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 .