(a) As in the dispensing of all prescription drugs, the pharmacist has the responsibility for all of the following:
- (1) Inspection and approval or rejection of all components, bulk drug substances (that is, active pharmaceutical ingredients), drug product containers, closures, in-process materials and labeling.
- (2) Preparation and review of all compounding records to assure that errors have not occurred in the compounding process.
- (3) Proper maintenance, cleanliness and use of all facilities and equipment used in compounding practice.
- (b) If errors have occurred, the pharmacist is responsible for conducting a full investigation, and creating and maintaining a record of the investigation which must include conclusions and corrective action.
Authority
The provisions of this § 27.603 issued under sections 4(j) and 6(k)(1) and (9) of the Pharmacy Act (63 P.S. § § 390-4(j) and 390-6(k)(1) and (9)).
Source
The provisions of this § 27.603 adopted June 21, 2019, effective June 22, 2019, 49 Pa.B. 3210.