(2) To be approved by the department, a proposed drug take-back program plan must:
(a) Identify and provide contact information for the program operator and each covered manufacturer participating in the proposed drug take-back program;
(b) Provide for a collection system that complies with ORS 459A.215, 459A.218 and 459A.221;
(c) Provide for a disposal system that complies with ORS 459A.224;
(d) Include policies and procedures to ensure the safe and secure handling and disposal of covered drugs;
(e) Include policies and procedures to ensure the security of patient information that may be printed on the packaging of a covered drug and compliance with any applicable federal laws and regulations;
(f) Set forth a plan to cover all costs associated with the proposed drug take-back program, with the costs of the proposed drug take-back program apportioned among each covered manufacturer participating in the proposed drug take-back program;
(g) Set forth goals with respect to the amount of drugs collected under the proposed drug take-back program and with respect to fostering full public awareness of the proposed drug take-back program;
(h) Provide public outreach and education in compliance with ORS 459A.227;
(i) Describe how the drug take-back program will provide convenient service in every county in this state, including how under the drug take-back program the program operator will establish at least one drop-off site:
(A) In each county in this state; and
(B) Per population center, plus an additional drop-off site for every 50,000 residents of the city or town located within a population center;
(j) Identify the transporters and waste disposal facilities that the program will use;
(k) Provide upon request of a covered entity a mail-back service option that is prepaid by the program; and
(L) Provide to a person who provides in-home hospice services, upon the person’s request, mail-back service supplies to be used by the hospice services patient.
(3) The department may waive the requirement of subsection (2)(i)(A) of this section with respect to a county if the proposed drug take-back program plan describes how the drug take-back program will provide mail-back service in the county.
(4) Drop-off sites described in subsection (2)(i) of this section must be located throughout a population center to provide reasonably convenient and equitable access to all residents of the population center.
(5) The drop-off site required under subsection (2)(i)(A) of this section may be the same drop-off site as the drop-off site required under subsection (2)(i)(B) of this section.
(6)(a) A modification to the manner in which a proposed drug take-back program will provide the public outreach and education described in subsection (2)(h) of this section is not subject to the requirements of ORS 459A.212 if the modification is in response to federal, state or local regulatory changes, or to changes in industry best practices that are made in good faith to improve the quality and outcomes of the outreach and education.
(b) A modification to the transporters and waste disposal facilities described in subsection (2)(j) of this section is not subject to ORS 459A.212 if the modification is made in response to federal, state or local regulatory changes, or to changes in industry best practices or contractors that are made in good faith and do not knowingly have a negative impact on the efficacy of the plan.
(7)(a) Not later than 90 days after receiving a plan under subsection (1) of this section, the department shall either approve or reject the plan. If the department rejects the plan, the department shall provide the reason or reasons for the rejection.
(b) Not later than 60 days after the department rejects a plan under paragraph (a) of this subsection, a program operator must submit to the department a revised plan for participating in a drug take-back program. Not later than 90 days after receiving a revised plan under this paragraph, the department shall either approve or reject the revised plan. If the department rejects the revised plan, the department shall provide the reason or reasons for the rejection.
(c) If the department rejects a revised plan under paragraph (b) of this subsection, the department may:
(A) Require the program operator to further revise the plan in accordance with the processes set forth in paragraph (b) of this subsection; or
(B) Impose a penalty on each covered manufacturer participating in the proposed drug take-back program as described in ORS 459A.239.
(d) Not later than four years after the department approves a plan under paragraph (a) of this subsection, a program operator must submit to the department an updated plan for the continued operation of a drug take-back program, in which the program operator describes any substantive changes to the drug take-back program that involve an element required under subsection (2) of this section. An updated plan is subject to the approval processes set forth in this subsection.
(8) The department shall make each plan submitted under subsection (1) of this section and each revised or updated plan submitted under subsection (7) of this section available to the public.
(9) As used in this section, "population center" means a city or town and the unincorporated area of the county that is within a 10-mile radius from the center of the city or town. [2019 c.659 §4]
Note: See note under 459A.200.