Preserving Patient Access to Compounded Medications Act of 2019
Latest action · Mar 29, 2019 Referred to the Subcommittee on Health.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedMar 28, 2019
- Passed HouseNot reached
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
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.Cosponsors 42
Members who signed on, in the order they did. Signatures ran from Mar 28, 2019 to Feb 4, 2020; 1 is an original cosponsor, there from the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-TX | Henry Cuellar | Original | Mar 28, 2019 |
| R-GA | Earl L. "Buddy" Carter | Apr 9, 2019 | |
| R-WA | Jaime Herrera Beutler | Apr 10, 2019 | |
| R-UT | Chris Stewart | Apr 12, 2019 | |
| R-AL | Gary J. Palmer | Apr 12, 2019 | |
| R-UT | Rob Bishop | Apr 12, 2019 | |
| D-NY | Yvette D. Clarke | Apr 12, 2019 | |
| R-PA | John Joyce | Apr 15, 2019 | |
| R-NE | Jeff Fortenberry | Apr 25, 2019 | |
| D-NJ | Jefferson Van Drew | Apr 25, 2019 | |
| R-AZ | Andy Biggs | Apr 29, 2019 | |
| I-MI | Justin Amash | May 7, 2019 | |
| R-PA | Brian K. Fitzpatrick | May 14, 2019 | |
| R-WA | Dan Newhouse | May 15, 2019 | |
| D-HI | Tulsi Gabbard | May 16, 2019 |
Committees 1
Where it was sent and what each committee and subcommittee did with it, in order.
| Chamber | Committee | What it did |
|---|---|---|
| House | Energy and Commerce Committee | Referred Mar 28, 2019 |
| Health Subcommittee | Referred Mar 29, 2019 |
Actions 3
Everything that happened, newest first.
- Mar 29, 2019Referred to the Subcommittee on Health.
- Mar 28, 2019Introduced in House
- Mar 28, 2019Referred to the House Committee on Energy and Commerce.
Research
What has been written about this bill: committee reports, cost estimates, the sponsor’s authority statement, printed hearings and the Congressional Research Service’s work.
Constitutional authority
The sponsor’s statement, as printed in the Congressional Record, vol. 165, no. 54, March 28, 2019, page H2918.
Related bills 1
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| HR 2871 | Preserving Patient Access to Compounded Medications Act of 2017 | Reintroduction of | Jun 16, 2017 |
Titles 2
Every title it has carried, official and short, at each stage.
- Official Title as Introduced
- To amend the Federal Food, Drug, and Cosmetic Act with respect to compounding pharmacies, and for other purposes.
- Short Title(s) as Introduced
- Preserving Patient Access to Compounded Medications Act of 2019
Subjects
Assigned by the Library of Congress. Policy area: Health.
Text 1
Each version as it was printed, newest first.
- Mar 28, 2019Introduced in House
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov; cost estimates are the Congressional Budget Office's, and the hearings are the printed hearings GovInfo publishes, which can appear months after the hearing.
