3.0.0
167
2025-05-27T14:12:59Z
2025-05-27T14:12:59Z
House
H
HR
2023-01-09
118
[Congressional Record Volume 169, Number 7 (Monday, January 9, 2023)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. GRIFFITH:H.R. 167.Congress has the power to enact this legislation pursuantto the following:This bill is enacted pursuant to the power granted toCongress under Article I, Section 8 of the United StatesConstitution[Page H111]
- hsif00
Energy and Commerce Committee
House
Standing
  - hsif14
Health Subcommittee
    - Referred to
2023-01-20T21:39:50Z
  - Referred To
2023-01-09T22:17:45Z
- 2023-01-20
  - hsif14
Health Subcommittee
1
House committee actions
Referred to the Subcommittee on Health.
Committee
- 2023-01-09
Referred to the House Committee on Energy and Commerce.
IntroReferral
H11100
2
House floor actions
  - hsif00
Energy and Commerce Committee
- 2023-01-09
Introduced in House
IntroReferral
Intro-H
9
Library of Congress
- 2023-01-09
Introduced in House
IntroReferral
1000
9
Library of Congress
- G000568
Rep. Griffith, H. Morgan [R-VA-9]
H.
Griffith
R
VA
Morgan
9
N
- C001063
Rep. Cuellar, Henry [D-TX-28]
Henry
Cuellar
D
TX
28
2023-01-09
True
- D000615
Rep. Duncan, Jeff [R-SC-3]
Jeff
Duncan
R
SC
3
2023-03-28
False
- H001086
Rep. Harshbarger, Diana [R-TN-1]
Diana
Harshbarger
R
TN
1
2023-05-15
False
- P000609
Rep. Palmer, Gary J. [R-AL-6]
Gary
Palmer
R
AL
J.
6
2023-06-05
False
- C001103
Rep. Carter, Earl L. "Buddy" [R-GA-1]
Earl
Carter
R
GA
L. "Buddy"
1
2023-06-30
False
- D000628
Rep. Dunn, Neal P. [R-FL-2]
Neal
Dunn
R
FL
P.
2
2023-07-25
False
- L000589
Rep. Lesko, Debbie [R-AZ-8]
Debbie
Lesko
R
AZ
8
2023-08-25
False
- M001215
Rep. Miller-Meeks, Mariannette [R-IA-1]
Mariannette
Miller-Meeks
R
IA
1
2023-08-29
False
- M001194
Rep. Moolenaar, John R. [R-MI-2]
John
Moolenaar
R
MI
R.
2
2023-09-21
False
- P000607
Rep. Pocan, Mark [D-WI-2]
Mark
Pocan
D
WI
2
2023-12-11
False
- N000194
Rep. Nickel, Wiley [D-NC-13]
Wiley
Nickel
D
NC
13
2024-01-25
False
- C001118
Rep. Cline, Ben [R-VA-6]
Ben
Cline
R
VA
6
2024-03-20
False
Health
- Drug safety, medical device, and laboratory regulation
2023-02-17T17:45:17Z
- Health information and medical records
2023-02-17T17:45:17Z
- Prescription drugs
2023-02-17T17:45:17Z
Health
2023-01-25T17:30:21Z
00
2023-01-09
Introduced in House
2023-02-28T20:07:57Z
Patient Access to Urgent-Use Pharmacy Compounding Act of 2023
This bill relaxes certain requirements for compounding drugs that are facing shortages.
Drug compounding is the process of mixing or otherwise altering drugs to create a medication. Currently, the Food and Drug Administration (FDA) allows for drug compounding subject to certain requirements. Generally, a licensed pharmacist or physician not registered with the FDA may only compound drugs in limited quantities for prescriptions for a specific individual patient. On the other hand, an FDA-registered outsourcing facility may compound drugs in bulk for use in medical facilities but is subject to additional requirements.
This bill allows a compounder not registered with the FDA to compound drugs in limited quantities for an urgent medical need not involving a specific patient if, among other requirements (1) the prescriber certifies that the prescriber is unable, despite reasonable attempts, to obtain certain related drugs with the same active ingredient and route of administration; (2) the compounded drug meets certain labeling requirements, including an indication that the compounded drug is provided only for urgent administration to a patient; and (3) the compounder requests and maintains certain records about patients receiving the compounded drug.
Furthermore, a restriction against an unregistered compounder regularly compounding (or compounding inordinate amounts of) what is essentially a copy of a commercially available drug shall not apply if the drug is on a shortage list maintained by the FDA or the American Society of Hospital Pharmacists.

Patient Access to Urgent-Use Pharmacy Compounding Act of 2023
- Display Title
45

Patient Access to Urgent-Use Pharmacy Compounding Act of 2023
2024-06-11T15:41:43Z
- Short Title(s) as Introduced
101

Patient Access to Urgent-Use Pharmacy Compounding Act of 2023
2024-05-24T13:43:09Z
Introduced in House
IH
- Official Title as Introduced
6

To amend the Federal Food, Drug, and Cosmetic Act to ensure patients have access to certain urgent-use compounded medications, and for other purposes.
2024-03-18T20:09:43Z
Introduced in House
IH
- Introduced in House
2023-01-09T05:00:00Z
  - https://www.govinfo.gov/content/pkg/BILLS-118hr167ih/xml/BILLS-118hr167ih.xml
2023-01-20
Referred to the Subcommittee on Health.
text/xml
EN
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