- (1) If methanol or acetic acid are used to manufacture psilocybin extract, a manufacturer must order tests for methanol or acetic acid for every process lot of psilocybin extract prior to selling or transferring the psilocybin extract or converting to another product type.
- (2) A batch fails solvent testing if a laboratory detects the presence of methanol above 3000 μg/g or acetic acid above 5000 μg/g in any sample.
- (3) If a sample from a batch fails solvent testing, the batch may be remediated using procedures that would reduce the concentration of solvents to less than the action level.
- (4) A batch that is remediated in accordance with section (3) of this rule, must be re-sampled and re-tested for solvents in accordance with these rules.
- (5) In addition to the requirements of section (1) of this rule, a manufacturer must submit one or more batches from a process lot for solvent testing upon written request by the Authority.
Statutory/Other Authority
ORS 475A.235 & ORS 475A.590
Statutes/Other Implemented
ORS 475A.235 & ORS 475A.590
History
PH 74-2022, adopt filed 05/19/2022, effective 05/20/2022