Where each compound actually stands, and with whom
Regulatory developments from the FDA, CDSCO, EMA and others — reported with the process step named precisely, because the gap between “discussed” and “approved” is where most health misinformation lives.
- Eight jurisdictions
- Nine distinct standings
- Dated as-of every entry
Authorities we track
Eight jurisdictions, tracked separately
The same molecule can be an approved medicine in one country and an unapproved substance in another. We never merge them into a single status.
Timeline
Recent developments
- FDAUnited StatesUnder consideration
Pharmacy Compounding Advisory Committee discussion of several research peptides
Substances including BPC-157, KPV, TB-500, MOTS-c, DSIP, Semax and Epitalon-related compounds were discussed. A committee discussion is a stage in an evaluation process. It is not a recommendation, a listing, or an approval.
- FDAUnited StatesNot approved
Warning letter — benefit-oriented content alongside a research-use-only disclaimer
The letter treated benefit-oriented product descriptions, and the sale of bacteriostatic water beside injectable compounds, as evidence of intended human use. A research-use-only disclaimer did not neutralise that content.
- CDSCOIndiaRestricted
New-drug pathway applies to first-time synthetic peptides
A peptide manufactured synthetically for the first time is treated as a new drug. The New Drugs and Clinical Trials Rules require Central Licensing Authority permission before import or manufacture for sale or distribution.
- FDAUnited StatesNot approved
Warning letter — research-use-only framing and human-directed marketing
An earlier letter in the same line of enforcement. Together these establish that site content, not the disclaimer, determines intended use.