Compounded drug products that are essentially copies of approved drug products under Section 503B of the Federal Food, Drug, and Cosmetic Act

Compounded drug products that are essentially copies of approved drug products under Section 503B 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
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 (15 pages))
Illustrations:
Illustrations
NLM Unique ID:
101720068 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/101720068