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Live watchlist previewNorth America
Audited 17 Aug 2026
CompoundUnited StatesCanadaSignal
BPC-157FDA proposed: do not addUnauthorizedNo final
TB-500FDA proposed: do not addUnauthorizedNo final
KPVFDA proposed: do not addUnauthorizedNo final
MOTS-cFDA proposed: do not addUnauthorizedNo final
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503A / 503BHealth CanadaEnforcementPayment riskOperator impact

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SourceWhat the regulator actually published
StatusWhat is—and is not—permitted now
ActionWhat your team should verify next

Status correction · 17 Aug 2026

BPC-157: FDA proposed against 503A listing; no final action posted

Current signalMonitor
01

What changed

FDA’s briefing weighed against listing, and the committee review did not itself change the law.

FDA’s July briefing proposed not adding BPC-157 free base or acetate to the Section 503A Bulks List. The advisory committee then reviewed the substances, but its advice is non-binding and FDA says a final determination follows completed review.

02

United States

Agency proposal: do not add; final determination not posted.

FDA cited poor characterization, insufficient effectiveness evidence for ulcerative colitis, limited safety information, and unresolved immunogenicity risk. The FDA meeting page does not currently post a final agency action.

03

Canada

Health Canada lists BPC-157 among unauthorized injectable peptides.

Its April 2026 advisory says “research use only” labelling does not make affected products legal or exempt from regulatory requirements.

04

Operator action

  • Do not treat an advisory signal as current authorization.
  • Verify jurisdiction, product status, and channel separately.
  • Re-review claims, payments, and partner terms before launch.

Evidence before interpretation

Every signal carries its audit trail.

  1. 1
    Monitor

    FDA, Health Canada, Federal Register, safety alerts, enforcement, and official meeting materials.

  2. 2
    Classify

    Separate approvals, recommendations, proposals, warnings, and commercial-policy changes.

  3. 3
    Translate

    State the likely operator impact, unresolved questions, and required professional review.

  4. 4
    Trace

    Attach publication dates, direct source links, and a visible update history.

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