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# Continuous Manufacturing and Counterfeit Devices Bills Pass
- URL: https://www.fdaweb.com/continuous-manufacturing-and-counterfeit-devices-bills-pass/
- Published: 2020-09-22T12:00:00.000Z
- Updated: 2026-09-14T16:29:47.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5147704

The U.S. House has passed two bills having wide implications for FDA in supporting continuous pharmaceutical manufacturing and combating counterfeit medical devices. HR 4866, “National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019,” was introduced by Reps. **Frank Pallone** (D-NJ) and **Brett Guthrie** (R-KY) and passed a voice vote 9/21\. The legislation would amend the 21st Century Cures Act to direct FDA to designate national centers of excellence to work with the agency and industry to craft a national framework for continuous manufacturing implementation, including supporting additional research and development of this technology, workforce development, standardization and collaborating with manufacturers to support adoption of continuous manufacturing, [lawmakers say](https://energycommerce.house.gov/newsroom/press-releases/pallone-eshoo-on-house-passage-of-ten-health-care-bills?ref=fdaweb.com). The bill authorizes $80 million to be appropriated for the centers each year from fiscal year 2021 through 2025.

In a [statement](https://energycommerce.house.gov/newsroom/press-releases/pallone-and-guthrie-introduce-legislation-to-support-continuous?ref=fdaweb.com), Pallone and Guthrie said drug manufacturing has changed very little in 50 years, with most companies still using “batch” manufacturing techniques that can be inefficient, slow, and may be subject to the risk of defects or errors during the manufacturing process. They describe continuous manufacturing as an emerging technology in which a finished product is produced in a continuous stream. “This technology allows product quality to be precisely controlled, reduces challenges in scaling up production, can more readily produce ranges of drug strengths and doses, and requires less physical space,” Pallone and Guthrie wrote. “This could allow more production sites to be located in the U.S.”

HR 5663, “Safeguarding Therapeutics Act,” was introduced by **Brett Guthrie** (R-KY) and **Eliot Engel** (D-NY) and it also passed by a voice vote. The bill would extend FDA’s administrative destruction authority to medical devices, which would allow FDA to destroy certain imported medical devices, such as diagnostic tests or surgical masks in instances where it believes such medical devices are adulterated, misbranded or unapproved and may pose a threat to the public health, as the agency currently does with drugs.