The US Food and Drug Administration (FDA) has finalised the rules on current good manufacturing practice (CGMP), certification, post-marketing safety reports, and labelling requirements for certain medical gases.
Issued earlier this month (June 2024), the final rule culminates a thorough process that began in 1978 when the FDA acknowledged the need for separate CGMPs for medical gases and resulted in proposed rules in May 2022.
The final rule fulfils the mandate under section 756 of the Consolidated Appropriations Act of 2017, to revise federal drug regulations specific to medical gases by 15th July 2017.
Commending the news, the Compressed Gas Association (CGA) said the final rule marks a significant step forward in enhancing the regulatory framework governing medical gases, ensuring both safety and quality standards are upheld across the industry.
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