1. Under the FD&C Act, what mainly determines whether a substance is legally a “drug” requiring FDA approval?

Its chemical structure alone
Its intended use, including whether it’s intended to treat or prevent disease in humans or animals
Whether it was discovered before or after 2000
Its country of manufacture

2. What does Category 2 on FDA’s interim 503A bulks list mean?

The substance is fully approved for compounding with no restrictions
FDA identified significant safety risks and would consider enforcement action against compounders using it
The substance has insufficient information to be evaluated at all
The substance has been permanently banned nationwide

3. At the July 2026 PCAC meeting, what was the outcome for BPC-157?

It was immediately added to the permanent 503A bulks list
The committee voted 8–6 (with one abstention) to recommend it for potential inclusion, though its Category 2 status hadn’t changed as of the vote
It was the one compound rejected by the committee
The meeting did not address BPC-157 at all

4. Which compound did the PCAC committee vote against in the July 2026 review?

TB-500
DSIP (emideltide)
Epitalon
Semax

5. Why doesn’t a favorable PCAC vote immediately change a substance’s regulatory status?

PCAC votes are legally binding but take a week to process
A PCAC recommendation is advisory; FDA must still decide whether to act through a separate formal rulemaking process
PCAC has no role in the 503A bulks list process
Favorable votes are automatically reversed after one year