Selecting a Quality Compounding Pharmacy

This guest post was written by Joe Cabaleiro R.Ph., Executive Director, Pharmacy Compounding Accreditation Board, PCAB (Webiste: www.pcab.org)

Practitioners of integrative medicine frequently rely on compounding pharmacies for medications that are not commercially available. Examples of these medications may include hormone preparations and or vitamin injections. One question many providers have is: “How do I select a quality compounding pharmacy?” This article will provide you with some tools for selecting a quality compounding pharmacy.

The first thing you should always determine: Is the pharmacy licensed in your state? This may seem like a basic question, but most states require that pharmacies be licensed in each state they do business in. Therefore, your practice may incur liability if it orders or uses medications from a pharmacy that is not licensed in the state your practice is located in. This can often be independently verified on your state’s Board of Pharmacy web site.

Is the pharmacy accredited by the Pharmacy Compounding Accreditation Board? PCAB sets quality standards and serves as a voluntary accrediting organization for compounding pharmacies. PCAB verifies that accredited pharmacies comply with quality assurance, quality control, and quality improvement standards through the use of on-site assessments performed by experienced pharmacist-surveyors. Using PCAB accreditation as one of your compounding pharmacy selection criteria will assure that the pharmacies you are considering have “gone the extra mile” to obtain independent validation that they comply with a set of nationally accepted quality standards. A list of PCAB accredited pharmacies is available here.

Does the pharmacy test finished preparations? Compounding medications is a complex process that can involve many critical steps. Practitioners that order or use compounded preparations should verify that the compounding pharmacy they use has a program for testing samples of their finished preparations. For non-sterile medications such as capsules, this includes potency testing. For sterile preparations, this testing should include evaluation of potency, sterility and endotoxins. Make a list of the most commonly used compounded preparations used in your practice and ask your compounding pharmacy how it verifies the quality of each. The pharmacy should be able to provide you with specific reports.

Does the pharmacy have a functioning recall mechanism? If the pharmacy has to recall a lot of a compounded preparation, it must have a process in place to identify which patients and practices received the lot number. If your practice has lot numbers of a compounded preparations available, ask the pharmacy which provided them to list which lot numbers of the medications your practice has received. The response should match the lot numbers of the medications you have on-site.

Does the pharmacy’s facility meet USP requirements? The United States Pharmacopeia publishes written standards for medicines and their ingredients. Included in these standards are chapters known as “USP <795>” and “USP<797>” that outline conditions and practices non-sterile (<795>) and sterile compounding (<797>) pharmacies should follow to ensure and verify the quality of their preparations. Ask the pharmacy if they are USP<795> and USP<797> compliant.

Finally, the International Academy of Compounding Pharmacists (iacprx.org) has published a “Compounding Pharmacy Assessment Questionnaire” available here. This tool has a comprehensive list of questions that will further help you identify top quality compounders.

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