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To amend the Federal Food, Drug, and Cosmetic Act with respect to compounding pharmacies, and for other purposes.

USA115th CongressHR-2871| House 
| Updated: 6/16/2017
H. Morgan Griffith

H. Morgan Griffith

Republican Representative

Virginia

Cosponsors (62)
Chris Stewart (Republican)Paul A. Gosar (Republican)Donald Norcross (Democratic)Thomas MacArthur (Republican)Bob Gibbs (Republican)Clay Higgins (Republican)F. James Sensenbrenner (Republican)Roger Marshall (Republican)Gregg Harper (Republican)Steven M. Palazzo (Republican)Pete Olson (Republican)Mike Johnson (Republican)Scott Taylor (Republican)Don Young (Republican)Joyce Beatty (Democratic)Steve Stivers (Republican)Neal P. Dunn (Republican)Robert J. Wittman (Republican)Darin LaHood (Republican)Pete Sessions (Republican)Andy Biggs (Republican)Jeff Duncan (Republican)Doug Collins (Republican)David Young (Republican)Earl L. "Buddy" Carter (Republican)Collin C. Peterson (Democratic)Rob Bishop (Republican)Ken Calvert (Republican)Rod Blum (Republican)Todd Rokita (Republican)Frank A. LoBiondo (Republican)Barry Loudermilk (Republican)Martha McSally (Republican)Walter B. Jones (Republican)Andy Barr (Republican)Justin Amash (Libertarian)Steve King (Republican)Ted Poe (Republican)Filemon Vela (Democratic)Chris Collins (Republican)Kevin Cramer (Republican)Jason Lewis (Republican)Henry Cuellar (Democratic)Gary J. Palmer (Republican)Mark E. Amodei (Republican)Dave Brat (Republican)Scott DesJarlais (Republican)Mac Thornberry (Republican)Jeff Fortenberry (Republican)Bob Goodlatte (Republican)Evan H. Jenkins (Republican)Mike Coffman (Republican)Sean P. Duffy (Republican)Cathy McMorris Rodgers (Republican)John J. Duncan (Republican)Louie Gohmert (Republican)Ted Budd (Republican)Jaime Herrera Beutler (Republican)David P. Roe (Republican)Brian Babin (Republican)Barbara Comstock (Republican)John Shimkus (Republican)

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Preserving Patient Access to Compounded Medications Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to expand the circumstances under which a drug may be compounded (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. (Drugs that are compounded do not need 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 scope of Food and Drug Administration (FDA) inspections of compounding pharmacies is limited to pertinent equipment, materials, containers, and labeling, which is the same scope as inspections of pharmacies. (Currently, the scope of inspections of compounding pharmacies is the same scope as inspections of drug manufacturers.) The bill eliminates the requirement for compounding pharmacies to register with the FDA as drug manufacturers.
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Timeline
Jun 12, 2017
Introduced in House
Jun 12, 2017
Referred to the House Committee on Energy and Commerce.
Jun 16, 2017
Referred to the Subcommittee on Health.
  • June 12, 2017
    Introduced in House


  • June 12, 2017
    Referred to the House Committee on Energy and Commerce.


  • June 16, 2017
    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

To amend the Federal Food, Drug, and Cosmetic Act with respect to compounding pharmacies, and for other purposes.

USA115th CongressHR-2871| House 
| Updated: 6/16/2017
Preserving Patient Access to Compounded Medications Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to expand the circumstances under which a drug may be compounded (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. (Drugs that are compounded do not need 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 scope of Food and Drug Administration (FDA) inspections of compounding pharmacies is limited to pertinent equipment, materials, containers, and labeling, which is the same scope as inspections of pharmacies. (Currently, the scope of inspections of compounding pharmacies is the same scope as inspections of drug manufacturers.) The bill eliminates the requirement for compounding pharmacies to register with the FDA as drug manufacturers.
View Full Text

Suggested Questions

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

Timeline
Jun 12, 2017
Introduced in House
Jun 12, 2017
Referred to the House Committee on Energy and Commerce.
Jun 16, 2017
Referred to the Subcommittee on Health.
  • June 12, 2017
    Introduced in House


  • June 12, 2017
    Referred to the House Committee on Energy and Commerce.


  • June 16, 2017
    Referred to the Subcommittee on Health.
H. Morgan Griffith

H. Morgan Griffith

Republican Representative

Virginia

Cosponsors (62)
Chris Stewart (Republican)Paul A. Gosar (Republican)Donald Norcross (Democratic)Thomas MacArthur (Republican)Bob Gibbs (Republican)Clay Higgins (Republican)F. James Sensenbrenner (Republican)Roger Marshall (Republican)Gregg Harper (Republican)Steven M. Palazzo (Republican)Pete Olson (Republican)Mike Johnson (Republican)Scott Taylor (Republican)Don Young (Republican)Joyce Beatty (Democratic)Steve Stivers (Republican)Neal P. Dunn (Republican)Robert J. Wittman (Republican)Darin LaHood (Republican)Pete Sessions (Republican)Andy Biggs (Republican)Jeff Duncan (Republican)Doug Collins (Republican)David Young (Republican)Earl L. "Buddy" Carter (Republican)Collin C. Peterson (Democratic)Rob Bishop (Republican)Ken Calvert (Republican)Rod Blum (Republican)Todd Rokita (Republican)Frank A. LoBiondo (Republican)Barry Loudermilk (Republican)Martha McSally (Republican)Walter B. Jones (Republican)Andy Barr (Republican)Justin Amash (Libertarian)Steve King (Republican)Ted Poe (Republican)Filemon Vela (Democratic)Chris Collins (Republican)Kevin Cramer (Republican)Jason Lewis (Republican)Henry Cuellar (Democratic)Gary J. Palmer (Republican)Mark E. Amodei (Republican)Dave Brat (Republican)Scott DesJarlais (Republican)Mac Thornberry (Republican)Jeff Fortenberry (Republican)Bob Goodlatte (Republican)Evan H. Jenkins (Republican)Mike Coffman (Republican)Sean P. Duffy (Republican)Cathy McMorris Rodgers (Republican)John J. Duncan (Republican)Louie Gohmert (Republican)Ted Budd (Republican)Jaime Herrera Beutler (Republican)David P. Roe (Republican)Brian Babin (Republican)Barbara Comstock (Republican)John Shimkus (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