot and cold water supply, exclusive of restroom facilities, with approved sewage disposal;

(iv) Shall be properly lighted and ventilated. The temperature of the telepharmacy shall be maintained within a range compatible with the proper storage of pharmaceuticals; and

(v) Shall have adequate shelving and counter space on which to work and the working surface shall be kept clear and uncluttered at all times.

(b) All telepharmacies operating in Wyoming shall meet the following security requirements:

(i) Shall be secured with solid core or metal doors with a deadbolt and a locking doorknob;

(ii) Shall have in place dedicated intrusion detectors, which provide coverage throughout the telepharmacy;

(iii) Shall have telepharmacy walls which extend to the roof or adjoining floor if a multistory building, or provide security acceptable to the Board;

(iv) Shall meet all other applicable federal or state regulations concerning security access; and

(v) Shall store controlled substances in a lockable cabinet which is securely fastened to the structure.

(i) A computer, scanner, and printer which meet the following requirements:

(A) All prescription data shall be processed utilizing the aforementioned electronic data processing equipment;

(B) All new prescriptions shall be scanned, sequentially numbered and the prescription labels shall be produced on site;

(C) Scanned prescription shall be displayable on the computer terminal at both the telepharmacy and parent pharmacy. Scanned prescriptions must be available for review for every new and refill prescription processed at the telepharmacy;

(D) All patient demographics, as well as all prescription information, shall be viewable at both the telepharmacy and parent pharmacy in a real time mode;

(E) Prescriptions dispensed at the telepharmacy site shall be distinguishable from those dispensed at the parent pharmacy including a unique label with a unique identifier in the prescription data base. Furthermore, the initials of the pharmacist who releases the prescription from the parent pharmacy shall appear on the prescription label;

(F) Video monitors used for the proper identification of and communication and consultation with persons receiving prescription drugs shall be a minimum of twelve inches (12") wide, be of high definition, and provided at both the telepharmacy and the parent pharmacy for direct visual contact between the pharmacist and the patient or the patient's agent; and

(G) The video and audio communication system used to counsel and interact with each patient or patient's caregiver shall be secure and HIPAA-compliant.

(ii) A real time data, video, and audio link with the parent pharmacy at all times the telepharmacy is open for business;

(iii) Fax capability;

(iv) Any automated dispensing device shall be approved by the Board prior to installation;

(v) A separate refrigerator located in the telepharmacy, which is sufficient in capacity to serve the needs of the telepharmacy that is equipped with a thermometer and provides a storage temperature of 36-46 degrees Fahrenheit (2-8 degrees Centigrade). The use of such refrigerator shall be limited to the storage of drugs. If a freezer compartment is utilized, it must maintain a temperature of -13 to +14 degrees Fahrenheit (-20 to -10 degrees Centigrade); and

(vi) Access to a current set of Wyoming pharmacy laws and Wyoming State Board of Pharmacy Newsletter by access to the Board's website.

(d) Upon written request and for good cause, the Board may waive any of the requirements of this chapter. A waiver that is granted under this section shall only be effective when issued by the Board in writing.

Section 7. Daily Operations.

(a) A telepharmacy site may not remain open for business if an interruption in data, video or audio link occurs. Whenever an interruption in data, video, or audio link occurs, no prescription shall be dispensed and a sign shall be posted noting the closure and an estimated time when resumption of services can be expected.

(b) The telepharmacy shall be staffed by a pharmacy technician or a pharmacy intern, licensed by the Board, or by a pharmacist whenever a pharmacy technician or intern is not available. Under no circumstance may the telepharmacy remain open for business unless a pharmacy technician, pharmacy intern or a pharmacist is on duty.

(c) A pharmacy technician may only perform those pharmacy functions as allowed in Chapter 10 of the Board's rules. Adequate supervision shall be provided by a pharmacist at the parent pharmacy utilizing the data, video and audio link.

(d) A pharmacy intern may only perform those duties as allowed in Chapter 3 of the Board's rules. Adequate supervision shall be provided by a pharmacist at the parent pharmacy utilizing the data, video and audio link.

(e) Data entry may be performed at the parent pharmacy or at the telepharmacy site. All entries performed at the telepharmacy site must be verified by a pharmacist at the parent pharmacy prior to dispensing of the prescription at the telepharmacy.

(f) Verification of prescriptions entered and dispensed at the telepharmacy site shall include:

(i) For a new prescription, the pharmacist at the parent pharmacy, utilizing the data/audio/video link, shall review the patient profile as required by the Board's rules, the original scanned prescription, the unit of use or stock package selected to be dispensed or the prescription vial that has been filled if traditional dispensing it utilized and the directions as entered by the pharmacy technician or intern. The pharmacist shall view the label affixed to the unit of use package or prescription container to assure accuracy using the image or video link. The offer to counsel shall be made by the pharmacist; or

(ii) For a refill prescription, the pharmacist at the parent pharmacy, utilizing the data/audio/video link, shall review the patient profile, the label, the filled prescription container to be dispensed and assure the label is affixed to the correct prescription container.

(g) Verifications of prescriptions entered at the parent pharmacy and dispensed at the telepharmacy shall include:

(i) The pharmacist shall perform a prospective drug use review of all new and refill prescriptions as outlined in the Board's rules.

(ii) Utilizing the audio/video link, the pharmacist shall review the label, the stock medication container selected for dispensing, and assure the label is affixed to the correct prescription container at the telepharmacy site.

(h) Counseling.

(i) All patients receiving a new prescription shall be counseled by a pharmacist in the consultation room or at a private, secure computer by audio/video link with the parent pharmacy or in person if the pharmacist is on duty at the telepharmacy;

(ii) All patient questions regarding medication therapy or questions regarding over-the-counter products shall be answered by a pharmacist at the parent pharmacy utilizing an audio/video link in the consultation room, at a private, secure computer, or in person if the pharmacist is on duty at the telepharmacy;

(iii) All counseling performed by the pharmacist shall be in accordance with the Board's rules; and

(iv) A pharmacy intern may provide counseling at the telepharmacy site provided all counseling is performed under the supervision of a pharmacist at the parent pharmacy and is conducted in the consultation room or at a private, secure computer utilizing an audio/video link to the parent pharmacy.

(i) Under no circumstance may a prescription be dispensed at the telepharmacy site until all verification required by this section has been fulfilled by a pharmacist at the parent pharmacy and the prescription has been released by the pharmacist. Release of the prescription by the pharmacist at the parent pharmacy shall be documented electronically for each prescription dispensed.

(j) Under no circumstance shall prescription drug samples be stored or dispensed at the telepharmacy site.

Section 8. Recordkeeping Requirements.

(a) All written prescriptions presented to the telepharmacy site shall be scanned into the electronic data processing equipment, such that on initial dispensing and each refill, the original prescription may be viewed on the monitor at both the telepharmacy and parent pharmacy site. All scanned prescriptions shall be retained electronically for at least two (2) years from the date scanned. All written prescriptions shall be delivered to the parent pharmacy for filing within 72 hours. Records shall be maintained at the parent pharmacy in files separate from the parent pharmacy files.

(b) Controlled substance records shall be maintained at the telepharmacy unless specific approval is granted for central storage as permitted by state and federal law.

(d) The establishment of minimum standards and practices necessary to ensure safety, accuracy, security, sanitation, recordkeeping, and patient confidentiality shall include:

(i) Identification of personnel authorized to have access to the drug storage and dispensing areas at the telepharmacy and to receive drugs delivered to the telepharmacy;

(ii) Procedures for the procurement of drugs and devices to the telepharmacy and into any automated dispensing device used, as applicable; and

(iii) The criteria for monthly in-person pharmacist inspection of the telepharmacy and appropriate documentation on a form designated by the Board.

Section 9. Pharmacist-in-Charge (PIC) Responsibilities.

(a) Unless an alternative PIC from the parent pharmacy is specifically designated in writing, the PIC of the parent pharmacy is the PIC for the telepharmacy.

(b) The PIC and pharmacist-on-duty are responsible for ensuring that the parent pharmacy and telepharmacy are staffed in accordance with Board rules.

Section 10. Delivery and Storage of Drugs.

(a) Prescription drugs shall be delivered to the telepharmacy when a pharmacy technician or pharmacist is present to accept delivery and verify that the drugs were actually received;

(b) An automated dispensing device shall be stocked with drugs only by a pharmacist licensed by the Board, a registered pharmacy technician or pharmacy intern under the supervision of a pharmacist; and

17-0

Wyoming Pharmacy Act, Rules and Regulations

History

Effective 2017-10-31

Chapter 15 Long Term Care Pharmacy Services

Wyo. Code R. 059.0001.15.05162017 § 1 Long Term Care Pharmacy Services

Authority.

These rules are promulgated as authorized by the Wyoming Pharmacy Act W.S. § 33-24-101 through -301.

History

Effective 2017-05-16

Wyo. Code R. 059.0001.15.05162017 § 2 Long Term Care Pharmacy Services

Purpose.

To regulate pharmacies who provide services to residents of long term care facilities.

History

Effective 2017-05-16

Wyo. Code R. 059.0001.15.05162017 § 3 Long Term Care Pharmacy Services

Scope.

Applies to any pharmacy or pharmacist providing services to a long term care facility.

History

Effective 2017-05-16

Wyo. Code R. 059.0001.15.05162017 § 4 Long Term Care Pharmacy Services

Definitions.

(a) "Long Term Care Facility" (LTCF) means any skilled or intermediate care nursing home, board and care home, or any resident behavioral health facility subject to regulation and licensure by the department of health. For the purpose of this Chapter, long term care facility does not include adult day care facilities, home health agencies, or assisted living facilities.

(b) "Consultant Pharmacist" in a long-term facility means a pharmacist licensed to engage in the practice of pharmacy in this State who is responsible for developing, coordinating, and supervising pharmacy services in a long-term care facility on a regularly scheduled basis.

(c) "Medication Order," as used in this rule means a written, verbal, facsimile or electronic order from a practitioner or the practitioner's authorized agent to a licensed nurse in the LTCF for a resident of that facility for administration of a drug or device. For purposes of this Chapter, a "medication order" is considered a prescription, with the exception of controlled substances which require a prescription from the practitioner.

(d) "Provider Pharmacy" means any pharmacy licensed by the Board that provides medications to residents of any long-term care facility pursuant to a medication order or prescription. A provider pharmacy must have a written agreement with the long-term care facility in order to provide services to the residents.

(e) "First Dose Pharmacy" means a pharmacy contracting with a provider pharmacy to ensure that drugs or devices are attainable to meet the immediate needs of the resident or if the provider pharmacy cannot provide services on an ongoing basis.

History

Effective 2017-05-16

Wyo. Code R. 059.0001.15.05162017 § 5 Long Term Care Pharmacy Services

Freedom of Choice.

No consultant pharmacist or provider pharmacy shall participate in any agreement or plan that infringes on any resident's right to freedom of choice as to the provider of pharmacy services. A resident in a long-term care facility shall have a choice of a provider pharmacy provided the provider pharmacy complies with this Chapter.

History

Effective 2017-05-16

Wyo. Code R. 059.0001.15.05162017 § 6 Long Term Care Pharmacy Services

Pharmacy Responsibilities.

A provider pharmacy shall be responsible for:

(a) Dispensing drugs pursuant to a medication order for an individual resident, properly labeled for that resident, as addressed in Chapter 2 of these rules, including the manufacturer's expiration date. If prepackaged or repackaged by the pharmacy, the expiration date shall be the lesser of the manufacturer's expiration date or twelve (12) months from the date of prepackaging or repackaging;

(b) Dispensing drugs for residents of long-term care facilities in packaging consistent with the drug distribution system required by the facility's policies and procedures;

(c) Developing a drug recall procedure that protects the health and safety of residents including immediate discontinuation of any recalled drug or device and subsequent notification of the prescriber and director of nursing of the facility. The drug recall policy must be readily retrievable at the provider pharmacy and the facility;

(d) Providing service twenty-four (24) hours a day, seven (7) days per week, either directly or by contract with another pharmacy. All "on-call" services shall be verifiable by the board and its inspectors. Ancillary boxes or automated dispensing devices may be used as outlined in Chapter 2 of these rules;.

(e) Performing prospective drug usage reviews for all new and refill medication orders as described in Chapter 9 of these rules;

(f) Providing sufficient and accurate information to facility staff regarding the appropriate administration and use of all dispensed drugs and devices;

(g) Providing intravenous (IV) services or contracting with another pharmacy to provide IV services, if the long term care facility is a skilled unit providing such services;

(h) Communicating with the consultant pharmacist and the facility regarding concerns and resolution thereof, including, but not limited to "on-call" services and IV services; and

(i) Returning non-controlled substance prescriptions dispensed to residents in long term care facilities for re-dispensing under specific conditions listed in Chapter 2. Controlled substance prescriptions dispensed to residents in long term care facilities cannot be returned to a pharmacy.

History

Effective 2017-05-16

Wyo. Code R. 059.0001.15.05162017 § 7 Long Term Care Pharmacy Services

Consultant Pharmacist Responsibilities.

(a) The consultant pharmacist shall assist the long-term care facility in developing policy and procedures for the following:

(i) The manner of issuance of prescription drugs provided by a provider pharmacy to residents of the long-term care facility;

(ii) Storage, administration and record-keeping for all medications administered to residents of the long-term care facility;

(iii) Inspection of drug storage areas;

(iv) Destruction or recycling of unused or discontinued resident medications; and

(v) Continuing education for nursing personnel regarding medication administration.

(b) Resident Drug Regimen Review.

(i) The primary duty of the consultant pharmacist is to apply his/her expertise on drugs to the resident's specific situation.

(ii) The consultant pharmacist shall review each resident's medical record at least monthly. State and federal regulations shall be the minimum standards for an adequate drug regimen review.

(iii) The consultant pharmacist shall communicate with provider pharmacies to enhance resident care.

History

Effective 2017-05-16

Wyo. Code R. 059.0001.15.05162017 § 8 Long Term Care Pharmacy Services

Automated Dispensing Device.

(a) No drug shall be distributed or issued by the use of any automated dispensing device unless the device and method of operation have been found to ensure the purity, potency and integrity of the drug, and to protect the drug from diversion, and provide that:

(i) The device shall be stocked with drugs only by a pharmacist licensed by the Board or a registered pharmacy technician or pharmacy intern under his supervision;

(ii) The device shall be used only for the furnishing of drugs for administration to residents of that facility; and

(iii) At the time of removal of any drug from the device, it shall automatically make a written or electronic record to be retained by the pharmacist for at least one (1) year, indicating:

(A) The date of removal of the drug;

(B) The name, strength, dosage form and quantity of the drug removed;

(D) The name or identification code of the nurse removing the drug from the device.

History

Effective 2017-05-16

Wyo. Code R. 059.0001.15.05162017 § 9 Long Term Care Pharmacy Services

First Dose Pharmacy Services.

Provider pharmacy may contract with another pharmacy (first dose pharmacy) for first dose services if in compliance as follows:

(a) Limited Purpose - Services are for the limited purpose of ensuring that drugs or devices are attainable to meet the needs of residents or if the provider pharmacy cannot provide services for the LTCF on an ongoing basis;

(b) Long Term Care Facility Approval - The provider pharmacy obtains approval from the LTCF to obtain first dose services for its residents;

(c) Written Contract - The provider pharmacy has a written contract with the first dose pharmacy outlining the services to be provided and the responsibilities and accountabilities of each party in fulfilling the terms of the contract; and

(d) Medication Orders - The provider pharmacy provides a valid verbal, electronic or paper medication order to the first dose pharmacy. A single medication order may be shared by a provider pharmacy and a first dose pharmacy with no transfer required.

History

Effective 2017-05-16

Chapter 16 Immunization Regulations

Wyo. Code R. 059.0001.16.08312023 § 1 Authority

These rules are promulgated as authorized by the Wyoming Pharmacy Act W.S. § 33-24-101 et. seq.

History

Effective 2023-08-31

Wyo. Code R. 059.0001.16.08312023 § 2 Definitions

(a) "Healthy Adults" means those individuals who are eighteen (18) years of age or older and have no absolute contraindications to receive immunizations allowed by this Chapter.

(b) "Healthy Minor" means those individuals who are seven (7) years of age or older but have not attained the age of eighteen (18) years old and have no absolute contraindications to receive immunizations allowed by this Chapter.

(c) "High Risk Adults" means those adults eighteen (18) years of age or older who may have an absolute or relative contraindication to receive immunizations for whom a physician has issued a prescription authorizing a pharmacist to dispense and administer an immunization.

(d) "High Risk Minors" means those individuals seven (7) years of age or older but who have not attained the age of eighteen (18) who may have an absolute or relative contraindication to receive immunizations for whom a physician has issued a prescription authorizing a pharmacist to dispense and administer an immunization.

History

Effective 2023-08-31

Wyo. Code R. 059.0001.16.08312023 § 3 Qualifications

(a) A pharmacist shall meet the following qualifications to prescribe and administer and a pharmacy intern shall meet the following qualifications to administer immunizations:

(i) Successfully complete:

(A) The American Pharmacists Association's (APhA) immunization training certification program entitled "Pharmacy-Based Immunization Delivery" or

(B) Other immunization training certification program accredited by ACPE specific to pharmacists.

(ii) Hold a current certification in basic cardiopulmonary resuscitation (CPR).

(iii) A copy of the training and CPR certification shall be maintained and readily retrievable.

(b) A registered pharmacy technician shall meet the following qualifications to administer immunizations:

(i) Successfully complete:

(A) The American Pharmacists Association's (APhA) immunization training certification program entitled "Pharmacy-Based Immunization Administration by Pharmacy Technicians" or

(B) Other immunization training certification program accredited by ACPE specific to pharmacy technicians.

(ii) Hold a current certification in basic cardiopulmonary resuscitation (CPR).

(iii) A copy of the training and CPR certification shall be maintained and readily retrievable.

(c) Pharmacists and pharmacy technicians shall complete a minimum of one (1) hour of continuing education related to immunizations annually. The continuing education must be by a provider approved by the Accreditation Council for Pharmacy Education (ACPE).

(d) It is unprofessional conduct for a pharmacist to prescribe and administer or a pharmacy intern or registered pharmacy technician to administer immunizations who is not in compliance with this Chapter.

(e) A pharmacy intern or pharmacy technician who is qualified to administer immunizations shall do so under the supervision of the pharmacist who is also qualified to administer immunizations.

History

Effective 2023-08-31

Wyo. Code R. 059.0001.16.08312023 § 4 Persons who may receive immunizations

(a) Pharmacists shall utilize the manufacturer's package insert for indications, contraindications, adverse reactions, dosing, route of administration, specifics regarding administration, and storage requirements for immunizations when prescribing, administering, and supervising the administration of vaccines.

(b) Parental or legal guardian consent shall be required for all minors receiving a immunization. The parent or legal guardian shall be present during the administration.

(c) A current Vaccine Information Statement, as provided by the CDC, shall be provided to each person receiving an immunization for each immunization administered. The Vaccine Information Statement is available from the CDC's website (http://www.cdc.gov).

History

Effective 2023-08-31

Wyo. Code R. 059.0001.16.08312023 § 5 Record-keeping

(a) An Immunization Questionnaire and Consent Form shall be completed for each individual receiving and immunization. The consent form shall include:

(i) Documentation that the pharmacist has discussed the side effects with the patient, including seeking treatment for side effects if they occur; and

(ii) A recommendation that the patient stays in the vicinity for fifteen (15) minutes after immunization administration.

(b) The Immunization Questionnaire and Consent Form shall be filed in a manner that will allow timely retrieval and shall be on file for two (2) years. All records shall be maintained in the pharmacy where the pharmacist who administered or provided supervision for the immunization is employed at the time the immunization is administered.

History

Effective 2023-08-31

Wyo. Code R. 059.0001.16.08312023 § 6 Emergencies

(a) A pharmacist authorized to prescribe and administer immunizations and a pharmacy intern or pharmacy technician authorized to administer immunizations may administer epinephrine in the management of an acute allergic reaction to an immunization. The pharmacist, pharmacy intern, or pharmacy technician shall follow the Advisory Committee on Immunization Practices (ACIP) Preventing and Managing Adverse Reactions General Best Practice Guidelines for Immunization. The ACIP Preventing and Managing Adverse Reactions General Best Practice Guidelines for Immunization incorporated by reference in this Chapter of these rules is the Vaccine Recommendations and Guidelines of the ACIP Preventing and Managing Adverse Reactions as existing on the effective date of this chapter. Copies of this document can be obtained from the Board at 1712 Carey Avenue, Suite 200, Cheyenne, Wyoming, 82002.

(b) The pharmacy shall post ACIP's Preventing and Managing Adverse Reactions in the private space or maintain a handout within the emergency kit. The emergency kit shall be maintained and immediately available to manage an immunization-related acute allergic reaction.

History

Effective 2023-08-31

Wyo. Code R. 059.0001.16.08312023 § 7 Immunization Administration Space Requirements

(a) The space to provide immunizations must provide reasonable privacy for the patient and be of capacity to perform CPR and any other life-saving measures necessary in the event of an immunization-related emergency.

(b) Immunizations may be administered by a pharmacist, or by a pharmacy intern or pharmacy technician under a qualified pharmacist's supervision at a site away from the pharmacy if proper storage, transportation and disposal of immunizations and supplies are followed.

History

Effective 2023-08-31

Wyo. Code R. 059.0001.16.08312023 § 8 Incorporation by Reference

(a) For any code, standard, rule or regulation incorporated by reference in these Rules:

(i) The Board has determined that incorporation of the full text in these rules could be cumbersome or inefficient given the length or nature of the rules;

(ii) The incorporation by reference does not include any later amendments or editions of the incorporated matter beyond the applicable date identified in subsection (ii) of this section;

(iii) The incorporated codes, standards, rules or regulations are maintained at 1712 Carey Avenue, Suite 200, Cheyenne, Wyoming 82002 and are available for public inspection any copying at cost as the same location.

History

Effective 2023-08-31

Chapter 18 Prescribing by Pharmacists

Wyo. Code R. 059.0001.18.08192025 § 1 Authority

These rules are promulgated as authorized by the Wyoming Pharmacy Act W.S. § 33-24-101 et seq.

History

Effective 2025-08-19

Wyo. Code R. 059.0001.18.08192025 § 2 Scope

This rule applies to any person licensed under Wyoming statutes as a pharmacist and who is practicing within the scope of their license.

History

Effective 2025-08-19

Wyo. Code R. 059.0001.18.08192025 § 3 Immunizations

Pharmacists may prescribe and administer immunizations in accordance with Board rules and W.S. § 33-24-157.

History

Effective 2025-08-19

Wyo. Code R. 059.0001.18.08192025 § 4 Opiate Antagonists

Pharmacists may prescribe and dispense opiate antagonists in accordance with Board rules and W.S. § 35-4-901 et seq.

History

Effective 2025-08-19

Wyo. Code R. 059.0001.18.08192025 § 5 Epinephrine Auto-Injectors

Pharmacists may prescribe and dispense epinephrine auto-injectors in accordance with Board rules and W.S. § 35-4-901 et seq.

History

Effective 2025-08-19

Chapter 19 Licensing of Pharmacists and Pharmacies

Wyo. Code R. 059.0001.19.12192018 § 1 Licensing of Pharmacists and Pharmacies

Authority.

These regulations are promulgated pursuant to the Wyoming Pharmacy Act W.S. § 33-24-101 through -301.

History

Effective 2018-12-19

Wyo. Code R. 059.0001.19.12192018 § 2 Licensing of Pharmacists and Pharmacies

Purpose.

The purpose of this regulation is to provide the regulations for licensing of pharmacists and pharmacies.

History

Effective 2018-12-19

Wyo. Code R. 059.0001.19.12192018 § 3 Licensing of Pharmacists and Pharmacies

Scope.

This chapter applies to any person, partnership, corporation, limited liability company, or other entity seeking licensure as a pharmacist of as a pharmacy providing pharmacy services within this state.

History

Effective 2018-12-19

Wyo. Code R. 059.0001.19.12192018 § 4 Licensing of Pharmacists and Pharmacies

Definitions.

(a) "Foreign pharmacy graduate" means a pharmacist whose undergraduate pharmacy degree was conferred by a recognized school of pharmacy outside of the United States, the District of Columbia and Puerto Rico. United States citizens who have completed their pharmacy education outside the United States are foreign pharmacy graduates. Foreign nationals who have graduated from schools in the United States are not foreign pharmacy graduates.

(b) "Institutional facility" means a hospital, convalescent home, nursing home, extended care facility, correctional or penal facility, or any other organization, public or private, which provides a physical environment for patients to obtain medical, surgical, and/or nursing services, except those places where physician, dentists, veterinarians, or other practitioners of the healing arts engage in private office practice.

(c) "Institutional Pharmacy" means a pharmacy where medications are dispensed to other health care professionals for administration to institutionalized patients served by an institutional facility, and which is:

(i) Located within the institutional facility, or

(ii) Located outside the institutional facility but only provides pharmacy services to institutionalized patients.

(d) "Non-resident pharmacy" means a licensed pharmacy located outside this State where drugs are dispensed and/or pharmacist care is provided to residents within this state.

(e) "Pharmacy" means an area(s) where drugs are dispensed and/or pharmacist care is provided.

(f) "Registered pharmacist" means an individual currently licensed by this state to engage in the practice of pharmacy.

(g) "Remodeled pharmacy" means an existing retail pharmacy that is relocated to a different address, or a pharmacy that undergoes remodeling at a cost equal to or greater than twenty-five thousand dollars ($25,000.00).

(h) "Resident retail pharmacy" means a licensed pharmacy located inside this State where drugs are dispensed and/or pharmacist care is provided to residents within this state.

History

Effective 2018-12-19

Wyo. Code R. 059.0001.19.12192018 § 5 Licensing of Pharmacists and Pharmacies

Pharmacist Licensure by Examination.

(a) The Board shall utilize those standardized examinations as prepared and administered by the National Association of Boards of Pharmacy (NABP). These standardized examinations shall include the following:

(i) North American Pharmacist Licensing Examination (NAPLEX®); and

(ii) Multistate Pharmacy Jurisprudence Examination (MPJE®).

(b) Applicants for licensure by examination will be licensed, provided they:

(i) Submit a properly completed "Pharmacist License by Examination" application, as provided by the Board, with the proper fee and fee/fingerprints for a criminal background check. However, any applicant who has on file at the Board office a criminal background history dated within twelve (12) months of the date of application need not resubmit fee/fingerprints for a criminal background history;

(ii) Pass the NAPLEX® with a minimum score of 75;

(A) Candidates who do not receive a passing grade on the NAPLEX® shall be allowed two (2) retakes, for a total of three (3) examinations.

(B) All retakes require payment of fees plus a forty-five (45) day waiting period, as required by NABP.

(iii) Pass the MPJE® for Wyoming with a minimum score of 75;

(A) Candidates who do not receive a passing grade on the MPJE® for Wyoming may retake the examination for a maximum of five (5) attempts.

(B) All retakes require payment of fees, plus a thirty (30) day waiting period, as required by NABP.

(iv) Meet the required practical experience requirement of 1,200 internship hours as specified in Chapter 3 of these rules;

(v) Complete all requirements within two (2) years of the date of application to the Board office;

(vi) Meet the requirements of W.S. § 33-24-116; and

(vii) Ensure the Board receives the results of a criminal background history report from the Wyoming Division of Criminal Investigation (DCI).

(c) Applicants who have applied for score transfer of their NAPLEX® examination to Wyoming will be licensed by examination provided they meet the following requirements:

(i) The NAPLEX® score transferred is 75 or more;

(ii) A properly completed "Pharmacist Licensure by Examination" application, as provided by the Board, with the proper fee, has been submitted to the Board office;

(iii) Pass the MPJE® for Wyoming with a minimum score of 75;

(A) Candidates who do not receive a passing grade on the MPJE® for Wyoming may retake the examination for a maximum of five (5) attempts.

(B) All retakes require payment of fees, plus a thirty (30) day waiting period, as required by the NABP.

(iv) The required practical experience requirement of 1,200 internship hours is met, as specified in Chapter 3 of these rules;

(v) All requirements completed within one (1) year of the date of the NAPLEX® examination, which was utilized for the score which was transferred to Wyoming;

(vi) Board receipt of a criminal background history report from the DCI; and

(vii) Meet the requirements of W.S. § 33-24-116.

(d) No candidate will be licensed until the required practical experience, as specified in Chapter 3 of these rules has been met.

(e) Candidates failing to meet all requirements within the time period allowed in this chapter must file a new application, including payment of the fees or, if applicable, seek licensure by license transfer, as outlined in this chapter.

(f) The Board reserves the right to require an interview with any applicant seeking licensure by examination to practice pharmacy in Wyoming.

(g) The Board shall charge fees to cover administrative costs, which shall include one (1) wall certificate and a renewal certificate for the current license year.

(h) Foreign pharmacy graduates, holding a FPGEC® Certificate issued by the Foreign Pharmacy Graduate Examination Committee ®, may apply for licensure as a pharmacist under this section. To be eligible for FPGEC® certification, applicants must satisfy the following requirements established by the FPGEC®:

(i) Provide verification of educational equivalency of an applicant's foreign pharmacy education and the applicant's licensure or registration as a pharmacist outside the United States;

(ii) Pass the Foreign Pharmacy Graduate Equivalency Examination (FPGEE®); and

(iii) Obtain an acceptable score on the Test of English as a Foreign Language Internet-based Test (TOEFL® iBT), with minimal scores of 21 for listening, 22 for reading, 26 for speaking and 24 for writing.

History

Effective 2018-12-19

Wyo. Code R. 059.0001.19.12192018 § 6 Licensing of Pharmacists and Pharmacies

Pharmacist Licensure by Reciprocal License Transfer.

(a) Any pharmacist, who is licensed by examination and is in good standing in any state which is a member of the NABP and who desires to be licensed by reciprocity into this state, shall proceed in the manner outlined by the NABP after first submitting the "Preliminary Application for Transfer of Pharmacist Licensure" obtained from the NABP.

(i) All candidates for license transfer shall be required to:

(A) File all appropriate applications with the Board;

(B) Pay the required application fee;

(D) Pay the required criminal background check fee;

(E) Pass the MPJE® for Wyoming;

(F) Prove good moral character;

(G) Prove they have been in active pharmacy practice, as defined in this chapter, for the year preceding the date of their application for license transfer. Applicants failing to show proof must complete an internship in Wyoming approved by the Board of no less than four hundred (400) hours;

(H) Meet all requirements under the Wyoming Pharmacy Act and these rules; and

(I) If applying as a foreign pharmacy graduate, possess a FPGEC® Certificate.

(ii) The Board must receive the applicant's criminal background history report from the DCI before a pharmacist license by transfer will be issued.

(iii) The Board shall not issue a pharmacist license by license transfer until all conditions under this chapter have been met.

(iv) All applications for licensure by reciprocity shall expire one (1) year from date of issue by the NABP.

(v) The Board reserves the right to require an interview with any applicant seeking licensure reciprocity to practice pharmacy in Wyoming.

(vi) In the event of rejecting an application, the fees paid to the Board will not be refunded.

(vii) The Board will accept licensure by reciprocity for pharmacists licensed in California after January 1, 2004.

History

Effective 2018-12-19

Wyo. Code R. 059.0001.19.12192018 § 7 Licensing of Pharmacists and Pharmacies

Reinstatement of Registered Pharmacist License After Failure to Renew, Returning from Inactive Status, Issuance of Duplicate License.

(a) If a person requests reinstatement of their registered pharmacist license when said license has lapsed only for failure to pay renewal fees, the person shall:

(i) Write a letter requesting consideration of reinstatement;

(ii) Pay all back renewal fees, including annual fines, up to a maximum of five (5) years;

(iii) Provide copies of approved continuing education (CE) certificates for those years the license was lapsed, to a maximum of five (5) years. All CE certificates must be from approved providers;

(iv) Provide at least two (2) recent letters from a pharmacist or a pharmacy owner attesting to good character;

(v) If licensed outside Wyoming, provide a letter from the board of pharmacy in the state where licensed and currently practicing. This letter must state current license status and indicate if the license has been subject to any investigation or disciplinary action by the Board;

(vi) Complete two (2) fingerprint cards, provided by the Board, and include a check made payable to the Wyoming State Board of Pharmacy in the amount of fifty dollars ($50.00) to cover the cost of the criminal background history; and

(vii) Provide a notarized employer affidavit attesting to the active practice of pharmacy in the year preceding the date of the application for reinstatement. Active practice requires that the pharmacist work a minimum of four hundred (400) hours during this time period.

(b) Minimum competency for an inactive pharmacist shall be established to the satisfaction of the Board. When a registered pharmacist has been out of the practice of pharmacy for an extended period of time and wishes to reactivate that license, the Board shall determine on an individual basis the requirements needed to reactivate that license. The requirements may include the following:

(i) Pass a jurisprudence examination;

(ii) Internship under direct supervision. The internship period may vary depending upon how long the individual was out of practice; or

(iii) Board interview.

History

Effective 2018-12-19

Wyo. Code R. 059.0001.19.12192018 § 8 Licensing of Pharmacists and Pharmacies

Reinstatement of a Revoked or Suspended Pharmacist or Pharmacy Technician License.

(a) A pharmacist or pharmacy technician whose license has been revoked or suspended by the Board may file an application, on a form supplied by the Board, requesting a hearing to present evidence to show why the license should be reinstated subject to the following:

(i) A pharmacist or pharmacy technician whose license was revoked by the Board may not file an application requesting a hearing until thirty-six (36) months have elapsed from the date the order revoking the pharmacist or pharmacy technician license became final;

(ii) A pharmacist or pharmacy technician whose license was suspended by the Board may not file an application requesting a hearing until one-half (1/2) of the suspension so ordered by the Board has elapsed;

(iii) A pharmacist shall submit an application fee of two hundred fifty dollars ($250.00) and pay for the cost of the hearing, if the Board issues an order denying reinstatement. The application fee is nonrefundable;

(iv) A pharmacy technician shall submit an application fee of one hundred twenty five dollars ($125.00) and pay for the cost of the hearing, if the Board issues an order denying reinstatement. The application fee is nonrefundable;

(v) The applicant must complete all questions and provide all information requested on the application;

(vi) An incomplete application and the accompanying fee will be returned and a hearing date will not be set by the Board; and

(vii) In the application, the pharmacist or pharmacy technician shall authorize any health professional who has examined or treated the applicant to disclose a diagnosis and the reasons for it to the Board and the Board staff.

(b) Applications received by the Board will be reviewed by the Executive Director. The Executive Director shall:

(d) To be reinstated, a pharmacist must prove that he or she has been rehabilitated so that further violation of Wyoming Statutes and Board rules is not likely to occur, and that he or she is competent to practice pharmacy. The Board may, as a condition to establish competency, require successful completion of one or more of the following:

(i) The NAPLEX® with a minimum score of 75;

(ii) The MPJE® with a minimum score of 75; or

(iii) An internship, not to exceed 1,200 hours, as prescribed by the Board.

(e) To be reinstated, a pharmacy technician must prove that he or she has been rehabilitated so that further violation of Wyoming Statutes and Board rules is not likely to occur, and that he or she is competent to function as a pharmacy technician. The Board, as a condition to establish competency, may require successful completion of the PTCB Pharmacy Technician Certification Examination.

History

Effective 2018-12-19

Wyo. Code R. 059.0001.19.12192018 § 9 Licensing of Pharmacists and Pharmacies

Licensing of Facilities.

(a) Prior to the issuing of the registration to operate a pharmacy or prescription department in Wyoming, the Board will inspect the pharmacy for minimum standards including space, fixtures, sanitation, reference library, technical equipment and security. The application will include the number of hours the pharmacy will be in operation per week.

(b) The facility application shall list the names of all licensed pharmacists employed, specifically identifying the Pharmacist-in-Charge (PIC). The PIC determines which employees shall have access to the pharmacy.

(c) The Board shall be notified within seven (7) days of every change in PIC. A controlled substance inventory is required when there is a change in PIC, at the time of the change. This inventory shall include the signatures of both the outgoing and incoming PIC, and the date and time the inventory was taken. If the inventory cannot be conducted with both pharmacists, then the incoming PIC shall conduct an inventory. A copy of the controlled substance inventory and signed Certification of Responsibilities as Pharmacist-in-Charge (PIC) shall be forwarded to the Board office within fifteen (15) days of conducting the inventory.

(d) When a pharmacy changes ownership, the original license becomes void and a new license must be secured by the new owner or owners. A new license is required even if there is no change in the name of the pharmacy or in the registered PIC of the pharmacy.

(e) In the case of a corporation, limited liability company or partnership holding a pharmacy license, the Board shall be notified and a new license applied for any time the majority of stock in the corporation is sold or a majority of the partners of the partnership or members of the limited liability company change. This shall constitute new ownership. Requirements for the change of ownership are the same as outlined in this section.

(f) A pharmacy license registers the pharmacy to which it is issued only at the location specified on the application and is not transferable.

(g) The Board shall be notified in writing at least thirty (30) days before a pharmacy change of address. The new location shall be inspected by the Board prior to issuance of an amended pharmacy license for the new location. The new location must meet all requirements for a new or remodeled pharmacy, as noted in this chapter.

(h) All licenses and certificates issued by the Board shall be displayed in a prominent place in the facility and always in view of the public.

(i) Resident Pharmacy Licenses shall indicate "Institutional" or "Retail."

History

Effective 2018-12-19

Wyo. Code R. 059.0001.19.12192018 § 10 Licensing of Pharmacists and Pharmacies

Minimum Structural and Equipment Requirements to Operate a Retail Pharmacy.

(a) All retail pharmacies operating in this State must meet the following requirements:

(i) The pharmacy shall include a sink with a hot and cold water supply, exclusive of restroom facilities, with adequate sewage disposal;

(ii) The pharmacy shall be properly lighted and ventilated. The temperature of the pharmacy shall be maintained within a range compatible with the proper storage of pharmaceuticals;

(iii) The pharmacy shall have adequate shelving; there shall be adequate counter space; the working surface shall be kept clear and uncluttered at all times for the preparation or compounding of prescriptions to meet the requirements of the pharmacy. Any pharmacy where compounding prescriptions occurs must meet the structural and equipment requirements identified in Chapter 13 of these rules;

(iv) A fax machine or similar electronic equipment capable of producing an identical document shall be located in the pharmacy;

(v) A separate refrigerator located in the pharmacy, with sufficient capacity to serve the needs of the pharmacy, equipped with a thermometer which provides a storage temperature of 36-46 degrees Fahrenheit (2-8 degrees Centigrade). The use of such refrigerator shall be limited to the storage of drugs. If a freezer compartment is utilized, it must maintain a temperature of -13 to 14 degrees Fahrenheit (-20 to -10 degrees Centigrade);

(vi) Class A prescription balance or electronic scale with 10 mg sensitivity if the pharmacy participates in compounding. Pharmacies that do not compound or do not dispense are not required to obtain or maintain a prescription balance or electronic scale;

(vii) A professional reference library (text or electronic format) that shall include the following:

(A) Current Wyoming pharmacy laws;

(B) Current edition of Facts and Comparisons or a comparable reference accepted by the Board;

(D) Wyoming State Board of Pharmacy quarterly newsletter by access to the Board website; and

(E) The current edition (as incorporated by reference in this Chapter), with supplements, of the U.S. Food and Drug Administration (FDA) "Orange Book" or an alternate reference that provides the same information as the FDA "Orange Book." Proven access to the Board website link to the Orange Book meets this requirement.

(viii) Pharmacies must maintain adequate security to deter theft of drugs by personnel or public. Security requirements for new or remodeled pharmacies must meet the requirements of this chapter. No person other than the pharmacist, intern or technician employed by the pharmacy shall be permitted in the pharmacy without the express consent of the PIC. If the pharmacy is located in a facility in which the public has access and the pharmacy's hours of operation are different from the rest of the facility, the pharmacy must be designed so that it can be securely locked and made inaccessible when the pharmacy is not open;

(ix) The pharmacy shall be arranged in an orderly fashion and kept clean. All required equipment shall be clean and in good operating condition;

(x) If automated counting devices are utilized, the pharmacy shall have a method to calibrate and verify the accuracy of the automated counting device and shall verify the accuracy and document doing so on a quarterly basis;

(xi) Consecutive numbering of all prescriptions must be maintained, along with appropriate printing equipment to product prescription drug labels; and

(xii) In addition to the requirements identified in this chapter, all pharmacies involved in the preparation of sterile compounded products must meet the requirements of Chapter 17 of these rules.

(b) In addition to the requirements of this chapter, except for a change of ownership of an existing pharmacy, an individual or business who opens a new pharmacy or remodels an existing retail pharmacy shall provide to the Board staff no later than thirty (30) calendar days prior to commencing construction or remodeling the pharmacy, a set of blueprints or other acceptable documents, which indicate the physical layout of the planned or remodeled pharmacy.

(i) The pharmacy shall consist of no less than 500 square feet;

(ii) The pharmacy shall include an identified counseling area, which is apart from the cash register, apart from the prescription "pick up" area, and offers sufficient privacy for counseling. A separation of three (3) feet is the minimum space between patients to allow for privacy during counseling. Pharmacies that do not provide prescription services to "Walk-in" customers are not required to have a counseling area;

(iii) Located within the pharmacy, but not counted in the square footage requirements of the pharmacy, shall be restroom facilities, access to which shall be limited to pharmacy staff;

(iv) Access to the pharmacy shall be secured as follows:

(A) If the pharmacy is located within another business, which does not have identical hours of operation, the pharmacy shall be secured with solid core or metal doors with a deadbolt and a locking doorknob. If glassed areas are utilized, then adequate intrusion detectors must be in place. Pharmacy walls must extend to the roof or provide security acceptable to the Board. The pharmacy shall meet all other applicable federal or state regulations concerning security access.

(B) Those pharmacies not included in (A) shall be secured with solid core, metal or safety glass exterior doors secured with a deadbolt, and must utilize an adequate intrusion detector. If the pharmacy shares a common wall with another business, this wall must extend to the roof. The pharmacy shall meet all other applicable federal or state regulations concerning security access.

(v) A separate refrigerator, sufficient in capacity to serve the needs of the pharmacy staff, shall be available for storage of employees' food or beverage. This refrigerator shall be identified for "Employee Use Only"; and

(vi) All prescription data shall be processed utilizing electronic data processing equipment and shall be sequentially numbered. There shall be adequate computer terminals and printers available to process anticipated prescription volume for the new or remodeled pharmacy.

(d) Upon written request, and for good cause, the Board may waive any of the requirements of this chapter. A waiver that is granted under this section shall only be effective when issued by the Board in writing.

(e) For a change in ownership of a retail or institutional pharmacy, the Board shall be notified at least twenty-one (21) days before the change.

History

Effective 2018-12-19

Wyo. Code R. 059.0001.19.12192018 § 11 Licensing of Pharmacists and Pharmacies

Specific Requirements for Licensure of Non-Resident Pharmacies to Ship Prescription Drugs into the State.

(a) Any pharmacy operating from outside this State that ships, mails or delivers, in any manner, a dispensed prescription drug or legend drug to a patient in this State shall obtain and hold a non-resident pharmacy license and, if applicable, a controlled substance registration.

(b) Said pharmacy license and controlled substance application shall be on forms supplied by the Board staff and shall be accompanied by the following information:

(i) A copy of the pharmacy license from the state of residence;

(ii) A copy of the latest inspection report from the state of residence;

(iii) A copy of current DEA registration;

(iv) A list of partners, members, or principal officers and registered agent for service of process, if any; and

(v) A list of all registered pharmacists and pharmacy technicians, specifying the PIC.

(d) The Board office shall be notified of any change in ownership or PIC within thirty (30) days.

(e) Each non-resident pharmacy shall comply with statutory or regulatory requirements of the Board including, but not limited to, the "Wyoming Drug Identification Act" (W.S. § 33-24-201 through 204) and the "Wyoming Generic Substitution Act" (W.S. § 33-24-146 through -151).

(f) Each non-resident pharmacy shall maintain records of all prescriptions dispensed to patients in the State in readily retrievable form.

(g) Each non-resident pharmacy shall maintain pharmacy hours that permit the timely dispensing of prescriptions to patients in this State and provide a toll-free telephone service to facilitate communication between patients in this State and a pharmacist who has access to patient records.

(h) Counseling shall be accomplished on new prescriptions either verbally or by written information accompanying the dispensed prescription.

(i) The Board may revoke, deny, or suspend the license and registration of any non-resident pharmacy for violations of W.S. § 33-24-152 and this chapter.

History

Effective 2018-12-19

Wyo. Code R. 059.0001.19.12192018 § 12 Licensing of Pharmacists and Pharmacies

Resident Retail Pharmacy Closure or Change of Ownership.

(a) Resident Retail Pharmacy Closure. Not less than twenty-one (21) days prior to a resident retail pharmacy, licensed by the Board, permanently ceasing operation, the Board shall receive written notice of the following:

(i) The last day the retail pharmacy will be open for business;

(ii) The proposed disposition of all prescription files, both hard copy and electronic records;

(iii) The proposed disposition of all prescription drug inventory, including controlled and non-controlled prescription drug products;

(iv) The proposed method of communicating to the public the last day the pharmacy will be open for business, the location of prescription records after the pharmacy closes, and how the patients can arrange for transfer of their prescription records to a pharmacy of their choice. Included in this communication shall be a description of the method of transfer of prescription records, including the last day a transfer may be made from the pharmacy closing and the initial date the prescription may be transferred from the pharmacy that acquired the prescription records. Communication to the public must begin no later than fourteen (14) days prior to the last day the pharmacy will be open for business;

(v) If prescription records are not transferred to another pharmacy, the name, address and telephone number of the custodian of prescription records must be provided. Prescription records must be maintained for two (2) years from the date of closure;

(vi) The scheduled date to have all signage removed from the exterior and interior of the building that includes the wording "drug," "pharmacy," "drugstore," "Rx," "Apothecary" or other terms or symbols that might indicate or signify by any advertising medium that such an establishment is a licensed pharmacy;

(vii) The name, address and telephone number of the custodian of records for the following documents, which must be maintained for two (2) years from the date of closure:

(A) Completed DEA 222 forms or retrievable electronic equivalent;

(B) Invoices for purchases of Schedule III, IV and V controlled substances; and

(viii) The date the Drug Enforcement Administration (DEA) was contacted regarding the closure and that all invoices and DEA 222 forms referencing the sale of controlled substances at closure, blank DEA 222 forms, and the DEA registration certificate were returned to the regional DEA office;

(ix) At the close of business on the last day the retail pharmacy is open for business, a controlled substance inventory, including all Schedule II, III, IV and V controlled substances, shall be taken. This inventory shall be dated and signed by the PIC. A copy shall be provided to the Board;

(x) An inspection of the pharmacy shall be conducted by the Board after the retail pharmacy has closed for business and all prescription drug stock has been removed. At the time of inspection, the following documents shall be provided to the Compliance Officer:

(A) A copy of the final controlled substance inventory;

(B) Documentation, as noted in this chapter, regarding notification to the public of the closure of the retail pharmacy;

(D) Documentation of the transfer of all prescription drug inventory (controlled and non-controlled) to a third party authorized to have such possession of inventory. Under no circumstance may prescription drug inventory remain in the possession of a person or business not authorized by law to have possession; and

(E) Any changes to information previously provided to the Board as required in this chapter.

(xi) It is unprofessional conduct for a retail pharmacy to close in a manner other than that prescribed in this chapter; and

(xii) If a retail pharmacy purchases the patient prescription records (electronic and hard copy prescription), those records shall be maintained by the acquiring retail pharmacy for a minimum of two (2) years from the date of closure.

(b) Resident Retail Pharmacy Change of Ownership. When a change of ownership necessitates a change of DEA registration number, the following is required:

(i) Not less than twenty-one (21) days prior to a resident retail pharmacy, licensed by the Board, changing ownership, without closing, the Board shall receive written notice of the following:

(A) The last day the seller will have ownership of the retail pharmacy;

(B) The proposed disposition of all prescription files, including both hard copy and electronic records;

(C) The proposed transfer of the prescription drug inventory, including controlled and non-controlled prescription drug products;

(D) The proposed method of communicating to the public the change in ownership, not later than fourteen (14) days prior to the date the ownership will change;

(E) The name, address and telephone number of the custodian of records for the following documents of the seller, which must be retained for two (2) years from the date of the transfer of ownership:

(I) Completed DEA 222 forms or retrievable electronic equivalent;

(II) Invoice for purchases of Schedule III, IV and V controlled substances; and

(III) Patient signature logs.

(F) The date the DEA was contacted regarding the change of ownership and confirmation that all invoices and DEA 222 forms referencing the sale of controlled substances at closure, blank DEA 222 forms, and the DEA registration certificate were delivered to the regional DEA office.

(ii) At the close of business on the last date the pharmacy is under the prior ownership, a controlled substance inventory, including all Schedule II, III, IV and V controlled substances shall be taken. This inventory shall be dated and signed by the PIC from the prior and the new ownership. A copy shall be provided to the Board;

(iii) An inspection of the pharmacy shall be conducted by the Board after the change in ownership. The following documents shall be provided to the Compliance Officer:

(A) Documentation of the transfer of all controlled and non-controlled prescription drug inventory will be provided to the Board. Under no circumstances may prescription drug inventory remain in the possession of the person or business not authorized to have possession;

(B) The Wyoming retail pharmacy license of the prior owner;

(D) Information necessary to process a new Wyoming retail pharmacy license, including information about the new PIC; and

(E) Information necessary to process a new Wyoming controlled substance registration and federal DEA registration.

(iv) It is unprofessional conduct for a retail pharmacy to transfer ownership in a manner other than that prescribed in this chapter.

History

Effective 2018-12-19

Wyo. Code R. 059.0001.19.12192018 § 13 Licensing of Pharmacists and Pharmacies

Institutional Pharmacy Closure.

(a) Not less than twenty-one (21) days prior to an institutional pharmacy licensed by the Board permanently ceasing operation, the Board shall receive written notice of the following:

(i) The last day the institutional pharmacy will be open for business;

(ii) The proposed disposition of all prescription drug inventory including controlled and non-controlled prescription drug products;

(iii) The name, address and telephone number of the custodian of records for the following documents, which must be maintained for two (2) years from the date of closure:

(A) Completed DEA 222 forms or retrievable electronic equivalent;

(B) Invoices for purchases of Schedule III, IV and V controlled substances; and

(iv) The date the DEA was contacted regarding the closure and confirmation that all invoices and DEA 222 forms referencing the sale of controlled substances at closure, blank DEA 222 forms and the DEA registration certificate were delivered to the regional DEA office.

(b) At the close of business on the last day the institutional pharmacy is open for business, a controlled substance inventory, including all Schedule II, III, IV and V controlled substances shall be taken. This inventory shall be dated and signed by the PIC. A copy shall be provided to the Board.

(c) An inspection of the pharmacy shall be conducted by the Board after the institutional pharmacy has closed for business and all prescription drug stock has been removed. At the time of inspection, the following documents shall be provided to the Compliance Officer:

(i) A copy of the final controlled substance inventory;

(ii) The Wyoming institutional pharmacy license;

(iii) Documentation of the transfer of all prescription drug inventory (controlled and non-controlled) to a third party authorized to have such possession of inventory. Under no circumstances may prescription drug inventory remain in the possession of a person or business that is not authorized by law to have possession; and

(iv) Any changes to information previously provided to the Board, as required in this chapter.

(d) It is unprofessional conduct for an institutional pharmacy to close in a manner than that prescribed in this chapter.

History

Effective 2018-12-19

Chapter 21 Fees

Wyo. Code R. 059.0001.21.05242023 Fees

FEES

CHAPTER 21

Section 1. Authority.

These regulations are promulgated pursuant to the Wyoming Pharmacy Act W.S. § 33-24-101 et seq.

Section 2. General Information.

(a) Fees shall be payable in the exact amount and shall be paid in advance of the licensing services rendered.

(b) All fees collected by the Board are non-refundable.

Section 3. Fees.

(a) The Board shall charge the following fees:

(i) Pharmacist licensure by examination or re-examination is seventy-five dollars ($75.00). This is separate from fees paid to the NABP for the NAPLEX® and the MPJE®.

(ii) Pharmacist licensure by reciprocity is two hundred dollars ($200.00). This is separate from fees paid to the NABP for the NAPLEX® and the MPJE®.

(iii) Pharmacist licensure renewal is one hundred dollars ($100.00) per year;

(iv) Pharmacy intern licensure is fifteen dollars ($15.00) per year;

(v) Pharmacy technician licensure and renewals are fifty dollars ($50.00) per year;

(vi) Pharmacy technician-in-training permit is fifteen dollars ($15.00);

(vii) Resident retail pharmacy license and renewals are one hundred fifty dollars ($150.00) per year;

(viii) Non-resident pharmacy license and renewals are three hundred dollars ($300.00) per year;

(ix) A prescription drug manufacturer, distributor, reverse distributor, or wholesaler license and renewals are two hundred seventy-five dollars ($275.00) per year;

(x) Medical oxygen manufacturer or distributor license and renewals are one hundred dollars ($100.00) per year;

(xi) Outsourcing facilities license and renewals are three hundred dollars ($300.00) per year;

(xii) Third party logistics provider license and renewals are two hundred seventy-five dollars ($275.00) per year;

(xiii) Wholesale distributors of prescription drugs for non-human use license and renewals are two hundred seventy-five dollars ($275.00) per year;

(xiv) Methamphetamine precursor retail distributor license and renewals are twenty-five dollars ($25.00) per year;

(xv) Ancillary drug supply permit and renewals are twenty-five dollars ($25.00) per year;

(xvi) Institutional pharmacy license and renewals are one hundred fifty dollars ($150.00) per year;

(xvii) The Board shall charge a two hundred fifty-dollar ($250.00) fee for preparing and sending mailing lists of pharmacists, pharmacy technicians, pharmacy interns, pharmacy technicians-in-training, pharmacies, controlled substance registrants and drug distributors. Each list shall constitute a separate mailing list. Federal and state agencies shall be exempt from payment of fees for mailing lists;

(xviii) The Board shall charge a thirty-five-dollar ($35.00) fee to verify the license of any non-resident pharmacy, manufacturer, distributor, wholesaler or reverse distributor; and

(xix) Duplicate licenses may be issued upon a licensee's request. There shall be a twenty-five-dollar ($25.00) fee charged for the duplicate license.

(b) The Board shall assess a late fee, in addition to the license or registration renewal fee, of licenses or registrants, as follows:

(i) A pharmacist whose license renewal application is postmarked, electronically submitted, or hand delivered to the Board office after December 31 shall be assessed a late fee of seventy-five dollars ($75.00) in addition to the license renewal fee;

(ii) A pharmacy interns whose license renewal application is postmarked or hand delivered to the Board office after September 30 shall be assessed a late fee of fifteen dollars ($15.00) in addition to the license renewal fee;

(iii) A pharmacy technician whose license renewal application is postmarked, electronically submitted, or hand delivered to the Board office after December 31 shall be assessed a late fee of thirty-five dollars ($35.00) in addition to the license renewal fee;

(iv) A resident pharmacy whose license renewal application is postmarked, electronically submitted, or hand delivered to the Board office after June 30 shall be assessed a late fee of two hundred dollars ($200.00) in addition to the license renewal fee;

(v) A non-resident pharmacy whose license renewal application is postmarked, electronically submitted, or hand delivered to the Board office after June 30 shall be assessed a late fee of three hundred dollars ($300.00) in addition to the license renewal fee;

(vi) A manufacturer, distributor, or wholesaler of prescription drug products (drugs or oxygen) whose license renewal application is postmarked, electronically submitted, or hand delivered to the Board office after June 30 shall be assessed a late fee of two hundred dollars ($200.00) in addition to the license renewal fee;

(vii) A medical oxygen distributor whose license renewal application is postmarked, electronically submitted, or hand delivered to the Board office after June 30 shall be assessed a late fee of one hundred dollars ($100.00) in addition to the license renewal fee;

(viii) An outsourcing facility whose license renewal application is postmarked, electronically submitted, or hand delivered to the Board office after June 30 shall be assessed a late fee of three hundred dollars ($300.00) in addition to the license renewal fee;

(ix) A third-party logistics provider whose license renewal application is postmarked, electronically submitted, or hand delivered to the Board office after June 30 shall be assessed a late fee of two hundred seventy-five dollars ($275.00) in addition to the license renewal fee;

(x) A wholesale distributor of prescription drugs for non-human use whose license renewal application is postmarked, electronically submitted, or hand delivered to the Board office after June 30 shall be assessed a late fee of two hundred seventy-five dollars ($275.00); and

(xi) An institutional pharmacy whose license renewal application is postmarked, electronically submitted, or hand delivered to the Board office after June 30 shall be assessed a late fee of two hundred dollars ($200.00) in addition to the license renewal fee.

History

Effective 2023-05-24

Chapter 22 Compounding

Wyo. Code R. 059.0001.22.08192025 § 1 Authority

These rules are promulgated as authorized by the Wyoming Pharmacy Act W.S. § 33-24-101 through -301.

History

Effective 2025-08-19

Wyo. Code R. 059.0001.22.08192025 § 2 Purpose

To reference the minimum standards of practice for nonsterile, sterile, hazardous, and radiopharmaceutical compounding in all pharmacy practice settings.

History

Effective 2025-08-19

Wyo. Code R. 059.0001.22.08192025 § 3 Scope

Applies to all licensees.

History

Effective 2025-08-19

Wyo. Code R. 059.0001.22.08192025 § 4 Incorporation by Reference

(a) All referenced general chapters of the United States Pharmacopeia - National Formulary (USP-NF), in subsection (2), are specifically referring to the USP-NF 2024, Issue 1, which is hereby incorporated and adopted by reference with the effective chapter dates of May 1, 2024. A subscription to all relevant chapters is available for purchase at www.uspnf.com.

(b) The Board has determined that posting the incorporated material on the Internet would constitute a violation of federal copyright law. At the time of adoption, the copyrighted incorporated material will be available for public inspection and examination, but may not be copied, at the Wyoming Department of Health, 2300 Capitol Avenue, Cheyenne, Wyoming 82002, and at the Wyoming State Board of Pharmacy, 1712 Carey Avenue, Suite 200, Cheyenne, Wyoming 82002.

(i) The USP-NF General Chapter 795 Pharmaceutical Compounding - Nonsterile Preparations incorporated by reference in this Chapter of these rules is the USP as existing on March 26, 2025, including amendments adopted by USP as of that date.

(ii) The USP-NF General Chapter 797 Pharmaceutical Compounding - Sterile Preparations incorporated by reference in this Chapter of these rules is the USP as existing on March 26, 2025, including amendments adopted by USP as of that date.

(iii) The USP-NF General Chapter 800 Hazardous Drugs—Handling in Healthcare Settings incorporated by reference in this Chapter of these rules is the USP as existing on March 26, 2025, including amendments adopted by USP as of that date.

(iv) The United States Pharmacopeia (USP) General Chapter 825 Radiopharmaceuticals - Preparation, Compounding, Dispensing, and Repackaging incorporated by reference in this Chapter of these rules is the USP as existing on March 26, 2025, including amendments adopted by USP as of that date.

History

Effective 2025-08-19