- (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.
Statutory/Other Authority
ORS 475A.235 & ORS 475A.590
Statutes/Other Implemented
ORS 475A.235 & ORS 475A.590
History
PH 58-2023, amend filed 12/21/2023, effective 01/01/2024
PH 74-2022, adopt filed 05/19/2022, effective 05/20/2022