Compounding botanicals: a legal perspective

To describe the effects of the new law, section 503A, "Pharmacy Compounding," of the Federal Food, Drug, and Cosmetic Act on the compounding of drugs, dietary supplements, and cosmetics.

The Food and Drug Administration (FDA) Modernization Act of 1997; Federal, Food, Drug, and Cosmetic Act; Code of Federal Regulations; Federal Register; Food and Drug Administration Guidances.

Pharmacy compounding, which traditionally is considered part of pharmacy practice and is regulated by the states, has been confused with drug manufacturing, an activity regulated by FDA. Section 503A, "Pharmacy Compounding," was enacted as part of the Food and Drug Administration Modernization Act of 1997 to distinguish compounding from manufacturing. This law addresses the compounding of drug products, but not necessarily the compounding of botanicals, which may be considered dietary supplements, cosmetics, or drugs.

Section 503A applies to the compounding of products intended for a drug use, but does not apply to compounded products that are intended for dietary supplement or cosmetic use. Compounded dietary supplements and cosmetics must instead adhere to relevant federal requirements, including those for good manufacturing practices and labeling.