article-20-51•ARSD Article 20:51 — PHARMACISTS
HEALTH HEALTH
Chapter 20:51:01
ARSD 20:51:01:01 Application for registration, Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 18 SDR 95, effective November 25, 1991; 33 SDR 73, effective November 6, 2006; 36 SDR 21, effective August 17, 2009; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
ARSD 20:51:01:02 Experience required
An applicant meeting the requirements of SDCL 36-11-16 for a license to practice pharmacy and who is examined after December 31, 2009, must have completed a pharmacy practice experience program that meets or exceeds the pharmacy practice experience requirements set forth in chapter 20:51:02.
Cross-References:
Goals and objectives of internship, § 20:51:02:01.01.
Required hours, § 20:51:02:12.01.
History
- Source: SL 1975, ch 16, § 1; 7 SDR 51, effective December 3, 1980; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 22 SDR 133, effective April 25, 1996; 36 SDR 21, effective August 17, 2009; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1).
- Law Implemented: SDCL 36-11-16.
ARSD 20:51:01:03 Application requirements
An applicant for licensure by examination shall provide the following to the board with the application:
(1) The application fee of thirty-five dollars;
(2) A photo of the applicant;
(3) A transcript showing graduation from a college of pharmacy approved by the American Council on Pharmaceutical Education; and
(4) A government-issued form of photo identification.
History
- Source: SL 1975, ch 16, § 1; 6 SDR 103, effective May 5, 1980; 8 SDR 144, effective May 4, 1982; 11 SDR 120, effective March 11, 1985; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 14 SDR 121, effective March 28, 1988; 15 SDR 20, effective August 9, 1988; 18 SDR 95, effective November 25, 1991; 22 SDR 133, effective April 25, 1996; 33 SDR 73, effective November 6, 2006; 36 SDR 21, effective August 17, 2009; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1), 36-11-16.
- Law Implemented: SDCL 36-11-16(2)(5)(6), 36-11-16.1.
ARSD 20:51:01:04 Examination
An applicant for licensure by examination shall successfully complete the North American Pharmacist Licensure Examination and the Multistate Jurisprudence Examination, South Dakota edition. A total scaled score of not less than seventy-five is required to pass each examination.
History
- Source: SL 1975, ch 16, § 1; 10 SDR 117, effective May 8, 1984; 12 SDR 178, effective May 11, 1986; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 18 SDR 95, effective November 25, 1991; 33 SDR 73, effective November 6, 2006; 36 SDR 21, effective August 17, 2009; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1).
- Law Implemented: SDCL 36-11-16(7).
ARSD 20:51:01:05 Repealed
History
- Source: SL 1975, ch 16, § 1; repealed, 12 SDR 86, effective November 27, 1985.
ARSD 20:51:01:06 Repealed
History
- Source: SL 1975, ch 16, § 1; 10 SDR 117, effective May 8, 1984; 12 SDR 178, effective May 11, 1986; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 13 SDR 179, effective June 2, 1987; 18 SDR 95, effective November 25, 1991; repealed, 36 SDR 21, effective August 17, 2009.
ARSD 20:51:01:06.01 Repealed
History
- Source: 10 SDR 117, effective May 8, 1984; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 18 SDR 95, effective November 25, 1991; repealed, 36 SDR 21, effective August 17, 2009.
ARSD 20:51:01:07 Repealed
History
- Source: SL 1975, ch 16, § 1; repealed, 12 SDR 178, effective May 11, 1986.
ARSD 20:51:01:08 Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; repealed, 22 SDR 133, effective April 25, 1996.
ARSD 20:51:01:09 Approved colleges of pharmacy, Repealed
History
- Source: 9 SDR 171, effective July 12, 1983; 11 SDR 92, effective January 16, 1985; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 17 SDR 37, effective September 9, 1990; 18 SDR 95, effective November 25, 1991; 22 SDR 32, effective September 14, 1995; 22 SDR 133, effective April 25, 1996; 33 SDR 73, effective November 6, 2006; 36 SDR 21, effective August 17, 2009; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:01:10 Application requirements for graduates from colleges of pharmacy located outside the United States
Any applicant for licensure by examination who is a graduate of a school or college of pharmacy located outside of the United States must submit the Foreign Pharmacy Graduate Examination Committee certification awarded by the National Association of Boards of Pharmacy. Any applicant must submit an application to the board in accordance with § 20:51:01:03.
The applicant shall obtain practical experience in one or more board-licensed pharmacies outlined in chapter 20:51:02 before applying for licensure as outlined in § 20:51:01:03.
History
- Source: 9 SDR 171, effective July 12, 1983; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 18 SDR 95, effective November 25, 1991; 22 SDR 133, effective April 25, 1996; 36 SDR 21, effective August 17, 2009; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1).
- Law Implemented: SDCL 36-11-16(5).
ARSD 20:51:01:11 North American Pharmacist Licensure Examination score transfer
An applicant meeting the requirements of this chapter who has taken the North American Pharmacist Licensure Examination in another state may transfer scores through the National Association of Boards of Pharmacy. To be eligible for licensure, an applicant must receive a passing grade in the Multistate Pharmacy Jurisprudence Examination, South Dakota edition, in accordance with § 20:51:01:04, within one year from the date the scores are transferred by the National Association of Boards of Pharmacy to the board.
History
- Source: 18 SDR 95, effective November 25, 1991; 33 SDR 73, effective November 6, 2006; 36 SDR 21, effective August 17, 2009; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1).
- Law Implemented: SDCL 36-11-16(7).
ARSD 20:51:01:12 Registration fee nonrefundable, Repealed
History
- Source: 18 SDR 95, effective November 25, 1991; 33 SDR 73, effective November 6, 2006; 36 SDR 21, effective August 17, 2009; 50 SDR 138, effective June 2, 2024.
Chapter 20:51:02
ARSD 20:51:02:01 Definitions
Terms defined in SDCL 36-11-2 have the same meaning in this chapter. As used in this chapter, "pharmacy intern" means a person who meets registration requirements as outlined in § 20:51:02:04 and is issued an intern certificate.
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 22 SDR 133, effective April 25, 1996; 31 SDR 35, effective September 19, 2004; 36 SDR 21, effective August 17, 2009; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1), 36-11-25.
- Law Implemented: SDCL 36-11-16(6), 36-11-25.
ARSD 20:51:02:01.01 Goal and objectives of internship
A pharmacy internship shall provide the pharmacy intern with the opportunity, over a period of time, to attain and build upon the intern's knowledge, skills, and ability to safely, efficiently, and effectively practice pharmacy under the laws and rules of the state.
The objectives of an internship are to provide each intern with the following responsibilities:
(1) To manage drug therapy to optimize patient outcomes.The pharmacy intern shall evaluate the patient and patient information to determine the presence of a disease or medical condition to determine the need for treatment or referral and to identify patient-specific factors that affect the patient's health to ensure the appropriateness of the patient's specific pharmacotherapeutic agents, dosing regimens, dosage forms, routes of administration, and delivery systems; and monitor the patient and patient information and manage the drug regimen to promote health and ensure safe and effective pharmacotherapy;
(2) To perform calculations required to compound, dispense, and administer medications; to select and dispense drugs and devices; and to prepare and compound extemporaneous preparations and sterile products;
(3) To assess, evaluate, and apply information to promote optimal healthcare and to educate patients and other healthcare professionals regarding prescription drugs, nonprescription drugs, and medical devices; and
(4) To develop a general understanding of the business procedures of a pharmacy and develop knowledge concerning the employment and supervision of pharmacy employees.
While performing these responsibilities, the pharmacy intern shall adhere to the professional, legal, moral, and ethical standards relative to the practice of pharmacy.
History
- Source: 31 SDR 35, effective September 19, 2004.
- General Authority: SDCL 36-11-10, 36-11-11(1), 36-11-25.
- Law Implemented: SDCL 36-11-25.
ARSD 20:51:02:02 Repealed
History
- Source: SL 1975, ch 16, § 1; repealed, 8 SDR 5, effective July 26, 1981.
ARSD 20:51:02:03 Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; repealed, 22 SDR 133, effective April 25, 1996.
ARSD 20:51:02:04 Registration
The board shall grant a certificate as a pharmacy intern to any person who has registered with the board on a form provided by the board and paid a fee of forty dollars. The board may not grant internship credit for experience obtained prior to the individual's registration as a pharmacy intern. A person who is eligible for registration by the board as a pharmacy intern must meet one of the following qualifications:
(1) A person who is enrolled in an Accreditation Council for Pharmacy Education (ACPE) accredited school or college of pharmacy and has completed one week of classes;
(2) A pharmacist applicant who is a graduate of an ACPE approved professional degree program of a school or college of pharmacy, awaiting examination for pharmacist licensure;
(3) A graduate who has established educational equivalency by obtaining a Foreign Pharmacy Graduate Examination Committee Certificate, for the purpose of obtaining practical experience as a requirement for licensure as a pharmacist pursuant to § 20:51:01:10; or
(4) A pharmacist licensure applicant awaiting board requirements for licensure or re-licensure.
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 22 SDR 133, effective April 25, 1996; 31 SDR 35, effective September 19, 2004; 36 SDR 21, effective August 17, 2009; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-10, 36-11-11(1), 36-11-25.
- Law Implemented: SDCL 36-11-25.
ARSD 20:51:02:04.01 South Dakota State University College of Pharmacy practice experiences, Repealed
History
- Source: 31 SDR 35, effective September 19, 2004; 36 SDR 21, effective August 17, 2009; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:02:04.02 Identification
A pharmacy intern shall be designated as a pharmacy intern in the intern's professional relationship and may not hold himself or herself out, directly or by inference, as a pharmacist. The board shall issue to the pharmacy intern a certificate for the purposes of identification and verification of his or her role as a pharmacy intern.
History
- Source: 36 SDR 21, effective August 17, 2009.
- General Authority: SDCL 36-11-11, 36-11-25.
- Law Implemented: SDCL 36-11-25.
ARSD 20:51:02:05 Renewal of certificate
Each pharmacy intern shall apply for renewal before October first each year. The board shall approve the application if the board finds that the applicant has continued pharmacy education in accordance with the rules of the board.
History
- Source: SL 1975, chi 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 22 SDR 133, effective April 25, 1996; 36 SDR 21, effective August 17, 2009; 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-11, 36-11-25.
- Law Implemented: SDCL 36-11-25.
ARSD 20:51:02:06 Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; repealed, 22 SDR 133, effective April 25, 1996.
ARSD 20:51:02:07 Affidavit needed for each practical experience
Any pharmacy intern seeking credit for practical experience as a qualification for licensure as a pharmacist pursuant to § 20:51:01:10 shall submit a separate affidavit on a form provided by the board for each practical experience.
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 22 SDR 133, effective April 25, 1996; 36 SDR 21, effective August 17, 2009; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11, 36-11-25.
- Law Implemented: SDCL 36-11-16(6), 36-11-25.
ARSD 20:51:02:08 Report required at end of each practical experience, Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 22 SDR 133, effective April 25, 1996; 52 SDR 27, effective September 15, 2025.
ARSD 20:51:02:09 Repealed
History
- Source: SL 1975, ch 16, § 1; repealed, 12 SDR 86, effective November 27, 1985.
ARSD 20:51:02:10 Practical experience defined
The term "practical experience," as it relates to qualification for licensure, means the following, when performed by the pharmacy intern under the immediate supervision of a pharmacist:
(1) The practice of pharmacy, as defined in SDCL 36-11-2.2; and
(2) The functions authorized to pharmacists in SDCL 36-11-19.1.
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 22 SDR 133, effective April 25, 1996; 52 SDR 27, effective September 15, 2025; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11, 36-11-25.
- Law Implemented: SDCL 36-11-16(6), 36-11-25.
ARSD 20:51:02:11 Supervising pharmacist requirements
A pharmacist who agrees to supervise the practical experience of a pharmacy intern must be readily available and in communication with the intern during all professional activities of the practical experience. A pharmacy intern may receive written or verbal prescriptions if the pharmacist reviews and makes the necessary professional determinations about the medication order.
A pharmacist shall verify the accuracy of all information entered into the prescription software platform by the pharmacy intern. The identity of the pharmacist must be included in the prescription record.
The pharmacist shall inspect the prepared prescription and verify the accuracy of the preparation, and its labeling, prior to dispensing the prescription to the patient or the patient's representative.
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 22 SDR 133, effective April 25, 1996; 26 SDR 92, effective January 6, 2000; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(1), 36-11-25.
- Law Implemented: SDCL 36-11-25.
ARSD 20:51:02:11.01 Number of interns
A pharmacist may not supervise more than two pharmacy interns at one time in the pharmacy. A pharmacy intern does not count for purposes of the ratio of technicians supervised by the pharmacist.
Cross Reference: Ratio, § 20:51:29:19.
History
- Source: 31 SDR 35, effective September 19, 2004; 36 SDR 21, effective August 17, 2009; 47 SDR 42, effective October 12, 2020.
- General Authority: SDCL 36-11-11(1), 36-11-25.
- Law Implemented: SDCL 36-11-25.
ARSD 20:51:02:12 Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; repealed, 22 SDR 133, effective April 25, 1996.
ARSD 20:51:02:12.01 Required hours
An applicant for licensure as a pharmacist pursuant to § 20:51:01:01 must complete a minimum of one thousand six hundred hours of practical experience.
History
- Source: 36 SDR 21, effective August 17, 2009; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1), 36-11-25.
- Law Implemented: SDCL 36-11-25.
ARSD 20:51:02:13 Internship experiences from other states
The board may give credit for practical experience obtained in another state.
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 22 SDR 133, effective April 25, 1996; 31 SDR 35, effective September 19, 2004; 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-11(1), 36-11-25.
- Law Implemented: SDCL 36-11-25.
ARSD 20:51:02:13.01 Foreign pharmacy graduates
History
- Source: 31 SDR 35, effective September 19, 2004; 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-11(1), 36-11-25.
- Law Implemented: SDCL 36-11-16, 36-11-25.
ARSD 20:51:02:14 Credit given for military and research activities
The Board of Pharmacy may approve up to four hundred hours of practical experience, as defined in § 20:51:02:10, for suitable military or research activities in the field of pharmacy as part of the experience requirement provided in § 20:51:02:12.01.
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11, 36-11-25.
- Law Implemented: SDCL 36-11-25.
ARSD 20:51:02:15 Badge required
While on duty, a pharmacy intern registered under this chapter must wear a badge identifying the intern as a pharmacy intern.
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 22 SDR 133, effective April 25, 1996; 50 SDSR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-11, 36-11-25.
- Law Implemented: SDCL 36-11-25.
ARSD 20:51:02:16 Denial of pharmacy intern registration
The board may deny an application for registration as a pharmacy intern for any violation of state or federal statutes or pharmacy laws or rules of any state.
History
- Source: 31 SDR 35, effective September 19, 2004; 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-11(1), 36-11-25.
- Law Implemented: SDCL 36-11-25.
ARSD 20:51:02:17 Sanctions, Repealed
History
- Source: 31 SDR 35, effective September 19, 2004; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:02:18 Disciplinary actions
If a pharmacy intern violates state or federal law or pharmacy rules of any state, the board may:
(1) Revoke the pharmacy intern certificate;
(2) Suspend the pharmacy intern certificate until further order of the board or for a specified period;
(3) Not renew the pharmacy intern certificate;
(4) Prohibit permanently, until further order of the board, or for a specified period, the pharmacy intern’s engagement in specified procedures, methods, or acts;
(5) Impose a probationary period;
(6) Refer the pharmacy intern to the health professionals assistance program; or
(7) Issue a letter of concern or public reprimand.
History
- Source: 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11, 36-11-25.
- Law Implemented: SDCL 36-11-25.
Chapter 20:51:04
ARSD 20:51:04:01 Application
An application to the board for licensure by reciprocity as a pharmacist must include the following:
(1) An electronic license transfer program application from the National Association of Boards of Pharmacy, completed on the National Association of Board of Pharmacy website; and
(2) A South Dakota reciprocating pharmacist application, with a non-refundable fee of one hundred fifty dollars.
History
- Source: SL 1975, ch 16, § 1; 6 SDR 103, effective May 5, 1980; 12 SDR 86, effective November 27, 1985; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 36 SDR 21, effective August 17, 2009; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1).
- Law Implemented: SDCL 36-11-16, 36-11-16.1, 36-11-19.
ARSD 20:51:04:02 Qualifications for reciprocity
To qualify for a reciprocal license, an applicant must:
(1) Be a licensed pharmacist in the state from which the pharmacist is reciprocating;
(2) Be in good standing as a pharmacist in the state from which the pharmacist is reciprocating at the time of application;
(3) Have engaged in the practice of pharmacy for a period of at least one year or have met the pharmacy practical experience requirements of this state within the one-year period immediately prior to the date of application; and
(4) Have passed the North American Pharmacist Licensure Examination, if the applicant first became a licensed pharmacist after January 1, 1980.
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 36 SDR 21, effective August 17, 2009; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1).
- Law Implemented: SDCL 36-11-19.
ARSD 20:51:04:03 Reciprocity requirements
In addition to the requirements of § 20:51:04:02, an applicant for reciprocity shall also meet the following requirements:
(1) The applicant may not have committed any act which may be construed by the board as a violation of state and federal laws, which might impair the discharge of the applicant's duties as a pharmacist; and
(2) The applicant must successfully complete the Multistate Pharmacy Jurisprudence Examination (MPJE), South Dakota edition. A total scaled score of not less than 75 is required to pass this examination.
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 29 SDR 37, effective September 26, 2002; 36 SDR 21, effective August 17, 2009.
- General Authority: SDCL 36-11-11(1).
- Law Implemented: SDCL 36-11-19.
ARSD 20:51:04:04 Application requirements, Repealed
History
- Source: SL 1975, ch 16, § 1; 3 SDR 45, effective December 18, 1976; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 29 SDR 37, effective September 26, 2002; 36 SDR 21, effective August 17, 2009; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
ARSD 20:51:04:05 Appearance before board
Before issuing a reciprocal license, the board may require the applicant to appear in person before the board for final consideration of the reciprocal application. The secretary of the board shall notify the applicant of the time and place of the required appearance.
History
- Source: SL 1975, ch 16, § 1; 10 SDR 117, effective May 8, 1984; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 36 SDR 21, effective August 17, 2009; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1).
- Law Implemented: SDCL 36-11-19.
ARSD 20:51:04:06 Repealed
History
- Source: SL 1975, ch 16, § 1; 6 SDR 103, effective May 5, 1980; 12 SDR 151, 12 SDR 155, effective July 1, 1986; repealed, 29 SDR 37, effective September 26, 2002.
ARSD 20:51:04:07 Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; repealed, 29 SDR 37, effective September 26, 2002.
ARSD 20:51:04:08 Reciprocal license identified by letter R
A license granted by reciprocity must be identified by the letter "R" preceding the license number.
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11.
- Law Implemented: SDCL 36-11-5, 36-11-19.
ARSD 20:51:04:09 Repealed
History
- Source: 6 SDR 103, effective May 5, 1980; 12 SDR 151, 12 SDR 155, effective July 1, 1986; repealed, 36 SDR 21, effective August 17, 2009.
Chapter 20:51:05
ARSD 20:51:05:00 Definitions
Terms used in this chapter mean:
(1) "Controlled drug," a substance as defined in SDCL 36-11-2.1 that is controlled under the provisions of SDCL chapter 34-20B and is listed in SDCL 34-20B-12 to 34-20B-26, inclusive;
(2) "Legend drug," a substance as defined in SDCL 34-20B-28.1; and
(3) "Prescription," has the same definition as prescription drug order in SDCL 36-11-2.
History
- Source: 8 SDR 101, effective February 28, 1982; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 50 SDR 138, effective June 2, 2024; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(1).
- Law Implemented: SDCL 36-11-2.1.
ARSD 20:51:05:01 Transferred
ARSD 20:51:05:02 Transferred
ARSD 20:51:05:03 Repealed
History
- Source: SL 1975, ch 16, § 1; repealed, 8 SDR 101, effective February 28, 1982.
ARSD 20:51:05:04 Repealed
History
- Source: SL 1975, ch 16, § 1; repealed, 6 SDR 103, effective May 5, 1980.
ARSD 20:51:05:05 Repealed
History
- Source: SL 1975, ch 16, § 1; repealed, 8 SDR 101, effective February 28, 1982.
ARSD 20:51:05:06 Transferred
ARSD 20:51:05:07 Transferred
ARSD 20:51:05:08 Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; repealed, SL 2012, ch 194, § 15, effective July 1, 2012.
ARSD 20:51:05:09 Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; repealed, SL 2012, ch 194, § 16, effective July 1, 2012.
ARSD 20:51:05:10 Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; repealed, SL 2012, ch 194, § 17, effective July 1, 2012.
ARSD 20:51:05:11 Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; repealed, 2012, ch 194, § 18, effective July 1, 2012.
ARSD 20:51:05:12 Repealed
History
- Source: SL 1975, ch 16, § 1; repealed, 6 SDR 103, effective May 5, 1980.
ARSD 20:51:05:13 Repealed
History
- Source: SL 1975, ch 16, § 1; repealed, 3 SDR 45, effective December 18, 1976.
ARSD 20:51:05:14 No advertising permitted on prescription blanks furnished to doctors, Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:05:15 Prescription required to dispense a drug
A pharmacist may dispense a drug only pursuant to a valid prescription issued by a licensed prescriber.
The prescription must contain:
(1) The full first and last legal name and address of the patient;
(2) The drug name, strength, dosage form, quantity prescribed, and directions for use;
(3) The name and address of the prescriber;
(4) The prescriber’s name and the date of issuance; and
(5) For a controlled drug, the prescriber's federal Drug Enforcement Administration registration number.
History
- Source: SL 1975, ch 16, § 1; transferred from § 20:51:05:01, 8 SDR 101, effective February 28, 1982; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 26 SDR 92, effective January 6, 2000; 40 SDR 40, effective September 16, 2013; 50 SDR 138, effective June 2, 2024; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(1).
- Law Implemented: SDCL 36-11-2.2.
ARSD 20:51:05:15.01 Identification required for controlled drug prescription
Except for inpatients in a health care facility licensed pursuant to SDCL chapter 34-12, the pharmacy must have a policy to verify the identity of anyone attempting to purchase or pick up a prescription for a controlled substance listed in SDCL chapter 34-20B. The pharmacy shall post a notice to the public that states “No prescription for a controlled drug may be sold without verification of purchaser identity per ARSD 20:51:05:15.01”.
History
- Source: 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-11(1).
- Law Implemented: SDCL 36-11-68.
ARSD 20:51:05:15.02 Delivery of a prescription -- Signature required
A prescription may be delivered to a pharmacist by the following methods if permitted by law:
(1) In writing;
(2) Via facsimile;
(3) Verbally; or
(4) Electronically.
A pharmacist or certified pharmacy intern shall promptly reduce a verbal prescription to a written record filed or electronically recorded in the same manner as a written prescription.
A handwritten, or facsimile prescription must be manually signed by the prescriber to be a valid prescription.
Cross References:
Facsimile transmission of Schedule II prescriptions, § 44:58:08:18.03.
Manner of issuance of prescriptions, § 44:58:08:05.
History
- Source: 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(1).
- Law Implemented: SDCL 36-11-2.2.
ARSD 20:51:05:15.03 Refilling of a prescription -- Requirements -- Controlled and noncontrolled drugs
A prescription may not be refilled except as designated on the original prescription or as subsequently authorized by the prescriber. Each refill must be entered on the back of the original prescription or captured electronically and must include the quantity dispensed, the date refilled, and the initials or name of the dispensing pharmacist.
Any prescription renewed by the prescriber constitutes a new and separate prescription, must be assigned a new serial number, and is subject to the restrictions in this section.
A noncontrolled legend drug may only be refilled for the total quantity on the prescription and not filled or refilled after twelve months from the original date of the prescription's issuance. If the prescriber is unable to be contacted to authorize a refill, the pharmacist may refill up to a thirty-day supply of the noncontrolled legend drug, if, in the professional judgement of the pharmacist, the drug is necessary to maintain the patient's health.
A Schedule III or IV controlled drug may only be refilled as authorized on the prescription and up to five times within six months after the date of the prescription's issuance. The partial dispensing of refills may not exceed the total quantity authorized on the prescription.
A Schedule II controlled drug may not be refilled. A pharmacist may partially fill a prescription for a Schedule II controlled drug according to the procedures set forth in §§ 44:58:08:18 and 44:58:08:18.01, and 21 C.F.R. §§ 1306.12 and 1306.13 (April 2, 2026). A prescription for a Schedule II controlled drug may not be filled later than six months after the date of issuance.
History
- Source: 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(1).
- Law Implemented: SDCL 36-11-2.2.
ARSD 20:51:05:16 Prescription for Schedule II controlled drug requires date and signature of prescriber -- Not refillable, Repealed
History
- Source: SL 1975, ch 16, § 1; transferred from § 20:51:05:02, 8 SDR 101, effective February 28, 1982; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 26 SDR 92, effective January 6, 2000; 40 SDR 40, effective September 16, 2013; 53 SDR 13, effective August 16, 2026.
ARSD 20:51:05:17 Oral prescription permitted for Schedule II controlled drug in emergency
A pharmacist may in an emergency as defined in SDCL 22-42-2.2 dispense a Schedule II controlled drug prescription according to the procedure set out in § 44:58:08:13.
History
- Source: 8 SDR 101, effective February 28, 1982; 12 SDR 151, 12 SDR 155, effective July 1, 1986.
- General Authority: SDCL 36-11-11.
- Law Implemented: SDCL 36-11-11.
ARSD 20:51:05:18 Partial filling of prescription for Schedule II controlled drug, Repealed
History
- Source: 8 SDR 101, effective February 28, 1982; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 26 SDR 92, effective January 6, 2000; 50 SDR 138, effective June 2, 2024; 53 SDR 13, effective August 16, 2026.
ARSD 20:51:05:19 Prescription required to dispense Schedule III or IV controlled drug -- Refill restricted, Repealed
History
- Source: 8 SDR 101, effective February 28, 1982; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 26 SDR 92, effective January 6, 2000; 40 SDR 40, effective September 16, 2013; 50 SDR 138, effective June 2, 2024; 53 SDR 13, effective August 16, 2026.
ARSD 20:51:05:20 Legend drug to be dispensed by prescription only -- Refill restricted, Repealed
History
- Source: SL 1975, ch 16, § 1; transferred from §§ 20:51:05:06 and 20:51:05:07, 8 SDR 101, effective February 28, 1982; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 26 SDR 92, effective January 6, 2000; 40 SDR 40, effective September 16, 2013; 50 SDR 138, effective June 2, 2024; 53 SDR 13, effective August 16, 2026.
ARSD 20:51:05:21 Labeling of prescription container for controlled or noncontrolled legend drug
A pharmacist filling a prescription for a controlled or noncontrolled legend drug shall attach to each container a label comprising:
(1) The date dispensed;
(2) The name, address, and telephone number of the pharmacy;
(3) The serial number of the prescription;
(4) The name of the prescriber;
(5) The name of the patient;
(6) The directions for, and precautions, if any, when using the drug;
(7) The name, strength, and quantity of the drug;
(8) The number of refills remaining; and
(9) The initials of the dispensing pharmacist.
All drugs dispensed for a specific nursing facility patient, including over-the-counter medications, are considered prescription medications and must be labeled as required in § 44:73:08:04.
Cross Reference: Storage and labeling of medications, § 44:73:08:04.
History
- Source: 8 SDR 101, effective February 28, 1982; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 26 SDR 92, effective January 6, 2000; 50 SDR 138, effective June 2, 2024; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(1), 36-11-46.6.
- Law Implemented: SDCL 36-11-46.6.
ARSD 20:51:05:22 Distribution of drugs to prescribers or pharmacies
A licensed pharmacy may distribute up to five percent of its controlled drugs and legend drugs to a prescriber licensed to prescribe, dispense, or distribute the drugs in the course of professional practice or to other licensed pharmacies, to meet temporary inventory shortages. The distribution must be completed using invoices containing the:
(1) Name, address, and Drug Enforcement Administration number, if required, of both locations involved in the transaction;
(2) Drug name, dosage form, and strength;
(3) Quantity of each drug sold; and
(4) Date of sale.
The sale of Schedule II drugs must include a completed Drug Enforcement Administration form 222. Copies of the invoices must be retained by both locations involved in the transaction for a period of two years from the date of the transaction.
History
- Source: 11 SDR 92, effective January 16, 1985; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1).
- Law Implemented: SDCL 36-11-14, 36-11A-4.
ARSD 20:51:05:23 Distribution of dialysate or dialysis devices by the manufacturer or manufacturer's agent to a patient - Exempt from pharmacy licensure
20 : 51 : 05 : 23 . Distribution of dialysate or dialysis devices by the manufacturer or manufacturer ' s agent to a patient - Exempt from pharmacy licensure. A manufacturer of dialysate and dialysis devices or an agent of a manufacturer may ship dialysate and dialysis devices directly to a patient in this state, to an agent of the patient, or to a health care practitioner or institution, for administration or delivery of dialysis therapy, to a patient with chronic kidney failure, without being licensed as a pharmacy in this state if the following criteria have been met:
(1) The manufacturer or manufacturer's agent shipping the dialysate is licensed as a wholesaler or other drug distributor;
(2) The dialysate is stored and delivered in the original, sealed, and labeled package from the manufacturing facility; and
(3) The dialysate or dialysis devices are delivered only upon receipt of a prescription order issued by a licensed practitioner and only if an order from a licensed pharmacy is transmitted to the manufacturer or the manufacturer's agent.
Records for all sales and distribution of dialysate must be retained and readily available for inspection for a period of two years from the date of the transaction.
History
- Source: 47 SDR 42, effective October 12, 2020.
- General Authority: SDCL 36-11-11(1).
- Law Implemented: SDCL 36-11-11(1).
Chapter 20:51:06
ARSD 20:51:06:01 Application for pharmacy license--Annual renewal required
History
- Source: SL 1975, ch 16, § 1; 2 SDR 56, effective February 11, 1976; 4 SDR 85, effective June 19, 1978; 11 SDR 151, effective May 15, 1985; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 24 SDR 160, effective May 26, 1998; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(3), 36-11-32, 36-11-35.
- Law Implemented: SDCL 36-11-32, 36-11-35.
ARSD 20:51:06:02 Ownership or control by pharmacist required, Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 50 SDR 138, effective June 2, 2024; 53 SDR 13, effective August 16, 2026.
ARSD 20:51:06:02.01 Pharmacist-in-charge -- Duties
An application for a license to conduct a pharmacy as specified in § 20:51:06:02 must indicate the pharmacist-in-charge, as defined in SDCL 36-11-2.
The pharmacist-in-charge must:
(1) Be employed or under contract for pharmacy services at the pharmacy;
(2) Establish policy and procedure for the pharmacy;
(3) Supervise all pharmacy employees;
(4) Establish recordkeeping systems for the purchase, safekeeping, storage, compounding, sale, and return of drugs; and
(5) Establish, implement, and document an ongoing quality assurance program in order to maintain and improve facilities, equipment, personnel performance, and the provision of patient care.
The pharmacist-in-charge shall notify the board immediately upon termination of employment.
History
- Source: 26 SDR 92, effective January 6, 2000; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(1)(3).
- Law Implemented: SDCL 36-11-2, 36-11-32, 36-11-37.
ARSD 20:51:06:03 Application for opening a new pharmacy
An application for a license to operate a new pharmacy within South Dakota must be filed with the board at least thirty days before the pharmacy's opening date. The board may inspect the pharmacy prior to the opening date.
History
- Source: SL 1975, ch 16, § 1; 6 SDR 103, effective May 5, 1980; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(3).
- Law Implemented: SDCL 36-11-32.
ARSD 20:51:06:04 Grounds for suspending or revoking, Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025; 53 SDR 13, effective August 16, 2026.
ARSD 20:51:06:05 Must be registered in order to advertise pharmacy name, Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:06:06 Transfer of pharmacy registration, Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:06:07 Changes in ownership or location reported to the board -- Patients notified of closure of pharmacy
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(3).
- Law Implemented: SDCL 36-11-35, 36-11-39.
ARSD 20:51:06:08 Valid permit must be displayed, Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 52 SDR 27, effective September 15, 2025.
ARSD 20:51:06:09 License expires one hundred twenty days after death of pharmacist owner, Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025; 53 SDR 13, effective August 16, 2026.
ARSD 20:51:06:10 Provisions for pharmacist temporary absence from pharmacy
Where the premises includes a licensed pharmacy and a general merchandise area, it is not a violation of SDCL chapter 36-11 if public entrances to the general merchandise area are kept open for business without a pharmacist on duty in the pharmacy, provided all entrances to the prescription department are closed for the transaction of business and a sign bearing the words "pharmacy services closed" has been posted by the pharmacist before leaving the premises. The prescription department must include sufficient security measures to protect the department from theft or access by unauthorized personnel. The prescription department must be secured by a continuous partition or wall, extending from the floor to the permanent ceiling, with doors capable of being securely locked to isolate the prescription department.
If the prescription department lacks the barrier and is closed, the entire business must be closed, locked, and secured to protect the area from theft or access by unauthorized personnel.
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(3).
- Law Implemented: SDCL 36-11-44.
ARSD 20:51:06:11 Pharmacy requirements for nonpharmacist owners, Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 26 SDR 92, effective January 6, 2000; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:06:12 Pharmacy requirements for pharmacist owners, Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 26 SDR 92, effective January 6, 2000; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:06:13 Repealed.
History
- Source: SL 1975, ch 16, § 1; 12 SDR 86, effective November 27, 1985; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 24 SDR 160, effective May 26, 1998; repealed, SL 2012, ch 194, § 19, effective July 1, 2012.
Chapter 20:51:07
ARSD 20:51:07:01 Pharmacy must comply with all public health regulations
A pharmacy must comply with all public health regulations regarding sanitation and is subject to South Dakota Board of Pharmacy inspections.
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(2).
- Law Implemented: SDCL 36-11-41, 36-11-64.
ARSD 20:51:07:02 Repealed
History
- Source: SL 1975, ch 16, § 1; 2 SDR 21, effective September 23, 1975; 6 SDR 103, effective May 5, 1980; 11 SDR 92, effective January 16, 1985; 12 SDR 151, 12 SDR 155, effective July 1, 1986; repealed, 14 SDR 19, effective August 11, 1987.
ARSD 20:51:07:03 Minimum equipment requirements
A pharmacy owner must make available and maintain all equipment needed to provide pharmacy services for the location, as determined by the pharmacist-in-charge. Any equipment that requires certification, maintenance, or calibration must be certified, maintained, or calibrated according to the manufacturer and United States Pharmacopeia guidelines. All equipment not in good working condition may not be used in the pharmacy.
History
- Source: SL 1975, ch 16, § 1; 6 SDR 103, effective May 5, 1980; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(4).
- Law Implemented: SDCL 36-11-41(1).
ARSD 20:51:07:04 Publication and reference library
All pharmacy staff must have access to South Dakota pharmacy laws and rules, federal laws and rules, all governing or regulatory agency documents needed to conduct pharmacy services, and the telephone number of the nearest poison control center. The required publications and materials may be printed or online. Reference material must be maintained and must include one current drug information reference that the pharmacist-in-charge determines to be necessary to provide pharmacy services to patients at that location.
History
- Source: 31 SDR 35, effective September 19, 2004; 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-11(4).
- Law Implemented: SDCL 36-11-41(2).
Chapter 20:51:08
ARSD 20:51:08:01 Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; repealed, SL 2012, ch 194, § 20, effective July 1, 2012.
ARSD 20:51:08:02 Repealed
History
- Source: SL 1975, ch 16, § 1; repealed, 12 SDR 86, effective November 27, 1985.
ARSD 20:51:08:03 Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; repealed, SL 2012, ch 194, § 21, effective July 1, 2012.
ARSD 20:51:08:04 Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; repealed, SL 2012, ch 194, § 22, effective July 1, 2012.
ARSD 20:51:08:05 Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; repealed, SL 2012, ch 194, § 23, effective July 1, 2012.
ARSD 20:51:08:06 Repealed
History
- Source: SL 1975, ch 16, § 1; 6 SDR 103, effective May 5, 1980; 12 SDR 151, 12 SDR 155, effective July 1, 1986; repealed, SL 2012, ch 194, § 24, effective July 1, 2012.
ARSD 20:51:08:07 Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; repealed, SL 2012, ch 194, § 25, effective July 1, 2012.
ARSD 20:51:08:08 Repealed
History
- Source: SL 1975, ch 16, § 1; repealed, 12 SDR 86, effective November 27, 1985.
ARSD 20:51:08:09 Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; repealed, SL 2012, ch 194, § 26, effective July 1, 2012.
Chapter 20:51:09
ARSD 20:51:09:01 Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 24 SDR 160, effective May 26, 1998; repealed, SL 2012, ch 194, § 27, effective July 1, 2012.
ARSD 20:51:09:02 Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; repealed, 24 SDR 160, effective May 26, 1998.
ARSD 20:51:09:03 Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 24 SDR 160, effective May 26, 1998; repealed, SL 2012, ch 194, § 28, effective July 1, 2012.
ARSD 20:51:09:04 Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 24 SDR 160, effective May 26, 1998; repealed, SL 2012, ch 194, § 29, effective July 1, 2012.
ARSD 20:51:09:05 Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 24 SDR 160, effective May 26, 1998; repealed, SL 2012, ch 194, § 30, effective July 1, 2012.
ARSD 20:51:09:06 Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 24 SDR 160, effective May 26, 1998; repealed, SL 2012, ch 194, § 31, effective July 1, 2012.
ARSD 20:51:09:07 Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 24 SDR 160, effective May 26, 1998; repealed, SL 2012, ch 194, § 32, effective July 1, 2012.
ARSD 20:51:09:08 Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; repealed, 24 SDR 160, effective May 26, 1998.
ARSD 20:51:09:09 Repealed
History
- Source: 24 SDR 160, effective May 26, 1998; repealed, SL 2012, ch 194, § 33, effective July 1, 2012.
Chapter 20:51:10
ARSD 20:51:10:01 Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; repealed, SL 2012, ch 194, § 34, effective July 1, 2012.
ARSD 20:51:10:02 Repealed
History
- Source: SL 1975, ch 16, § 1; repealed, 12 SDR 86, effective November 27, 1985.
ARSD 20:51:10:03 Repealed
History
- Source: SL 1975, ch 16, § 1; repealed, 12 SDR 86, effective November 27, 1985.
ARSD 20:51:10:04 Repealed
History
- Source: SL 1975, ch 16, § 1; repealed, 12 SDR 86, effective November 27, 1985.
ARSD 20:51:10:05 Repealed
History
- Source: SL 1975, ch 16, § 1; repealed, 12 SDR 86, effective November 27, 1985.
ARSD 20:51:10:06 Repealed
History
- Source: SL 1975, ch 16, § 1; repealed, 12 SDR 86, effective November 27, 1985.
ARSD 20:51:10:07 Repealed
History
- Source: SL 1975, ch 16, § 1; repealed, 12 SDR 86, effective November 27, 1985.
ARSD 20:51:10:08 Repealed
History
- Source: SL 1975, ch 16, § 1; repealed, 12 SDR 86, effective November 27, 1985.
ARSD 20:51:10:09 Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; repealed, SL 2012, ch 194, § 35, effective July 1, 2012.
Chapter 20:51:13
ARSD 20:51:13:01 Repealed
History
- Source: SL 1975, ch 16, § 1; repealed, 12 SDR 86, effective November 27, 1985.
ARSD 20:51:13:02 Return of unused drugs
Except as otherwise provided by chapters 20:51:21 and 20:51:35, pharmacists and pharmacies may not accept from patients or their agents, for reuse, reissue, or resale, any unused drugs, prescribed medications, sickroom supplies, or hygienic surgical appliances or garments. In a hospital with a licensed pharmacy, unused drugs, sickroom supplies, hygienic surgical appliances or garments, and other items dispensed for hospital inpatients may be returned to the pharmacy, for credit and disposition by a pharmacist, if the integrity of the products and packages is maintained.
History
- Source: SL 1975, ch 16, § 1; 8 SDR 5, effective July 26, 1981; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 29 SDR 37, effective September 26, 2002; 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-11(1).
- Law Implemented: SDCL 34-20H-2, 36-11-33.
ARSD 20:51:13:02.01 Return of unused unit dose and unit of issue drugs by patients in hospice programs, nursing facilities, or assisted living facilities
Only unused unit dose or unit of issue drugs from patients in a hospice program, a nursing facility, or an assisted living facility may be returned to the pharmacy that dispensed the drugs for credit and redispensing. The pharmacy may only return and re-dispense drugs in accordance with the following requirements:
(1) The facility or hospice program consults with a licensed pharmacist for oversight of the drug distribution to ensure that a person trained and knowledgeable in the storage, use, and administration of the drug has been in control of any drug being returned to the pharmacy and that the unit dose or unit of issue drug has not come into the physical possession of the patient for whom it was prescribed;
(2) The pharmacist-in-charge has received written approval from the board of a protocol detailing the procedure used to repackage, label, transfer, restock, redispense, and credit any unit dose or unit of issue drugs returned to the pharmacy;
(3) The drugs are provided in the manufacturer's unit dose packaging or are repackaged by the pharmacy in accordance with chapter 20:51:21;
(4) The unit dose package is labeled by the manufacturer with the drug lot number and expiration date;
(5) If the drug is repackaged by the pharmacy, each single unit dose or each unit of issue prepackaged or repackaged container must include:
(a) The name and strength of the medication;
(b) A suitable expiration date, not later than the expiration date on the manufacturer's container or one year from the date the drug is prepackaged or repackaged;
(c) The date the product was prepackaged or repackaged;
(d) The manufacturer's lot number, expiration date, and identity unless maintained in the internal records of the pharmacy; and
(e) The identity of the pharmacist responsible for prepackaging or repackaging unless maintained in the internal records of the pharmacy;
(6) The drug's packaging is tamper resistant and shows no evidence of contamination;
(7) The unit dose drugs or unit of issue drugs have not reached the expiration date;
(8) The drugs have not been dispensed in packaging that intermingles different drugs in a single compartment; and
(9) The drugs are not controlled drugs.
Unused unit dose drugs or unit of issue drugs that are returned under this section may be redispensed pursuant to § 20:51:13:02.03.
Cross Reference: Unit dose systems, chapter 20:51:21.
History
- Source: 10 SDR 38, effective October 27, 1983; 12 SDR 82, effective November 19, 1985; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 18 SDR 95, effective November 25, 1991; 29 SDR 37, effective September 26, 2002; SL 2004, ch 249, § 3, effective July 1, 2004; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1)(14).
- Law Implemented: SDCL 34-20H-2, 36-11-46.6.
ARSD 20:51:13:02.02 Repealed
History
- Source: 11 SDR 151, effective May 15, 1985; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 18 SDR 95, effective November 25, 1991; repealed, 29 SDR 37, effective September 26, 2002.
ARSD 20:51:13:02.03 Redispensing unit dose and unit of issue drugs returned from hospice programs, nursing facilities, or assisted living facilities
Unused unit dose or unit of issue drugs that are returned under § 20:51:13:02.01 may be redispensed in accordance with the following requirements:
(1) Drugs in a manufacturer's unit dose package may be redispensed as often as necessary, if the integrity of the original product and package is maintained; and
(2) Drugs that have been repackaged into a unit of issue package by the pharmacy may be redispensed into a unit of issue distribution system and mixed with drugs of a different lot number, provided that all lot numbers and expiration dates are placed on the unit of issue package or in the internal record.
History
- Source: 18 SDR 95, effective November 25, 1991; 29 SDR 37, effective September 26, 2002; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1)(14).
- Law Implemented: SDCL 34-20H-2, 36-11-46.6.
ARSD 20:51:13:02.04 Repackaging drugs from prescription container
Drugs that were repackaged and were not dispensed, or drugs transferred directly from one pharmacy to another pharmacy, may be repackaged into unit dose or unit of issue packaging if the following information is obtained by the pharmacy:
(1) Date received;
(2) Name of drug;
(3) Strength;
(4) Quantity;
(5) Expiration date;
(6) Manufacturer's lot number;
(7) Manufacturer; and
(8) National Drug Code.
The expiration date for the repackaged drug must not exceed the shorter of one year from the date the drug is prepackaged or repackaged or the manufacturer's container expiration date.
History
- Source: 18 SDR 95, effective November 25, 1991; 29 SDR 37, effective September 26, 2002; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1).
- Law Implemented: SDCL 34-20H-2, 36-11-46.6.
ARSD 20:51:13:03 Free choice of pharmacies
The following notice must be displayed conspicuously at all times in all licensed pharmacies:
"NOTICE TO THE PUBLIC
FREE CHOICE OF PHARMACIES
Any person has the right and privilege of having a prescription filled at the pharmacy of the person's choice. This South Dakota Board of Pharmacy notice must be displayed conspicuously at all times in all licensed pharmacies."
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1).
- Law Implemented: SDCL 34-12B-1.
ARSD 20:51:13:04 Splitting fees or rebates prohibited, Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:13:05 Reserved
ARSD 20:51:13:06 Off-site medication control in a hospital or medical clinic -- Approval -- Requirements
A licensed pharmacy may provide drugs as defined in SDCL 36-11-2.1 to a hospital or medical clinic for dispensing to patients when access to a pharmacy is limited. The pharmacy providing the medications retains ownership of the medications until dispensed to the patient and shall ensure proper storage and recordkeeping. For medications to be maintained off-site in a hospital or medical clinic, State Board of Pharmacy approval must be granted.
To receive board approval, the pharmacist-in-charge shall provide the board with the address of the hospital or clinic, a drug list, and the drug quantities to be dispensed to patients.
To maintain board approval, the pharmacist-in-charge shall ensure:
(1) Drugs be kept in a locked cabinet with access only by authorized licensed healthcare professionals;
(2) Prior to dispensing a medication, there must be a drug order in the patient's record, and a copy of the drug order or prescription is sent to the pharmacy;
(3) Dispensing at the hospital or medical clinic must be done by the prescriber, or, if the label is prepared by a nurse, the label must otherwise comply with § 20:51:05:21 and the prescriber must verify the drug and the directions prior to dispensing;
(4) A written information sheet must be provided to the patient at time of dispensing for each drug;
(5) Inventory of all drugs stored off-site must include a record of each time a drug is dispensed from the supply; and
(6) A pharmacist conducts an on-site inspection at the off-site location at least every ninety days. The inspection must verify the inventory of drugs, expiration dates, proper storage conditions, and review of applicable policies and procedures with authorized hospital or medical clinic staff. Documentation of the inspection must be stored at the licensed pharmacy and retained for two years.
History
- Source: 52 SDR 27, effective September 15, 2025; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(1)(3).
- Law Implemented: SDCL 36-11-2.2, 36-11-14.
ARSD 20:51:13:07 Remote drop site -- Designation -- Ownership
A licensed pharmacy may designate a remote drop site where a patient or a designated person may pick up a dispensed prescription. The pharmacy utilizing the site retains ownership of any prescription packages deposited at the site until received by the patient or designated person.
History
- Source: 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(16).
- Law Implemented: SDCL 36-11-1, 36-11-10, 36-11-44, 36-11-74.
ARSD 20:51:13:08 Remote drop site -- Board approval
A licensed pharmacy must obtain approval from the State Board of Pharmacy before utilizing a remote drop site.
To obtain approval, the pharmacist-in-charge shall submit the following to the board:
(1) The name, address, and license number of the pharmacy;
(2) The name and address of the remote drop site;
(3) The policies and procedures for the remote drop site; and
(4) Security measures for the site, including an image of the locked cabinet.
The pharmacist-in-charge must report to the board any changes to an approved remote drop site regarding changes to policy and procedures or the security measures of the remote drop site. Proposed changes to an approved remote drop site must be approved by the board prior to implementation.
History
- Source: 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(1)(16).
- Law Implemented: SDCL 36-11-2.2(3), 36-11-44, 36-11-74.
ARSD 20:51:13:09 Remote drop site -- Requirements
If a licensed pharmacy utilizes a remote drop site, the pharmacist-in-charge must ensure the following remote drop site requirements are met:
(1) The remote drop site has a locked cabinet for storage of prescription packages;
(2) Access to the locked cabinet is limited to trained designated staff;
(3) Prescription packages are placed in the locked cabinet immediately upon delivery to the remote drop site;
(4) Only the minimum information needed to identify the patient is listed on the outside packaging;
(5) The identity of the patient or designated person who is picking up the prescription package is documented on the prescription package log;
(6) The person picking up the prescription package signs the prescription package log;
(7) A designated staff member inventories the prescription packages at least weekly and provides a list of unclaimed prescription packages to the pharmacy staff;
(8) A licensed or registered pharmacy staff member inspects the remote drop site for compliance at least quarterly; and
(9) A licensed pharmacist inspects the remote drop site for compliance at least annually.
History
- Source: 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(16).
- Law Implemented: SDCL 36-11-1, 36-11-10, 36-11-44, 36-11-74.
ARSD 20:51:13:10 Remote drop site -- Recordkeeping
A licensed pharmacy utilizing a remote drop site must maintain the following records in the pharmacy:
(1) A list of all staff at the remote drop site who have been trained and have access to prescription packages;
(2) A list of all prescription packages delivered to the remote drop site; and
(3) Documentation of required inspections.
These records must be retained for at least two years.
History
- Source: 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(16).
- Law Implemented: SDCL 36-11-1, 36-11-10, 36-11-44, 36-11-74.
ARSD 20:51:13:11 Remote drop site -- Adverse issues and investigation -- Suspension
The State Board of Pharmacy may inspect each remote drop site. Upon notification of any adverse issues at a remote drop site, the board shall investigate the reported issue. Upon investigation, if the board determines the remote drop site is not being maintained as approved, the board must notify the pharmacist-in-charge, in writing, that the remote drop site approval is suspended pending full review by the board at the next regularly scheduled meeting.
History
- Source: 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(16).
- Law Implemented: SDCL 36-11-1, 36-11-10, 36-11-44, 36-11-74.
Chapter 20:51:14
ARSD 20:51:14:01 Annual pharmacist license renewal
The fee for an annual pharmacist license renewal is one hundred twenty-five dollars. The fee is non-refundable.
History
- Source: SL 1975, ch 16, § 1; 6 SDR 103, effective May 5, 1980; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 15 SDR 20, effective August 9, 1988; 23 SDR 26, 23 SDR 47, effective August 26, 1996; 28 SDR 24, effective September 2, 2001; 52 SDR 27, effective September 15, 2025; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-23.
- Law Implemented: SDCL 36-11-23.
ARSD 20:51:14:02 Repealed
History
- Source: SL 1975, ch 16, § 1; repealed, 12 SDR 86, effective November 27, 1985.
ARSD 20:51:14:03 Repealed
History
- Source: SL 1975, ch 16, § 1; repealed, 12 SDR 86, effective November 27, 1985.
ARSD 20:51:14:04 Equivalent drug products, Repealed
History
- Source: 13 SDR 179, effective June 2, 1987; 17 SDR 37, effective September 9, 1990; 18 SDR 95, effective November 25, 1991; 19 SDR 93, effective December 31, 1992; 20 SDR 28, effective August 30, 1993; 22 SDR 32, effective September 14, 1995; 26 SDR 92, effective January 6, 2000; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:14:05 Administrative rule waiver or modification -- Request -- Prohibitions -- Board approval -- Notification
The State Board of Pharmacy may grant a waiver to modify or waive the requirements of this article if the waiver improves the quality of or access to pharmacy services. The board may not grant a waiver for licensure, registration, education, or examination requirements.
A request for a waiver must be presented to the board on a form provided by the board and outlined in § 20:51:14:06. All waiver requests on behalf of a pharmacy must be submitted by the pharmacist-in-charge. The board shall consider the waiver request at its next available regularly scheduled meeting and may approve the waiver if:
(1) The waiver will improve the quality of or access to pharmacy services;
(2) The waiver will not adversely affect, directly or indirectly, the health, safety, or well-being of the public; and
(3) The practices under the waiver are equivalent or superior to those prescribed by the rule being waived or modified.
The board shall deny any waiver if the board determines the above requirements have not been met.
If a waiver is granted, the board shall provide the licensee or pharmacist-in-charge with written notice. The notice must be kept at the licensed pharmacy or practice location and be available for review during any inspection by the board.
History
- Source: 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11.
- Law Implemented: SDCL 36-11-1, 36-11-10.
ARSD 20:51:14:06 Waiver application -- Requirements
A licensee or pharmacist-in-charge requesting a waiver shall submit an application on a form provided by the State Board of Pharmacy. The application shall include the following information:
(1) The license number of the licensee responsible for overseeing the waiver;
(2) The specific location where the waiver is to be implemented;
(3) The reason for the waiver request;
(4) A description of the process or practice that is being implemented at the location;
(5) The rule that needs to be waived or modified to improve quality or access through the new process or practice;
(6) A description of how the process is to be monitored to ensure patient the health, safety, and well-being of the public is not compromised; and
(7) The proposed timeframe for which the waiver is requested.
History
- Source: 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-1, 36-11-11.
- Law Implemented: SDCL 36-11-1, 36-11-10.
ARSD 20:51:14:07 Granted waiver -- Annual review -- Adverse issue -- Suspension and review
The State Board of Pharmacy shall review each waiver at least annually. Upon notification by the State Board of Pharmacy, the board shall investigate the reported issue. Upon investigation, if the board determines the requirements of § 20:51:14:05 are not upheld, the board shall notify the licensee or pharmacist-in-charge, in writing, that the waiver is suspended pending full review by the board at the next available regularly scheduled meeting. During the suspension, the licensee or pharmacist-in-charge must ensure compliance with all rules in this article, regardless of any rule that was waived.
History
- Source: 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-1, 36-11-11.
- Law Implemented: SDCL 36-11-1, 36-11-10.
Chapter 20:51:15
ARSD 20:51:15:01 Definition and general provisions
Terms used in this chapter mean:
(1) “Chart order,” a lawful order entered on the chart or medical record of a patient or resident of a licensed healthcare facility by a practitioner, or a designated agent, for a drug or device;
(2) "Hospice program," a coordinated program of inpatient services providing palliative rather than curative care for a patient;
(3) "Part-time pharmacy," the provision of pharmaceutical services by a pharmacist under a pharmacy license issued by the board, on less than a full-time operation basis, in hospitals, nursing facilities, and related facilities in which pharmaceutical services are limited to inpatients; and
(4) "Pharmaceutical services":
(a) The operation, management, or control of a pharmacy;
(b) Preparing, compounding, processing, packaging, labeling, or dispensing one or more doses of medication either upon a prescription or chart order of an authorized practitioner for subsequent administration to, or use by, a patient; and
(c) Any other act, service, operation, or transaction incidental to subsections (4)(a) and (b) requiring, involving, or employing the science or art of any branch of the pharmaceutical profession.
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; SL 2004, ch 249, § 2, effective July 1, 2004; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1), 36-11-33.
- Law Implemented: SDCL 36-11-33.
ARSD 20:51:15:02 Pharmaceutical services supervised by pharmacist, Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 52 SDR 27, effective September 15, 2025; 53 SDR 13, effective August 16, 2026.
ARSD 20:51:15:03 Central area to be licensed as a pharmacy
The central area in a hospital, nursing facility, hospice program, or related facility, where drugs are procured, stored, and issued, and where pharmaceutical services are performed, must be licensed as a pharmacy. The pharmacy must meet all requirements of South Dakota and federal law and the rules of the board.
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1)(3), 36-11-33.
- Law Implemented: SDCL 36-11-33.
ARSD 20:51:15:04 Dispensing limited to pharmacist, Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 52 SDR 27, effective September 15, 2025.
ARSD 20:51:15:05 Transferring drugs from original containers limited to pharmacists
The act of transferring a drug or preparation from an original container to a new container is an act of dispensing which is restricted to a licensed pharmacist.
For purposes of this section, a container is "original" if it has been packaged by a licensed manufacturer and is labeled in compliance with federal and state law.
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11.
- Law Implemented: SDCL 36-11-33.
ARSD 20:51:15:06 Removing a single dose from prescription container
Removing a single dose of medication from a prescription container which has been dispensed by a pharmacist to a medicine cup and placing this medicine cup on a tray with appropriate identification constitutes a step in administration of medication.
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986.
- General Authority: SDCL 36-11-11.
- Law Implemented: SDCL 36-11-33.
ARSD 20:51:15:07 Preparing a solution, Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
ARSD 20:51:15:08 Medication floor stocks
Licensed hospitals and intensive care units having an organized medical staff, may maintain necessary floor stocks of medications at the nurses' station.
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986.
- General Authority: SDCL 36-11-11.
- Law Implemented: SDCL 36-11-33.
ARSD 20:51:15:09 Filling or refilling of nursing station containers limited to pharmacists, Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:15:10 Part-time pharmacy license -- Fee -- Renewal
The fee to apply for a part-time pharmacy license is one hundred sixty dollars. The fee for renewal of a part-time pharmacy license is one hundred sixty dollars. The licensee and renewal fees are non-refundable.
History
- Source: SL 1975, ch 16, § 1; 2 SDR 56, effective February 11, 1976; 4 SDR 85, effective June 19, 1978; 11 SDR 151, effective May 15, 1985; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 24 SDR 160, effective May 26, 1998; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(3), 36-11-33.
- Law Implemented: SDCL 36-11-33.
ARSD 20:51:15:11 Schedule of attendance by pharmacist
A licensed pharmacist employed or otherwise engaged to supply pharmaceutical services at a part-time pharmacy may have a flexible schedule of attendance, but the pharmacist must be present for a sufficient number of hours weekly to:
(1) Maintain an adequate supply of medications at the service areas from which medications are administered;
(2) Maintain all required records;
(3) Perform other services permitted or required by law; and
(4) Provide adequate control over all pharmaceutical services rendered by the hospital, nursing facility, hospice program, or related facility.
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11, 36-11-33.
- Law Implemented: SDCL 36-11-33.
ARSD 20:51:15:12 Storage of drugs located in areas other than the pharmacy
If a pharmacy in a hospital, nursing facility, or other related facility stores drugs in a location other than the pharmacy and outside of an automated mechanical distribution device, the pharmacist-in-charge must maintain the following information:
(1) Location of drugs;
(2) List of drugs at each location;
(3) A record of quarterly checks of all storage locations by pharmacy employees; and
(4) A list of authorized staff roles who have access to those drugs.
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 50 SDR 138, effective June 2, 2024; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(1)(4).
- Law Implemented: SDCL 36-11-33.
ARSD 20:51:15:13 Access to pharmacy -- Records
Except as provided below, only a licensed pharmacist may have access to the pharmacy.
If the pharmacist is absent from the hospital, nursing facility, hospice program, or other related facility, a registered nurse or licensed practical nurse designated by the hospital, nursing facility, hospice program, or other related facility may obtain, from the pharmacy, a drug necessary to administer to a patient in carrying out treatment and medication orders as prescribed by a licensed prescriber when the drug is not available in floor supplies, or the emergency drug kit, to meet the immediate need of the patient. The nurse shall leave in the pharmacy, on a suitable form, a record of any drugs removed, showing the name of the patient, the name of the drug, the dosage form and strength, the amount taken, and the date and time the drugs were removed, and shall sign the record. The nurse shall leave the record and the container from which the dose was taken to be checked by the pharmacist. These records must be retained in the pharmacy for two years.
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(1)(4), 36-11-33.
- Law Implemented: SDCL 36-11-2.2, 36-11-33, 36-11-68.
ARSD 20:51:15:14 Pharmacy must be in a separate room
The pharmacy, within the hospital, nursing facility, hospice program, or related facility must be in a separate room and locked at all times when a licensed pharmacist is not on duty.
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11, 36-11-33.
- Law Implemented: SDCL 36-11-33.
ARSD 20:51:15:15 Pharmacist controls emergency drugs in health care facilities
A pharmacist of a licensed pharmacy in a hospital, nursing facility, hospice program, or related facility may provide, upon written request of the health care facility's prescribers, a defined supply of drugs in an emergency drug kit or crash cart. The emergency drugs must meet the immediate therapeutic needs of a patient to prevent harm to the patient due to a delay in obtaining the drugs from the pharmacy. The emergency drugs must remain the property of the licensed pharmacy and must be stored on-site in a suitable, controlled location in the health care facility. The pharmacy staff shall inspect all emergency drugs at least monthly.
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 26 SDR 92, effective January 6, 2000; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(1)(4), 36-11-33.
- Law Implemented: SDCL 36-11-2.2, 36-11-33.
ARSD 20:51:15:15.01 Pharmacist controls emergency kit in nursing facility
A licensed pharmacy may provide to a nursing facility a limited quantity of controlled legend drugs, a limited amount of noncontrolled legend drugs, and nonprescription drugs, for emergency and supportive treatment, if requested in writing by the medical director. The provider pharmacy shall retain control of all drugs provided in emergency kits.
Emergency kits are governed by the following requirements:
(1) The medical director, director of nursing, and provider pharmacist shall jointly determine and prepare a limited list of emergency drugs by identity and quantity;
(2) No more than ten different controlled drugs may be stored in the emergency kit, which may not contain more than twenty doses of any controlled drug;
(3) The provider pharmacy and nursing facility must jointly have a policy in place outlining the time of the nursing staff notifying the provider pharmacy of any drug taken from the emergency kit;
(4) The provider pharmacy staff shall inventory and restock the contents of the emergency kit after reported use or at least monthly;
(5) The emergency kit must be stored in a suitable, controlled location in the nursing facility to prevent the unauthorized access of the drugs within it. The emergency kit exterior must be labeled clearly to indicate it is an emergency kit and is for emergency use only. The emergency kit must contain the name, strength, quantity, and expiration date of drugs contained therein; and
(6) The provider pharmacy must provide each facility where an emergency kit is placed with a contact number to a pharmacist twenty-four hours a day.
All other controlled and noncontrolled legend drugs must be obtained from a licensed pharmacy of the patient's choosing pursuant to SDCL 34-12B-1 and 34-12B-2.
History
- Source: 26 SDR 92, effective January 6, 2000; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(1)(4).
- Law Implemented: SDCL 36-11-2.2, 36-11-33.
ARSD 20:51:15:16 Minimum standards for pharmacy service, Repealed
History
- Source: SL 1975, ch 16, § 1; 12 SDR 86, effective November 27, 1985; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:15:17 Repealed
History
- Source: SL 1975, ch 16, § 1; repealed, 12 SDR 86, effective November 27, 1985.
ARSD 20:51:15:18 Storage of a patient's own medication
The pharmacist-in-charge of a pharmacy in a hospital, nursing facility, hospice program, or related facility shall have a policy and procedure in place regarding medications brought into the facility by a patient. For patient's own medications that are controlled substances, the policy must state that an inventory is taken and a physical count of each controlled medication is included. The medications must be stored in a manner that prevents unintended access by the patient and others, harm, theft, or diversion.
The patient's health record must contain documentation that the patient's home medications are being stored.
History
- Source: 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11.
- Law Implemented: SDCL 36-11-2.2(3), 36-11-10, 36-11-33.
Chapter 20:51:16
ARSD 20:51:16:01 Repealed
History
- Source: SL 1975, ch 16, § 1; repealed, 12 SDR 151, 12 SDR 155, effective July 1, 1986.
ARSD 20:51:16:02 Repealed
History
- Source: SL 1975, ch 16, § 1; repealed, 12 SDR 151, 12 SDR 155, effective July 1, 1986.
ARSD 20:51:16:03 The pharmacist's relation to the public
In the pharmacist's relation to the public, the pharmacist shall:
(1) Uphold the approved legal standards of the United States Pharmacopeia and the National Formulary, and encourage the use of official drugs and preparations. The pharmacist purchases, compounds, and dispenses only drugs of good quality;
(2) Use every precaution to safeguard the public when dispensing any drugs or preparations. Being legally entrusted with the dispensing and sale of these products, the pharmacist assumes responsibility by upholding and conforming to the laws and regulations governing the distribution of these substances;
(3) Seek to enlist and to merit the confidence of the public. The pharmacist zealously guards this confidence. The pharmacist considers the knowledge and confidence that the pharmacist gains of the ailments of patients as entrusted to the pharmacist's honor, and does not divulge these facts;
(4) Hold the health and safety of the pharmacist's patients to be of first consideration; the pharmacist makes no attempt to prescribe for or treat diseases or to offer for sale any drug or medical device merely for profit;
(5) Keep the pharmacy clean, neat, sanitary, and well equipped with accurate measuring and weighing devices and other apparatus suitable for the proper performance of professional duties;
(6) Be a good citizen and uphold and defend the laws of the states and nation; the pharmacist shall keep informed concerning pharmacy and drug laws and other laws pertaining to health and sanitation, and cooperate with enforcement authorities;
(7) Support constructive efforts on behalf of the public health and welfare. The pharmacist seeks representation on public health committees and projects, and offers to them full cooperation; and
(8) At all times seek only fair and honest remuneration for services.
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-43.
- Law Implemented: SDCL 36-11-43.
ARSD 20:51:16:04 The pharmacist's relations to other health professions
In the pharmacist's relations to other health professions, the pharmacist shall:
(1) Willingly make available the pharmacist's expert knowledge of drugs to the other health professions;
(2) Refuse to prescribe or diagnose, but refer those needing these services to a licensed prescriber;
(3) Compound and dispense prescriptions carefully and accurately, using correct pharmaceutical skill and procedure. If there is a question in the pharmacist's mind regarding the ingredients of a prescription, a possible error, or the safety of the directions, the pharmacist must privately consult the practitioner before making any changes. The pharmacist shall exercise the best professional judgment following the prescriber's directions in the matter of refilling prescriptions, copying the formula upon the label, or giving a copy of the prescription to the patient. The pharmacist may add extra directions or caution on poison labels for the wishes of the prescriber and the safety of the patient; and
(4) Not have clandestine arrangements either directly or indirectly with a licensed prescriber or any person, partnership, or corporation by which fees are divided or in which secret or coded prescriptions are involved.
History
- Source: SL 1975, ch 16, § 1; 12 SDR 86, effective November 27, 1985; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-43.
- Law Implemented: SDCL 34-12B-4, 34-12B-6, 36-11-43.
ARSD 20:51:16:05 The pharmacist's relations to fellow pharmacists
In relations to fellow pharmacists, the pharmacist:
(1) Strives to perfect and enlarge the pharmacist's professional knowledge. The pharmacist contributes to the scientific progress of the profession of pharmacy and encourages and participates in research, investigation, and study. The pharmacist keeps informed regarding professional matters by reading current pharmaceutical, scientific, and medical literature, attending seminars and other means;
(2) Seeks to attract to the profession of pharmacy youths of good character and intellectual capacity and aids in their instruction;
(3) The pharmacist associates with organizations having for their objective the betterment of the pharmaceutical profession and contributes time, energy, and funds to carry on the work of these organizations;
(4) The pharmacist keeps the pharmacist's reputation in public esteem by continuously giving the kind of professional service that earns its own reward. The pharmacist does not engage in any activity or transaction that will bring discredit or criticism to self or to the profession;
(5) The pharmacist will expose any corrupt or dishonest conduct of any member of the profession which comes to the pharmacist's certain knowledge, through those accredited processes provided by the civil laws of the rules and regulations of pharmaceutical organizations, and the pharmacist will aid in driving the unworthy out of the calling;
(6) The pharmacist does not lend support or the pharmacist's name to the promotion of objectionable or unworthy products;
(7) The pharmacist courteously aids a fellow pharmacist who may request advice or professional information or who, in an emergency, may need supplies;
(8) The pharmacist will not imitate the labels of a competitor or attempt to take any unfair advantage of a competitor's professional or commercial success. The pharmacist does not fill orders that the pharmacist knows are intended for a competitor. The pharmacist deals fairly with manufacturers and wholesalers and recognizes the significance and legal aspects of brand names and trademarked products. The pharmacist adheres to fair business practices, meets obligations promptly and fulfills agreements and contracts; and
(9) The pharmacist is proud to display in the pharmacist's establishment the pharmacist's own name and the names of other pharmacists employed by the pharmacist.
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986.
- General Authority: SDCL 36-11-43.
- Law Implemented: SDCL 36-11-43.
Chapter 20:51:17
ARSD 20:51:17:01 Definitions
Terms used in this chapter mean:
(1) "Automated mechanical distribution device," a mechanical device that is located in a health care facility, delivers a drug or drug device other than by administration or dispensing, and uses automated data processing technology to:
(a) Limit access of stocked drugs or drug devices to authorized personnel;
(b) Record the identity of all personnel who have access to drugs or drug devices stocked within the device; and
(c) Document both stocking and removal transactions;
(2) "Automated prescription dispensing device," a mechanical device that aids in the process of dispensing medication in a retail pharmacy or health care facility including storing, counting, and labeling medications; and
(3) "Health care facility," any facility licensed pursuant to SDCL chapter 34-12.
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 22 SDR 32, effective September 14, 1995; 26 SDR 92, effective January 6, 2000; 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-11(5).
- Law Implemented: SDCL 36-11-15, 36-11-30, 36-11-33.
ARSD 20:51:17:01.01 Approval for use of automated mechanical distribution device, Repealed
History
- Source: 26 SDR 92, effective January 6, 2000; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:17:01.02 Pharmacist shall review first-dose prescription drug order -- Exception
The first dose of a prescription drug may not be removed from an automated mechanical distribution device until a pharmacist has reviewed the prescriber's orders. In a health care facility, medical staff may request, in writing, drugs that may be removed without review by a pharmacist in an emergency situation.
History
- Source: 26 SDR 92, effective January 6, 2000; 50 SDR 138, effective June 2, 2024; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(5).
- Law Implemented: SDCL 36-11-2.2(3).
ARSD 20:51:17:02 Procedures for distributing or dispensing drugs in automated mechanical distribution and automated prescription dispensing device
Drugs may be distributed or dispensed by an automated mechanical distribution device or by an automated prescription dispensing device under the following conditions:
(1) The automated device is controlled by the pharmacist-in-charge. The pharmacist-in-charge shall develop policies and procedures to address all situations in which drugs are stocked, secured, removed, and accounted for;
(2) The automated device must be stocked with a supply of drugs by a pharmacist or a person authorized by the pharmacist-in-charge. The pharmacist shall maintain electronic or written stocking, distribution, and dispensing records;
(3) The pharmacist-in-charge shall designate the persons who have access to all or part of the automated device in which drugs or medicines are stored;
(4) All drugs stored in the device must be correctly labeled. The label must contain the following information:
(a) The name of each drug;
(b) The strength of each drug;
(c) The manufacturer's lot or internal control number of each drug; and
(d) The expiration date of each drug; and
(5) When using automated mechanical or electronic devices as pharmaceutical tools, the pharmacy must arrange to provide pharmaceutical services if the device fails.
Notwithstanding any provisions of this section, the pharmacist-in-charge of the pharmacy is responsible for maintaining and enforcing written procedures that establish safeguards for distributing or dispensing drugs and medicines through the automated device.
History
- Source: SL 1975, ch 16, § 1; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 22 SDR 32, effective September 14, 1995; 26 SDR 92, effective January 6, 2000; 50 SDR 138, effective June 2, 2024; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(5), 36-11-72(6).
- Law Implemented: SDCL 36-11-2.2(3), 36-11-46.4, 36-11-46.6.
ARSD 20:51:17:03 Stand-alone automated mechanical distribution device and automated prescription dispensing device -- License required
If a stand-alone automated mechanical distribution device or an automated prescription dispensing device is used to store, distribute, dispense, or track drugs, and there is no pharmacy license on the premises, the owner of the device must apply to the board to license the automated device as a pharmacy.
History
- Source: 50 SDR 138, effective June 2, 2024; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(5), 36-11-72(6).
- Law Implemented: SDCL 36-11-30, 36-11-33.
Chapter 20:51:19
ARSD 20:51:19:01 Continuing professional education defined
As used in this chapter continuing professional education is accredited, post-registration professional educational experience derived from participation in postgraduate studies, institutes, seminars, lectures, conferences, workshops, and such other forms of educational experiences designed to maintain the professional competency of the practice of pharmacy, improve professional skills, and preserve pharmaceutical standards for the purpose of the protection of the health and welfare of the citizens of the state of South Dakota.
History
- Source: 4 SDR 54, effective February 26, 1978; 12 SDR 151, 12 SDR 155, effective July 1, 1986.
- General Authority: SDCL 36-11-10, 36-11-11.
- Law Implemented: SDCL 36-11-23.2.
ARSD 20:51:19:02 Active pharmacist defined, Repealed
History
- Source: 4 SDR 54, effective February 26, 1978; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 53 SDR 13, effective August 16, 2026.
ARSD 20:51:19:03 Hours required
To qualify for a renewal of a pharmacist license or reinstatement, a pharmacist must complete twelve hours of approved continuing education. The twelve hours of approved continuing education required each year for renewal must be completed within the twenty-four months before the pharmacist's license expires. If a pharmacist applies for yearly renewal of the pharmacist's license pursuant to SDCL 36-11-23, in order to receive renewal, the pharmacist must have completed the required hours. If the pharmacist has a certification to administer immunizations, the pharmacist must complete one hour of continuing education related to immunizations, which may be one of the required twelve hours.
For the purposes of this section:
(1) “Approved continuing education,” means continuing pharmaceutical education programs made available by an approved provider; and
(2) “Approved provider,” means any association, corporation, educational institution, organization, or person who has been accredited by the Accreditation Council on Pharmaceutical Education as having met its criteria, indicating the ability to provide quality continuing pharmaceutical education programs, or any sponsor approved by the board in § 20:51:19:09.
History
- Source: 4 SDR 54, effective February 26, 1978; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 16 SDR 98, effective December 3, 1989; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1), 36-11-23.2.
- Law Implemented: SDCL 36-11-23.1 to 36-11-23.4, inclusive.
ARSD 20:51:19:03.01 Extension of time for good cause
For good cause, the board may grant to a pharmacist an extension of time, not exceeding six months, in which to comply with the continuing education requirement in § 20:51:19:03.
History
- Source: 9 SDR 171, effective July 12, 1983; 12 SDR 151, 12 SDR 155, effective July 1, 1986.
- General Authority: SDCL 36-11-23.2.
- Law Implemented: SDCL 36-11-23.2.
ARSD 20:51:19:04 Hours defined
The hourly value for continuing education credit is defined as the measurement of value applied to a particular accredited continuing pharmacy educational activity as assigned by the board relative to maintaining the competency of a registrant.
History
- Source: 4 SDR 54, effective February 26, 1978; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-11, 36-11-23.2.
- Law Implemented: SDCL 36-11-23.1 to 36-11-23.4, inclusive.
ARSD 20:51:19:05 Pharmacists keep own records
Pharmacists are responsible for maintaining their own records of continuing education hours for three years from the program completion date.
History
- Source: 4 SDR 54, effective February 26, 1978; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 16 SDR 98, effective December 3, 1989.
- General Authority: SDCL 36-11-10, 36-11-11.
- Law Implemented: SDCL 36-11-23.2.
ARSD 20:51:19:05.01 Audit to verify hours earned
The board shall audit at least five percent of licensed pharmacists at random annually after licensure to verify their continuing education.
History
- Source: 9 SDR 171, effective July 12, 1983; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-23.2.
- Law Implemented: SDCL 36-11-23.2, 36-11-23.3.
ARSD 20:51:19:06 Continuing education from other states
The board may accept continuing education hours obtained in any state, if the program is approved by the other state's board of pharmacy.
History
- Source: 4 SDR 54, effective February 26, 1978; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-11(1), 36-11-23.2.
- Law Implemented: SDCL 36-11-23.2.
ARSD 20:51:19:07 Newly licensed registrants
Continuing education requirements for newly licensed pharmacists must be calculated at the rate of one hour per month of continuing education credit from the date of registration until license expiration.
History
- Source: 4 SDR 54, effective February 26, 1978; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-11(1), 36-11-23.2.
- Law Implemented: SDCL 36-11-23.2, 36-11-23.3.
ARSD 20:51:19:08 Different ways of obtaining accredited continuing education hours, Repealed
History
- Source: 4 SDR 54, effective February 26, 1978; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:19:09 Sponsors defined
A sponsor shall be any person, school association, or corporation who wishes to develop a continuing education program.
History
- Source: 4 SDR 54, effective February 26, 1978; 12 SDR 151, 12 SDR 155, effective July 1, 1986.
- General Authority: SDCL 36-11-10, 36-11-11.
- Law Implemented: SDCL 36-11-23.2.
ARSD 20:51:19:10 Program approval
Each continuing education program must be approved by the board. Sponsors must apply for approval to the board, on forms furnished by the board, at least thirty days before the initiation of the course. The board shall send written notice of its approval or disapproval to sponsors.
The board must give each approved program an identification number and an hourly value. The board's approval of a program expires at the end of two years.
Each program evaluated must be supported by backup material, such as a brochure and learning objectives.
History
- Source: 4 SDR 54, effective February 26, 1978; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 16 SDR 98, effective December 3, 1989; 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-11(1).
- Law Implemented: SDCL 36-11-23.2, 36-11-23.4.
ARSD 20:51:19:11 Forms required for continuing education sponsors
The form for approval of continuing education programs must be completed by the sponsor and submitted to the board. The form must include the following information:
(1) Name of the sponsor and address;
(2) Name of the person in charge;
(3) Location of the program;
(4) Estimated number of the pharmacists and technicians participating;
(5) General title of the program;
(6) Type of program;
(7) How the program objectives will be met;
(8) Estimated contact time;
(9) How attendance or participation will be proven;
(10) How certificates will be awarded; and
(11) A copy of any examination, if utilized.
History
- Source: 4 SDR 54, effective February 26, 1978; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-11(1).
- Law Implemented: SDCL 36-11-23.2, 36-11-23.4.
ARSD 20:51:19:12 Program changes
Program changes shall be submitted to the board for approval prior to enactment by a sponsor. The board shall approve or disapprove program changes within 15 days.
History
- Source: 4 SDR 54, effective February 26, 1978; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 16 SDR 98, effective December 3, 1989.
- General Authority: SDCL 36-11-10, 36-11-11.
- Law Implemented: SDCL 36-11-23.2.
ARSD 20:51:19:13 Frequency of participation
Continuing education credit will be given only once for a participant's successful completion of a program.
History
- Source: 4 SDR 54, effective February 26, 1978; 12 SDR 151, 12 SDR 155, effective July 1, 1986.
- General Authority: SDCL 36-11-10, 36-11-11.
- Law Implemented: SDCL 36-11-23.2.
ARSD 20:51:19:14 Attendance by board or council members
Any member or staff of the State Board of Pharmacy or advisory council on continuing education established in SDCL 36-11-23.4 may attend and supervise any continuing education program.
History
- Source: 4 SDR 54, effective February 26, 1978; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11, 36-11-23.2.
- Law Implemented: SDCL 36-11-23.2, 36-11-23.4.
ARSD 20:51:19:15 Sponsors' records
Sponsors shall retain a file of participants' program completion for four years.
History
- Source: 4 SDR 54, effective February 26, 1978; 12 SDR 151, 12 SDR 155, effective July 1, 1986.
- General Authority: SDCL 36-11-10, 36-11-11.
- Law Implemented: SDCL 36-11-23.2.
ARSD 20:51:19:16 Sponsor to provide list of pharmacists and technicians attending program
The sponsor of a continuing education program shall provide to the board a written or electronic list of the pharmacists and technicians attending within thirty days after completion of the program or a licensed pharmacist may not use the hours or credits earned to qualify for continuing professional education.
History
- Source: 9 SDR 171, effective July 12, 1983; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-23.2.
- Law Implemented: SDCL 36-11-23.1 to 36-11-23.4, inclusive.
Chapter 20:51:20
ARSD 20:51:20:01 Input of drug information into prescription software platform to be by pharmacist or under supervision of pharmacist
History
- Source: 5 SDR 77, effective March 20, 1979; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 50 SDR 138, effective June 2, 2024; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(12), 36-11-68.
- Law Implemented: SDCL 36-11-2.2(1)(3), 36-11-25, 36-11-68.
ARSD 20:51:20:02 Requirements for storing prescription information
If a prescription software platform is used to store prescription information, the platform must:
(1) Maintain the confidentiality and integrity of the information contained in the platform;
(2) Be capable of producing a hard-copy daily summary of controlled substance transactions;
(3) Provide online retrieval of original prescription order information for those prescription orders that are currently authorized for refilling;
(4) Be capable of recording and storing all dates of any prescription refill and the initials of the pharmacist;
(5) Be capable of producing a patient profile indicating all drugs being dispensed and the date of all prescription refills; and
(6) Be capable of being reconstructed in the event of a computer malfunction or accident resulting in destruction of the platform.
History
- Source: 5 SDR 77, effective March 20, 1979; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 50 SDR 138, effective June 2, 2024; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(12), 36-11-68.
- Law Implemented: SDCL 36-11-68.
ARSD 20:51:20:03 Original prescription to be retained
The original prescription order must be retained manually or electronically, according to law. To keep original prescriptions in an electronic format, the prescription software platform must be capable of producing a copy of the original prescription that was entered into the platform via a scan or an electronic record.
History
- Source: 5 SDR 77, effective March 20, 1979; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 40 SDR 40, effective September 16, 2013; 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-11(12), 36-11-68.
- Law Implemented: SDCL 36-11-68.
ARSD 20:51:20:04 Use of common prescription software platform
Two or more affiliated pharmacies licensed by the board may utilize a common prescription software platform to practice pharmacy as defined in SDCL 36-11-2.2. Prescriptions may be refilled at any of these pharmacies as long as each pharmacy is identified by a unique code that documents the location of each filling and provisions are made to assure that the number of authorized refills is not exceeded.
A nonresident pharmacy not licensed by the board and sharing a common prescription software platform with a pharmacy licensed by the board may not practice pharmacy in this state.
History
- Source: 16 SDR 98, effective December 3, 1989; 26 SDR 92, effective January 6, 2000; 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-11(12).
- Law Implemented: SDCL 36-11-2.2, 36-11-19.2, 36-11-19.8, 36-11-68.
Chapter 20:51:21
ARSD 20:51:21:01 Definitions
Terms used in this chapter mean:
(1) "Container," that which holds the drug and is or may be in direct contact with the drug, without interacting chemically or physically affecting the drug placed in it so as to alter the strength, quality, or purity of the drug beyond the official compendium requirements;
(2) "Customized patient drug package," a package that contains two or more drugs per compartment;
(3) "Unit dose," a single dose of a drug in an individually sealed, labeled container ready for administration;
(4) "Unit dose package," an individual package that contains one single unit dose of a drug packaged by a manufacturer or a pharmacy and preserves the integrity and identity of the drug from the point of packaging to the point of administration; and
(5) "Unit of issue package," a package that provides multiple units of the same drug doses, each separated in a medication card or other specifically designed container.
History
- Source: 8 SDR 5, effective July 26, 1981; 12 SDR 151, 12 SDR 155, effective July 1, 1986; definition of "unit dose packaging" transferred from § 20:51:21:02, 18 SDR 95, effective November 25, 1991; 29 SDR 37, effective September 26, 2002; 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-11(1).
- Law Implemented: SDCL 36-11-2.2.
ARSD 20:51:21:01.01 Prepackaging and repackaging
In a pharmacy, prepackaging and repackaging may be done only by:
(1) A pharmacist; or
(2) A certified pharmacy intern or registered pharmacy technician, under the immediate supervision of a pharmacist.
All packaged drugs may be dispensed or distributed only from the premises where the drugs are prepackaged or repackaged. The prepackaged or repackaged drugs may only be distributed to a location that is under the same ownership as, or is affiliated with, the premises where drugs are prepackaged or repackaged. Any container used for prepackaging or repackaging must meet United States Pharmacopeia compendium requirements. A drug's packaging must meet the requirements of § 20:51:13:02.01 for the drug to be returned for credit or redispensing.
For purposes of this section, "prepackage" means to prepare a drug in a container for dispensing, prior to the receipt of an order. The packaging may be in a unit dose, single dose, or unit of issue package for use in a unit dose dispensing system, in a container suitable for a traditional dispensing system, or in a customized patient drug package.
For purposes of this section, "repackage" means to prepare a unit dose, single dose, unit of issue package, customized patient drug package, or traditional dispensing system package for dispensing pursuant to an existing order.
History
- Source: 29 SDR 37, effective September 26, 2002; 50 SDR 138, effective June 2, 2024; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(1).
- Law Implemented: SDCL 36-11-2.2(3), 36-11-46.6.
ARSD 20:51:21:02 Transferred
ARSD 20:51:21:03 Pharmacist to interpret original order of practitioner, Repealed
History
- Source: 8 SDR 5, effective July 26, 1981; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 18 SDR 95, effective November 25, 1991; 29 SDR 37, effective September 26, 2002; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:21:04 Repealed
History
- Source: 8 SDR 5, effective July 26, 1981; 12 SDR 151, 12 SDR 155, effective July 1, 1986; repealed, 18 SDR 95, effective November 25, 1991.
ARSD 20:51:21:05 Labeling of unit dose and unit of issue package -- Relabeling of unit dose and unit of issue system
Unit dose and unit of issue packages must be labeled in accordance with subdivision 20:51:13:02.01(5).
After any change in dosage or administration schedule, the pharmacy must relabel the unit of issue package no later than the next medication exchange.
History
- Source: 8 SDR 5, effective July 26, 1981; 9 SDR 14, effective August 8, 1982; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 18 SDR 95, effective November 25, 1991; 29 SDR 37, effective September 26, 2002; 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-11(1).
- Law Implemented: SDCL 36-11-2.2.
ARSD 20:51:21:05.01 Recall of a drug in unit dose distribution system
If a specific repackaged drug is recalled, all doses labeled with the lot number of the recalled drug must be removed from the unit dose distribution system. All doses of that drug not labeled with a lot number must be removed from the unit dose distribution system.
For the purpose of this section, “Unit dose distribution system," means a drug distribution system that is in a pharmacy outlet, hospital, or other health care facility and uses unit dose packages, or unit of issue packages, labeled in accordance with § 20:51:21:05 and preserves the identity of the drug until the time of administration.
History
- Source: 9 SDR 14, effective August 8, 1982; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 18 SDR 95, effective November 25, 1991; 29 SDR 37, effective September 26, 2002; 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-11(1).
- Law Implemented: SDCL 36-11-2.2.
ARSD 20:51:21:05.02 Manufacturer packaging
If the unit dose package or unit of issue package is obtained from the manufacturer and complies with applicable federal requirements, such packaging may be dispensed without the additional labeling as required in § 20:51:21:05.
History
- Source: 29 SDR 37, effective September 26, 2002.
- General Authority: SDCL 36-11-11(1).
- Law Implemented: SDCL 34-12B-2, 36-11-11(1).
ARSD 20:51:21:06 Pharmacist to maintain drug profile
A pharmacist shall maintain a drug profile for each patient whose drugs are delivered in a unit dose or unit of issue system.
History
- Source: 8 SDR 5, effective July 26, 1981; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 18 SDR 95, effective November 25, 1991; 29 SDR 37, effective September 26, 2002; 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-11(1).
- Law Implemented: SDCL 36-11-68.
ARSD 20:51:21:07 Pharmacist to be responsible for delivery of drugs to healthcare facility
A pharmacist is responsible for the delivery of drugs packaged in a unit dose or unit of issue system to a healthcare facility. Drugs must be delivered before the scheduled time of administration to the patient.
History
- Source: 8 SDR 5, effective July 26, 1981; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 18 SDR 95, effective November 25, 1991; 29 SDR 37, effective September 26, 2002; 50 SDR 138, effective June 2, 2024; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(1).
- Law Implemented: SDCL 36-11-2.2(1)(3).
Chapter 20:51:22
ARSD 20:51:22:00 Repealed
History
- Source: 26 SDR 92, effective January 6, 2000; repealed, 31 SDR 35, effective September 19, 2004.
ARSD 20:51:22:01 Repealed
History
- Source: 12 SDR 82, effective November 19, 1985; 12 SDR 151, 12 SDR 155, effective July 1, 1986; repealed, 31 SDR 35, effective September 19, 2004.
ARSD 20:51:22:02 Repealed
History
- Source: 12 SDR 82, effective November 19, 1985; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 26 SDR 92, effective January 6, 2000; repealed, 31 SDR 35, effective September 19, 2004.
ARSD 20:51:22:03 Repealed
History
- Source: 12 SDR 82, effective November 19, 1985; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 13 SDR 179, effective June 2, 1987; 26 SDR 92, effective January 6, 2000; repealed, 31 SDR 35, effective September 19, 2004.
ARSD 20:51:22:04 Repealed
History
- Source: 12 SDR 82, effective November 19, 1985; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 21 SDR 35, effective August 30, 1994; repealed, 31 SDR 35, effective September 19, 2004.
ARSD 20:51:22:05 Support personnel
Pharmacy support personnel are those persons other than a licensed pharmacist, a certified pharmacy intern, or a registered pharmacy technician, who may perform delivery, billing, custodial, maintenance, clerical, or other nontechnical duties assigned by the pharmacist under the pharmacist's general supervision.
Appropriately trained pharmacy support personnel may perform the following nontechnical functions involving the handling of prescription drugs, delegated to them by the pharmacist:
(1) Placing a prescription container into a bag or sack for delivery to the patient as part of the sales transaction after the accuracy of the prescription has been verified by the pharmacist;
(2) Opening drug shipments and affixing appropriate inventory or price stickers to drug stock bottles or containers;
(3) Answering telephones and filing processed, hard-copy prescriptions and other pharmacy records;
(4) Receiving a patient's request for a prescription refill, excluding the processing of the refill request; and
(5) Delivering drugs to patient care areas, long-term care facilities, patient residences, or patient employment locations, excluding the restocking of automated medication distribution systems.
History
- Source: 31 SDR 35, effective September 19, 2004; 50 SDR 138, effective June 2, 2024; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(1).
- Law Implemented: SDCL 36-11-1, 36-11-2.2, 36-11-10.
ARSD 20:51:22:06 Identification of pharmacy support personnel
A pharmacy support person shall, while on duty, wear a visible identification badge that clearly identifies the person as a pharmacy support person and depicts the person's first name.
History
- Source: 50 SDR 138, effective June 2, 2024; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(1).
- Law Implemented: SDCL 36-11-1, 36-11-10.
Chapter 20:51:23
ARSD 20:51:23:01 Transfer of original prescription information permitted
For the purpose of dispensing prescriptions, a pharmacy may transfer prescription information to another pharmacy, subject to the following requirements:
(1) The transfer is limited to the total quantity authorized on the original prescription;
(2) The transfer is communicated directly between two licensed pharmacists or registered pharmacy interns, either verbally or by facsimile; and
(3) Both the original and the transferred prescriptions are kept for two years from the date of the last refill.
History
- Source: 17 SDR 170, effective May 16, 1991; 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-11(1).
- Law Implemented: SDCL 36-11-2.2.
ARSD 20:51:23:02 Requirements of transferring pharmacist or intern
The pharmacist or intern transferring the prescription information shall:
(1) Record on the original prescription:
(a) The name and address of the pharmacy to which the prescription is transferred;
(b) The name of the pharmacist or intern receiving the prescription information;
(c) The name of the pharmacist or intern transferring the prescription information; and
(d) The date of the transfer.
(2) Record the number of refills transferred. If all refills are transferred, the original prescription shall be marked "void".
History
- Source: 17 SDR 170, effective May 16, 1991; 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-11(1).
- Law Implemented: SDCL 36-11-2.2, 36-11-25.
ARSD 20:51:23:03 Requirements of receiving pharmacist or intern
The pharmacist or intern receiving the transferred prescription information shall:
(1) Write the word "transfer" on the face of the transferred prescription;
(2) Record on the transferred prescription:
(a) The original date of issuance;
(b) The original prescription number and the number of refills authorized on the original prescription;
(c) The number of valid refills remaining and the date of the last refill;
(d) The name and address of the pharmacy from which the prescription information is transferred; and
(e) The name of the transferring and the receiving pharmacist or intern; and
(3) Clarify verbally any unclear information on a facsimile.
History
- Source: 17 SDR 170, effective May 16, 1991; 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-11(1).
- Law Implemented: SDCL 36-11-2.2, 36-11-25.
ARSD 20:51:23:04 Additional requirements for controlled substances
The following additional requirements apply to the transfer of controlled substances listed in SDCL 34-20B-18 to 34-20B-26, inclusive:
(1) The transfer of original prescription drug order information is permissible between pharmacies once, after which the original prescription is void;
(2) The transferring pharmacist shall write the word "void" on the face of the invalidated prescription drug order and record on the prescription the drug enforcement administration (DEA) registration number of the pharmacy to which the prescription is transferred; and
(3) The receiving pharmacist shall record the DEA registration number of the pharmacy from which the prescription was transferred.
History
- Source: 17 SDR 170, effective May 16, 1991.
- General Authority: SDCL 36-11-11.
- Law Implemented: SDCL 36-11-11.
ARSD 20:51:23:05 Pharmacies with electronic prescription software platforms
A pharmacy having an electronic prescription software platform does not need to record information on the original prescription if the platform has the capacity to store all of the information required in §§ 20:51:23:02 to 20:51:23:04, inclusive, and has a mechanism to prohibit the transfer or refilling of prescription drug orders for controlled substances that have been previously transferred.
History
- Source: 17 SDR 170, effective May 16, 1991; 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-11(1)(12).
- Law Implemented: SDCL 36-11-68.
ARSD 20:51:23:06 Exemption for pharmacies using common prescription software
Pharmacies electronically accessing the same prescription records on a common prescription software platform are exempt from this chapter if the requirements of § 20:51:20:04 are met.
History
- Source: 17 SDR 170, effective May 16, 1991; 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-11(1)(12).
- Law Implemented: SDCL 36-11-2.2, 36-11-68.
ARSD 20:51:23:07 Prescription orders for patients discharged from hospitals, Repealed
History
- Source: 17 SDR 170, effective May 16, 1991; 50 SDR 138, effective June 2, 2024.
Chapter 20:51:24
ARSD 20:51:24:01 Transitory patient defined, Repealed
History
- Source: 19 SDR 93, effective December 31, 1992; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:24:02 Patient record system
A pharmacy must maintain a record system of patients for whom it dispenses prescription drug orders. The patient record system must provide for the immediate retrieval of information necessary for the dispensing pharmacist to identify previously dispensed drugs or drug devices at the time a prescription drug order is presented for dispensing. The record must include as much of the following information as the pharmacy is able to obtain:
(1) The full legal name of the patient for whom the drug or drug device is intended;
(2) The address and telephone number of the patient;
(3) The patient's age or date of birth;
(4) The patient's gender;
(5) A list of all prescription drugs or drug devices obtained by the patient at the pharmacy maintaining the patient record during the two-year period immediately preceding the most recent entry, showing the prescription number, name and strength of the drug or drug device, the quantity and date received, and the name of the prescriber;
(6) Any known allergies, drug reactions, idiosyncrasies, and chronic conditions or disease states of the patient;
(7) The identity of any other drugs, including over-the-counter drugs and drug devices currently being used by the patient, which may relate to a prospective drug review;
(8) Comments of the pharmacist relevant to the individual's drug therapy, including any information peculiar to the specific patient or drug; and
(9) If the patient is an animal, the profile must include the species and owner's name.
History
- Source: 19 SDR 93, effective December 31, 1992; 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-68.
- Law Implemented: SDCL 36-11-68.
ARSD 20:51:24:03 Reasonable effort to obtain information
A reasonable effort to obtain information is an oral or written request for the information listed in § 20:51:24:02 made by the pharmacist or a designee to the patient or the patient's caregiver.
History
- Source: 19 SDR 93, effective December 31, 1992.
- General Authority: SDCL 36-11-68.
- Law Implemented: SDCL 36-11-68.
ARSD 20:51:24:04 Maintenance of records
A pharmacy shall maintain information in a patient record system for at least two years from the date of the last entry in the record. The information must be readily retrievable and may be maintained in an electronic data system or as a paper copy.
History
- Source: 19 SDR 93, effective December 31, 1992; 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-68.
- Law Implemented: SDCL 36-11-68.
Chapter 20:51:25
ARSD 20:51:25:01 Definition
"Adverse drug reaction," when used in this chapter, means a clinically significant, undesirable effect experienced by a patient as a result of a course of drug therapy.
History
- Source: 19 SDR 93, effective December 31, 1992; 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-68.
- Law Implemented: SDCL 36-11-68.
ARSD 20:51:25:02 Review of patient's record
A pharmacist shall review the patient's record when a prescription drug order or refill request is presented for dispensing in order to identify:
(1) Overutilization, or use of a drug in quantities or for durations that put the patient at risk of an adverse drug reaction;
(2) Underutilization, or use of a drug by a patient in an insufficient quantity to achieve a desired therapeutic goal;
(3) Therapeutic duplication, or use of two or more drugs from the same therapeutic class in a way that the combined daily dose puts the patient at risk of an adverse drug reaction;
(4) Drug-disease contraindications, or the potential for or the occurrence of an undesirable alteration of the therapeutic effect of a given drug because of the presence of a disease condition in the patient or an adverse effect of the drug on the patient's disease condition;
(5) Adverse drug-drug interactions, or the potential for or the occurrence of an adverse drug reaction as a result of the patient using two or more drugs together;
(6) Incorrect drug dosage, or the dosage lies outside the daily dosage range specified in the manufacturer's package insert for the drug as necessary to achieve therapeutic benefit;
(7) Incorrect duration of drug treatment, or the number of days of prescribed therapy exceeds or falls short of the recommendations contained in the manufacturer's package insert for the drug;
(8) Drug-allergy interactions, or the significant potential for or the occurrence of an allergic reaction as a result of drug therapy; or
(9) Clinical abuse or misuse.
The pharmacist shall attempt to avoid or resolve any problems identified during the review and may consult with the prescriber.
History
- Source: 19 SDR 93, effective December 31, 1992; 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-68.
- Law Implemented: SDCL 36-11-2.2, 36-11-68.
ARSD 20:51:25:03 Elements of counseling
Patient counseling involves:
(1) The name and description of the drug;
(2) The dosage form, dose, route of administration, and duration of drug therapy;
(3) The intended use of the drug and its expected action;
(4) Special directions and precautions for preparation, administration, and use by the patient;
(5) Common severe side effects, adverse drug reactions, interactions, and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur;
(6) Techniques for self-monitoring drug therapy;
(7) Storage requirements;
(8) Prescription refill information;
(9) Action to be taken if a dose is missed; and
(10) The pharmacist's comments relevant to the individual's drug therapy, including any other information peculiar to the specific patient or drug.
History
- Source: 19 SDR 93, effective December 31, 1992; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-68.
- Law Implemented: SDCL 36-11-2.2(2), 36-11-68.
ARSD 20:51:25:04 Standards for counseling
The pharmacist is responsible for meeting standards for counseling as follows:
(1) If a prescription drug is dispensed for the first time to a patient, the pharmacist shall orally counsel the patient or caregiver in person whenever practicable. If the prescription drug is delivered or mailed, the pharmacist shall initiate counseling by telephone. If the counseling cannot be completed by telephone, the pharmacist may use alternative forms of patient information;
(2) If a prescription drug has been previously dispensed to a patient and review of the patient's record reveals any condition listed in §20:51:25:02, the pharmacist shall orally counsel the patient or caregiver in person whenever practicable. If the prescription drug is delivered or mailed, the pharmacist shall initiate counseling by telephone. If the counseling cannot be completed by telephone, the pharmacist may use alternative forms of information;
(3) If a prescription drug has been previously dispensed to a patient and the patient's record shows no change in the dosage, form, strength, or directions for use, the pharmacist or designee may offer counseling to a patient or caregiver in one or more of the following ways:
(a) Face-to-face;
(b) By a notation affixed to or written on the bag in which the prescription is dispensed; or
(c) By telephone.
History
- Source: 19 SDR 93, effective December 31, 1992.
- General Authority: SDCL 36-11-68.
- Law Implemented: SDCL 36-11-68.
ARSD 20:51:25:05 Alternative forms of patient information
Alternative forms of patient information as referenced in § 20:51:25:04 are written information leaflets, pictogram labels, video programs, or information generated by electronic data processing equipment. Alternative forms of patient information must advise the patient or caregiver that the pharmacist may be contacted for consultation in person at the pharmacy or by telephone. A pharmacist may use alternative forms of patient information to supplement patient counseling.
History
- Source: 19 SDR 93, effective December 31, 1992; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-68.
- Law Implemented: SDCL 36-11-68.
ARSD 20:51:25:06 Record of counseling
The absence of a record signifies that counseling was accepted and provided or that an offer was made. Failure to complete counseling to a patient or caregiver shall be recorded for the following instances:
(1) The patient or caregiver refuses to accept the pharmacist's personal oral counseling;
(2) Counseling was not practicable; or
(3) Counseling could not be accomplished by telephone contact.
History
- Source: 19 SDR 93, effective December 31, 1992.
- General Authority: SDCL 36-11-68.
- Law Implemented: SDCL 36-11-68.
Chapter 20:51:27
ARSD 20:51:27:01 Definitions
In addition to terms defined by SDCL 36-11-2, terms used in this chapter mean:
(1) "Home state," the state in which the dispensing facilities of a nonresident pharmacy are located.
History
- Source: 24 SDR 40, effective October 5, 1997.
- General Authority: SDCL 36-11-11(4).
- Law Implemented: SDCL 36-11-19.3.
ARSD 20:51:27:02 Application form
The application form for licensure of a nonresident pharmacy must include the information required by SDCL 36-11-19.3 and:
(1) Evidence of licensure in good standing in the nonresident pharmacy's home state;
(2) A description of any disciplinary action against the nonresident pharmacy or the nonresident pharmacy owner, in the home state or any other state within the last four years and the reason for the action;
(3) If the pharmacist-in-charge is not the sole owner or part owner of the merchandise and fixtures of the nonresident pharmacy, an affidavit as described in SDCL 36-11-32;
(4) A list of all other states in which the pharmacy is licensed;
(5) A description of pharmacy services provided to patients located in this state; and
(6) The results of an inspection performed by the regulatory or licensing agency of the home state, any accreditation agency recognized by the board, or the United States Food and Drug Administration, which has been conducted on-site at the nonresident pharmacy within the last four years, and any deficiencies on the inspection that required corrective action.
History
- Source: 24 SDR 40, effective October 5, 1997; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(3).
- Law Implemented: SDCL 36-11-19.3, 36-11-19.4.
ARSD 20:51:27:03 Application fee
The fee to accompany the initial application for a nonresident pharmacy license and each application for renewal is two hundred dollars. The fees are non-refundable.
History
- Source: 24 SDR 40, effective October 5, 1997; 24 SDR 160, effective May 26, 1998; 50 SDR 138, effective June 2, 2024; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(3), 36-11-19.3, 36-11-19.5.
- Law Implemented: SDCL 36-11-19.3, 36-11-19.5.
ARSD 20:51:27:04 Report of change in ownership or location -- Application required
The owner of a nonresident pharmacy or persons delegated by the owner shall report the following to the board:
(1) Change in pharmacist-in-charge, notify within ten days of change in position status;
(2) Ownership change, notify within thirty days after the transaction;
(3) Change in location, notify within thirty days after the transaction. If the location change is to a different state, a new application is required pursuant to § 20:51:27:02; and
(4) Closure of a nonresident pharmacy, notify at least ten days prior to closure.
History
- Source: 24 SDR 40, effective October 5, 1997; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(3).
- Law Implemented: SDCL 36-11-1, 36-11-10, 36-11-19.3, 36-11-19.5, 36-11-37, 36-11-39.
Chapter 20:51:28
ARSD 20:51:28:01 Authority to administer influenza immunizations
A pharmacist may administer influenza immunizations to eligible patients 18 years of age and older if the pharmacist meets the qualifications set forth in this chapter and has been granted authorization by the board.
History
- Source: 29 SDR 37, effective September 26, 2002; 47 SDR 42, effective October 12, 2020.
- General Authority: SDCL 36-11-11(1), 36-11-19.1.
- Law Implemented: SDCL 36-11-19.1.
ARSD 20:51:28:01.01 Authority to administer immunizations
20 : 51 : 28 : 01.01 . Authority to administer immunizations. A pharmacist may administer immunizations by prescription drug order signed by a practitioner or by protocol signed by a physician if the pharmacist meets the criteria set forth in § 20:51:28:02 and is authorized by the board.
History
- Source: 47 SDR 42, effective October 12, 2020.
- General Authority: SDCL 36-11-11(1), 36-11-19.1.
- Law Implemented: SDCL 36-11-19.1.
ARSD 20:51:28:02 Qualifications for authorization to administer immunizations
The board may authorize a pharmacist who:
(1) Is licensed to practice pharmacy in this state;
(2) Has completed an approved training program; and
(3) Is certified in cardiopulmonary resuscitation.
History
- Source: 29 SDR 37, effective September 26, 2002; 47 SDR 42, effective October 12, 2020.
- General Authority: SDCL 36-11-11(1), 36-11-19.1.
- Law Implemented: SDCL 36-11-19.1.
ARSD 20:51:28:02.01 Qualifications for interns to administer immunizations
20 : 51 : 28 : 02.01 . Qualifications for interns to administer immunizations. A pharmacy intern may administer immunizations in a pharmacy if the intern:
(1) Is registered as a pharmacy intern in this state;
(2) Has successfully completed an approved training program;
(3) Is certified in cardiopulmonary resuscitation; and
(4) Is directly supervised by a pharmacist who has a current authorization to administer immunizations in this state.
History
- Source: 47 SDR 42, effective October 12, 2020.
- General Authority: SDCL 36-11-11(1), 36-11-19.1, 36-11-25.
- Law Implemented: SDCL 36-11-19.1, 36-11-25.
ARSD 20:51:28:02.02 Qualifications for pharmacy technicians to administer immunizations
A pharmacy technician may administer immunizations if the technician:
(1) Is registered as a certified pharmacy technician by the State Board of Pharmacy as set forth in § 20:51:29:06;
(2) Has successfully completed an immunization training program approved by the board for technicians;
(3) Is certified in cardiopulmonary resuscitation;
(4) Is immediately supervised by a pharmacist who has a current authorization to administer immunizations in this state; and
(5) Completes one hour of continuing education related to immunizations annually.
All technician immunization training, continuing education, and cardiopulmonary resuscitation documents must be kept in the pharmacy for five years and available for inspection at any time.
History
- Source: 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(1)(13), 36-11-19.1.
- Law Implemented: SDCL36-11-1, 36-11-2(23), 36-11-10, 36-11-19.1(1).
ARSD 20:51:28:03 Repealed
History
- Source: 29 SDR 37, effective September 26, 2002; 47 SDR 42, effective October 12, 2020.
ARSD 20:51:28:04 Training program requirements
The training program for administration of immunizations must include the following course of study:
(1) Basic immunology and the human immune response;
(2) Mechanics of immunity, adverse effects, dose, and administration schedule of available vaccines;
(3) Response to an emergency situation as a result of the administration of an immunization;
(4) Administration of injections; and
(5) Record keeping and reporting requirements as set forth in § 20:51:28:05.
Any training program must be accredited by the Accreditation Council for Pharmacy Education and must provide a certificate to a pharmacist or intern who has successfully completed the training program.
History
- Source: 29 SDR 37, effective September 26, 2002; 47 SDR 42, effective October 12, 2020.
- General Authority: SDCL 36-11-11(1), 36-11-19.1.
- Law Implemented: SDCL 36-11-19.1.
ARSD 20:51:28:05 Record keeping and reporting requirements
A pharmacist authorized under this chapter to administer immunizations shall maintain in the pharmacy, administered for a minimum of five years:
(1) The name, address, and date of birth of each patient who received an immunization;
(2) The date of administration and site of the injection;
(3) The name, dose, manufacturer's lot number, and expiration date of the vaccine;
(4) The name and address of the patient's primary health care provider, as identified by the patient;
(5) The name of the person administering the immunization;
(6) A record of any consultation or other professional information provided to the patient; and
(7) The name and date of the Vaccine Information Sheet provided to the patient.
The pharmacy must report all administrations of immunizations to the South Dakota Immunization Information System within 14 days of the immunization. The required records as set forth in this section are open to inspection by the board and must be made available upon the board's request.
History
- Source: 29 SDR 37, effective September 26, 2002; 47 SDR 42, effective October 12, 2020.
- General Authority: SDCL 36-11-11(1), 36-11-19.1.
- Law Implemented: SDCL 36-11-19.1.
ARSD 20:51:28:06 Confidentiality of records maintained
The records identified in § 20:51:28:05 that include specific patient information are confidential records. Nothing in this section affects the requirements of SDCL 36-11-69 relating to the release of confidential patient information.
History
- Source: 29 SDR 37, effective September 26, 2002; 47 SDR 42, effective October 12, 2020.
- General Authority: SDCL 36-11-11(1), 36-11-19.1.
- Law Implemented: SDCL 36-11-19.1, 36-11-69.
ARSD 20:51:28:07 Renewal of authorization to administer immunizations
The authorization to administer immunizations must be renewed on or before September 30. A pharmacist desiring to renew the authorization shall attest to the following:
(1) The pharmacist is certified in cardiopulmonary resuscitation; and
(2) The pharmacist has completed one hour of continuing education related to immunizations.
The board may audit for compliance with the renewal requirements of this section.
History
- Source: 29 SDR 37, effective September 26, 2002; 47 SDR 42, effective October 12, 2020.
- General Authority: SDCL 36-11-11(1), 36-11-19.1.
- Law Implemented: SDCL 36-11-19.1.
Chapter 20:51:29
ARSD 20:51:29:00 Definitions
Terms used in SDCL 36-11-2 have the same meaning when used in this chapter.
Additionally, as used in this chapter, "pharmacy intern" has the definition set forth in § 20:51:02:01.
History
- Source: 31 SDR 35, effective September 19, 2004; 38 SDR 121, effective January 17, 2012; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(1)(13).
- Law Implemented: SDCL 36-11-1, 36-11-2, 36-11-10, 36-11-25.
ARSD 20:51:29:01 Purpose of registration
A registration program for all pharmacy technicians is established for the primary purpose of assuring the competency of registered pharmacy technicians and for purposes of identifying, tracking, and bringing disciplinary actions against pharmacy technicians.
History
- Source: 31 SDR 35, effective September 19, 2004; 38 SDR 121, effective January 17, 2012; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1)(13).
- Law Implemented: SDCL 36-11-2(22).
ARSD 20:51:29:02 Registration required
Any individual employed in this state as a pharmacy technician shall obtain and maintain during the employment a current registration as a pharmacy technician pursuant to this chapter. Any person accepting employment as a pharmacy technician in this state who fails to register as a pharmacy technician as required by rule may be subject to disciplinary action in accordance with § 20:51:29:27.
History
- Source: 31 SDR 35, effective September 19, 2004; 38 SDR 121, effective January 17, 2012; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1)(13).
- Law Implemented: SDCL 36-11-2(22).
ARSD 20:51:29:03 Initial application for registration
Any individual must submit an initial application for registration as a pharmacy technician to the board within thirty days of accepting employment as a pharmacy technician in a licensed pharmacy located in South Dakota.
The board may issue an initial pharmacy technician registration to any individual who is:
(1) Sixteen years of age or older; and
(2) Employed by a full-time or part-time pharmacy or enrolled in a pharmacy technician job exploration program through the high school the individual is attending.
History
- Source: 31 SDR 35, effective September 19, 2004; 38 SDR 121, effective January 17, 2012; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(1)(13).
- Law Implemented: SDCL 36-11-2(23).
ARSD 20:51:29:04 College- or vocational-based training program
A person who is enrolled in a college- or vocational-based pharmacy technician training program shall obtain a pharmacy technician registration from the board prior to beginning any on-site practical experience.
History
- Source: 31 SDR 35, effective September 19, 2004; 38 SDR 121, effective January 17, 2012; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1)(13).
- Law Implemented: SDCL 36-11-2(22).
ARSD 20:51:29:05 Exemptions from registration
A registered pharmacy intern whose South Dakota certificate is in good standing and who performs any function described in § 20:51:29:21 is not required to register as a pharmacy technician with the board.
History
- Source: 31 SDR 35, effective September 19, 2004; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1)(13), 36-11-25.
- Law Implemented: SDCL 36-11-2(22), 36-11-25.
ARSD 20:51:29:06 Certification of pharmacy technicians
A pharmacy technician may obtain national certification. To obtain registration as a certified technician, the person must be certified by a national organization and have passed a pharmacy technician certification examination that is accredited by the National Commission for Certifying Agencies.
Pharmacy technician national certification does not supplant the need for a licensed pharmacist to exercise control over the performance of a delegated function nor does national certification exempt the pharmacy technician from registration pursuant to this chapter.
History
- Source: 31 SDR 35, effective September 19, 2004; 38 SDR 121, effective January 17, 2012; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1)(13).
- Law Implemented: SDCL 36-11-2(22).
ARSD 20:51:29:07 Registration application form -- Fee
The application for registration as a pharmacy technician must be on a form approved by the board and be accompanied by the fee set forth in § 20:51:29:12.
History
- Source: 31 SDR 35, effective September 19, 2004; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(1)(13).
- Law Implemented: SDCL 36-11-2(23), 36-11-11(13).
ARSD 20:51:29:08 Declaration of current impairment or limitations
The applicant shall declare any current use of drugs, alcohol, or other chemical substances that in any way impairs or limits the applicant's ability to perform the duties of a pharmacy technician with reasonable skill and safety.
History
- Source: 31 SDR 35, effective September 19, 2004; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1)(13).
- Law Implemented: SDCL 36-11-2(22).
ARSD 20:51:29:09 Felony or misdemeanor crimes
The applicant shall declare any history of being charged with, convicted of, or entering a plea of guilty or no contest to, a felony or misdemeanor crime other than any traffic violation with a fine under one hundred dollars.
History
- Source: 31 SDR 35, effective September 19, 2004; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1)(13).
- Law Implemented: SDCL 36-11-2(22).
ARSD 20:51:29:10 Sworn signature
The applicant shall sign and attest to the accuracy of the application under penalty of perjury and shall submit it to the board.
History
- Source: 31 SDR 35, effective September 19, 2004; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1)(13).
- Law Implemented: SDCL 36-11-2(22).
ARSD 20:51:29:11 Registration renewal, Repealed
History
- Source: 31 SDR 35, effective September 19, 2004; 38 SDR 121, effective January 17, 2012; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:29:12 Initial and renewal registration fees
The fee for initial registration as a pharmacy technician is twenty-five dollars. The renewal fee for registration is twenty-five dollars. The registration fee must be paid at the time the initial application or the renewal application is submitted. The fees paid to the board are non-refundable.
History
- Source: 31 SDR 35, effective September 19, 2004; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(1)(13).
- Law Implemented: SDCL 36-11-2(23), 36-11-11(13).
ARSD 20:51:29:13 Expiration of registration -- Requirements for renewal -- Continuing education
Registration as a pharmacy technician expires on October thirty-first and must be renewed annually. To renew the registration, the pharmacy technician must submit to the board:
(1) A renewal application;
(2) The non-refundable renewal fee; and
(3) Proof of:
(a) Having completed, within the last twenty-four months, six hours of continuing education that have not been utilized as continuing education credit for a prior registration; or
(b) Current national certification from a pharmacy technician program accredited by the National Commission for Certifying Agencies.
An individual who continues employment as a pharmacy technician without a current registration may be subject to disciplinary actions as set forth in § 20:51:29:27.
History
- Source: 31 SDR 35, effective September 19, 2004; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(1)(13).
- Law Implemented: SDCL 36-11-1, 36-11-2(23), 36-11-10.
ARSD 20:51:29:14 Registration verification
The pharmacist-in-charge of a pharmacy utilizing a registered pharmacy technician is responsible for verifying that any technician working in the pharmacy is registered with the board and compliant with all rules of this chapter. Any violation by the technician may be grounds for disciplinary action against the pharmacist-in-charge.
History
- Source: 31 SDR 35, effective September 19, 2004; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(1)(13).
- Law Implemented: SDCL 36-11-1, 36-11-2(23), 36-11-2.2, 36-11-10.
ARSD 20:51:29:15 Notification to the board
A registered pharmacy technician shall, within ten days of any change in the technician's name, address, or pharmacy employment status, report that change to the board.
History
- Source: 31 SDR 35, effective September 19, 2004; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1)(13).
- Law Implemented: SDCL 36-11-2(22).
ARSD 20:51:29:16 Training and utilization of pharmacy technicians
The pharmacist-in-charge of a pharmacy utilizing a registered pharmacy technician shall ensure that the technician receives adequate training in the tasks performed by technicians working at that pharmacy. A licensed pharmacy employing a registered pharmacy technician shall develop, implement, and periodically review written policies and procedures for training and utilizing technicians appropriate to the practice of pharmacy at that pharmacy. Each pharmacy shall specify the frequency of review in its policies. Each pharmacy shall document and maintain each registered pharmacy technician's training for the duration of employment. The pharmacy shall make its policies and procedures and documentation of registered pharmacy technician training available for inspection by the board.
History
- Source: 31 SDR 35, effective September 19, 2004; 38 SDR 121, effective January 17, 2012; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(1)(13).
- Law Implemented: SDCL 36-11-1, 36-11-2(23). 36-11-10.
ARSD 20:51:29:17 Identification of pharmacy technicians
A registered pharmacy technician shall, while on duty, wear a visible identification badge that clearly identifies the person as a pharmacy technician and includes the technician's first name.
History
- Source: 31 SDR 35, effective September 19, 2004; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1)(13).
- Law Implemented: SDCL 36-11-2(22).
ARSD 20:51:29:18 Misrepresentation prohibited
A registered pharmacy technician may not represent themself as a pharmacist.
History
- Source: 31 SDR 35, effective September 19, 2004; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1)(13).
- Law Implemented: SDCL 36-11-2(22).
ARSD 20:51:29:19 Ratio
Except as provided in § 20:51:29:19.02, up to three registered pharmacy technicians may be on duty in a pharmacy for every pharmacist on duty. A pharmacy intern does not count in this ratio.
Cross-Reference: Number of interns, § 20:51:02:11.01.
History
- Source: 31 SDR 35, effective September 19, 2004; 42 SDR 19, effective August 19, 2015; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1)(13).
- Law Implemented: SDCL 36-11-2(22).
ARSD 20:51:29:19.01 Repealed
History
- Source: 33 SDR 73, effective November 6, 2006; 36 SDR 21, effective August 17, 2009; repealed, 42 SDR 19, effective August 19, 2015.
ARSD 20:51:29:19.02 Exception to ratio for hospital, mail order, and long-term care pharmacy
The maximum ratio of pharmacists to registered pharmacy technicians who may be on duty in a hospital, mail order, or long-term care pharmacy is determined by the pharmacist-in-charge. Regardless of the ratio, the following requirements must be met:
(1) Medication must be dispensed pursuant to a legal prescription;
(2) The technology must include tablet or product imaging or bar code scanning, to ensure accuracy in the prescription filling process;
(3) A role-based access software automation system that places stop points within the prescription filling process must be used, and the system must require a pharmacist's intervention before the prescription may move to the next step in the prescription dispensing process;
(4) Pharmacy software that screens and detects drug allergies, identifies drug interactions, and checks age-appropriate dosage ranges must be used;
(5) A pharmacist shall review clinically significant computer warnings of drug interactions, therapy duplications, and contraindications;
(6) Electronic surveillance technology must be used to control access or to provide continuous monitoring of all areas where drugs are stored or dispensed;
(7) All non-pharmacist personnel who input patient drug information into a computer or whose duties include receiving, packaging, or shipping of drugs, or who have access to any areas where drugs are dispensed, must be registered as a pharmacy technician in accordance with this chapter or be a pharmacy intern under chapter 20:51:02;
(8) In hospital and long-term care pharmacies, nursing personnel in facilities served by the pharmacy shall have telephone access to a pharmacist twenty-four hours a day, seven days a week. In mail order pharmacies, a patient shall have access to a pharmacist twenty-four hours a day, seven days a week on a dedicated pharmacist staff line;
(9) Drug information must be readily available to pharmacists;
(10) A quality assurance program that identifies and evaluates dispensing errors, accompanied by a continuous quality improvement program that assures dispensing accuracy, must be in place;
(11) The pharmacy must maintain written policies and procedures for all clerical, supportive, technical, and clinical pharmacy functions;
(12) There must be written policies and procedures for training pharmacy personnel, including ongoing training programs for all personnel and documentation of that training for each employee; and
(13) There must be a monitoring program designed to prevent diversion of controlled substances. The program must include perpetual inventory of all scheduled controlled drugs. Routine audits must be conducted by pharmacy personnel to review purchases versus dispensing of controlled drugs to deter and detect diversion.
History
- Source: 36 SDR 21, effective August 17, 2009; 42 SDR 19, effective August 19, 2015; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1)(13).
- Law Implemented: SDCL 36-11-2(22), 36-11-19.2, 36-11-33.
ARSD 20:51:29:20 Delegation and supervision of technical functions
A pharmacist may delegate any technical dispensing function to a registered pharmacy technician provided the function is performed under the immediate personal supervision of the pharmacist delegating the function. The pharmacist shall provide and document the final verification for the accuracy, validity, completeness, and appropriateness of the patient's prescription or medication order prior to the delivery of the medication to the patient or the patient's representative.
The physical presence requirement of the pharmacist does not apply when utilizing an automated mechanical distribution device. The registered pharmacy technician may place medications into the automated mechanical distribution device that have been checked by the pharmacist. The pharmacist is not required to accompany the registered pharmacy technician when placing medications into the automated mechanical distribution device. The automated mechanical distribution device must be capable of printing out a record of medications filled by the registered pharmacy technician. The record must be checked and verified by the pharmacist daily.
History
- Source: 31 SDR 35, effective September 19, 2004; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1)(5)(13).
- Law Implemented: SDCL 36-11-2(22), 36-11-44.
ARSD 20:51:29:21 Technical functions
At the discretion of the supervising pharmacist, technical functions that may be delegated to a registered pharmacy technician are:
(1) Performing packaging, manipulative, or repetitive tasks relating to the processing of a prescription or medication order in a licensed pharmacy;
(2) Accepting prescription refill authorization communicated to a pharmacy by a prescriber, or by the prescriber's agent. Any changes other than the number of refills on the prescription may not be accepted by a technician and must be accepted by a pharmacist or pharmacy intern;
(3) Contacting prescribers to obtain prescription refill authorization;
(4) Collecting pertinent patient information;
(5) Inspecting drug supplies provided and controlled by a South Dakota licensed pharmacy, including drug supplies maintained in an automated mechanical distribution device, emergency medical room, ambulance, long-term care facility, hospital nursing unit, or hospice facility; and
(6) Assisting the pharmacist with the preparation of medications for administration to the patient topically, by injection, or by other approved methods.
History
- Source: 31 SDR 35, effective September 19, 2004; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1)(13).
- Law Implemented: SDCL 36-11-2(22).
ARSD 20:51:29:22 Tasks a pharmacy technician may not perform
A registered pharmacy technician may not:
(1) Provide the final verification for the accuracy, validity, completeness, or appropriateness of a filled prescription or medication order;
(2) Conduct prospective drug use review or evaluate a patient's medication record for purposes identified in § 20:51:25:02;
(3) Provide final verification of automated dispensing medication fill records for accuracy and completeness;
(4) Make decisions that require a pharmacist's professional judgment;
(5) Accept new verbal prescription medication orders communicated to the pharmacy by a prescriber or the prescriber's agent; or
(6) Provide pharmaceutical services in a pharmacy without a pharmacist being present, except as authorized in chapter 20:51:30.
A violation of this section may be grounds for disciplinary action as provided in § 20:51:29:27.
History
- Source: 31 SDR 35, effective September 19, 2004; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1)(13).
- Law Implemented: SDCL 36-11-2(22).
ARSD 20:51:29:23 Misrepresentative deeds
A registered pharmacy technician may not make any statement tending to deceive, misrepresent, or mislead anyone, or be a party to or an accessory to any fraudulent or deceitful practice or transaction in a pharmacy.
History
- Source: 31 SDR 35, effective September 19, 2004; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1)(13).
- Law Implemented: SDCL 36-11-2(22).
ARSD 20:51:29:24 Confidentiality
In the absence of express written consent from the patient or a written order or direction of a court, except where the best interests of the patient require, a registered pharmacy technician may not divulge or reveal to any person other than as outlined in SDCL 36-11-69, any of the following information:
(1) The contents of any prescription drug order or medication, the therapeutic effect thereof, or the nature of professional pharmaceutical services rendered to the patient;
(2) The nature, extent, or degree of illness suffered by the patient; or
(3) Any medical information furnished by the prescriber.
History
- Source: 31 SDR 35, effective September 19, 2004; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1)(13).
- Law Implemented: SDCL 36-11-2(22), 36-11-69.
ARSD 20:51:29:25 Illegal or unethical behavior
A registered pharmacy technician may not exhibit illegal or unethical behavior in connection with the technician's pharmacy employment. Illegal or unethical behavior are verbal or physical abuse, coercion, intimidation, harassment, sexual advances, threats, degradation of character, profanity, indecent or obscene conduct, and theft. A violation of this section may be grounds for disciplinary action as provided for in § 20:51:29:27.
History
- Source: 31 SDR 35, effective September 19, 2004; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1)(13).
- Law Implemented: SDCL 36-11-2(22).
ARSD 20:51:29:26 Denial of registration
The board may deny an initial or renewal application for registration as a pharmacy technician for any violation of:
(1) The laws of this state, another state, or the United States, relating to prescription drugs, controlled substances, or nonprescription drugs; or
(2) This chapter.
History
- Source: 31 SDR 35, effective September 19, 2004; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1)(13).
- Law Implemented: SDCL 36-11-2(22).
ARSD 20:51:29:27 Disciplinary actions
For violations of this chapter, the board may:
(1) Revoke a pharmacy technician registration;
(2) Suspend a pharmacy technician registration until further order of the board or for a specified period;
(3) Not renew a pharmacy technician registration;
(4) Prohibit permanently, until further order of the board, or for a specified period, the engaging in specified procedures, methods, or acts;
(5) Impose a probationary period;
(6) Refer the pharmacy technician to the health professionals' assistance program; or
(7) Issue a letter of concern or public reprimand.
History
- Source: 31 SDR 35, effective September 19, 2004; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1)(13).
- Law Implemented: SDCL 36-2A-2, 36-2A-6, 36-11-2(22).
Chapter 20:51:30
ARSD 20:51:30:01 Definitions
Terms defined in SDCL 36-11-71 have the same meaning when used in this chapter.
History
- Source: 35 SDR 183, effective February 2, 2009; 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-11(1), 36-11-72.
- Law Implemented: SDCL 36-11-71.
ARSD 20:51:30:02 Application for remote pharmacy site
No remote pharmacy may be established, operated, or maintained without a remote pharmacy license issued by the State Board of Pharmacy. An application for licensure to establish, operate, or maintain a remote pharmacy must be made on a form provided by the board. The applicant shall submit an initial, non-refundable license fee of two hundred dollars and provide a set of blueprints and documentation showing that all requirements of this chapter have been met. The applicant shall demonstrate to the board that there is limited or no access to pharmacy services in the community where the remote pharmacy is to be located. When considering whether to approve an application, the board shall consider the needs of the community. The board shall approve or disapprove an application within sixty days of receipt.
History
- Source: 35 SDR 183, effective February 2, 2009; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(1), 36-11-72(1).
- Law Implemented: SDCL 36-11-1, 36-11-10, 36-11-30, 36-11-71(2), 36-11-72(1).
ARSD 20:51:30:03 Ownership or control by pharmacist required
The State Board of Pharmacy may not issue a license to conduct a remote pharmacy to any pharmacist applicant unless the pharmacist applicant is an owner, or part owner, of the place of business from which the pharmacist is to practice telepharmacy, or unless the non-pharmacist owner of the place of business from which the pharmacist is to practice telepharmacy files an affidavit outlined in SDCL 36-11-32(1).
History
- Source: 35 SDR 183, effective February 2, 2009; 52 SDR 27, effective September 15, 2025; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-11(1), 36-11-72(1).
- Law Implemented: SDCL 36-11-1, 36-11-10, 36-11-32, 36-11-71(2).
ARSD 20:51:30:04 Board inspection
No remote pharmacy may provide pharmacy services until the board has inspected the remote pharmacy for minimum equipment, size, security, and sanitation standards as set forth in § 20:51:07:01 and found the remote pharmacy to be in compliance with such standards.
History
- Source: 35 SDR 183, effective February 2, 2009.
- General Authority: SDCL 36-11-11(1), 36-11-72(1).
- Law Implemented: SDCL 36-11-71, 36-11-72.
ARSD 20:51:30:05 License renewal
A remote pharmacy license expires on June thirtieth of each year and may be renewed annually by filing an application provided by the State Board of Pharmacy. The non-refundable renewal fee is two hundred dollars.
History
- Source: 35 SDR 183, effective February 2, 2009; 53 SDR 13, effective August 16, 2026.
- General Authority: SDCL 36-11-72(1).
- Law Implemented: SDCL 36-11-72(1)(a).
ARSD 20:51:30:06 License required
Any pharmacy licensed by the board may operate a remote pharmacy in South Dakota. The remote pharmacy is considered an extension of the central pharmacy. However, the remote pharmacy must have its own license as a pharmacy.
History
- Source: 35 SDR 183, effective February 2, 2009.
- General Authority: SDCL 36-11-72(1).
- Law Implemented: SDCL 36-11-72(1).
ARSD 20:51:30:07 Audiovisual link
There must be a continuously accessible, two-way audiovisual link between the central pharmacy and the remote pharmacy. The transmission of information through the computer link must make information available to the central pharmacy and the remote pharmacy simultaneously. The video camera used for the certification of prescriptions must be of sufficient quality and resolution so that the certifying pharmacist can visually identify the markings on tablets and capsules. A second camera is required to meet security needs if the camera used to certify prescriptions is not able to monitor activities in other parts of the remote site.
History
- Source: 35 SDR 183, effective February 2, 2009.
- General Authority: SDCL 36-11-11(1), 36-11-72(2).
- Law Implemented: SDCL 36-11-72(2).
ARSD 20:51:30:08 Remote pharmacy identification sign
Each remote site shall display a sign easily viewable by customers stating "This business is a remote pharmacy, supervised by a pharmacist located at ( insert name of pharmacy and address )".
History
- Source: 35 SDR 183, effective February 2, 2009.
- General Authority: SDCL 36-11-11(1), 36-11-72(2),(5).
- Law Implemented: SDCL 36-11-72(2),(5).
ARSD 20:51:30:09 Restricted access to remote pharmacy
Access to the remote pharmacy prescription department must be limited to authorized pharmacy personnel. The security system at the remote pharmacy must allow for tracking of each entry into the pharmacy. The pharmacist-in-charge shall review the log of entries at least weekly.
History
- Source: 35 SDR 183, effective February 2, 2009; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1), 36-11-72(2)(5).
- Law Implemented: SDCL 36-11-71, 36-11-72(2)(5).
ARSD 20:51:30:10 Telephone number
The remote pharmacy must provide a telephone number that patients and prescribers may use to contact the central pharmacy. The telephone number must be printed on the label of each prescription container.
History
- Source: 35 SDR 183, effective February 2, 2009; 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-11(1)(4), 36-11-46.6, 36-11-72(2)(5).
- Law Implemented: SDCL 36-11-71.
ARSD 20:51:30:11 Pharmacist staffing requirements
Any pharmacist performing services in support of a remote pharmacy, whether those services are performed at the central pharmacy or the remote pharmacy, must be licensed by the board. A copy of the pharmacist's license must be posted in any remote pharmacy to which the pharmacist provides services.
History
- Source: 35 SDR 183, effective February 2, 2009.
- General Authority: SDCL 36-11-11(1), 36-11-13, 36-11-72(3).
- Law Implemented: SDCL 36-11-72(3).
ARSD 20:51:30:12 Technician and intern staffing requirements
Each remote pharmacy must be staffed with a certified pharmacy technician registered with the board or a registered pharmacy intern. A certified pharmacy technician registered with the board working at a remote pharmacy without an onsite pharmacist, pharmacy intern, or another certified pharmacy technician registered with the board that meets the requirements of this section, must have a minimum of one thousand hours of experience as a registered pharmacy technician in accordance with chapter 20:51:29 and must be certified in accordance with § 20:51:29:06. Five hundred hours of this experience must be in the central pharmacy or the remote telepharmacy with an onsite pharmacist, pharmacy intern, or another certified pharmacy technician registered with the board meeting the experience requirements for technicians in this section. A pharmacy intern may work at a remote pharmacy if the intern has at least five hundred hours of experience as a registered pharmacy intern in accordance with chapter 20:51:02.
History
- Source: 35 SDR 183, effective February 2, 2009; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1)(13), 36-11-72(3).
- Law Implemented: SDCL 36-11-2(22), 36-11-25, 36-11-71.
ARSD 20:51:30:13 Pharmacist-to-technician ratio
The pharmacist on duty at a central pharmacy may supervise no more than the number of registered pharmacy technicians allowed in accordance with § 20:51:29:19. The total number of allowed registered pharmacy technicians may be divided between the central pharmacy and the remote pharmacy in any manner. However, each remote pharmacy must have at least one pharmacy technician or pharmacy intern, who meets the requirements in § 20:51:30:12, on duty when it is open if a pharmacist is not present.
History
- Source: 35 SDR 183, effective February 2, 2009; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1), 36-11-72(3).
- Law Implemented: SDCL 36-11-2(22), 36-11-71.
ARSD 20:51:30:14 Prescription workload
Any central pharmacy providing telepharmacy services shall provide pharmacist staffing to meet the prescription workload of both the central pharmacy and the remote pharmacy.
History
- Source: 35 SDR 183, effective February 2, 2009.
- General Authority: SDCL 36-11-11(1), 36-11-72(3).
- Law Implemented: SDCL 36-11-72(3).
ARSD 20:51:30:15 Requirements for prescription orders
Only a pharmacist may take a verbal prescription order. A registered pharmacy technician at the remote pharmacy may not accept verbal orders for new prescriptions but may accept written orders. A written order for a new prescription may be entered at the central pharmacy or the remote pharmacy. The pharmacist must approve or override all drug utilization review alerts.
History
- Source: 35 SDR 183, effective February 2, 2009; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1), 36-11-72(5).
- Law Implemented: SDCL 36-11-2(22), 36-11-2.2, 36-11-71.
ARSD 20:51:30:16 Requirements for operation
The following requirements apply when operating a remote pharmacy:
(1) The remote pharmacy may only be open if a computer link, video link, and audio link with the central pharmacy are functioning properly. If any link is not functioning properly, the remote pharmacy must be closed unless a pharmacist is working at the remote pharmacy;
(2) No remote pharmacy may be open when the central pharmacy is closed, unless a pharmacist is working at the remote pharmacy;
(3) Any prescription filled at the remote pharmacy must be profiled, reviewed, and interpreted by a pharmacist at the central pharmacy before the prescription is dispensed;
(4) Any remotely dispensed prescriptions must have a label properly prepared in accordance with § 20:51:05:21 attached to the final drug container before the pharmacist verifies the dispensing process. This prescription verification process must be done in real time. All prescription verification must be documented in the computer record. The computer must be capable of carrying the initials of the registered pharmacy technician preparing the prescription and the pharmacist verifying the prescription. Verification is required for both new prescriptions and refills;
(5) When the patient receives a prescription, the pharmacist must use audiovisual communication to counsel the patient regarding use of the prescription being dispensed. Counseling is required only for new prescriptions. The pharmacist must meet the counseling standards in accordance with § 20:51:25:04; and
(6) The remote pharmacy must maintain a log, signed by the patient, that documents a patient's refusal for counseling by the pharmacist.
History
- Source: 35 SDR 183, effective February 2, 2009; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1), 36-11-72(2),(3),(4),(5).
- Law Implemented: SDCL 36-11-2(22), 36-11-2.2, 36-11-71.
ARSD 20:51:30:17 Routine quality assurance required
The pharmacist-in-charge must adhere to the following procedures:
(1) An inspection of the remote pharmacy shall be conducted by a licensed pharmacist at weekly intervals or more if deemed necessary. Inspection must be documented and kept on file at the remote pharmacy and available upon request by the board;
(2) Implement and conduct a quality assurance plan that provides for on-going review of dispensing errors, with appropriate action taken, if necessary, to assure patient safety;
(3) Verify controlled substance prescriptions for both accuracy and legitimacy of the original prescription by the pharmacist-in-charge or a designated pharmacist during weekly inspection visits;
(4) Maintain records of all controlled substances stocked by the remote pharmacy through a daily perpetual inventory. Controlled substance perpetual inventory records must be available for inspection by the board's inspectors. A remote pharmacy stocking controlled drugs must be registered by the Drug Enforcement Administration and South Dakota Department of Health;
(5) Conduct an inventory of all controlled substances at least monthly to verify accuracy.
History
- Source: 35 SDR 183, effective February 2, 2009.
- General Authority: SDCL 36-11-11(1), 36-11-72(4),(5).
- Law Implemented: SDCL 36-11-72(4),(5).
ARSD 20:51:30:18 Use of automated prescription dispensing device, Repealed
History
- Source: 35 SDR 183, effective February 2, 2009; 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025; 53 SDR 13, effective August 16, 2026.
Chapter 20:51:31
ARSD 20:51:31:01 Definitions
Terms used in this chapter mean:
(1) "Compounding," the constitution, reconstitution, combination, dilution, or another process causing a change in the form, composition, or strength of any ingredient or any other attribute of a product;
(2) "Hazardous drug," a pharmaceutical that is antineoplastic, carcinogenic, mutagenic, or teratogenic;
(3) “Nonsterile compounding," the process of combining, admixing, diluting, pooling, reconstituting other than as provided in the manufacturer's labeling, or otherwise altering a drug or bulk drug substance to create a non-sterile preparation; and
(4) "Sterile compounding," the aseptic processing of any pharmaceutical preparation that is required to be sterile when administered to patients.
History
- Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-11(1)(3).
- Law Implemented: SDCL 36-11-2.2(3).
ARSD 20:51:31:02 Standards and procedures, Repealed
History
- Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:31:03 Manual required, Repealed
History
- Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:31:04 Physical environment requirements for sterile products, Repealed
History
- Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:31:05 Requirement for primary engineering control device or room, Repealed
History
- Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:31:06 Placement of primary engineering control device, Repealed
History
- Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:31:07 Compounding aseptic isolator (CAI), Repaled
History
- Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:31:08 Exception for placement of CAI, Repealed
History
- Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:31:09 Ante area requirements, Repealed
History
- Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:31:10 Delayed implementation, Repealed
History
- Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:31:11 Cleaning, maintenance, and supplies, Repealed
History
- Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:31:12 Additional records required, Repealed
History
- Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:31:13 Quality assurance, Repealed
History
- Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:31:14 Pharmacist responsibilities, Repealed
History
- Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:31:15 Training documentation, Repealed
History
- Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:31:16 Reference requirements, Repealed
History
- Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:31:17 Labeling requirements, Repealed
History
- Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:31:18 Microbial contamination risk levels, Repealed
History
- Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:31:19 Low-risk preparations, Repealed
History
- Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:31:20 Medium-risk preparations, Repealed
History
- Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:31:21 High-risk preparations, Repealed
History
- Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:31:22 Immediate-use preparations, Repealed
History
- Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:31:23 Utilization of single-dose and multiple-dose containers, Repealed
History
- Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:31:24 Utilization of proprietary bag and vial systems, Repealed
History
- Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:31:25 Sterilization methods, Repealed
History
- Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:31:26 Media-fill testing by personnel, Repealed
History
- Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:31:27 Environmental monitoring requirements, Repealed
History
- Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:31:28 Storage and delivery of sterile preparations, Repealed
History
- Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:31:29 Additional requirements for preparation of hazardous drugs, Repealed
History
- Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:31:30 Responsibilities for patient care, Repealed
History
- Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:31:31 Patient or caregiver education and training, Repealed
History
- Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.
ARSD 20:51:31:32 Compounding and hazardous drug handling standards--United States Pharmacopeia compounding standards implemented by reference
Reference: United States Pharmacopeia--Compounding Compendium (February 1, 2024), available at https://online.uspnf.com/uspnf. Cost: $250 for individual user.
History
- Source: 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(3)(8).
- Law Implemented: SDCL 36-11-2.2(3), 36-11-11(3)(8), 36-11-46.
ARSD 20:51:31:33 Policy and procedure manual
The pharmacist-in-charge must prepare and maintain a policy and procedure manual for compounding practices. The policy and procedure manual must include a quality assurance program and all applicable United States Pharmacopeia requirements, and be available for inspection by the board.
Reference: United States Pharmacopeia--Compounding Compendium (February 1, 2024), available at https://online.uspnf.com/uspnf. Cost: $250 for individual user.
History
- Source: 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(3)(8).
- Law Implemented: SDCL 36-11-2.2(3), 36-11-46.
ARSD 20:51:31:34 Compounding requirements
Any pharmacy that engages in compounding must adhere to physical, equipment, and environmental requirements established by United States Pharmacopeia. Pharmacy owner shall provide compounding staff with access to current reference materials applicable to compounding.
Reference: United States Pharmacopeia--Compounding Compendium (February 1, 2024), available at https://online.uspnf.com/uspnf. Cost: $250 for individual user.
History
- Source: 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(3)(8).
- Law Implemented: SDCL 36-11-2.2(3), 36-11-46.
ARSD 20:51:31:35 Delivery service
History
- Source: 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-11(3)(4).
- Law Implemented: SDCL 36-11-44.
ARSD 20:51:31:36 Disposal of pharmaceutical hazardous waste
The pharmacist-in-charge is responsible for ensuring that there is a designated process for proper disposal of pharmaceutical hazardous waste in accordance with applicable state and federal requirements.
History
- Source: 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-11(3).
- Law Implemented: SDCL 36-11-2.2(3), 36-11-46.
ARSD 20:51:31:37 Quality assurance
Any pharmacy that compounds prescriptions must have a quality assurance program with the following elements:
(1) A documented, ongoing program for the monitoring of personnel, components, equipment, and facilities used for preparation of compounded pharmaceuticals that conforms to applicable state and federal law;
(2) If errors have occurred, the pharmacist-in-charge is responsible for conducting a full investigation. A written record of the investigation must be completed and include conclusions and follow-up;
(3) The pharmacist-in-charge is responsible for proper maintenance, cleanliness, and use of facilities and equipment used in compounding;
(4) All pharmacists and pharmacy technicians, who assist in compounding drug products, must have documented training and competency testing as required by state and federal law;
(5) Training must be conducted by qualified individuals on a continuing basis with frequencies outlined in United States Pharmacopeia to ensure that compounding pharmacy personnel remain up to date with operations, policies, and procedures;
(6) Only personnel authorized by the pharmacist-in-charge may be in the immediate vicinity of compounding operations; and
(7) A compounded drug is adulterated if it has been prepared, packed, or held under insanitary conditions. For the purpose of this section, “insanitary conditions” means a condition of exposure to contamination with filth which may be rendered injurious to health.
History
- Source: 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-11(3).
- Law Implemented: SDCL 36-11-2.2(3), 36-11-42, 36-11-46.
Chapter 20:51:32
ARSD 20:51:32:01 Definitions
Terms defined in SDCL 34-20E-1 have the same meaning in this article.
History
- Source: 37 SDR 214, effective May 30, 2011; 45 SDR 86, effective December 24, 2018.
- General Authority: SDCL 34-20E-20.
- Law Implemented: SDCL 34-20E-1, 34-20E-20.
ARSD 20:51:32:02 Data submission
Each dispenser may submit the data to the central repository using any electronic device compatible with the board's receiving device or the receiving device of the board's contracted vendor every 24 hours or by midnight of the next business day after dispensing. The data submitted to the central repository may be on electronic media approved by the board accompanied by a transmittal form identifying the dispenser submitting the electronic media, the number of prescription records included on the media, and the individual submitting the media.
If the dispenser does not have an automated recordkeeping system capable of producing an electronic report of the required data in the format established by the American Society for Automation in Pharmacy (ASAP), the dispenser may request a waiver from the electronic reporting requirement from the board.
If the board grants a waiver from the electronic reporting requirement, then the dispenser shall comply with an alternative method of reporting the data as determined by the board, such as submitting the required data on a form approved by the board.
History
- Source: 37 SDR 214, effective May 30, 2011; 45 SDR 86, effective December 24, 2018.
- General Authority: SDCL 34-20E-20.
- Law Implemented: SDCL 34-20E-2, 34-20E-3, 34-20E-20(1).
ARSD 20:51:32:03 Data elements
The information submitted for each prescription shall include the following items:
(1) Dispenser name and identification number;
(2) Date prescription filled;
(3) Prescription number;
(4) Prescription is new or is a refill;
(5) Identification code for drug dispensed;
(6) Quantity dispensed;
(7) Day's supply dispensed;
(8) Number of refills ordered;
(9) Patient name;
(10) Patient address;
(11) Patient date of birth;
(12) Patient gender;
(13) Prescriber identification number;
(14) Date prescription issued by the prescriber;
(15) Pharmacy phone number;
(16) Code identifying type of payment;
(17) Prescriber last name;
(18) Prescriber first name; and
(19) Prescriber phone number.
History
- Source: 37 SDR 214, effective May 30, 2011; 45 SDR 86, effective December 24, 2018.
- General Authority: SDCL 34-20E-20(2).
- Law Implemented: SDCL 34-20E-2, 34-20E-3, 34-20E-20(2).
ARSD 20:51:32:04 Access to data
Healthcare practitioners authorized to prescribe or dispense controlled substances may request on-line access to the data for the purpose of providing patient health care. A healthcare practitioner authorized to prescribe may designate one or more persons who are licensed or registered with the respective regulatory board to serve as a delegate. Prior to being granted access to program information, a practitioner or delegate shall submit a request for registration and program access. The board will verify the licensure status of the practitioner or delegate with the appropriate licensing authority. In the case of integration, as defined in SDCL subdivision 34-20E-1(9), the board may allow an entity's credentialing process to verify licensure status. The program safeguards to protect the privacy of the data include a secure login and password for the practitioners authorized to access the data.
The board shall conduct regular reviews of data access by practitioners to identify possible violations of law or breach of professional standards that may have occurred. Whenever such information is identified, the board will notify the appropriate professional licensing, certification or regulatory agency or entity, and provide information necessary for an investigation.
History
- Source: 37 SDR 214, effective May 30, 2011; 45 SDR 86, effective December 24, 2018.
- General Authority: SDCL 34-20E-20(4).
- Law Implemented: SDCL 34-20E-7(1), 34-20E-12, 34-20E-20(4).
ARSD 20:51:32:05 Disclosure of data
Each request for information from the central repository must be submitted on a form or electronic platform provided by the board and may be mailed, faxed, or submitted electronically to the board office. The information may be mailed, faxed or submitted electronically to the individual requesting the profile, and marked "confidential".
A prescriber or dispenser may request patient information electronically or in writing if the request:
(1) Is signed or submitted on an electronic platform by the prescriber, delegate, or dispenser requesting the information and includes the business name and address;
(2) Includes the patient's name, date of birth, purpose of the request, and the date range for the profile; and
(3) Includes a statement indicating a prescriber or a dispenser and patient relationship exists.
History
- Source: 37 SDR 214, effective May 30, 2011; 45 SDR 86, effective December 24, 2018.
- General Authority: SDCL 34-20E-20(4).
- Law Implemented: SDCL 34-20E-5, 34-20E-7(1).
ARSD 20:51:32:06 Disclosure of data -- Individual
An individual or the individual's agent, authorized in writing, may request prescription information of the individual or the individual's minor child.
The individual requesting the prescription information or an authorized agent of the individual shall submit a signed, written request on a form provided by the board for records of the individual's prescriptions reported to the program.
The individual or agent will be required to present a current government-issued photo identification at the time of delivery of the request.
An individual who is unable to personally deliver the request to the board office may submit a request by mail or a commercial delivery service. The request shall comply with the provisions above, a copy of the current government issued photo identification shall be enclosed, and the signature of the requesting individual shall be notarized.
History
- Source: 37 SDR 214, effective May 30, 2011.
- General Authority: SDCL 34-20E-20.
- Law Implemented: SDCL 34-20E-7(2), 34-20E-20(4).
ARSD 20:51:32:07 Disclosure of data -- Regulatory board
A state board or regulatory agency with appropriate authority may request information electronically or in writing.
The request shall include a statement of its purpose and authority, the name and license number of the individual, the date range requested, and the specific reasons for the request.
The request shall be signed or submitted electronically by the authorized agent and include the mailing address for the board or agency.
History
- Source: 37 SDR 214, effective May 30, 2011; 45 SDR 86, effective December 24, 2018.
- General Authority: SDCL 34-20E-20.
- Law Implemented: SDCL 34-20E-7(3), 34-20E-20(4).
ARSD 20:51:32:08 Disclosure of data -- Law enforcement
A local, state, and federal law enforcement or prosecutorial official engaged in the enforcement of laws related to controlled substances may request information for the purpose of an investigation or prosecution of the drug-related activity or probation or parole compliance of an individual. The board shall verify the status of the law enforcement or prosecutorial official with the appropriate authority.
The electronic or written request shall include the individual's name and date of birth, the date range requested, and the specific reasons for the request, that must be approved by the board prior to the release of the information.
The request shall be signed by the authorized official and include that person's mailing address.
History
- Source: 37 SDR 214, effective May 30, 2011; 45 SDR 86, effective December 24, 2018.
- General Authority: SDCL 34-20E-20(4).
- Law Implemented: SDCL 34-20E-7(4), 34-20E-20(4).
ARSD 20:51:32:09 Disclosure of data -- Court orders
The board shall provide program information in response to court orders and warrants. The board shall provide program information in response to court issued subpoenas.
History
- Source: 37 SDR 214, effective May 30, 2011.
- General Authority: SDCL 34-20E-20(4).
- Law Implemented: SDCL 34-20E-7(7), 34-20E-20(4).
ARSD 20:51:32:10 Disclosure of data -- Other entities
Other designated entities may request profiles or information as identified in SDCL 34-20E-7.
The request shall include the date range requested, the specific reasons for the request, and the individual's name and birth date if applicable.
The request shall be signed by the authorized individual and include that person's mailing address.
History
- Source: 37 SDR 214, effective May 30, 2011; 45 SDR 86, effective December 24, 2018.
- General Authority: SDCL 34-20E-20(4).
- Law Implemented: SDCL 34-20E-7(5)(6)(8) and (9).
ARSD 20:51:32:11 Data retention
All dispenser records of prescriptions reported to the program shall be retained by the board for a period of three years following the date of the record. All records of access to or query of program information shall be retained by the board for a period of three years following the date of the record. At least semiannually, all program information identified as exceeding that three-year period shall be deleted from the program and discarded in a manner to maintain the confidentiality of the program information and data. Statistical data and reports from which all personally identifiable information has been removed or which do not contain personally identifiable information may be retained by the board for historical purposes.
History
- Source: 37 SDR 214, effective May 30, 2011.
- General Authority: SDCL 34-20E-20.
- Law Implemented: SDCL 34-20E-20(2)(4) and (5).
Chapter 20:51:33
ARSD 20:51:33:01 Applicability, Repealed
History
- Source: 45 SDR 86, effective December 24, 2018; 52 SDR 27, effective September 15, 2025.
ARSD 20:51:33:02 Complaints, Repealed
History
- Source: 45 SDR 86, effective December 24, 2018; 52 SDR 27, effective September 15, 2025.
ARSD 20:51:33:03 Investigations, Repealed
History
- Source: 45 SDR 86, effective December 24, 2018; 52 SDR 27, effective September 15, 2025.
ARSD 20:51:33:04 Completion of complaint investigation, Repealed
History
- Source: 45 SDR 86, effective December 24, 2018; 52 SDR 27, effective September 15, 2025.
ARSD 20:51:33:05 Status of complainant, Repealed
History
- Source: 45 SDR 86, effective December 24, 2018; 52 SDR 27, effective September 15, 2025.
ARSD 20:51:33:06 Effect of failure to renew during investigation, Repealed
History
- Source: 45 SDR 86, effective December 24, 2018; 52 SDR 27, effective September 15, 2025.
Chapter 20:51:34
ARSD 20:51:34:01 Applicability, Repealed
History
- Source: 45 SDR 86, effective December 24, 2018; 53 SDR 13, effective August 16, 2026.
ARSD 20:51:34:02 Petitions for hearing, Repealed
History
- Source: 45 SDR 86, effective December 24, 2018; 53 SDR 13, effective August 16, 2026.
ARSD 20:51:34:03 Filing of petitions for hearing, Repealed
History
- Source: 45 SDR 86, effective December 24, 2018; 53 SDR 13, effective August 16, 2026.
ARSD 20:51:34:04 Scheduling of hearing, Repealed
History
- Source: 45 SDR 86, effective December 24, 2018; 53 SDR 13, effective August 16, 2026.
ARSD 20:51:34:05 Hearing procedure, Repealed
History
- Source: 45 SDR 86, effective December 24, 2018; 53 SDR 13, effective August 16, 2026.
ARSD 20:51:34:06 Final board decision, Repealed
History
- Source: 45 SDR 86, effective December 24, 2018; 53 SDR 13, effective August 16, 2026.
ARSD 20:51:34:07 Notice of decision, Repealed
History
- Source: 45 SDR 86, effective December 24, 2018; 53 SDR 13, effective August 16, 2026.
ARSD 20:51:34:08 Assessment of costs of disciplinary hearings, Repealed
History
- Source: 45 SDR 86, effective December 24, 2018; 53 SDR 13, effective August 16, 2026.
ARSD 20:51:34:09 Board member conflict of interest, Repealed
History
- Source: 45 SDR 86, effective December 24, 2018; 53 SDR 13, effective August 16, 2026.
ARSD 20:51:34:10 Board member potential conflict of interest, Repealed
History
- Source: 45 SDR 86, effective December 24, 2018; 53 SDR 13, effective August 16, 2026.
Chapter 20:51:35
ARSD 20:51:35:01 Definitions
Terms defined in SDCL 34-20H-1 have the same meaning when used in this chapter. Terms used in this chapter mean:
(1) "Board," South Dakota Board of Pharmacy as defined in SDCL 36-11-2(3);
(2) "Controlled substance," the substances described, defined, or provided in SDCL 34-20B-11 to 34-20B-26, inclusive;
(3) "Donor," any natural person or entity legally authorized to possess drugs with a license or permit in good standing in the state in which it is located, and government agencies and entities that are federally authorized to possess drugs;
(4) "Eligible patient," an indigent, uninsured, or underinsured person;
(5) "Health care facility," a:
(a) Facility licensed pursuant to SDCL chapter 34-12; or
(b) Similar licensed facility located in another state;
(6) "Health care professional," a:
(a) Physician licensed pursuant to SDCL chapter 36-4;
(b) Certified nurse practitioner or certified nurse midwife licensed pursuant to SDCL chapter 36-9A;
(c) Physician assistant licensed pursuant to SDCL chapter 36-4A;
(d) Dentist licensed pursuant to SDCL chapter 36-6A;
(e) Optometrist licensed pursuant to SDCL chapter 36-7;
(f) Podiatrist licensed pursuant to SDCL chapter 36-8; or
(g) Pharmacist licensed pursuant to SDCL chapter 36-11;
(7) "Indigent individual," any person who does not have sufficient money, credit, or insurance to pay for prescribed medication;
(8) "Pharmacist-in-charge," as defined in § 20:51:06:02.01;
(9) "Prescription Drugs," legend drugs as defined in SDCL 34-20B-28.1; and
(10) "Program," the donated prescription drug and medical supply redispensing program established by the board pursuant to SDCL chapter 34-20H.
Cross Reference: Drugs and Substances Control, SDCL chapter 34-20B.
History
- Source: 49 SDR 51, effective November 27, 2022.
- General Authority: SDCL 34-20H-7.
- Law Implemented: SDCL 34-20H-7.
ARSD 20:51:35:02 Eligibility criteria for participating pharmacies
Participation in the program is voluntary. In order to participate, a pharmacy must:
(1) Comply with all applicable federal and state laws and hold an active, nonrestricted, board-issued license in good standing; and
(2) Submit on a form provided by the board:
(a) The pharmacy name, street address, telephone number, and board-issued license number;
(b) The name and license number of the pharmacist-in-charge as defined in § 20:51:06:02.01; and
(c) A statement, signed and dated by the pharmacist-in-charge, indicating that the pharmacy meets the eligibility requirements under this section and that all pharmacists shall comply with the requirements of this chapter.
A pharmacy may withdraw from participation in the program at any time by providing written notice to the board on a form prescribed by the board.
History
- Source: 49 SDR 51, effective November 27, 2022.
- General Authority: SDCL 34-20H-7(2)(5).
- Law Implemented: SDCL 34-20H-4.
ARSD 20:51:35:03 Criteria for donating and accepting donated prescription drugs and supplies
A participating pharmacy may only accept the following donations from natural persons eighteen years or older or entities, who are in lawful possession of the donation:
(1) A prescription drug that:
(a) Is in its original sealed and tamper-evident packaging. However, a drug in a single-unit dose or blister pack with the outside packaging opened may be accepted if the single-unit package is not opened;
(b) Has packaging containing the lot number and expiration date of the drug. If the lot number is not retrievable, all specified medications must be destroyed in the event of a recall;
(c) Has an expiration date that is more than six months after the date the drug was donated. A donated prescription drug bearing an expiration date that is six months or less after the date the prescription drug was donated may be accepted and distributed if the drug is in high demand and can be dispensed for use prior to the drug's expiration date;
(d) Has no physical signs of tampering, misbranding, deterioration or adulteration, whether to the drug itself or its packaging, and there is no reason to otherwise believe that the drug is adulterated; and
(e) If the drug has not been continually under the control of a health care professional, a pharmacy, or other legally authorized entity allowed to possess prescription drugs, the participating pharmacy must collect a donation form that is signed by the donor or that person’s authorized representative attesting to the manufacturer’s recommended proper storage of the prescription drug; and
(2) A medical supply that is:
(a) In its original, unopened, sealed packaging; and
(b) Not adulterated or misbranded.
History
- Source: 49 SDR 51, effective November 27, 2022.
- General Authority: SDCL 34-20H-7(2)(3)(5).
- Law Implemented: SDCL 34-20H-2.
ARSD 20:51:35:04 Prescription drugs which may not be donated or accepted
In addition to the grounds for donation rejection in SDCL 34-20H-2, no prescription drug that requires storage temperatures other than normal room temperature, as specified by the manufacturer, may be donated or accepted except a drug donated directly from a drug manufacturer or other entity authorized to possess prescription drugs.
History
- Source: 49 SDR 51, effective November 27, 2022.
- General Authority: SDCL 34-20H-7(2).
- Law Implemented: SDCL 34-20H-2, 34-20H-4(1).
ARSD 20:51:35:05 Inspecting and documenting donated prescription drugs and supplies
A pharmacist-in-charge designated pharmacist at the participating pharmacy shall inspect a donated prescription drug or medical supply to determine, to the extent reasonably possible, that the drug or supply is not adulterated or misbranded, is safe and suitable for dispensing, and is not ineligible. The pharmacist who inspects the drug or supply shall sign the donor form stating the above. If a participating pharmacy receives a drug or medical supply from another participating pharmacy, the receiving participating pharmacy does not need to reinspect the drug or supply when receiving a copy of the donor form with the inspection information. The transfer of the drug or supply from one participating pharmacy to another must be documented in both the receiving and the donating pharmacy.
After inspecting donated prescription drugs and medical supplies, the participating pharmacy must inventory and document the donation in the board’s program database.
History
- Source: 49 SDR 51, effective November 27, 2022.
- General Authority: SDCL 34-20H-4(3), 34-20H-7(2)(3)(5).
- Law Implemented: SDCL 34-20H-2, 34-20H-4(3), 34-20H-9.
ARSD 20:51:35:06 Acceptance, storage, and destruction of donated prescription drugs and supplies
A participating pharmacy shall store a donated drug or medical supply in a storage area under environmental conditions appropriate for the drug or supply being stored. Donated prescription drugs and medical supplies may not be stored with nondonated inventory.
When a donated prescription drug or medical supply is not inspected immediately upon receipt, a participating pharmacy must quarantine the donation until it has been inspected and approved for dispensing under the program.
A participating pharmacy shall destroy donations that are not suitable for dispensing and make a record of the destruction.
Prescription drugs and medical supplies may be donated on the premises of a participating pharmacy to a person designated by the pharmacy. A drop box may not be used to deliver or accept donations.
History
- Source: 49 SDR 51, effective November 27, 2022.
- General Authority: SDCL 34-20H-7(2)(3).
- Law Implemented: SDCL 34-20H-3, 34-20H-4(1).
ARSD 20:51:35:07 Return or destruction of donated controlled substances
A controlled substance may not be accepted for donation. A controlled substance submitted for donation must be returned immediately to the donor or the donor’s representative who provided the controlled substance. In the event that a controlled substance enters the participating pharmacy and it is not practicable to return the controlled substance to the donor or the donor’s representative due to an inability to identify the donor or the donor’s representative or due to the refusal by the donor or the donor’s representative to receive them, the abandoned controlled substance must be documented and destroyed rendering the chemical compound to be non-retrievable per 21 C.F.R. § 1300.05(b), in effect on April 1, 2021. A pharmacist or other person with authority to dispense controlled substances shall destroy the controlled substance. Another employee of the participating pharmacy shall witness the destruction.
History
- Source: 49 SDR 51, effective November 27, 2022.
- General Authority: SDCL 34-20H-7(2)(3).
- Law Implemented: SDCL 34-20H-2, 34-20H-3.
ARSD 20:51:35:08 Recalls
If a participating pharmacy receives a recall notification, the pharmacy shall perform a uniform destruction of the recalled, donated prescription drug or medical supply and complete the destruction information form for the drug or medical supply destroyed. If a recalled drug or recalled medical supply has been dispensed, the participating pharmacy shall immediately notify the recipient of the recalled drug or supply pursuant to established pharmacy recall procedures. The participating pharmacy shall remove the recalled prescription drug or supply from the program database.
History
- Source: 49 SDR 51, effective November 27, 2022.
- General Authority: SDCL 34-20H-7(2)(5).
- Law Implemented: SDCL 34-20H-4(1), 34-20H-9.
ARSD 20:51:35:09 Criteria for dispensing donated prescription drugs and supplies
A donated drug or medical supply may be dispensed only if:
(1) The drug or supply is prescribed by a health care professional for use by an eligible patient and is dispensed by a licensed pharmacist in a participating pharmacy;
(2) The participating pharmacy dispenses to an individual requesting a drug or supply through the program as follows, in descending order of priority:
(a) An indigent individual;
(b) An individual who has no active third-party prescription drug reimbursement coverage for the drug or medical supply prescribed; and
(c) Any other individual;
(3) The participating pharmacy dispenses the donated prescription drug or supply in compliance with all applicable federal and state laws and regulations for dispensing prescription drugs and supplies;
(4) The participating pharmacy dispensing the prescription drug or medical supply removes the original donor’s identification and the name of the dispensing pharmacy from the package prior to dispensing the drug or supply; and
(5) The participating pharmacy documents the dispensing in the board’s program database.
History
- Source: 49 SDR 51, effective November 27, 2022.
- General Authority: SDCL 34-20H-7(1)(2)(3).
- Law Implemented: SDCL 34-20H-4(1), 34-20H-7(1), 34-20H-3.
ARSD 20:51:35:10 Acceptance form for individuals to receive donated prescription drugs and supplies
An individual who requests and receives a prescription drug or medical supply from the program shall, prior to receipt of the drug or medical supply, sign an acceptance form attesting that:
(1) The individual is an eligible patient;
(2) The individual acknowledges that the drug or supply has been donated; and
(3) The individual waives the requirement for child-resistant packaging, if applicable.
History
- Source: 49 SDR 51, effective November 27, 2022.
- General Authority: SDCL 34-20H-7(2)(5).
- Law Implemented: SDCL 34-20H-7(1)(a)(b).
ARSD 20:51:35:11 Handling fee
A participating pharmacy may charge the recipient of a donated drug or medical supply a handling fee, not to exceed twenty-five dollars, to cover mailing, handling, or dispensing costs. A prescription drug or medical supply dispensed through the program is not eligible for reimbursement under any insurance or medical assistance program.
History
- Source: 49 SDR 51, effective November 27, 2022.
- General Authority: SDCL 34-20H-7(4).
- Law Implemented: SDCL 34-20H-6.
Chapter 20:51:36
ARSD 20:51:36:01 Definitions
Terms used in this chapter mean:
(1) "Central fill pharmacy," a pharmacy under the same ownership as the originating pharmacy or contracted to provide prescription filling or processing on behalf of the originating pharmacy; and
(2) "Originating pharmacy," a pharmacy that receives prescription drug orders from a patient, an agent of the patient, or a prescriber, and outsources the filling or processing of the order to a central fill pharmacy that dispenses the prescription to the patient or agent of the patient.
History
- Source: 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-11(1)(3).
- Law Implemented: SDCL 36-11-2.2, 36-11-19.1.
ARSD 20:51:36:02 License required
Any pharmacy acting as a central fill pharmacy in this state must be licensed pursuant to SDCL 36-11-32 and not licensed as a pharmacy under SDCL 36-11-33. Any central fill pharmacy located outside the state must be licensed as a non-resident pharmacy. Any originating pharmacy located in this state must be licensed pursuant to SDCL 36-11-32.
History
- Source: 50 SDR 138, effective June 2, 2024; 52 SDR 27, effective September 15, 2025.
- General Authority: SDCL 36-11-11(1)(3).
- Law Implemented: SDCL 36-11-19.2, 36-11-19.3, 36-11-30.
ARSD 20:51:36:03 Requirements for central fill
The originating pharmacy and central fill pharmacy must:
(1) Be under the same ownership or have a signed legal contract to provide central fill services;
(2) Share a common prescription software platform, as described in § 20:51:20:04;
(3) Ensure a pharmacist, from either pharmacy, performs a prospective drug utilization review in accordance with § 20:51:25:02 before dispensing any prescription. The identity of the pharmacist must be available to both pharmacies in the prescription record; and
(4) Have a policy and procedure, approved by both pharmacies, that outlines each pharmacy’s role in the transaction and ensures patient safety and privacy.
History
- Source: 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-11(1)(3)(12).
- Law Implemented: SDCL 36-11-2.2, 36-11-68, 36-11-69.
ARSD 20:51:36:04 Label requirements
The label for prescriptions filled by a central fill pharmacy must meet the requirements in §§ 20:51:05:21 and 44:58:08:20 and must indicate that the prescription was filled at a central fill pharmacy. The label must contain the name, address, and phone number of the originating pharmacy.
History
- Source: 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-11(1)(3).
- Law Implemented: SDCL 36-11-2.2(3).
ARSD 20:51:36:05 Patient requests
History
- Source: 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-11(1)(3).
- Law Implemented: SDCL 36-11-36.
ARSD 20:51:36:06 Patient requests. A patient may request not to utilize central fill pharmacy service. The pharmacy must comply with the request. Source: 50 SDR 138, effective June 2, 2024. General Authority: SDCL 36-11-11(1)(3). Law Implemented: SDCL 34-12B-1
Patient requests. A patient may request not to utilize central fill pharmacy service. The pharmacy must comply with the request.
History
- Source: 50 SDR 138, effective June 2, 2024.
- General Authority: SDCL 36-11-11(1)(3).
- Law Implemented: SDCL 34-12B-1.
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