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Preserving Patient Access to Compounded Medications Act of 2019

USA116th CongressHR-1959| House 
| Updated: 3/29/2019
H. Morgan Griffith

H. Morgan Griffith

Republican Representative

Virginia

Cosponsors (42)
David Schweikert (Republican)Chris Stewart (Republican)Paul A. Gosar (Republican)Adrian Smith (Republican)Clay Higgins (Republican)John R. Carter (Republican)Pete Olson (Republican)Don Young (Republican)Jefferson Van Drew (Republican)Neal P. Dunn (Republican)Robert J. Wittman (Republican)Darin LaHood (Republican)Andy Biggs (Republican)Jeff Duncan (Republican)Earl L. "Buddy" Carter (Republican)Rob Bishop (Republican)Dan Newhouse (Republican)Barry Loudermilk (Republican)Mario Diaz-Balart (Republican)Justin Amash (Libertarian)Steve King (Republican)Mike D. Rogers (Republican)John Joyce (Republican)John R. Moolenaar (Republican)Bruce Westerman (Republican)Trey Hollingsworth (Republican)Mark E. Green (Republican)Henry Cuellar (Democratic)Tulsi Gabbard (Democratic)Gary J. Palmer (Republican)Mac Thornberry (Republican)Debbie Lesko (Republican)Jeff Fortenberry (Republican)Yvette D. Clarke (Democratic)Bradley Byrne (Republican)Brian K. Fitzpatrick (Republican)Bill Posey (Republican)Ben Cline (Republican)Tom Graves (Republican)Ted Budd (Republican)Jaime Herrera Beutler (Republican)David P. Roe (Republican)

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Preserving Patient Access to Compounded Medications Act of 2019 This bill addresses regulations governing compounding pharmacies. The bill expands the circumstances under which a drug may be compounded (i.e., manufactured at small scale) to allow pharmacists and physicians to compound drugs for administration to patients in an office or clinical setting, in accordance with state law. (Compounded drugs are not required to meet certain federal requirements regarding manufacturing, labeling, or approval.) Dietary supplements may be used in the compounding of a drug. The bill exempts from interstate distribution limits the dispensing of a compounded drug from the facility where it is compounded to a patient or health facility. The bill limits the scope of Food and Drug Administration (FDA) inspections of compounding pharmacies to certain equipment, materials, containers, and labeling. This aligns the scope of inspections of compounding pharmacies with the scope of inspections of other pharmacies. (Currently, the scope of inspections of compounding pharmacies is the same as the scope of inspections of drug manufacturers.) The bill also eliminates the requirement for compounding pharmacies to register with the FDA as drug manufacturers.
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Timeline
Mar 28, 2019
Introduced in House
Mar 28, 2019
Referred to the House Committee on Energy and Commerce.
Mar 29, 2019
Referred to the Subcommittee on Health.
  • March 28, 2019
    Introduced in House


  • March 28, 2019
    Referred to the House Committee on Energy and Commerce.


  • March 29, 2019
    Referred to the Subcommittee on Health.

Health

Administrative law and regulatory proceduresBusiness recordsDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationNutrition and dietPrescription drugs

Preserving Patient Access to Compounded Medications Act of 2019

USA116th CongressHR-1959| House 
| Updated: 3/29/2019
Preserving Patient Access to Compounded Medications Act of 2019 This bill addresses regulations governing compounding pharmacies. The bill expands the circumstances under which a drug may be compounded (i.e., manufactured at small scale) to allow pharmacists and physicians to compound drugs for administration to patients in an office or clinical setting, in accordance with state law. (Compounded drugs are not required to meet certain federal requirements regarding manufacturing, labeling, or approval.) Dietary supplements may be used in the compounding of a drug. The bill exempts from interstate distribution limits the dispensing of a compounded drug from the facility where it is compounded to a patient or health facility. The bill limits the scope of Food and Drug Administration (FDA) inspections of compounding pharmacies to certain equipment, materials, containers, and labeling. This aligns the scope of inspections of compounding pharmacies with the scope of inspections of other pharmacies. (Currently, the scope of inspections of compounding pharmacies is the same as the scope of inspections of drug manufacturers.) The bill also eliminates the requirement for compounding pharmacies to register with the FDA as drug manufacturers.
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Suggested Questions

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Timeline
Mar 28, 2019
Introduced in House
Mar 28, 2019
Referred to the House Committee on Energy and Commerce.
Mar 29, 2019
Referred to the Subcommittee on Health.
  • March 28, 2019
    Introduced in House


  • March 28, 2019
    Referred to the House Committee on Energy and Commerce.


  • March 29, 2019
    Referred to the Subcommittee on Health.
H. Morgan Griffith

H. Morgan Griffith

Republican Representative

Virginia

Cosponsors (42)
David Schweikert (Republican)Chris Stewart (Republican)Paul A. Gosar (Republican)Adrian Smith (Republican)Clay Higgins (Republican)John R. Carter (Republican)Pete Olson (Republican)Don Young (Republican)Jefferson Van Drew (Republican)Neal P. Dunn (Republican)Robert J. Wittman (Republican)Darin LaHood (Republican)Andy Biggs (Republican)Jeff Duncan (Republican)Earl L. "Buddy" Carter (Republican)Rob Bishop (Republican)Dan Newhouse (Republican)Barry Loudermilk (Republican)Mario Diaz-Balart (Republican)Justin Amash (Libertarian)Steve King (Republican)Mike D. Rogers (Republican)John Joyce (Republican)John R. Moolenaar (Republican)Bruce Westerman (Republican)Trey Hollingsworth (Republican)Mark E. Green (Republican)Henry Cuellar (Democratic)Tulsi Gabbard (Democratic)Gary J. Palmer (Republican)Mac Thornberry (Republican)Debbie Lesko (Republican)Jeff Fortenberry (Republican)Yvette D. Clarke (Democratic)Bradley Byrne (Republican)Brian K. Fitzpatrick (Republican)Bill Posey (Republican)Ben Cline (Republican)Tom Graves (Republican)Ted Budd (Republican)Jaime Herrera Beutler (Republican)David P. Roe (Republican)

Health Subcommittee, Energy and Commerce Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Administrative law and regulatory proceduresBusiness recordsDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationNutrition and dietPrescription drugs