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HR 1959 116th Congress House

Preserving Patient Access to Compounded Medications Act of 2019

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

Introduced: July 16, 2019 Introduced by: Griffith, H. Morgan Republican · Virginia See on congress.gov
Health Administrative law and regulatory proceduresBusiness recordsDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulation
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Nutrition and dietPrescription drugs
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This bill died when the 116th Congress ended
It never became law before the 116th Congress (2019–2020) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Mar 29, 2019
Referred to the Subcommittee on Health.
Mar 28, 2019
Referred to the House Committee on Energy and Commerce.
Mar 28, 2019
Introduced in House
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 Latest action March 29, 2019

Referred to the Subcommittee on Health.

 Plain-English summary Congressional Research Service

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.
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
 Cosponsors 37
All 37 Democratic 2 Republican 22
R
LaHood, Darin
Illinois · Feb 4, 2020
 R
Diaz-Balart, Mario
Florida · Oct 30, 2019
 R
Wittman, Robert J.
Virginia · Sep 13, 2019
 R
Cline, Ben
Virginia · Sep 12, 2019
Hollingsworth, Trey
· Aug 6, 2019
 R
Budd, Ted
North Carolina · Jul 22, 2019
 R
Dunn, Neal P.
Florida · Jul 18, 2019
Graves, Tom
· Jul 16, 2019
 R
Moolenaar, John R.
Michigan · Jun 27, 2019
King, Steve
· Jun 10, 2019
Olson, Pete
· Jun 6, 2019
Roe, David
· Jun 6, 2019
 R
Smith, Adrian
Nebraska · Jun 5, 2019
 R
Carter, John R.
Texas · Jun 4, 2019
 R
Loudermilk, Barry
Georgia · Jun 4, 2019
 R
Schweikert, David
Arizona · Jun 4, 2019
 R
Westerman, Bruce
Arkansas · Jun 4, 2019
Byrne, Bradley
· Jun 3, 2019
 R
Rogers, Mike D.
Alabama · May 30, 2019
THORNBERRY, WILLIAM
· May 30, 2019
 R
Gosar, Paul A.
Arizona · May 23, 2019
 R
Higgins, Clay
Louisiana · May 20, 2019
Gabbard, Tulsi
· May 16, 2019
 R
Newhouse, Dan
Washington · May 15, 2019
 R
Fitzpatrick, Brian K.
Pennsylvania · May 14, 2019
Amash, Justin
· May 7, 2019
 R
Biggs, Andy
Arizona · Apr 29, 2019
Fortenberry, Jeff
· Apr 25, 2019
 R
Van Drew, Jefferson
New Jersey · Apr 25, 2019
 R
Joyce, John
Pennsylvania · Apr 15, 2019
Bishop, Rob
· Apr 12, 2019
 D
Clarke, Yvette D.
New York · Apr 12, 2019
 R
Palmer, Gary J.
Alabama · Apr 12, 2019
Stewart, Chris
· Apr 12, 2019
Herrera Beutler, Jaime
· Apr 10, 2019
 R
Carter, Earl L. "Buddy"
Georgia · Apr 9, 2019
 D
Cuellar, Henry
Texas · Mar 28, 2019
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 1959: Preserving Patient Access to Compounded Medications Act of 2019. 116th Congress. Open America. https://openamerica.io/bill/116-HR-1959/
MLA
"H.R. 1959: Preserving Patient Access to Compounded Medications Act of 2019." 116th Congress, 2026, Open America, https://openamerica.io/bill/116-HR-1959/.
Bluebook (legal)
H.R. 1959, 116th Cong. (2026), https://openamerica.io/bill/116-HR-1959/.
Markdown link
[H.R. 1959: Preserving Patient Access to Compounded Medications Act of 2019](https://openamerica.io/bill/116-HR-1959/)
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