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GUIDANCE DOCUMENT

Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act Guidance for Industry April 2016

Download the Draft Guidance Document
Draft

Not for implementation. Contains non-binding recommendations.

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

Pharmacies located within a hospital or standalone pharmacies that are part of a health system 18 frequently provide compounded drug products for administration within the hospital or health 19 system. Some of these compounders have registered with FDA as outsourcing facilities under 20 section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) and others 21 are state-licensed pharmacies subject to section 503A of the FD&C Act. This guidance describes 22 how FDA intends to apply section 503A of the FD&C Act to drugs compounded by licensed 23 pharmacists or physicians in state-licensed hospital or health system pharmacies for use within 24 the hospital or health system.

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.