Compounding botanicals: a legal perspective.
OBJECTIVE
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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Valentino
J G
JG
United States Pharmacopeia (USP), Rockville, Md., USA.
Bormel
F G
FG
D003358:Cosmetics / Q000592:standards; D003625:Data Collection; D019587:Dietary Supplements / Q000592:standards*; D004339:Drug Compounding / Q000592:standards*; D006801:Humans; D007880:Legislation, Drug; D008517:Phytotherapy; D010946:Plants, Medicinal / Q000627:therapeutic use*; D014481:United States; D014486:United States Food and Drug Administration
D003358:Cosmetics