Or. Admin. R. 333-333-2060
Current through Register Vol. 63, No. 8, August 1, 2024
Section 333-333-2060 - Psilocybin Extract Manufacturing Requirements(1) A manufacturer with a psilocybin extraction endorsement may use only water, vegetable glycerin, acetic acid, ethanol and methanol as solvents in extraction. All other solvents are prohibited.(2) A manufacturer with a psilocybin extraction endorsement may not use extraction processes intended to manipulate the ratio of any analyte or to manipulate the ratio of compound relative to another analyte or compound present in the fungi used in extraction.(3) A manufacturer with a psilocybin extraction endorsement may not remove psilocybin analyte from psilocybin extracts. This section does not prevent diluting extracts with inactive ingredients.(4) A manufacturer with a psilocybin extraction endorsement may not use denatured alcohol.(5) A manufacturer with a psilocybin extraction endorsement may not apply pressure or heat over 140 degrees Fahrenheit when using the solvents ethanol or methanol to manufacture psilocybin extracts.(6) If using methanol or ethanol, a manufacturer must process psilocybin extracts in a room with equipment, including all electrical installations that meet the requirements of the Oregon Structural Specialty Code, related Oregon Specialty Codes and the Oregon Fire Code.(7) The manufacturer's licensed premises must be licensed by the Oregon Department of Agriculture as a food establishment and must comply with applicable provisions of OAR chapter 603, division 21, division 24, division 25 and division 28.Or. Admin. R. 333-333-2060
PH 74-2022, adopt filed 05/19/2022, effective 5/20/2022; PH 58-2023, amend filed 12/21/2023, effective 1/1/2024Statutory/Other Authority: ORS 475A.235
Statutes/Other Implemented: ORS 475A.235