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2021-06-02
Health Subcommittee
hsif14
1
House committee actions
Referred to the Subcommittee on Health.
Committee
H11100
2021-06-01
Energy and Commerce Committee
hsif00
2
House floor actions
Referred to the House Committee on Energy and Commerce.
IntroReferral
Intro-H
2021-06-01
9
Library of Congress
Introduced in House
IntroReferral
1000
2021-06-01
9
Library of Congress
Introduced in House
IntroReferral
2021-06-01T19:04:00Z
Referred to
House
Energy and Commerce Committee
2021-06-02T17:37:35Z
Referred to
Health Subcommittee
hsif14
hsif00
Standing
C001063
28
Henry
Rep. Cuellar, Henry [D-TX-28]
Cuellar
D
2021-06-01
TX
H001086
1
Diana
Rep. Harshbarger, Diana [R-TN-1]
Harshbarger
R
2021-06-11
TN
D000615
3
Jeff
Rep. Duncan, Jeff [R-SC-3]
Duncan
R
2021-06-22
SC
G000565
4
Paul
Rep. Gosar, Paul A. [R-AZ-4]
Gosar
A.
R
2021-06-28
AZ
P000609
6
Gary
Rep. Palmer, Gary J. [R-AL-6]
Palmer
J.
R
2021-07-26
AL
D000628
2
Neal
Rep. Dunn, Neal P. [R-FL-2]
Dunn
P.
R
2021-07-29
FL
C001103
1
Earl
Rep. Carter, Earl L. "Buddy" [R-GA-1]
Carter
L. "Buddy"
R
2021-10-08
GA
S001180
5
Kurt
Rep. Schrader, Kurt [D-OR-5]
Schrader
D
2021-10-19
OR
W000804
1
Robert
Rep. Wittman, Robert J. [R-VA-1]
Wittman
J.
R
2021-11-03
VA
S001172
3
Adrian
Rep. Smith, Adrian [R-NE-3]
Smith
R
2021-11-17
NE
L000589
8
Debbie
Rep. Lesko, Debbie [R-AZ-8]
Lesko
R
2022-03-16
AZ
J000302
13
John
Rep. Joyce, John [R-PA-13]
Joyce
R
2022-06-07
PA
C001054
1
Jerry
Rep. Carl, Jerry L. [R-AL-1]
Carl
L.
R
2022-11-03
AL
Congressional Research Service, Library of Congress
This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
2021-06-01
2021-06-02
Referred to the Subcommittee on Health.
House
Health
G000568
9
H.
Rep. Griffith, H. Morgan [R-VA-9]
N
Griffith
Morgan
R
VA
Drug safety, medical device, and laboratory regulation Health information and medical records Prescription drugs
2021-06-01
Introduced in House
 <p><strong>Patient Access to Urgent-Use Pharmacy Compounding Act of 2021</strong></p> <p>This bill relaxes certain requirements for compounding drugs that are facing shortages. </p> <p>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.</p> <p>This bill allows a compounder not registered with the FDA to compound drugs in limited quantities for urgent medical need not involving a specific patient if, among other things, (1) the prescriber certifies that they are unable to obtain, despite reasonable attempts, 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.</p> <p>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. </p>
2022-07-21T14:26:39Z
00
2021-06-01T04:00:00Z
Introduced in House
https://www.govinfo.gov/content/pkg/BILLS-117hr3662ih/xml/BILLS-117hr3662ih.xml
Patient Access to Urgent-Use Pharmacy Compounding Act of 2021
IH
Introduced in House
To amend the Federal Food, Drug, and Cosmetic Act to ensure patients have access to certain urgent-use compounded medications, and for other purposes.
Official Title as Introduced
Patient Access to Urgent-Use Pharmacy Compounding Act of 2021
Display Title
IH
Introduced in House
Patient Access to Urgent-Use Pharmacy Compounding Act of 2021
Short Title(s) as Introduced
HR
2023-02-17T17:45:18Z
2023-02-17T17:45:18Z
3.0.0
2021-06-02
Health Subcommittee
hsif14
1
House committee actions
Referred to the Subcommittee on Health.
Committee
H11100
2021-06-01
Energy and Commerce Committee
hsif00
2
House floor actions
Referred to the House Committee on Energy and Commerce.
IntroReferral
Intro-H
2021-06-01
9
Library of Congress
Introduced in House
IntroReferral
1000
2021-06-01
9
Library of Congress
Introduced in House
IntroReferral
G000568
9
H.
Rep. Griffith, H. Morgan [R-VA-9]
N
Griffith
Morgan
R
VA
C001063
28
Henry
Rep. Cuellar, Henry [D-TX-28]
Cuellar
D
2021-06-01
TX
H001086
1
Diana
Rep. Harshbarger, Diana [R-TN-1]
Harshbarger
R
2021-06-11
TN
D000615
3
Jeff
Rep. Duncan, Jeff [R-SC-3]
Duncan
R
2021-06-22
SC
G000565
4
Paul
Rep. Gosar, Paul A. [R-AZ-4]
Gosar
A.
R
2021-06-28
AZ
P000609
6
Gary
Rep. Palmer, Gary J. [R-AL-6]
Palmer
J.
R
2021-07-26
AL
D000628
2
Neal
Rep. Dunn, Neal P. [R-FL-2]
Dunn
P.
R
2021-07-29
FL
C001103
1
Earl
Rep. Carter, Earl L. "Buddy" [R-GA-1]
Carter
L. "Buddy"
R
2021-10-08
GA
S001180
5
Kurt
Rep. Schrader, Kurt [D-OR-5]
Schrader
D
2021-10-19
OR
W000804
1
Robert
Rep. Wittman, Robert J. [R-VA-1]
Wittman
J.
R
2021-11-03
VA
S001172
3
Adrian
Rep. Smith, Adrian [R-NE-3]
Smith
R
2021-11-17
NE
L000589
8
Debbie
Rep. Lesko, Debbie [R-AZ-8]
Lesko
R
2022-03-16
AZ
J000302
13
John
Rep. Joyce, John [R-PA-13]
Joyce
R
2022-06-07
PA
C001054
1
Jerry
Rep. Carl, Jerry L. [R-AL-1]
Carl
L.
R
2022-11-03
AL
Drug safety, medical device, and laboratory regulation Health information and medical records Prescription drugs
2021-06-01
Introduced in House
 <p><strong>Patient Access to Urgent-Use Pharmacy Compounding Act of 2021</strong></p> <p>This bill relaxes certain requirements for compounding drugs that are facing shortages. </p> <p>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.</p> <p>This bill allows a compounder not registered with the FDA to compound drugs in limited quantities for urgent medical need not involving a specific patient if, among other things, (1) the prescriber certifies that they are unable to obtain, despite reasonable attempts, 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.</p> <p>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. </p>
2022-07-21T14:26:39Z
00
Patient Access to Urgent-Use Pharmacy Compounding Act of 2021
IH
Introduced in House
To amend the Federal Food, Drug, and Cosmetic Act to ensure patients have access to certain urgent-use compounded medications, and for other purposes.
Official Title as Introduced
Patient Access to Urgent-Use Pharmacy Compounding Act of 2021
Display Title
IH
Introduced in House
Patient Access to Urgent-Use Pharmacy Compounding Act of 2021
Short Title(s) as Introduced
2021-06-02
Referred to the Subcommittee on Health.