This publication applies to the bulk manufacturing of medical gases as follows:

• bulk air separation (oxygen, USP and nitrogen, NF) manufacturing and distribution facilities;
• bulk carbon dioxide, USP manufacturing and distribution facilities;
• bulk helium, USP manufacturing and distribution facilities; and
• bulk nitrous oxide, USP manufacturing and distribution facilities.

This publication is intended to address current good manufacturing practice (CGMP) requirements for:

• Designated medical gases as defined in Section 575(1) of the Federal Food, Drug, and Cosmetic Act (Act) or combinations thereof; and
• Other medical gases as defined in Section 575(2) of the Act that may be approved via a new drug application (NDA) or abbreviated new drug application (ANDA) for which the sponsor has shown through a science based risk management plan that this standard provides appropriate CGMPs.

Throughout this publication the terms medical gas or medical gases are used to refer to these categories of products.

This publication does not apply to:

• Firms that engage in the filling, repackaging, transfilling, mixing, and/or relabeling of compressed medical gas (CMG) classified as drugs. See CGA M-2, Standard for the Manufacture of Medical Gases Classified as Drugs;
• Refrigerated liquid oxygen USP that is filled at a patient’s residence or is filled, repackaged, transfilled, and/or relabeled by home respiratory care companies; and
• Drugs that are defined as Investigational New Drug Applications.

See the United States Pharmacopeia and National Formulary (USP-NF) for information on the USP and NF designations for medical gases.