Or. Admin. Code § 333-333-7030

Current through Register Vol. 64, No. 1, January 1, 2025

Section 333-333-7030 - Speciation Testing

(1) A manufacturer must order a test for a batch taken from the first harvest lot recorded in a calendar year to ensure that the lot contains Psilocybe cubensis. This test must be performed prior to transferring the harvest lot to another licensee or converting the harvest lot to a psilocybin extract or edible psilocybin product.

(2) Following the test described in section (1) of this rule, a manufacturer must order tests for the first batch harvested in each calendar month that a harvest lot is recorded to ensure that the lot contains Psilocybe cubensis.

(3) A batch fails speciation testing if the test demonstrates that the batch does not contain Psilocybe cubensis.

(4) If a batch fails speciation testing, a manufacturer must order tests for every harvest lot for a period of 12 months following the failed test to ensure that batches contain Psilocybe cubensis. This test must be performed prior to transferring the harvest lot to another licensee or converting the harvest lot to a psilocybin extract or edible psilocybin product.

(5) In addition to the requirements of section (1) of this rule, a manufacturer must submit one or more batches from a harvest lot or process lot for speciation testing upon written request by the Oregon Health Authority.

Or. Admin. Code § 333-333-7030

PH 74-2022, adopt filed 05/19/2022, effective 5/20/2022; PH 58-2023, amend filed 12/21/2023, effective 1/1/2024

Statutory/Other Authority: ORS 475A.235 & ORS 475A.590

Statutes/Other Implemented: ORS 475A.235 & ORS 475A.590