CHAPTER 20:51:31
COMPOUNDING PRACTICES
Section
20:51:31:01 Definitions.
20:51:31:02 Standards and procedures, Repealed.
20:51:31:03 Manual required, Repealed.
20:51:31:04 Physical environment requirements for sterile products, Repealed.
20:51:31:05 Requirement for primary engineering control device or room, Repealed.
20:51:31:06 Placement of primary engineering control device, Repealed.
20:51:31:07 Compounding aseptic isolator (CAI), Repaled.
20:51:31:08 Exception for placement of CAI, Repealed.
20:51:31:09 Ante area requirements, Repealed.
20:51:31:10 Delayed implementation, Repealed.
20:51:31:11 Cleaning, maintenance, and supplies, Repealed.
20:51:31:12 Additional records required, Repealed.
20:51:31:13 Quality assurance, Repealed.
20:51:31:14 Pharmacist responsibilities, Repealed.
20:51:31:15 Training documentation, Repealed.
20:51:31:16 Reference requirements, Repealed.
20:51:31:17 Labeling requirements, Repealed.
20:51:31:18 Microbial contamination risk levels, Repealed.
20:51:31:19 Low-risk preparations, Repealed.
20:51:31:20 Medium-risk preparations, Repealed.
20:51:31:21 High-risk preparations, Repealed.
20:51:31:22 Immediate-use preparations, Repealed.
20:51:31:23 Utilization of single-dose and multiple-dose containers, Repealed.
20:51:31:24 Utilization of proprietary bag and vial systems, Repealed.
20:51:31:25 Sterilization methods, Repealed.
20:51:31:26 Media-fill testing by personnel, Repealed.
20:51:31:27 Environmental monitoring requirements, Repealed.
20:51:31:28 Storage and delivery of sterile preparations, Repealed.
20:51:31:29 Additional requirements for preparation of hazardous drugs, Repealed.
20:51:31:30 Responsibilities for patient care, Repealed.
20:51:31:31 Patient or caregiver education and training, Repealed.
20:51:31:32 Compounding and hazardous drug handling standards--United States Pharmacopeia compounding standards implemented by reference.
20:51:31:33 Policy and procedure manual.
20:51:31:34 Compounding requirements.
20:51:31:35 Delivery service.
20:51:31:36 Disposal of pharmaceutical hazardous waste.
20:51:31:37 Quality assurance.
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.
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).
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 chapter, and the United States PharmacopeiaUnited States Pharmacopeia–National Formulary (February 1, 2024), General Chapter 797 Pharmaceutical Compoundingcompounding – Sterile Preparations, General Chapter 795 Pharmaceutical Compoundingcompounding – Nonsterile Preparations, General Chapter 800 Hazardous Drugsdrugs – Handling in Healthcare Settings, and General Chapter 825 Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging.
Source: 50 SDR 138, effective June 2, 2024.
General Authority: SDCL 36-11-11(3)(8).
Law Implemented: SDCL 36-11-2.2(3), 36-11-11(3)(8), 36-11-46.
Reference: United States Pharmacopeia--Compounding Compendium (February 1, 2024), available at https://online.uspnf.com/uspnf. Cost: $800 for individual user.
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, all applicable United States Pharmacopeia requirements, and be available for inspection by the board.
Source: 50 SDR 138, effective June 2, 2024.
General Authority: SDCL 36-11-11(3)(8).
Law Implemented: SDCL 36-11-2.2(3), 36-11-46.
Reference: United States Pharmacopeia--Compounding Compendium (February 1, 2024), available at https://online.uspnf.com/uspnf. Cost: $800 for individual user.
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 compounding staff shall have access to current reference materials applicable to compounding.
Source: 50 SDR 138, effective June 2, 2024.
General Authority: SDCL 36-11-11(3)(8).
Law Implemented: SDCL 36-11-2.2(3), 36-11-46.
Reference: United States Pharmacopeia--Compounding Compendium (February 1, 2024), available at https://online.uspnf.com/uspnf. Cost: $800 for individual user.
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: SDCL 36-11-44.
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, effective June 2, 2024.
General Authority: SDCL 36-11-11(3).
Law Implemented: SDCL 36-11-2.2(3), 36-11-46.
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.
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.
