USP<797> (Pharmaceutical Compounding – Sterile Preparations) became effective in 2004. 460.200 – Pharmacy Compounding Guidance was issued by FDA in 2002. The FDA has issued Warning Letters to pharmacy compounding facilities in violation of requirements outlined in <797> and 460.200, and FDA oversight of compounding facilities has increased. GQA can provide expertise in auditing to meet these requirements as well as design and develop procedures, systems, and facilities.
GQA has worked with several compounding pharmacies to evaluate their compliance to USP <797> and the FDA guidance document. We have the experience and background to help with developing and improving the systems to ensure compliance.