S.D. Admin. R. 20:51:31:37

Current through Register Vol. 50, page 159, June 17, 2024

Section 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.

S.D. Admin. R. 20:51:31:37

50 SDR 138, effective 6/2/2024

General Authority: SDCL 36-11-11(3).

Law Implemented: SDCL 36-11-2.2(3), 36-11-42, 36-11-46.