Description
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “Medical Gases -- Current Good Manufacturing Practice.” This guidance is intended to assist manufacturers of medical gases in complying with regulations for current good manufacturing practice (CGMP) that become effective on December 18, 2025 (note, the conforming amendments to the CGMP requirements for combination products became effective February 2, 2026). These regulations are specific to medical gases for human and animal use and, like all CGMP requirements, contain the minimum requirements to ensure that manufacturing processes operate under a state of control to meet prespecified quality standards for identity, strength, quality, and purity, but are tailored more narrowly to how medical gases are manufactured, packaged, labeled, stored, and distributed. This draft guidance is being issued to reflect new and revised regulations in several areas to reduce the regulatory burden, as appropriate, for the medical gas industry. This draft guidance revises and replaces the draft guidance entitled “Current Good Manufacturing Practice for Medical Gases” issued in June 2017.
Scope & Applicability
Product Classes
7Guidance for industry on manufacturing practices for medical gases; Draft Guidance for Industry regarding Current Good Manufacturing Practice; Current Good Manufacturing Practice for Medical Gases; Subject of the CGMP guidance
A DMG received from one source that is commingled or further distributed
cylinders requiring color coding on the shoulder
containers requiring 360 degree wraparound labels; Containers capable of being transported and intended to be attached to a medical gas supply system
Designated medical gases as defined in section 575 of the FD&C Act; Specific reporting requirements for cylinder, dewar, or tank units
Includes oxygen, nitrogen, nitrous oxide, carbon dioxide, helium, carbon monoxide, and medical air.; stability testing and expiration dating are not required for DMGs; Referred to as DMGs in distribution records; A drug manufactured or stored in a liquefied, nonliquefied, or cryogenic state
Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
Stakeholders
6Entity responsible for submitting NDINs
Entities including curbside vendors maintaining batch records; Manufacturers that transfer finished medical gas from one container to another
Source of the initial COA for DMGs; The person that initially produces a DMG by chemical reaction or physical separation
Facility supplying raw materials or ingredients; Facility providing raw materials to a manufacturer
Oversees reprocess or rework of batches
Personnel engaged in the manufacture or processing of medical gas.
Regulatory Context
Attributes
5specific colors identifying medical gases
controls in place to maintain the strength, composition, and purity
Specific identified portion of a batch or amount produced in a unit of time
Specific quantity of a drug intended to have uniform character and quality
should be based on appropriate supportive stability data
Identified Hazards
Hazards
3Risk associated with construction, traffic flow, and shared equipment.; Risk from raw food to RTE food or from insanitary objects; Personnel handling RTE foods touch contaminated surfaces
detected by hammer or dead-ring test
Risk if gas-specific outlet connections are removed
Related CFR Sections (20)
- 21CFR213.68§ 213.68 Automatic, mechanical, and electronic equipment.
(a) Automatic, mechanical, and electronic equipment used in the manufacture, processing, packing, and holding of medical gases shall be routinely calibrated, inspected, and checked according to a written program designed to ensure proper performance. Written procedures and records of calibration, inRead full regulation →
- 21CFR213.3§ 213.3 Definitions.
(a) The definitions and interpretations contained in section 201 of the Federal Food, Drug, and Cosmetic Act shall be applicable to such terms when used in this part.Read full regulation →
- 21CFR213.22§ 213.22 Responsibilities of quality unit.
(a) There shall be a quality unit that shall have the responsibility and authority to approve or reject all components, medical gas containers and closures, in-process materials, packaging material, labeling, and medical gases, and the authority to review production records to assure that no errors Read full regulation →
- 21CFR213.94§ 213.94 Medical gas containers and closures.
(a) Medical gas containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the gas beyond the official or established requirements.Read full regulation →
- 21CFR213.208§ 213.208 Salvaging of medical gases.
Medical gases in containers that have been subjected to improper storage conditions may be salvaged unless their containers have been subjected to adverse conditions that impact the identity, strength, quality, and purity of the gas or integrity of the container closure. Whenever there is a questionRead full regulation →
- 21CFR213.204§ 213.204 Returned medical gases.
Returned medical gases shall be identified as such and held. If the conditions under which such returned gases have been held, stored, or shipped before or during their return, or if the condition of the gas, its container, carton, or labeling, as a result of storage or shipping, casts doubt on the Read full regulation →
- 21CFR213.196§ 213.196 Distribution records.
Distribution records shall contain the name of the medical gas, lot or batch number, name and address of the consignee, and date and quantity shipped. For medically appropriate combinations of designated medical gases, the distribution record shall include the percentage of each gas.Read full regulation →
- 21CFR213.166§ 213.166 Stability testing and expiration dating for medical gases marketed under applications submitted under section 505 or section 512 of the Federal Food, Drug, and Cosmetic Act.
(a) For medical gases marketed under applications submitted under section 505 or section 512 of the Federal Food, Drug, and Cosmetic Act, any stability testing performed and any expiration date established shall be in accordance with paragraph (b) of this section, subject to the conditions establishRead full regulation →
- 21CFR213.160§ 213.160 General requirements.
(a) The establishment of any specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms required by this subpart, including any change in such specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms, shall be drafted Read full regulation →
- 21CFR213.194§ 213.194 Laboratory records.
(a) Laboratory records related to the manufacture of a medical gas must include complete data derived from all tests necessary to assure compliance with established specifications and standards, including examinations and assays, as follows:Read full regulation →
- 21CFR213.189§ 213.189 Batch production and control records.
(a) Batch production and control records shall be prepared for each batch of medical gas produced.Read full regulation →
- 21CFR201.328§ 201.328 Labeling of medical gas containers.
(a) Portable cryogenic medical gas containers. For the purposes of this section a portable cryogenic medical gas container is one that is capable of being transported and is intended to be attached to a medical gas supply system within a hospital, health care entity, nursing home, other facility, orRead full regulation →
- 21CFR213.180§ 213.180 General requirements.
(a) Record availability. All records required under this part, or copies of such records, shall be readily available for authorized inspection during the retention period at the establishment where the activities described in such records occurred and are subject to copying as part of such inspectioRead full regulation →
- 21CFR213.165§ 213.165 Testing and release for distribution.
(a) For each batch of medical gas, there shall be appropriate laboratory determination of satisfactory conformance to final specifications for the medical gas, including the identity and strength, prior to release.Read full regulation →
- 21CFR213.150§ 213.150 Warehousing and distribution procedures.
(a) Written procedures shall be established, and followed, describing the distribution of medical gases and including a system by which the distribution of each lot can be readily determined to facilitate its recall if necessary.Read full regulation →
- 21CFR201.17§ 201.17 Drugs; location of expiration date.
When an expiration date of a drug is required, e.g., expiration dating of drug products required by § 211.137 of this chapter , it shall appear on the immediate container and also the outer package, if any, unless it is easily legible through such outer package. However, when single-dose containers Read full regulation →
- 21CFR213.130§ 213.130 Packaging and labeling operations.
There shall be written procedures designed to assure that correct labels, labeling, and packaging materials are used for medical gases; such written procedures shall be followed. These procedures shall incorporate the following features:Read full regulation →
- 21CFR213.125§ 213.125 Labeling issuance.
(a) Labeling and packaging operations must be controlled to prevent labeling and product mix-ups. Procedures shall be written and followed describing in sufficient detail the control procedures employed for the issuance of labeling.Read full regulation →
- 21CFR213.122§ 213.122 Materials examination and usage criteria.
(a) There shall be written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, examination, and/or testing of labeling and packaging materials; such written procedures shall be followed. Labeling and packaging materials shall be representatively samplRead full regulation →
- 21CFR213.84§ 213.84 Testing and approval or rejection of components, containers, and closures.
(a) Components, containers, and closures (including valves) shall be examined for conformance with appropriate written procedures and specifications, and approved or rejected, prior to the manufacturing or filling process. In lieu of such examination by the firm, a statement of verification that theRead full regulation →
Related Warning Letters (10)
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CGMP/Finished Pharmaceuticals/Adulterated
SV Labs Corporation
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Guangdong Renhe Guozhuang Biotechnology Co., Ltd.
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Medinatura New Mexico, Inc.
- 2025-12-16
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- 2025-12-11
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Catalent Indiana, LLC
- 2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
DeVere Manufacturing Inc.
- 2025-12-09
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- 2025-12-09
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Seaway Pharma Inc.
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PQ Pharmacy, LLC
See Also (8)
- COVID-19: Developing Drugs and Biological Products for Treatment or Prevention: Guidance for Industry (Status: Final)
- Chapter 1 - General (Status: Final)
- Using Electronic Means to Distribute Certain Product Information: Guidance for Industry (Status: Final)
- CPG Sec. 400.210, Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs (Status: Final)
- Guidance for Industry: Questions and Answers on Juice HACCP Regulation (2003) (Status: Final)
- Guidance for Industry: Juice Hazard Analysis Critical Control Point Hazards and Controls Guidance, First Edition (Status: Final)
- Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (Status: Final)
- Final In Vivo Bioavailability-Bioequivalence Studies- Analytical (Status: Final)