FDA Proposes Standards for Drugs on ‘Difficult to Compound’ List

The FDA is proposing to establish criteria for the lists of drug products or categories of drug products that present difficulties for compounding under certain sections of the Federal Food, Drug, and Cosmetic Act.

The Food and Drug Administration’s proposed rule (RIN 0910-AI3) would amend its regulations to add two lists identifying drug products or categories of drug products. The products or categories that appear on those lists can’t qualify for certain statutory exemptions, and may not be compounded under either Section 503A or Section 503B of the FDCA, the agency said in the proposal Tuesday.

Those sections ...