FDA Guidance for Industry: Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act
Title:
FDA Guidance for Industry: Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act
Origin/Publisher:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM469119.pdf
Content:
This guidance announces FDA’s intention with regard to enforcement of section 503A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 353a) to regulate entities that compound drugs, now that section 503A has been amended by Congress to remove the advertising and solicitation provisions that were held unconstitutional by the U.S. Supreme Court in 2002 (see section II below).