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Securing America’s Medicine Cabinet Act of 2021

USA117th CongressHR-70| House 
| Updated: 2/2/2021
Vern Buchanan

Vern Buchanan

Republican Representative

Florida

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Securing America's Medicine Cabinet Act of 2021 This bill encourages the development and approval of advanced pharmaceutical manufacturing technologies and designates certain university research centers to assist in developing such technologies. The Food and Drug Administration (FDA) must continue to evaluate and approve new drug manufacturing technologies included in an application for drug approval and expedite the development and implementation of such technologies. The FDA must designate such a technology as an advanced manufacturing technology if it is likely to (1) prevent or resolve a drug shortage, (2) maintain an adequate supply of critical medications for national emergencies, or (3) promote the adoption of innovative approaches to drug design and manufacturing. The sponsor of such a designated technology must provide the FDA with certain related scientific evidence. After receiving this evidence, if the FDA validates the technology for a proposed use, then the sponsor may use the validated technology across multiple manufacturing product lines within the same use context without obtaining additional FDA validation. The FDA must designate certain institutions of higher education as National Centers of Excellence in Advanced Pharmaceutical Manufacturing. Among other requirements, such centers must demonstrate the ability to provide federal agencies with technical assistance and to train a future workforce in such technologies.
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Timeline

Bill from Previous Congress

HR 116-6708
Securing America’s Medicine Cabinet Act of 2020
Jan 4, 2021
Introduced in House
Jan 4, 2021
Referred to the House Committee on Energy and Commerce.
Feb 2, 2021
Referred to the Subcommittee on Health.
Aug 3, 2021

Latest Companion Bill Action

S 117-2589
Introduced in Senate
  • Bill from Previous Congress

    HR 116-6708
    Securing America’s Medicine Cabinet Act of 2020


  • January 4, 2021
    Introduced in House


  • January 4, 2021
    Referred to the House Committee on Energy and Commerce.


  • February 2, 2021
    Referred to the Subcommittee on Health.


  • August 3, 2021

    Latest Companion Bill Action

    S 117-2589
    Introduced in Senate

Health

Advanced technology and technological innovationsCongressional oversightDrug safety, medical device, and laboratory regulationEducational facilities and institutionsEmergency medical services and trauma careGovernment information and archivesHealth technology, devices, suppliesHigher educationManufacturingMedical researchPrescription drugsResearch and developmentTechnology assessment

Securing America’s Medicine Cabinet Act of 2021

USA117th CongressHR-70| House 
| Updated: 2/2/2021
Securing America's Medicine Cabinet Act of 2021 This bill encourages the development and approval of advanced pharmaceutical manufacturing technologies and designates certain university research centers to assist in developing such technologies. The Food and Drug Administration (FDA) must continue to evaluate and approve new drug manufacturing technologies included in an application for drug approval and expedite the development and implementation of such technologies. The FDA must designate such a technology as an advanced manufacturing technology if it is likely to (1) prevent or resolve a drug shortage, (2) maintain an adequate supply of critical medications for national emergencies, or (3) promote the adoption of innovative approaches to drug design and manufacturing. The sponsor of such a designated technology must provide the FDA with certain related scientific evidence. After receiving this evidence, if the FDA validates the technology for a proposed use, then the sponsor may use the validated technology across multiple manufacturing product lines within the same use context without obtaining additional FDA validation. The FDA must designate certain institutions of higher education as National Centers of Excellence in Advanced Pharmaceutical Manufacturing. Among other requirements, such centers must demonstrate the ability to provide federal agencies with technical assistance and to train a future workforce in such technologies.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline

Bill from Previous Congress

HR 116-6708
Securing America’s Medicine Cabinet Act of 2020
Jan 4, 2021
Introduced in House
Jan 4, 2021
Referred to the House Committee on Energy and Commerce.
Feb 2, 2021
Referred to the Subcommittee on Health.
Aug 3, 2021

Latest Companion Bill Action

S 117-2589
Introduced in Senate
  • Bill from Previous Congress

    HR 116-6708
    Securing America’s Medicine Cabinet Act of 2020


  • January 4, 2021
    Introduced in House


  • January 4, 2021
    Referred to the House Committee on Energy and Commerce.


  • February 2, 2021
    Referred to the Subcommittee on Health.


  • August 3, 2021

    Latest Companion Bill Action

    S 117-2589
    Introduced in Senate
Vern Buchanan

Vern Buchanan

Republican Representative

Florida

Health Subcommittee, Energy and Commerce Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Advanced technology and technological innovationsCongressional oversightDrug safety, medical device, and laboratory regulationEducational facilities and institutionsEmergency medical services and trauma careGovernment information and archivesHealth technology, devices, suppliesHigher educationManufacturingMedical researchPrescription drugsResearch and developmentTechnology assessment