PA Board of Pharmacy Issues Compounding Regulations
After nine years of deliberation, the Pennsylvania Board of Pharmacy (Board) issued final regulations (effective June 22, 2019) setting new standards for pharmacist compounding of drug products. While the final regulations are substantially less onerous than as originally proposed, the regulations represent the Board’s commitment to ensuring compounding is performed in a safe and reliable manner in Pennsylvania.
Notably, the final regulations apply only to pharmacists and pharmacy technicians. Compounding of medications by medical doctors and other licensed health care providers remains subject to the jurisdiction of their respective licensure boards. Further, the final regulations adopt the Federal Food, Drug, and Cosmetic Act (FDCA) definition of compounding, which specifically excludes “mixing, reconstituting, or other such acts” performed in accordance with directions found on FDA-approved manufacturer product labeling.
Substantively, the final regulations require all compounding pharmacists and pharmacy technicians to comply with Section 503a of the FDCA and all FDA regulations applicable to compounding. Compounding pharmacists and pharmacy technicians must also comply with all requirements set forth in the United States Pharmacopeia (USP). Further, Pennsylvania pharmacists and pharmacy technicians must also adhere to the following, among other requirements:
Pharmacists must retain responsibility for inspection and approval of all components, bulk drug products (active pharmaceutical ingredients), product containers, closures, in-process materials, and labeling associated with compounded products;
Pharmacists must retain responsibility for preparation and review of all compounding records;
Pharmacists must retain responsibility for maintenance, cleanliness, and use of all facilities and equipment used in compounding, including specialty equipment and automated processes;
Pharmacists must provide direct, immediate and personal supervision of all pharmacy technicians that perform compounding;
Pharmacy technicians may not engage in compounding unless authorized by a written protocol maintained by the pharmacy’s pharmacist-in-charge;
Compounded medication labeling must comply with general labeling requirements applicable to all drug product containers under Pennsylvania and federal law; and
Compounding pharmacists must maintain all original compounded medication records in a readily available format in the pharmacy for at least two years following the date of the records.
Moreover, in the event of a compounding error, the final regulations impose an affirmative duty on pharmacists responsible for compounding to conduct a “full investigation,” which includes documenting a record of the investigation and issuing conclusions and corrective actions.
The Board’s final regulations impose new requirements on pharmacists and pharmacy technicians engaged in compounding, including maintenance of written protocols related to compounding as well as documentation requirements.