ORS 475A.290 Manufacturer license; fees; rules

The manufacture of psilocybin products is subject to regulation by the Oregon Health Authority.

A psilocybin product manufacturer must have a manufacturer license issued by the authority for the premises at which the psilocybin products are manufactured. To hold a manufacturer license issued under this section, a psilocybin product manufacturer:

Must apply for a license in the manner described in ORS 475A.245;

Must provide proof that the applicant is 21 years of age or older;

Must, until January 1, 2025:

If the direct owner of the business operating or to be operated under the license is a legal entity, provide proof that more than 50 percent of the shares, membership interests, partnership interests, or other ownership interests of the legal entity are held, directly or indirectly, by one or more individuals who have been residents of this state for two or more years;

If the direct owner of the business operating or to be operated under the license is a partnership that is not a legal entity, provide proof that more than 50 percent of the partnership interests of the partnership are held, directly or indirectly, by one or more individuals who have been residents of this state for two or more years; and

If the direct owner of the business operating or to be operated under the license is an individual, provide proof that the individual has been a resident of this state for two or more years; and

Must meet the requirements of any rule adopted by the authority under subsections

and (4) of this section.

If the applicant is not the owner of the premises at which the psilocybin is to be

manufactured, the applicant shall submit to the authority signed informed consent from the owner of the premises to manufacture psilocybin at the premises.

The authority may adopt rules regarding the informed consent described in this subsection.

The authority shall adopt rules that:

Require a psilocybin product manufacturer to annually renew a license issued under this section;

Establish application, licensure and renewal of licensure fees for psilocybin product manufacturers; and

Require psilocybin products manufactured by psilocybin product manufacturers to be tested in accordance with ORS 475A.590.

Fees adopted under subsection (4)(b) of this section:

May not exceed, together with other fees collected under ORS 475A.210 to 475A.722, the cost of administering ORS 475A.210 to 475A.722; and

Shall be deposited in the Psilocybin Control and Regulation Fund established under