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FDA Emphasizing Supplier Controls

In the wake of recent drug quality incidents such as heparin contamination, the FDA is seriously considering how drug ingredient supply chains need to be audited, according to staff from CDER’s Officer of Compliance. Steve Wolfgang, a consumer safety officer … Continue reading

Pharmaceutical Compounding

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, … Continue reading

21 CFR 111 Compliance

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