scope:

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 [2].

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 [3];

• 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 [4].