Patient Access to Urgent-Use Pharmacy Compounding Act of 2023

Summary

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.

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Timeline

1. 9 January 2023

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

2. 9 January 2023

   Introduced

   Introduced in House

   Source: IntroReferral

3. 9 January 2023

   Introduced

   Introduced in House

   Source: IntroReferral

4. 20 January 2023

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 9 January 2023 · Official file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 9 January 2023

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 9 January 2023

  ViewDownloadOpen at official source

• Introduced in House

  summary · EN · 9 January 2023

  Open at official source

Sponsors

• H. Griffith · R · Sponsor
• Henry Cuellar · D · Sponsor
• Jeff Duncan · R · Cosponsor
• Rep. Harshbarger, Diana [R-TN-1] · R · Cosponsor
• Gary Palmer · R · Cosponsor
• Rep. Carter, Earl L. "Buddy" [R-GA-1] · R · Cosponsor
• Neal Dunn · R · Cosponsor
• Debbie Lesko · R · Cosponsor
• Mariannette Miller-Meeks · R · Cosponsor
• John Moolenaar · R · Cosponsor
• Rep. Pocan, Mark [D-WI-2] · D · Cosponsor
• Wiley Nickel · D · Cosponsor
• Ben Cline · R · Cosponsor
• · hsif00 · Standing

Related records

• related to ← Patient Access to Urgent-Use Pharmacy Compounding Act of 2021