2022-10458: Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases

Summary

The Food and Drug Administration (FDA, the Agency, or we) is proposing new regulations that would amend the requirements concerning current good manufacturing practice (CGMP) and postmarketing safety reporting that apply to certain medical gases. FDA further proposes to establish regulations regarding certification of designated medical gases and amend the labeling regulations that apply to certain medical gases. This action, if finalized, will clarify the regulatory obligations of entities that manufacture, process, pack, label, or distribute certain medical gases, as well as reduce regulatory burden in this area. This proposed rule is intended to establish requirements that are more specifically tailored to the medical gas industry.

The agency’s own summary, as published.

What this changes

Amends 9 parts of the Code of Federal Regulations — the standing rules this notice rewrites.

• 21 CFR 4 Regulation of Combination Products
• 21 CFR 16 Regulatory Hearing Before the Food and Drug Administration
• 21 CFR 201 Labeling
• 21 CFR 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General
• 21 CFR 211 Current Good Manufacturing Practice for Finished Pharmaceuticals
• 21 CFR 213 Current Good Manufacturing Practice for Medical Gases
• 21 CFR 230 Certification and Postmarketing Reporting for Designated Medical Gases
• 21 CFR 314 Applications for FDA Approval to Market a New Drug
• 21 CFR 514 New Animal Drug Applications