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GUIDANCE DOCUMENT

Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry January 2018

Final
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

To qualify for exemptions under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C
Act), a drug product must be compounded by a licensed pharmacist or physician who does not compound
regularly or in inordinate amounts any drug products that are essentially copies of a commercially
available drug product, among other conditions. This guidance sets forth FDA’s policies regarding
this provision of section 503A, including the terms commercially available, essentially a copy of a
commercially available drug product, and regularly or in inordinate amounts.
 


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.