January 10, 2025

FDA releases final interim guidance on bulk drug substances for both 503As and 503Bs 

STOP THE PRESSES! Earlier this week, the FDA released its final interim guidance for compounding using bulk drug substances — and it’s applicable to both 503A compounding pharmacies and 503B outsourcing facilities. This new guidance supersedes the 2017 versions of the same titles. If you haven’t reviewed the documents yet, you can access them here for some relaxing bedtime reading:

Key Takeaways

Too long? Not ready to read the whole thing? Here’s what’s changed and what you need to know:

  1. Category 1 substances remain usable
    Bulk drug substances in Category 1 can continue to be used in compounding by both traditional pharmacies and outsourcing facilities.
  2. Categories 2 and 3 have been eliminated
    Importantly, the FDA has removed categories 2 and 3. While this does not affect compounding practices (substances in these categories were already prohibited from use in compounding), it underscores the FDA’s intent to streamline and clarify regulatory oversight. Compounders must recognize that substances formerly listed in categories 2 and 3 remain prohibited from use in any compounded preparations.
  3. New nominations must go through the PCAC process
    Newly nominated API will have to go through the PCAC process to be added to the official bulks lists going forward.