August 23, 2024

Compounding post-Chevron

At least three issues affecting pharmacy compounding might be affected by the overturning of the decades-old “Chevron doctrine.” With federal agencies having their authority complicated (or potentially stripped altogether in certain circumstances) by the SCOTUS “Loper” ruling, APC commissioned a briefing from the Hanszen Laporte law firm.

To be clear, the memo is not an expression of APC’s position on the issues, and we do not endorse it. It’s strictly informational and speculative. We believe, however, that it’s important for members to understand how that ruling might affect these three pharmacy compounding policy issues.

Remember, the analysis isn’t about FDA’s actions themselves, but if and how the Loper ruling might open those actions to a legal challenge. The issues:

  1. FDA’s memorandum of understanding with states regarding shipping compounded medications out of state — “Loper’s holding may prove significant in determining the outcome of this issue.”
  2. The FDA’s Demonstrably Difficult to Compound lists for both 503A pharmacies and 503B facilities — “For now, the issue is not yet ripe for a legal challenge [due to Loper].”
  3. Non-binding guidance documents, including GFI 256 — “[I]t would be an uphill battle to convince a court that FDA does not possess the designated authority to regulate veterinary products.”