Legis Daily

Patient Access to Urgent-Use Pharmacy Compounding Act of 2021

USA117th CongressHR-3662| House 
| Updated: 6/2/2021
H. Morgan Griffith

H. Morgan Griffith

Republican Representative

Virginia

Cosponsors (13)
Diana Harshbarger (Republican)Paul A. Gosar (Republican)Adrian Smith (Republican)Neal P. Dunn (Republican)Robert J. Wittman (Republican)Jeff Duncan (Republican)Jerry L. Carl (Republican)Earl L. "Buddy" Carter (Republican)Kurt Schrader (Democratic)John Joyce (Republican)Henry Cuellar (Democratic)Gary J. Palmer (Republican)Debbie Lesko (Republican)

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Patient Access to Urgent-Use Pharmacy Compounding Act of 2021 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 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. 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.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
Jun 1, 2021
Introduced in House
Jun 1, 2021
Referred to the House Committee on Energy and Commerce.
Jun 2, 2021
Referred to the Subcommittee on Health.
  • June 1, 2021
    Introduced in House


  • June 1, 2021
    Referred to the House Committee on Energy and Commerce.


  • June 2, 2021
    Referred to the Subcommittee on Health.

Health

Drug safety, medical device, and laboratory regulationHealth information and medical recordsPrescription drugs

Patient Access to Urgent-Use Pharmacy Compounding Act of 2021

USA117th CongressHR-3662| House 
| Updated: 6/2/2021
Patient Access to Urgent-Use Pharmacy Compounding Act of 2021 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 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. 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.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
Jun 1, 2021
Introduced in House
Jun 1, 2021
Referred to the House Committee on Energy and Commerce.
Jun 2, 2021
Referred to the Subcommittee on Health.
  • June 1, 2021
    Introduced in House


  • June 1, 2021
    Referred to the House Committee on Energy and Commerce.


  • June 2, 2021
    Referred to the Subcommittee on Health.
H. Morgan Griffith

H. Morgan Griffith

Republican Representative

Virginia

Cosponsors (13)
Diana Harshbarger (Republican)Paul A. Gosar (Republican)Adrian Smith (Republican)Neal P. Dunn (Republican)Robert J. Wittman (Republican)Jeff Duncan (Republican)Jerry L. Carl (Republican)Earl L. "Buddy" Carter (Republican)Kurt Schrader (Democratic)John Joyce (Republican)Henry Cuellar (Democratic)Gary J. Palmer (Republican)Debbie Lesko (Republican)

Health Subcommittee, Energy and Commerce Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Drug safety, medical device, and laboratory regulationHealth information and medical recordsPrescription drugs