FDA's 21st Century Cures Act Reshapes EUA Authority and GMP Waiver Powers for MCM Manufacturers

GMP compliance obligations do not disappear during a public health emergency, but under the 21st Century Cures Act (H.R. 34; PL: 114-255), signed into law on December 13, 2016, FDA holds explicit authority to waive Current Good Manufacturing Practice requirements when issuing Emergency Use Authorizations for medical countermeasures (MCMs). For plant heads and QA directors building emergency preparedness protocols, that statutory carve-out defines both the ceiling of regulatory flexibility and the floor of documentation risk.

Section 3088 of the Cures Act amends FDA's EUA authority under section 564 of the FD&C Act to extend emergency use provisions to animal drugs, including the power to waive cGMP compliance, issue emergency dispensing orders, make CDC Emergency Use Instructions available, and extend product expiration dates. FDA's 2017 guidance, Emergency Use Authorization of Medical Products and Related Authorities, applies to this expanded authority, though the agency has acknowledged that novel questions around animal drug EUAs will be addressed as operational experience accumulates.

Beyond EUA mechanics, the Cures Act introduced a priority review voucher (PRV) program for material threat MCMs under section 3086, codified at 21 U.S. Code § 360bbb-4a. Upon approval of a qualifying MCM application, FDA awards a PRV that can be used by the recipient or sold to another sponsor. A PRV converts a standard 10-month review timeline to a 6-month priority review goal, a meaningful compression for any manufacturer carrying a late-stage MCM asset through the approval pathway.

Additional Cures Act provisions with operational relevance include support for complex adaptive trial designs, real-world evidence frameworks, a Limited Populations Antibacterial and Antifungal Drug program, and harmonization of FDA human subjects protections with the Federal Policy for the Protection of Human Subjects (the Common Rule). A proposed rule implementing section 3024, covering waivers of informed consent for minimal risk studies, completed its comment period in March 2019; FDA has indicated it will withdraw the associated guidance once those regulations take effect.

For regulatory affairs leads, the PRV program's draft guidance, issued January 17, 2018, remains the operative reference for eligibility criteria, and tracking issued and redeemed material threat MCM vouchers provides a practical signal of pipeline activity in the countermeasure space.

The degree to which manufacturers can operationalize cGMP waiver provisions within their site master files and emergency response SOPs will determine how quickly compliant supply can reach authorized channels when an EUA is activated.

Source: FDA via What's New: Drugs RSS Feed, October 28, 2026.