NLM Digital Collections

Compounded drug products that are essentially copies of a commercially available drug product under Section 503A of the Federal Food, Drug, and Cosmetic Act

Collection:
Health Policy and Services Research
Series Title(s):
Guidance for industry
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Drug Evaluation and Research (U.S.). Office of Compliance. Office of Unapproved Drugs and Labeling Compliance, issuing body.
Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, January 2018
Language(s):
English
Format:
Text
Subject(s):
Drug Compounding -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.
Genre(s):
Guideline
Technical Report
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (12 pages))
Illustrations:
Illustrations
NLM Unique ID:
101720065 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/101720065