Guideline

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Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act
Internet:	http://www.fda.gov/cder/guidance/2839dft.pdf
Origin/Publisher:	Center for Drug Evaluation and Research; Food and Drug Administration; 5600 Fishers Lane; Rockville, MD 20857; http://www.fda.gov/cder/guidance/index.htm
Content:	This Guidance describes FDA's policy on enforcement of section 503A of the Federal Food, Drug, and Cosmetic Act. (Section 503A provides that every bulk drug substance used in compounding must comply with an applicable and current USP or NF monograph).
Status:	Draft
Document Type:	FDA Guidance for Industry