H.R. 1959 · 116th Congress
Preserving Patient Access to Compounded Medications Act of 2019
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Never voted on. It didn't reach a floor vote before the 116th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
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GriffithSponsor42 cosponsors · 4 D, 38 R
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Cuellar
BC
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Carter
JH
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Herrera Beutler
RB
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Bishop
YC
D
Clarke
GP
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Palmer
CS
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Stewart
JJ
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Joyce
JF
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Fortenberry
JV
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Van Drew
AB
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Biggs
JA
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Amash
BF
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Fitzpatrick
DN
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Newhouse
TG
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Gabbard
CH
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Higgins
DL
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Lesko
PG
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Gosar
JD
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Duncan
MR
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Rogers
MT
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Thornberry
BB
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Byrne
JC
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Carter
BL
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Loudermilk
DS
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Schweikert
BW
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Westerman
AS
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Smith
PO
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Olson
PR
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Roe
SK
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King
JM
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Moolenaar
TG
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Graves
ND
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Dunn
TB
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Budd
MG
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Green
TH
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Hollingsworth
BC
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Cline
RW
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Wittman
DY
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Young
BP
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Posey
MD
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Diaz-Balart
DL
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LaHood1 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
Preserving Patient Access to Compounded Medications Act of 2019
What it does: CRS summary · Introduced in House · Mar 28, 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.Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Preserving Patient Access to Compounded Medications Act of 2019
Latest action (Mar 29, 2019): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Mar 28, 2019
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.