Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-4000 - Application Process

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Applications
			 must be submitted to the Oregon Health Authority (Authority) in the form and
			 manner prescribed by the Authority.
(2) The application fee specified in OAR
			 333-333-4060(1)  must be submitted at the time of application in the form and
			 manner prescribed by the Authority.
(3) An application must include the
			 following:
(a) The names and required
			 information for all individuals and legal entities who are applicants as
			 required by OAR 333-333-4030.
(b)
			 Any forms and information required by the Authority to evaluate the license
			 application.
(c) A social equity
			 plan as required by OAR 333-333-4020.
(d) Until January 1, 2025, proof of residency
			 if required by OAR 333-333-4050.
(e) For manufacturer, service center and
			 laboratory license applicants, a map and diagram of the proposed license
			 premises, including the boundaries of the licensed premises relative to its
			 location, identification of any unlicensed areas within the building where the
			 licensed premises is located including suite numbers if applicable,
			 identification of any residence or other unlicensed structures located on the
			 same tax lot as the premises proposed to be licensed, a scaled floor plan
			 identifying all points of ingress and egress, camera locations, limited access
			 areas, client administration areas and areas where psilocybin products will be
			 stored within the licensed premises as required by OAR 333-333-4510. The
			 Authority may request additional documents or information related to the
			 proposed licensed premises, including but not limited to photographs of the
			 premises.
(f) If the applicant for
			 a manufacturer license is not the owner of the real property proposed to be
			 licensed, a written statement signed by the property owner that shows that the
			 owner consents to manufacturing of psilocybin products on the property. This
			 requirement must be satisfied by using the designated form published by the
			 Authority on its website.
(g) For
			 service center applicants, a service center emergency plan as described in OAR
			 333-333-4460.
(h) For service
			 center applicants whose proposed licensed premises includes outdoor
			 administration areas, a detailed description of the outdoor administration
			 areas including their location and verification that the area is free from
			 hazards as required by OAR 333-333-5210.
(i) For service center and manufacturer
			 applicants, a statement that every individual person and legal entity who holds
			 a financial interest in the entity proposed to be licensed complies with the
			 requirements of ORS 475A.280.
(j) For facilitator applicants, documentation
			 that the applicant has completed training at a training program with curriculum
			 that has been approved by the Authority and that meets the requirements of OAR
			 333-333-3005  to OAR 333-333-3090.
(k) For facilitator applicants, documentation
			 that the applicant has passed the exam required by ORS
			 475A.325.
(l) For laboratory applicants, documentation
			 that the applicant has received accreditation as described in ORS
			 475A.606.