Compounding pharmacies make up a very small portion of American pharmacies. Pharmacists in compounding pharmacies spend their time compounding specific preparations for patients pursuant to a prescription. Even though there is a small number of compounding pharmacies, they are still regulated, but by who?
Topic 1: Authorities
A: All state licensed pharmacists and pharmacies involved in compounding are subject to a degree of oversight by both federal and state authorities for which they are licensed in.
C: The Drug Enforcement Agency (DEA) has oversight for controlled substances used in compounded medications.
Topic 2: USP
A: The United States Pharmacopeial Convention (USP) was established in 1820 and issues standards that apply to compounding
B: The two chapters that are most relevant to compounding pharmacies at this time are USP 797 (sterile products/formulations) and USP 795 (non-sterile products/formulations). The standards discuss prevention of microbial contamination, beyond-use dating, and stability
C: Compliance with these chapters and other USP chapters are considered a standard of pharmacy practice
Topic 3: PCAB
A: The pharmacy profession has one accrediting body, established in 2007, for compounding pharmacies called the Pharmacy Compounding Accreditation Board (PCAB).
B: It was established by various organizations, including the American Pharmacists Association, and is governed by the National Association of Boards of Pharmacy, USP, the International Academy of Pharmaceutical Compounding, and several pharmacy practitioner associations
C: PCAB accredited pharmacies have proven to achieve a superior level of quality assurance recognition for sterile and nonsterile compounded preparations.
Although compounding pharmacies make up a small number of total pharmacies in the United States, they are regulated to a degree by state and federal authorities. Taking it a step further with PCAB accreditation provides consumers with a strong indicator of the quality of products that they receive from accredited pharmacies. FYI, the American Association of Equine Practitioners recommends and American Animal Hospital Association endorses prescribing to PCAB accredited compound pharmacies to avoid the pitfalls of compounding.