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Preventing Drug Shortages Act

USA116th CongressHR-6080| House 
| Updated: 3/4/2020
Scott H. Peters

Scott H. Peters

Democratic Representative

California

Cosponsors (8)
Brett Guthrie (Republican)Eliot L. Engel (Democratic)Gus M. Bilirakis (Republican)Kurt Schrader (Democratic)Richard Hudson (Republican)John Joyce (Republican)Anna G. Eshoo (Democratic)Michael T. McCaul (Republican)

Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Preventing Drug Shortages Act This bill expands existing manufacturer reporting requirements related to shortages of life-saving drugs and contains other related provisions. The bill requires a manufacturer of an active pharmaceutical ingredient of a life-saving drug to notify the Food and Drug Administration (FDA) of an interruption that is likely to lead to a meaningful disruption in the ingredient's supply, whereas under current law this requirement generally applies only to the manufacturer of a life-saving drug that faces a supply disruption. The notification must contain specified information, including any alternative sources for the ingredient. The bill also requires a manufacturer of a life-saving drug or an active pharmaceutical ingredient for such a drug to include in its annual product registration the specific facilities where the drug or ingredient is manufactured. The FDA may also require the manufacturer to conduct periodic risk assessments to address vulnerabilities in its supply chain. The Government Accountability Office shall report to Congress on the FDA's intra-agency coordination in assessing drug shortage risks.
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Timeline
Mar 4, 2020
Introduced in House
Mar 4, 2020
Referred to the House Committee on Energy and Commerce.
  • March 4, 2020
    Introduced in House


  • March 4, 2020
    Referred to the House Committee on Energy and Commerce.

Health

Related Bills

  • S 116-2723: Mitigating Emergency Drug Shortages Act
Business recordsGovernment studies and investigationsHealth information and medical recordsHealth technology, devices, suppliesManufacturingPrescription drugs

Preventing Drug Shortages Act

USA116th CongressHR-6080| House 
| Updated: 3/4/2020
Preventing Drug Shortages Act This bill expands existing manufacturer reporting requirements related to shortages of life-saving drugs and contains other related provisions. The bill requires a manufacturer of an active pharmaceutical ingredient of a life-saving drug to notify the Food and Drug Administration (FDA) of an interruption that is likely to lead to a meaningful disruption in the ingredient's supply, whereas under current law this requirement generally applies only to the manufacturer of a life-saving drug that faces a supply disruption. The notification must contain specified information, including any alternative sources for the ingredient. The bill also requires a manufacturer of a life-saving drug or an active pharmaceutical ingredient for such a drug to include in its annual product registration the specific facilities where the drug or ingredient is manufactured. The FDA may also require the manufacturer to conduct periodic risk assessments to address vulnerabilities in its supply chain. The Government Accountability Office shall report to Congress on the FDA's intra-agency coordination in assessing drug shortage risks.
View Full Text

Suggested Questions

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

Timeline
Mar 4, 2020
Introduced in House
Mar 4, 2020
Referred to the House Committee on Energy and Commerce.
  • March 4, 2020
    Introduced in House


  • March 4, 2020
    Referred to the House Committee on Energy and Commerce.
Scott H. Peters

Scott H. Peters

Democratic Representative

California

Cosponsors (8)
Brett Guthrie (Republican)Eliot L. Engel (Democratic)Gus M. Bilirakis (Republican)Kurt Schrader (Democratic)Richard Hudson (Republican)John Joyce (Republican)Anna G. Eshoo (Democratic)Michael T. McCaul (Republican)

Energy and Commerce Committee

Health

Related Bills

  • S 116-2723: Mitigating Emergency Drug Shortages Act
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Business recordsGovernment studies and investigationsHealth information and medical recordsHealth technology, devices, suppliesManufacturingPrescription drugs