Or. Admin. Code § 333-333-2100

Current through Register Vol. 63, No. 12, December 1, 2024

Section 333-333-2100 - Psilocybin Manufacturing Records

A manufacturer with a psilocybin extraction, or edible psilocybin production endorsement must create and maintain standard policies and procedures that include but are not limited to:

(1) Instructions and ingredients for making each psilocybin product;

(2) The procedure for making each process lot homogenous;

(3) If applicable, the procedure for purging and disposing of any solvent or other unwanted product from a psilocybin extract;

(4) Procedures for conducting necessary safety checks prior to commencing production of psilocybin products;

(5) Procedures for cleaning all equipment, counters and surfaces;

(6) Procedures for preventing growth of pathogenic organisms and toxin formations;

(7) Proper handling and storage of any solvent or other chemical used in processing in accordance with material safety data sheets and other applicable laws;

(8) Proper disposal of any waste produced during processing in accordance with applicable laws, rules and regulations;

(9) Appropriate use of any necessary safety or sanitary equipment; and

(10) Emergency procedures to be followed in case of fire, chemical spill or other emergencies.

Or. Admin. Code § 333-333-2100

PH 74-2022, adopt filed 05/19/2022, effective 5/20/2022

Statutory/Other Authority: ORS 475A.235

Statutes/Other Implemented: ORS 475A.235