§ 418-16.212. Changes to existing stewardship programs; new programs.

(a)

Changes.

(1)

Substantive changes may be made to an existing approved stewardship program only with the prior written approval of the health officer. Substantive changes include changes in the location, number or operating hours of drop-off sites or periodic take-back events; changes in collection methods; changes in mail-back service procedures; changes in the policies or procedures to be followed by persons handling collected unwanted covered drugs; changes required in response to federal, state or local laws or regulations; and changes in stewardship program operators or participating producers. Except as set forth in subsection 418-16.206(d)(2), the participating producers identified in the approved stewardship plan shall submit any proposed substantive changes to the health officer in the form of an amended stewardship plan, along with a written explanation of the change(s) and payment of a fee established by the board by resolution. The health officer will approve an amended stewardship plan if it conforms to applicable requirements set forth in Section 418-16.208. If an amended stewardship plan submitted to the health officer under this section is rejected by the health officer for non-conformance with the applicable requirements set forth in Section 418-16.208, the approved stewardship program may continue to operate in accordance with the approved stewardship plan.

(2)

The following non-substantive changes to an approved stewardship program may be made only with twenty days advance written notification by the program operator to the health officer: Changes in location of a collection kiosk within a retail pharmacy; changes in methods of distribution of prepaid, preaddressed mailers used for the mail-back of unwanted covered drugs; changes in contact information for the program operator and participating producers; and changes in the system described in subsection 418-16.208(d).

(3)

Other than the changes described in subsections (a)(1) and (a)(2), changes may be made to an approved stewardship program without the prior approval of or notification to the health officer.

(4)

An approved stewardship plan that is changed in accordance with this section will be deemed an approved stewardship plan. An approved stewardship program that is changed in accordance with this section will be deemed an approved stewardship program.

(b)

New Programs. After implementation of an approved stewardship program, a participating producer may propose the formation of a new stewardship program by submitting to the health officer a stewardship plan that conforms to the requirements set forth in Section 418-16.208, together with payment of a fee established by the board by resolution.

(Ord. No. 2016-24, § IV, 12-20-16)