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
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter 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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2016-D-1309.