The FDA has issued the final rule establishing regulations to require current good manufacturing practices (CGMPs) for dietary supplements. These new regulations will require that dietary supplement manufacturers put into place proper controls to insure that dietary supplements are processed … Continue reading
Compounding PharmacyUSP<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.