June 21, 2024

Demonstrably difficult list, demonstrably problematic

The FDA is proposing a rule that would add categories to both the 503A and 503B demonstrably difficult to compound (DDC) lists — a plan that has a host of issues.

In a letter this week to the agency, APC laid out the majority of those issues, starting with the fact that the FDA doesn’t have the authority to make that kind of change to the 503A list. In short, “FDA’s intention to introduce categories to the 503A DDC list is not authorized by Congress; FDA does not have the statutory authority to add categories of products to the 503A DDC list.” Adding drug products, sure, but adding entire categories is not stipulated in the authorizing statute.

We pointed out other problems with the proposed rule. Terms like “complex” and “complexity” — both of which are used — are vague and subjective. It’s one thing to use them in conversation, but quite another to craft a regulation around them.

“We ask that the agency include specific limitations to define ‘complex’ and ‘complexity’ as used in the evaluation criteria,” we wrote, “and delineate exactly what level of complexity and evidence of potential adverse events would exceed the acceptable threshold.”

There are also the facts that 1) it isn’t clear when or whether the agency will allow public comments on the DDC lists, and 2) that there’s no procedure for removing items from the lists. And, of course, there’s no evidence any of the items the FDA plans to add to the DDC lists are even compounded by either 503A or 503B pharmacies — it’s a solution (and a poor one at that) without a problem.

You can read the full text of our letter here (PDF).