South Dakota Administrative Code

20:51:31:20. Medium-risk preparations. Repealed. Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.

20:51:31:21. High-risk preparations. Repealed. Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.

20:51:31:22. Immediate-use preparations. Repealed. Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.

20:51:31:23. Utilization of single-dose and multiple-dose containers. Repealed. Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.

20:51:31:24. Utilization of proprietary bag and vial systems. Repealed. Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.

20:51:31:25. Sterilization methods. Repealed. Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.

20:51:31:26. Media-fill testing by personnel. Repealed. Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.

20:51:31:27. Environmental monitoring requirements. Repealed. Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.

20:51:31:28. Storage and delivery of sterile preparations. Repealed. Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.

20:51:31:29. Additional requirements for preparation of hazardous drugs. Repealed. Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.

20:51:31:30. Responsibilities for patient care. Repealed. Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.

20:51:31:31. Patient or caregiver education and training. Repealed. Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.

20:51:31:32. Compounding and hazardous drug handling standards -- United States Pharmacopeia compounding standards implemented by reference. All sterile compounding, nonsterile compounding,compounding and repackagingrepackage must be handled in accordance with federal law, this c…

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 requirement…

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 …

20:51:31:35. Delivery to patients. The pharmacist-in-charge shall ensure the environmental control, stability, and sterility of all preparations delivered or shipped to patients. Source: 50 SDR 138, effective June 2, 2024. General Authority: SDCL 36-11-11(3)(4). Law Implemented: …

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. Source: 50 SDR 138,…

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…

Rule 20:51:32:01 Definitions. 20:51:32:01. Definitions. Terms defined in SDCL 34-20E-1 have the same meaning in this article. 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-…

Rule 20:51:32:02 Data submission. 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 midn…

Rule 20:51:32:03 Data elements. 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 refi…

Rule 20:51:32:04 Access to data. 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 prescr…

Rule 20:51:32:05 Disclosure of data. 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 i…

Rule 20:51:32:06 Disclosure of data -- Individual. 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 …

Rule 20:51:32:07 Disclosure of data -- Regulatory board. 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 a…

Rule 20:51:32:08 Disclosure of data -- Law enforcement. 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 pu…

Rule 20:51:32:09 Disclosure of data -- Court orders. 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. Source: 3…

Rule 20:51:32:10 Disclosure of data -- Other entities. 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…

Rule 20:51:32:11 Data retention. 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…

20:51:33:01. Applicability. Repealed. Source: 45 SDR 86, effective December 24, 2018; 52 SDR 27, effective September 15, 2025.

20:51:33:02. Complaints. Repealed. Source: 45 SDR 86, effective December 24, 2018; 52 SDR 27, effective September 15, 2025.

20:51:33:03. Investigations. Repealed. Source: 45 SDR 86, effective December 24, 2018; 52 SDR 27, effective September 15, 2025.

20:51:33:04. Completion of complaint investigation. Repealed. Source: 45 SDR 86, effective December 24, 2018; 52 SDR 27, effective September 15, 2025.

20:51:33:05. Status of complainant. Repealed. Source: 45 SDR 86, effective December 24, 2018; 52 SDR 27, effective September 15, 2025.

20:51:33:06. Effect of failure to renew during investigation. Repealed. Source: 45 SDR 86, effective December 24, 2018; 52 SDR 27, effective September 15, 2025.

20:51:34:01. Applicability. Repealed. Source: 45 SDR 86, effective December 24, 2018; 53 SDR 13, effective August 16, 2026.

20:51:34:02. Petitions for hearing. Repealed. Source: 45 SDR 86, effective December 24, 2018; 53 SDR 13, effective August 16, 2026.

20:51:34:03. Filing of petitions for hearing. Repealed. Source: 45 SDR 86, effective December 24, 2018; 53 SDR 13, effective August 16, 2026.

20:51:34:04. Scheduling of hearing. Repealed. Source: 45 SDR 86, effective December 24, 2018; 53 SDR 13, effective August 16, 2026.

20:51:34:05. Hearing procedure. Repealed. Source: 45 SDR 86, effective December 24, 2018; 53 SDR 13, effective August 16, 2026.

20:51:34:06. Final board decision. Repealed. Source: 45 SDR 86, effective December 24, 2018; 53 SDR 13, effective August 16, 2026.

20:51:34:07. Notice of decision. Repealed. Source: 45 SDR 86, effective December 24, 2018; 53 SDR 13, effective August 16, 2026.

20:51:34:08. Assessment of costs of disciplinary hearings. Repealed. Source: 45 SDR 86, effective December 24, 2018; 53 SDR 13, effective August 16, 2026.

20:51:34:09. Board member conflict of interest. Repealed. Source: 45 SDR 86, effective December 24, 2018; 53 SDR 13, effective August 16, 2026.

20:51:34:10. Board member potential conflict of interest. Repealed. Source: 45 SDR 86, effective December 24, 2018; 53 SDR 13, effective August 16, 2026.

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 …

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…