Public Citizen Offers Comments on FDA’s Guidance Documents for the Pharmacy Compounding and Outsourcing Industries

View as PDF: Repackaging of Drugs | Biological Products | Adverse Events

Public Citizen comments on three draft guidance documents put out by the Food and Drug Administration intended to offer guidance to industry on the repackaging of drugs, the mixing, diluting, and repackaging biological products, and adverse event reporting by outsourcing facilities. Public Citizen generally supports the proposed documents, but urges FDA to impose tighter requirements in some areas to protect public health.