Compounding is not manufacturing and therefore does take some time in formulating, preparing, and packaging each individual custom preparation.

Compounded medicines are needed for many reasons. Some of which include; pediatric, lower, or higher doses than what is available in manufactured form; alternate dosage forms such as suspensions, solutions or topical creams and gels; and combining medicines to enhance therapeutic adherence.

Compounding is regulated by the individual State Boards of Pharmacy, the United States Pharmacopeia (USP), and now an accrediting body called the Pharmacy Compounding Accreditation Board (PCAB). The FDA and DEA mainly handle manufactured medicines.

The USP develops standards for not only community pharmacies that prepare compounded medicines but also large manufacturers and have used some of the same basic ideas in manufacturing to create good compounding processes. Specifically, USP chapters 795, for non-sterile preparations, and chapter 797, for sterile compounds, address how a pharmacy should design the workspace, train the employees, verify ingredient purity, maintain equipment, and verify their quality processes.

Pierce Apothecary meets or exceeds USP compounding requirements. We recently began work on accreditation through PCAB; a lengthy and tiring process!