- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and Research
This document is intended to provide guidance on general principles for submitting information on packaging materials used for human drugs and biologics. This guidance supersedes the FDA Guideline for Submitting Documentation for Packaging for Human Drugs and Biologics, issued in February 1987 and the packaging policy statement issued in a letter to industry dated June 30, 1995 from the Office of Generic Drugs. This guidance is not intended to describe the information that should be provided about packaging operations associated with drug product manufacture.
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-1997-D-0145.