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
21CFR 111Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements The Food and Drug Administration (FDA) has issued a final rule regarding current good manufacturing practice (CGMP) for dietary supplements. The final rule establishes the minimum CGMPs necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement. The final rule is one of many actions related to dietary supplements being taken to promote and protect the public health. 21CFR 111 applies to both domestic and foreign companies that manufacture, test, package, label, hold, or distribute dietary supplements in the United States. Compliance enforcement to the regulation will be phased in, based on company size, over 3 years.