FDA publishes Final Rule on Medical Gases

The U.S. FDA has implemented a new rule mandating certification for medical gases and updating GMP requirements, safety reporting, and labeling. Collaborating with stakeholders and Congress over years, the FDA aimed to refine regulations in the medical gas manufacturing sector. The document "Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases" details obligations for companies manufacturing, processing, packaging, labeling, or distributing medical gases under the Federal Food, Drug, and Cosmetic Act 575(1).

Key provisions include:

• Clarifying labeling to specify ingredients and quality, updating warnings for some gases, and simplifying requirements for large quantities or transport containers.
• Establishing GMP standards tailored to medical gas production, labeling, and distribution, addressing container reuse and gas mixing, considering the stability of gases in pressurized containers.
• Implementing certification processes for specific medical gases, requiring annual reporting, and allowing for withdrawal or cancellation of approvals by the authority.
• Adjusting safety reporting to exempt certain events for selected medical gases from mandatory reporting to the authority.