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Compliance Policy Guide on Chapter 4 Human Drugs

Editors’ Note. A Compliance Policy Guide (CPG) on Pharmacy Compounding of Human Drugs was issued by the Office of Regulatory Affairs of the U.S. Food and Drug Administration in May, 2002. This CPG supercedes the 1992 CPG on pharmacy compounding. This CPG relates to Sub Chapter 460, Section 460.200 Pharmacy Compounding of Chapter 4 Human Drugs. This CPG is of direct relevance to prescribers and compounders because it describes the current FDA position on what are lawful and acceptable compounding practices. Many compounding pharmacists provide valuable service through preparation of dosage forms that are not commercially available and that are needed for special cases. But compounding requires special skills and some compounders lack the specialized knowledge needed to make safe, effective and reasonably stable extemporaneous formulation. Regrettably a few compounders who do not regularly seek the needed knowledge prepare ineffective and even dangerous extemporaneous preparations. The Journal will continue to provide guidance to professionals who wish to increase their compounding knowledge and who need information to assure that the compounders they use have sufficient knowledge, skills and equipment to meet appropriate compounding standards. This guidance document was prepared by the Office of Regulatory Policy and the Office of Compliance in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration. It is in the public domain.