69.48.040  <<  69.48.050 >>   69.48.060

Drug take-back program approvalProgram modifications.

(1) By July 1, 2019, a program operator must submit a proposal for the establishment and implementation of a drug take-back program to the department for approval. The department shall approve a proposed program if the applicant submits a completed application, the proposed program meets the requirements of subsection (2) of this section, and the applicant pays the appropriate fee established by the department under RCW 69.48.120.
(2) To be approved by the department, a proposed drug take-back program must:
(a) Identify and provide contact information for the program operator and each participating covered manufacturer;
(b) Identify and provide contact information for the authorized collectors for the proposed program, as well as the reasons for excluding any potential authorized collectors from participation in the program;
(c) Provide for a collection system that complies with RCW 69.48.060;
(d) Provide for a handling and disposal system that complies with RCW 69.48.080;
(e) Identify any transporters and waste disposal facilities that the program will use;
(f) Adopt policies and procedures to be followed by persons handling covered drugs collected under the program to ensure safety, security, and compliance with regulations adopted by the United States drug enforcement administration, as well as any applicable laws;
(g) Ensure the security of patient information on drug packaging during collection, transportation, recycling, and disposal;
(h) Promote the program by providing consumers, pharmacies, and other entities with educational and informational materials as required by RCW 69.48.070;
(i) Demonstrate adequate funding for all administrative and operational costs of the drug take-back program, with costs apportioned among participating covered manufacturers;
(j) Set long-term and short-term goals with respect to collection amounts and public awareness; and
(k) Consider: (i) The use of existing providers of pharmaceutical waste transportation and disposal services; (ii) separation of covered drugs from packaging to reduce transportation and disposal costs; and (iii) recycling of drug packaging.
(3)(a) No later than one hundred twenty days after receipt of a drug take-back program proposal, the department shall either approve or reject the proposal in writing to the applicant. The department may extend the deadline for approval or rejection of a proposal for good cause. If the department rejects the proposal, it shall provide the reason for rejection.
(b) No later than ninety days after receipt of a notice of rejection under (a) of this subsection, the applicant shall submit a revised proposal to the department. The department shall either approve or reject the revised proposal in writing to the applicant within ninety days after receipt of the revised proposal, including the reason for rejection, if applicable.
(c) If the department rejects a revised proposal, the department may:
(i) Require the program operator to submit a further revised proposal;
(ii) Develop and impose changes to some or all of the revised proposal to address deficiencies;
(iii) Require the covered manufacturer or covered manufacturers that proposed the rejected revised proposal to participate in a previously approved drug take-back program; or
(iv) Find the covered manufacturer out of compliance with the requirements of this chapter and take enforcement action as provided in RCW 69.48.110.
(4) The program operator must initiate operation of an approved drug take-back program no later than one hundred eighty days after approval of the proposal by the department.
(5)(a) Proposed changes to an approved drug take-back program that substantially alter program operations must have prior written approval of the department. A program operator must submit to the department such a proposed change in writing at least fifteen days before the change is scheduled to occur. Changes requiring prior approval of the department include changes to participating covered manufacturers, collection methods, achievement of the service convenience goal described in RCW 69.48.060, policies and procedures for handling covered drugs, education and promotion methods, and selection of disposal facilities.
(b) For changes to a drug take-back program that do not substantially alter program operations, a program operator must notify the department at least seven days before implementing the change. Changes that do not substantially alter program operations include changes to collection site locations, methods for scheduling and locating periodic collection events, and methods for distributing prepaid, preaddressed mailers.
(c) A program operator must notify the department of any changes to the official point of contact for the program no later than fifteen days after the change. A program operator must notify the department of any changes in ownership or contact information for participating covered manufacturers no later than ninety days after such change.
(6) No later than four years after a drug take-back program initiates operations, and every four years thereafter, the program operator must submit an updated proposal to the department describing any substantive changes to program elements described in subsection (2) of this section. The department shall approve or reject the updated proposal using the process described in subsection (3) of this section.
(7) The department shall make all proposals submitted under this section available to the public and shall provide an opportunity for written public comment on each proposal.

NOTES:

Sunset Act application: See note following chapter digest.
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