[Federal Register Volume 68, Number 87 (Tuesday, May 6, 2003)]
[Notices]
[Pages 24005-24006]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-11073]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03D-0165]


Draft Guidance for Industry on the Current Good Manufacturing 
Practices for Medical Gases; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Current Good 
Manufacturing Practice for Medical Gases.'' This draft guidance 
discusses how the requirements in Title 21, Code of Federal 
Regulations, parts 210 and 211, current good manufacturing practice 
(CGMP) regulations apply to medical gases. Medical gases are subject to 
these regulations because they are considered prescription drugs.

DATES: Submit written or electronic comments on the draft guidance by 
September 3, 2003. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance for industry to the Office of Drug Information (HFD-240), 
Center for Drug Evaluation and Research, Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed label 
to assist that office in processing your requests. Submit written 
comments on the draft guidance to the Dockets Management Branch (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Duane S. Sylvia, Center for Drug 
Evaluation and Research (HFD-325), Food and Drug Administration, 7520 
Standish Pl., suite 272, Rockville, MD 20855, 301-594-0095 x 8, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance is intended to provide recommendations on how to 
comply with CGMPs for manufacturing, filling, transfilling, cascading, 
and transferring compressed and cryogenic medical gases. The guidance 
should help manufacturers and distributors comply with the CGMP 
requirements to ensure the identity, strength, quality, and purity of 
medical gases.
    FDA's first guidance on compressed medical gases was issued in June 
of 1981 and revised in 1983. In February of 1989, FDA issued a revised 
guidance to address issues related to the home care area, including the 
delivery of oxygen to patients at home. Once finalized, this guidance 
will supersede those earlier versions. The guidance has been updated to 
reflect CGMPs in FDA's regulations, 21 CFR parts 210 and 211.
    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practice regulations (21 CFR

[[Page 24006]]

10.115). The draft guidance, when finalized, will represent the 
agency's current thinking on CGMPs for medical gases. It does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the requirements of the applicable statutes and 
regulations.

II. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments to http://www.fda.gov/dockets/ecomments or two paper copies of any written comments, except 
that individuals may submit one paper copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/ohrms/dockets/default.htm, and http://www.fda.gov/cder/dmpq/gases.htm.

    Dated: April 29, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-11073 Filed 5-5-03; 8:45 am]
BILLING CODE 4160-01-S