South Dakota Administrative Code

Rule 20:51:30:04 Board inspection. 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 …

Rule 20:51:30:05 License renewal. 20:51:30:05. License renewal. A remote pharmacy license expires on June 30 of each year and may be renewed annually by filing an application provided by the board. The renewal fee is $200. Source: 35 SDR 183, effective February 2, 2009. General A…

Rule 20:51:30:06 License required. 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 …

Rule 20:51:30:07 Audiovisual link. 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 t…

Rule 20:51:30:08 Remote pharmacy identification sign. 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 a…

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 …

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. Source: 35 SDR 183, effective February 2, 20…

Rule 20:51:30:11 Pharmacist staffing requirements. 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…

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 wi…

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 …

Rule 20:51:30:14 Prescription workload. 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. Source: 35 SDR 183, effective…

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 prescript…

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 p…

Rule 20:51:30:17 Routine quality assurance required. 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…

20:51:30:18. Use of automated prescription dispensing device. If the remote pharmacy uses an automated mechanical dispensing device, the stocking and loading of this device must either be checked by a pharmacist, prior to use, or employ a secure barcoding system or its equivalent…

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 d…

20:51:31:02. Standards and procedures. Repealed. Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.

20:51:31:03. Manual required. Repealed. Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.

20:51:31:04. Physical environment requirements for sterile products. Repealed. Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.

20:51:31:05. Requirement for primary engineering control device or room. Repealed. Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.

20:51:31:06. Placement of primary engineering control device. Repealed. Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.

20:51:31:07. Compounding aseptic isolator (CAI). Repealed. Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.

20:51:31:08. Exception for placement of CAI. Repealed. Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.

20:51:31:09. Ante area requirements. Repealed. Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.

20:51:31:10. Delayed implementation. Repealed. Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.

20:51:31:11. Cleaning, maintenance, and supplies. Repealed. Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.

20:51:31:12. Additional records required. Repealed. Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.

20:51:31:13. Quality assurance. Repealed. Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.

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

20:51:31:15. Training documentation. Repealed. Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.

20:51:31:16. Reference requirements. Repealed. Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.

20:51:31:17. Labeling requirements. Repealed. Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.

20:51:31:18. Microbial contamination risk levels. Repealed. Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.

20:51:31:19. Low-risk preparations. Repealed. Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.

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: …