- (1) A manufacturer must order tests for every batch of finished psilocybin product from a harvest lot or process lot to determine the concentration (potency) of psilocybin and psilocin in the product.
- (2) A process lot of homogenized fungi, psilocybin extract or edible psilocybin product fails potency testing if the amount of psilocybin or psilocin between primary and duplicate samples taken from the batch exceeds 20 percent relative percent difference between samples.
- (3) 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 potency 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