You have probably heard about the fungal meningitis outbreak and associated deaths that resulted from a tainted injection product shipped to multiple states by a compounding pharmacy in the Boston, MA, area. This case begs the question – how does one determine the quality and safety of products from their own compounding pharmacy. Here are some rules of thumb that will help. Ask your compounding pharmacist the following questions:
Do you follow all appropriate USP standards for compounding? Do you provide ongoing training for yourself and your staff? Do you only use ingredients from FDA-registered suppliers? Can you provide documentation that demonstrates the quality and safety of your product?
The USP sets national standards for both manufacturing and compounding. These are considered minimum standards that must be met by manufacturers and compounding pharmacies. One way to know your pharmacy meets these standards is if they are accredited by the Pharmacy Compounding Accreditation Board (PCAB), a national, non-profit, voluntary, accreditation board. You can visit their website for more information and to search for an accredited pharmacy near you. Website is www.pcab.org
Compounding is growing nationally because it provides services and products that cannot be obtained otherwise. It is in your own self-interest to make sure that the compounder you use meets national standards for providing a high quality and safe products.