Or. Admin. Code § 333-333-6200
Current through Register Vol. 63, No. 12, December 1, 2024
Section 333-333-6200 - [Effective 1/1/2025] Suspension, Cancellation, Civil Penalties, Sanction Schedule(1) The Authority may suspend or revoke: (a) A license issued under ORS chapter 475A for violation of a provision of ORS chapter 475A or these rules, in accordance with section (4) of this rule.(b) A permit issued under ORS 475A.480 for violation of a provision of ORS chapter 475A or these rules, in accordance with section (4) of this rule.(2) Civil Penalties. (a) The Authority may impose a civil penalty under ORS 475A.513, ORS 475A.618, or ORS 475A.654 for violation of a provision of ORS chapter 475A or these rules, in accordance with section (4) of this rule.(b) Failure to pay a civil penalty imposed by final order of the Authority is a violation.(3) The Authority uses the following violation categories for licensees licensed under ORS chapter 475A: (a) Category I - Violations that pose the highest risk to public health and safety or make a licensee ineligible for a license.(b) Category II - Violations that create a threat or substantial likelihood of a threat to public health or safety.(c) Category III - Violations that create an increased risk to public health or safety.(d) Category IV - Violations that are technical in nature and are inconsistent with the orderly regulation of the testing, sale or manufacture of psilocybin products and the provision of psilocybin services.(4) Violation sanctions. (a) The Authority may sanction a licensee or permittee in accordance with the guidelines set forth in Exhibit 1, incorporated by reference.(b) Exhibit 1 lists the proposed sanctions for single or repeat violations that occur within a two-year period for each category described in section (3) of this rule. The Authority may allege multiple violations in a single notice and may count violations alleged in notices issued within the previous two-year period toward the total number of violations. In calculating the total number of violations, the Authority may consider a proposed violation for which the Authority has not yet issued a final order.(c) The proposed sanctions in Exhibit 1 are guidelines. If the Authority finds one or more mitigating or aggravating circumstances, it may assess a lesser or greater sanction, up to and including revocation. Mitigating circumstances may decrease the sanction but will not result in dismissal of the violation. The Authority may decrease or increase a sanction to prevent inequity or to take account of particular circumstances in the case.(d) Mitigating circumstances include, but are not limited to: (A) Making a good faith effort to prevent a violation.(B) Extraordinary cooperation in the violation investigation demonstrating the licensee or permittee accepts responsibility.(e) Aggravating circumstances include, but are not limited to:(A) Receiving a prior warning about one or more compliance problems.(B) Repeated failure to comply with laws.(C) Efforts to conceal a violation.(D) Intentionally committing a violation.(E) A violation involving more than one client or employee.(F) A violation involving unwanted or inappropriate touching of a client.(G) A violation involving injury or death.(H) A violation involving the transfer of psilocybin products to anyone other than a client during an administration session.(I) A violation that resulted in a monetary benefit for the licensee or conduct that intended to create a monetary benefit for the licensee.(J) Three or more violations within a two-year-period, regardless of the category, where the number of violations indicate a disregard for the law or failure to control the licensed premises.(5) A licensee may not avoid the sanction for a violation or the application of the provision for successive violations by changing their corporate structure for example, by adding or dropping a partner or converting to another form of legal entity when the individuals who own, operate, or control the licensed entity are substantially similar.Or. Admin. Code § 333-333-6200
PH 206-2022, adopt filed 12/27/2022, effective 12/27/2022; PH 82-2024, amend filed 11/22/2024, effective 1/1/2025Statutory/Other Authority: ORS 475A.235, ORS 475A.420 & ORS 475A.425
Statutes/Other Implemented: ORS 475A.235, ORS 475A.420 & ORS 475A.425