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Pinealon regulatory status

Current status of Pinealon in the United States: Unscheduled. In sport: WADA prohibited. Details, sources, and the dated timeline follow.

By the PeptideAgent Editorial Team. Draft, pending editorial review.  Last verified

What is the current status of Pinealon?

Regulatory: UnscheduledWADA: WADA prohibitedVerified: Verified Sep 22, 2026
FDA and compounding
Pinealon has never been nominated to or reviewed for the FDA 503A or 503B bulks lists and does not appear on the FDA Category 2 page (current as of April 22, 2026). It is not a component of any approved drug, so a 503A pharmacy has no lawful basis to compound it. It is not an FDA approved drug and is sold in Russia only as a supplement, not a medicine.
WADA
WADA prohibited
Access path
  1. Not legally available for human use in the United States.
  2. Not an FDA approved drug and not compoundable under 503A or 503B.
  3. Sold as a supplement in Russia; imported and research use only products are not verified for identity or purity.

Full Pinealon page: evidence, dosing in the literature, and sources

How has the status of Pinealon changed over time?

No dated regulatory event has been recorded for Pinealon. That usually means no FDA, PCAC, Federal Register, or WADA action has named it specifically. Category-wide actions are listed on the tracker hub.

Sources

Numbered citations in the answers above point here, followed by the regulatory sources on record for Pinealon and the source of each dated event.

  1. [1]FDA: Certain bulk drug substances for use in compounding that may present significant safety risks (Category 2 list and withdrawn nominations, current as of April 22, 2026)FDA, 2026
  2. [2]FDA Pharmacy Compounding Advisory Committee (July 2026 meeting on peptide nominations)FDA, 2026
  3. [3]FDA: Compounding and the FDA, questions and answersFDA, 2026
  4. [4]WADA Prohibited List, section S0 non-approved substancesWADA, 2026