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Home U.S. FDA Drug Regulations U.S. FDA Drug Registration and Listings › Medical Gases

U.S. FDA Medical Gas Establishment Registration & Listing Requirements

Medical gases (e.g., oxygen, carbon dioxide, helium, nitrogen, nitrous oxide, medical air, and 49 combinations of these) are drugs within the meaning of section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (Act) and pursuant to section 503(b)(1)(A) of 51 the Act are required to be dispensed by prescription. Compressed Medical Gases (CMG) are any liquefied or vaporized gas alone or in combination with other gases which is a drug as defined by Section 201(g)(1) of the Act.



Medical Gases intended for use in the United States are considered drugs by the U.S. FDA. As such, establishments that manufacturer or process Medical Gases are considered drug manufacturers. Therefore, Medical Gas Establishments are subject to U.S. FDA drug registration and listing requirements.

Registrar Corp assists companies with the following Medical Gas requirements:
Drug Certificates Issued By Registrar Corp
  • U.S. FDA Medical Gas Establishment Registration
  • U.S. FDA Medical Gas Listing Submissions
  • Obtaining a DUNS Number
  • U.S. Agent Requirements
  • Registrant Contact Requirements
  • U.S. FDA Medical Gas Labeling Requirements


If you do not have an Establishment Registration Number and a Listing for your Medical Gas with U.S. FDA

New U.S. FDA Medical Gas Registration and Listings  ››

If you already have an Establishment Registration Number and a Listing for your Medical Gas with U.S. FDA

  
Option 1:  Update your existing Medical Gas Registration and Listing information
Click the Update button below for any of the following:
  • Update your Medical Gas Establishment Registration
  • Update an existing Medical Gas Listing with U.S. FDA
  • List another Medical Gas with U.S. FDA
  • Change U.S. Agent or Registrant Contact
Update Medical Gas Registration and Listing Information  ››

  
Option 2:   Order a Certificate of Registration issued by Registrar Corp
Companies registered with U.S. FDA often are asked by their customers and suppliers to verify their registration and listings. A Certificate of Registration issued by Registrar Corp serves to verify your compliance with Medical Gas Registration and Listing requirements.

Order Your Medical Gas Certificate  ››





 
U.S. FDA Regulations:

U.S. FDA Regulation: 21 C.F.R. Part 207
























Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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