Or. Admin. R. 333-333-4200

Current through Register Vol. 63, No. 8, August 1, 2024

Section 333-333-4200 - Notification of Changes

(1) An applicant or licensee must notify the Oregon Health Authority (Authority) in writing within 10 business days of any of the following:

(a) Adding or removing an individual or legal entity who qualifies as an applicant under OAR 333-333-1010 or OAR 333-333-4030.

(b) A change in contact information for any person listed as an applicant or licensee.

(c) A change in licensee's operational name.

(d) Any closure of the licensed premises lasting more than 30 days.

(e) Any conviction for any misdemeanor or felony committed by an individual listed as an applicant or licensee.

(f) Any arrest for conduct that occurred on the licensed premises.

(g) Any theft of psilocybin products or cash from the licensed premises.

(2) If after receipt of information required under subsection (1)(a) of this rule the Authority determines that the addition of an individual or legal entity applicant could result in an initial or renewal application denial under OAR 333-333-4130 or serve as the basis of a license suspension or revocation, the Authority:

(a) Will notify the licensee of its determination.

(b) Will give the licensee 30 calendar days to take actions to ensure the individual or entity does not qualify as an applicant and provide documentation to the Authority that demonstrates such actions have been taken.

(c) May propose license suspension or revocation under OAR 333-333-4130 if the licensee does not comply with subsection (b) of this section.

(3) If applicable, the licensee must pay the change fee specified in OAR 333-333-4060 prior to making changes to their licensed premises or approved licensees that require inspections or additional applicants.

(4) A licensee who wishes to change the location of the licensed premises must submit a change of location request including required forms and documents and the license application fee specified in OAR 333-333-4060(1).

(a) A licensee that submits a change of location request is not required to pay an additional annual license fee.

(b) A change of location request submitted under this rule must be submitted in a form and manner prescribed by the Authority and must include:

(A) For changes to manufacturer or service center license location, a land use compatibility statement from the city or county that authorizes land use in the city or county where the new licensed premises will be located.

(B) For manufacturer, service center and laboratory license applicants, a map or diagram of the new location's licensed premises including the boundaries of the licensed premises relative to its location, identification of any residence or other structures located on the same tax lot as the premises proposed to be licensed that will not be included in the licensed premises, and a scaled floor plan identifying all limited access areas and client administration areas. The Authority may request additional documents or information related to the new locations, including but not limited to photographs of the premises to be licensed.

(C) For a manufacturer license, if the licensee is not the owner of the real property where the new location will be located, a written statement on a form prescribed by the Authority and signed by the property owner that shows that the owner consents to manufacturing of psilocybin products on the property. The form will be published by the Authority on its website.

(5) The Authority may require a licensee to submit a new application including all required forms and documents and the fee specified in OAR 333-333-4060 for a change in ownership structure that is 51 percent or greater. For the purposes of this rule, a change is considered to be 51 percent or greater if natural persons who did not hold a direct or indirect interest in the entity at the start of the license year will collectively hold a direct or indirect interest of 51 percent or greater.

(6) The Authority may require a licensee to submit a new application including all required forms and documents and the fee specified in OAR 333-333-4060 for a change in ownership structure if the change in ownership structure results in changing the licensee's status from a non-profit entity to another type of entity.

Or. Admin. R. 333-333-4200

PH 206-2022, adopt filed 12/27/2022, effective 12/27/2022; PH 58-2023, amend filed 12/21/2023, effective 1/1/2024

Statutory/Other Authority: ORS 475A.235

Statutes/Other Implemented: ORS 475A.235