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

https://www.federalregister.gov/documents/2024/06/18/2024-13190/current-good-manufacturing-practice-certification-postmarketing-safety-reporting-and-labeling Today, FDA announced a final rule that establishes certification regulations for certain medical gases and amends the requirements for current good manufacturing practice (CGMP), postmarketing safety reporting, and labeling. FDA has engaged with stakeholders and Congress for several years to gather input and evaluate the need for regulatory changes within the medical gas industry. This rule clarifies the regulatory obligations of entities that manufacture, process, pack, label, or distribute medical gases. Key provisions established include: Labeling requirements to clarify the statement of ingredients and quantity of contents, revise warning statements for certain designated medical gases, and establish more limited labeling requirements for bulk or transport containers. CGMP requirements that recognize important differences in how medical gases are manufactured, labeled, and distributed, including the reuse of containers and labeling; mixing and commingling of gases; that gases are generally manufactured in a closed, pressurized system; and that many medical gases are generally not expected to expire or degrade. Regulations to codify the certification process for designated medical gases, including provisions regarding supplemental applications, annual reporting, and withdrawal or revocation of approval of an application. Safety reporting requirements that recognize certain events related to designated medical gases need not be reported to the agency.