May 26, 2023

FDA hears from APC leaders

On Wednesday, APC’s Executive Committee and Federal Legislative Committee leaders met virtually with 30+ representatives of FDA’s Office of Compounding Quality and Compliance team to discuss a range of issues impacting pharmacy compounding. OCQC director Gail Bormel initiated the twice-a-year listening sessions with APC two years ago so her team could benefit from hearing our suggestions and concerns.

This week’s topics included:

  • Appreciation for the agency’s beta lactam guidance document and the recent agency response to NABP on BOP “essentially a copy” confusion
  • Proposed MOU/adverse events legislation
  • HR 167: Urgent use legislation
  • Status of DTE reclass in light of APC’s substantive comments and recommendations
  • Compounded hormones and patient-reported outcomes
  • Status of rulemaking for 503A bulk list interim items
  • Agency summary of 483s over past year (relevant findings, recurring themes) for industry use in training
  • Agency’s ibuprofen/acetaminophen shortage response and the 503B direct-to-503A model – pros and cons
  • Requesting and update on our previous input about the PCAC process: lack of deliberation, short time limit on presenters, and limitation on industry rep participation in discussions