Document ID: FDA-2015-N-3043-0001
Agency: fda
Document Type: Notice
Title: Compressed Medical Gases-Warning Letters for Specific Violations
Covering Liquid and Gaseous Oxygen; Withdrawal of Compliance Policy
Guide
Posted Date: 2015-09-03T04:00Z

[Federal Register Volume 80, Number 171 (Thursday, September 3, 2015)]
[Notices]
[Page 53311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21874]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3043]

Compressed Medical Gases-Warning Letters for Specific Violations 
Covering Liquid and Gaseous Oxygen; Withdrawal of Compliance Policy 
Guide

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
withdrawal of Compliance Policy Guide (CPG) Section 435.100, entitled 
``Compressed Medical Gases--Warning Letters for Specific Violations 
Covering Liquid and Gaseous Oxygen.''

DATES: The withdrawal is effective September 3, 2015.

FOR FURTHER INFORMATION CONTACT: Mary E. Kennelly, Office of Regulatory 
Affairs, 10903 New Hampshire Ave., Bldg. 32, Rm. 4338, Silver Spring, 
MD 20993, 240-402-9577.

SUPPLEMENTARY INFORMATION: A Compliance Policy Guide (CPG) on medical 
gases was originally issued on November 5, 1987, in the Agency's Manual 
of Compliance Policy Guides. In a notice published in the Federal 
Register of September 16, 1992 (57 FR 42757), FDA announced the 
availability of a revised CPG on this topic entitled ``Compressed 
Medical Gases--Warning Letters for Specific Violations Covering Liquid 
and Gaseous Oxygen'' (CPG 7132a.16). Subsequently, the Agency's Manual 
of Compliance Policy Guides was reorganized and this material became 
Section 435.100. The CPG provided guidance to FDA district offices for 
issuing warning letters to firms that are engaged in filling cylinders 
with gas(es) for medical use that are not operating in conformance with 
the adulteration, misbranding, and/or new drug provisions of the 
Federal Food, Drug, and Cosmetic Act.
    On March 15, 2015, FDA implemented the revised Compliance Program 
Guidance Manual (CPGM) 7356.002E, entitled ``Compressed Medical 
Gases,'' available at http://www.fda.gov/downloads/ICECI/ComplianceManuals/ComplianceProgramManual/UCM125417.pdf. CPGM 7356.002E 
instructs FDA staff regarding a range of subjects, including, but not 
limited to, the inspections and investigations, regulatory and/or 
administrative action, and the issuance of warning letters related to 
compressed medical gases. As the CPGM 7356.002E articulates FDA's 
current thinking on issuing warning letters related to compressed 
medical gases, CPG Section 435.100 is withdrawn.

    Dated: August 28, 2015.
Steven Solomon,
Deputy Associate Commissioner for Regulatory Affairs.
[FR Doc. 2015-21874 Filed 9-2-15; 8:45 am]
BILLING CODE 4164-01-P