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.