APC Compounders on Capitol Hill 2023

  • APC’s Compounders on Capitol Hill 2023 wrapped up with 162 Congressional visits, adding a half dozen new sponsors to its drug shortage legislation in the House and cultivating serious interest in the bill language from a handful of Senate offices.
  • FDA, Director, Office of Compounding Quality and Compliance: Gail Bormel
    • 503A Compounding Pharmacies are a key part of the overall industry ecosystem in the United States to deliver pharmaceutical products to patients (In addition to big pharma, small pharma, and 503B Outsourcing facilities)
    • 503A Compounding Pharmacies can be important solutions to Drug Shortages in the United States
      • Used the FDA’s temporary guidance to 503A compounding pharmacies during COVID-19 as examples of what can be done. The FDA agency works directly with 503A Compounding Pharmacies to address a short-term need and deliver a solution in an accelerated time frame.
      • MediZap POV: The structure and use of this guidance are likely to inform future guidance.
      • The FDA maintains a drug shortage list, but admittedly, drugs arrive on the list after it is known by other channels, including hospital networks, pharmacists, healthcare providers, and patients.  In addition, the ASHP (American Society of Health-System Pharmacists) maintains a list https://www.ashp.org/drug-shortages/current-shortages?loginreturnUrl=SSOCheckOnly.
    • A4PC advertisement on Drug Shortages and landing page to support federal policymakers: https://www.compounding.com/shortages-policymakers, where you can download Issue Brief: Patient Access to Urgent-Use Pharmacy Compounding Act of 2023.  HR167 would allow 503As to fill gaps in coverage when 503Bs cannot.   
    • APC’s Scott Brunner queried Bormel on a range of issues, including an FDA-proposed (yet not publicly released) rule awaiting review at OMB that would both create new criteria for inclusion on the “demonstrably difficult to compound” list and add certain items to that list.  “Because of our interest in protecting compounded hormones, our antennae went up on this one,” Brunner told the OCQC director. Though she would not say exactly what is in the proposed rule, Bormel provided context for it by indicating that it represents the necessary rulemaking resulting from items recommended for inclusion on the list by the Pharmacy Compounding Advisory Committee over the past several years. She also reiterated that any action on compounded hormones would be considered and recommended by PCAC.
    • To help you educate your prescribers, APC and the Pharmacy Compounding Foundation have developed five member-only briefing documents you can share with physicians and other medical professionals: https://a4pc.org/advocacy/educating-prescribers/
      • The Truth About Pharmacy Compounding, explains the regulatory framework under which compounders operate and provides an overview of what can and cannot be compounded under federal law.
      • Compounding Peptides: It’s Complicated. This briefing explains restrictions on peptide compounding and uncertainty surrounding the list of semaglutide on FDA’s Drug Shortage List.
      • Prescription Compliance: DEA’s “Wet Signature” Requirement. This briefing explains how the Drug Enforcement Agency’s (DEA) “wet signature” requirement applies to electronic prescriptions for controlled substances.
      • Documenting Medical Rationale. With the enforcement of FDA’s GFI 256 set to commence April 1, 2023, APC has developed this briefing to help you coach the veterinarians you work with on what they must document on prescriptions for compounded animal drugs.
      • Compounding for Racehorses: An Overview for Veterinarians. As a tightly regulated sport, horseracing has specific rules and regulations regarding the use of drugs in horses, including compounded ones.

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