Or. Admin. Code § 333-333-2030

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

Section 333-333-2030 - Manufacturer Endorsements

(1) A manufacturer may only produce and sell psilocybin products if the manufacturer has received an endorsement from the Oregon Health Authority (Authority) for that type of product. Endorsement types are:

(a) Fungi cultivation;

(b) Psilocybin extraction; and

(c) Edible psilocybin production.

(2) An applicant for a manufacturer license must request an endorsement upon submission of an initial application but may also request to add or remove an endorsement at any time following licensure.

(3) To apply for an endorsement, an applicant or licensee must submit a form prescribed by the Authority that identifies the proposed endorsement.

(4) Only one application and license fee are required regardless of how many endorsements an applicant or licensee requests or when the request is made.

(5) An individual manufacturer may hold multiple endorsements.

(6) The Authority may deny a manufacturer's request for an endorsement or revoke an existing endorsement if the manufacturer cannot or does not meet the requirements of these rules. If the Authority denies or revokes approval, the manufacturer has a right to a hearing under ORS chapter 183.

Or. Admin. Code § 333-333-2030

PH 74-2022, adopt filed 05/19/2022, effective 5/20/2022; PH 58-2023, amend filed 12/21/2023, effective 1/1/2024

Statutory/Other Authority: ORS 475A.235 & ORS 475A.295

Statutes/Other Implemented: ORS 475A.235 & ORS 475A.295