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SMALL ENTITY COMPLIANCE GUIDE

2016 Medical Gas Container-Closure Rule Questions and Answers Guidance for Industry Guidance for Industry January 2017

Download the Final Small Entity Compliance Guide
Final
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended to help small businesses better understand and comply with recently issued regulations on current good manufacturing practice (CGMP) and labeling for medical gases. On November 18, 2016 (81 FR 81685), FDA published a final rule “Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements” (ContainerClosure Rule or final rule). The final rule amends certain CGMP regulations regarding medical gases to increase the likelihood that the contents of medical gas containers are accurately identified on labeling and by container coloring and to reduce the likelihood of the wrong gas being connected to a supply system by requiring gas-specific outlet connections. The final rule also revises an existing labeling regulation (21 CFR 201.161) that exempts listed medical gases from certain otherwise-applicable labeling requirements under specified conditions (including meeting the applicable medical gas labeling and container closure requirements and including certain warning statement(s))

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.

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