Modifying the requirements for drug take-back programs.

CERTIFICATION OF ENROLLMENT SECOND SUBSTITUTE HOUSE BILL 1161 Chapter 155, Laws of 2021 67th Legislature 2021 Regular Session DRUG TAKE-BACK PROGRAMS —VARIOUS PROVISIONS EFFECTIVE DATE: July 25, 2021 Passed by the House March 8, 2021 Yeas 97 Nays 0 LAURIE JINKINS Speaker of the House of Representatives Passed by the Senate April 11, 2021 Yeas 48 Nays 0 DENNY HECK President of the Senate CERTIFICATE I, Bernard Dean, Chief Clerk of the House of Representatives of the State of Washington, do hereby certify that the attached is SECOND SUBSTITUTE HOUSE BILL 1161 as passed by the House of Representatives and the Senate on the dates hereon set forth. BERNARD DEAN Chief Clerk Approved May 3, 2021 2:09 PM FILED May 3, 2021 JAY INSLEE Governor of the State of Washington Secretary of State State of Washington AN ACT Relating to modifying the requirements for drug take-back 1 programs; amending RCW 69.48.010, 69.48.050, 69.48.070, 69.48.120, 2 43.131.423, and 43.131.424; and creating a new section.3 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF WASHINGTON:4 Sec. 1. RCW 69.48.010 and 2018 c 196 s 1 are each amended to 5 read as follows: 6 (1) Abuse, fatal overdoses, and poisonings from prescription and 7 over-the-counter medicines used in the home have emerged as an 8 epidemic in recent years. Poisoning is the leading cause of 9 unintentional injury-related death in Washington, and more than 10 ninety percent of poisoning deaths are due to drug overdoses. 11 Poisoning by prescription and over-the-counter medicines is also one 12 of the most common means of suicide and suicide attempts, with 13 poisonings involved in more than twenty-eight thousand suicide 14 attempts between 2004 and 2013. 15 (2) Home medicine cabinets are the most common source of 16 prescription drugs that are diverted and misused. Studies find about 17 seventy percent of those who abuse prescription medicines obtain the 18 drugs from family members or friends, usually for free. People who 19 are addicted to heroin often first abused prescription opiate 20 medicines. Unused, unwanted, and expired medicines that accumulate in 21 SECOND SUBSTITUTE HOUSE BILL 1161 Passed Legislature - 2021 Regular Session State of Washington 67th Legislature 2021 Regular Session By House Appropriations (originally sponsored by Representatives Peterson, Davis, Pollet, and Thai) READ FIRST TIME 02/22/21. p. 1 2SHB 1161.SL homes increase risks of drug abuse, overdoses, and preventable 1 poisonings. 2 (3) A safe system for the collection and disposal of unused, 3 unwanted, and expired medicines is a key element of a comprehensive 4 strategy to prevent prescription drug abuse, but disposing of 5 medicines by flushing them down the toilet or placing them in the 6 garbage can contaminate groundwater and other bodies of water, 7 contributing to long-term harm to the environment and animal life.8 (4) The legislature therefore finds that it is in the interest of 9 public health to establish a single, uniform, statewide system of 10 regulation for safe and secure collection and disposal of medicines 11 through ((a uniform )) drug "take-back" program s operated and funded 12 by drug manufacturers. 13 NEW SECTION. Sec. 2. (1) The legislature finds that in 2018, 14 the legislature passed Engrossed Substitute House Bill No. 1047, 15 which required drug manufacturers that sell drugs into Washington to 16 operate a drug take-back program to collect and dispose of 17 prescription and over-the-counter drugs. Further, the legislature 18 finds that there is uncertainty about whether, under current law, 19 more than one drug take-back program may operate.20 (2) Therefore, the legislature intends to clearly authorize the 21 department of health to approve and allow the operation of multiple 22 drug take-back programs that meet all statutory requirements.23 Sec. 3. RCW 69.48.050 and 2018 c 196 s 5 are each amended to 24 read as follows: 25 (1) By July 1, 2019, a program operator must submit a proposal 26 for the establishment and implementation of a drug take-back program 27 to the department for approval. Proposals from new entities seeking 28 to become a program operator after July 1, 2019, may be submitted as 29 provided in subsection (7) of this section. The department shall 30 approve a proposed program if the applicant submits a completed 31 application, the proposed program meets the requirements of 32 subsection (2) of this section, and the applicant pays the 33 appropriate proposal review fee established by the department under 34 RCW 69.48.120. The department may approve drug take-back programs 35 proposed by one or more program operators consistent with the 36 provisions of this section.37 p. 2 2SHB 1161.SL (2) To be approved by the department, a proposed drug take-back 1 program, independent of any other operating program, must:2 (a) Identify and provide contact information for the program 3 operator and each participating covered manufacturer;4 (b) Identify and provide contact information for the authorized 5 collectors for the proposed program, as well as the reasons for 6 excluding any potential authorized collectors from participation in 7 the program; 8 (c) Provide for a collection system that complies with RCW 9 69.48.060; 10 (d) Ensure that physical collection sites are the primary method 11 of collection across the state and that methods of supplementing 12 physical collection site service are the secondary methods for 13 collection as required by RCW 69.48.060(3) (b) through (d). A drug 14 take-back program's use of supplemental mail-back distribution 15 locations or periodic collection events in any areas underserved by 16 physical collection sites may provide collection services to no more 17 than 15 percent of the state's residents;18 (e) Provide for a handling and disposal system that complies with 19 RCW 69.48.080; 20 (((e))) (f) Identify any transporters and waste disposal 21 facilities that the program will use; 22 (((f))) (g) Adopt policies and procedures to be followed by 23 persons handling covered drugs collected under the program to ensure 24 safety, security, and compliance with regulations adopted by the 25 United States drug enforcement administration, as well as any 26 applicable laws; 27 (((g))) (h) Ensure the security of patient information on drug 28 packaging during collection, transportation, recycling, and disposal;29 (((h))) (i) Promote the program by providing consumers, 30 pharmacies, and other entities with educational and informational 31 materials as required by RCW 69.48.070; 32 (((i))) (j) Demonstrate adequate funding for all administrative 33 and operational costs of the drug take-back program, with costs 34 apportioned among participating covered manufacturers;35 (((j))) (k) Set long-term and short-term goals with respect to 36 collection amounts and public awareness; and 37 (((k))) (l) Consider: (i) The use of existing providers of 38 pharmaceutical waste transportation and disposal services; (ii) 39 p. 3 2SHB 1161.SL separation of covered drugs from packaging to reduce transportation 1 and disposal costs; and (iii) recycling of drug packaging.2 (3)(a) No later than one hundred twenty days after receipt of a 3 drug take-back program proposal, the department shall either approve 4 or reject the proposal in writing to the applicant. The department 5 may extend the deadline for approval or rejection of a proposal for 6 good cause. If the department rejects the proposal, it shall provide 7 the reason for rejection. 8 (b) No later than ninety days after receipt of a notice of 9 rejection under (a) of this subsection, the applicant shall submit a 10 revised proposal to the department. The department shall either 11 approve or reject the revised proposal in writing to the applicant 12 within ninety days after receipt of the revised proposal, including 13 the reason for rejection, if applicable. 14 (c) If the department rejects a revised proposal, the department 15 may: 16 (i) Require the program operator to submit a further revised 17 proposal; 18 (ii) Develop and impose changes to some or all of the revised 19 proposal to address deficiencies; 20 (iii) Require the covered manufacturer or covered manufacturers 21 that proposed the rejected revised proposal to participate in a 22 previously approved drug take-back program; or 23 (iv) Find the covered manufacturer out of compliance with the 24 requirements of this chapter and take enforcement action as provided 25 in RCW 69.48.110. 26 (4) The program operator must ((initiate operation of )) fully 27 implement an approved drug take-back program no later than one 28 hundred eighty days after approval of the proposal by the department.29 (5)(a) Proposed changes to an approved drug take-back program 30 that substantially alter program operations must have prior written 31 approval of the department. A program operator must submit to the 32 department such a proposed change in writing at least fifteen days 33 before the change is scheduled to occur. Changes requiring prior 34 approval of the department include changes to participating covered 35 manufacturers, collection methods, achievement of the service 36 convenience goal described in RCW 69.48.060, policies and procedures 37 for handling covered drugs, education and promotion methods, and 38 selection of disposal facilities. 39 p. 4 2SHB 1161.SL (b) For changes to a drug take-back program that do not 1 substantially alter program operations, a program operator must 2 notify the department at least seven days before implementing the 3 change. Changes that do not substantially alter program operations 4 include changes to collection site locations, methods for scheduling 5 and locating periodic collection events, and methods for distributing 6 prepaid, preaddressed mailers. 7 (c) A program operator must notify the department of any changes 8 to the official point of contact for the program no later than 9 fifteen days after the change. A program operator must notify the 10 department of any changes in ownership or contact information for 11 participating covered manufacturers no later than ninety days after 12 such change. 13 (6) ((No later than four years after a drug take-back program 14 initiates operations )) By July 1, 2024 , and every four years 15 thereafter, ((the)) all program operator s must submit an updated 16 proposal to the department describing any substantive changes to 17 program elements described in subsection (2) of this section. The 18 department shall approve or reject the updated proposal using the 19 process described in subsection (3) of this section.20 (7)(a) On July 1, 2021, the department will begin the review of 21 new proposals received by that date from entities seeking to become a 22 program operator.23 (b) Beginning July 1, 2024, and every four years thereafter, the 24 department will review new proposals from entities seeking to become 25 a program operator.26 (c) The department shall approve a proposal if it meets the 27 requirements in subsection (2) of this section and the applicant pays 28 the appropriate fee established by the department under RCW 29 69.48.120. The department must approve or reject proposals received 30 using the process provided in subsection (3) of this section.31 (8)(a) If there is a single approved drug take-back program at 32 any time and that program operator intends to leave the program for 33 any reason, participating manufacturers must find a new entity to 34 take over operations of the existing program without a break in 35 program services. The new entity may not make changes to the 36 operations of the approved program, which must be consistent with the 37 proposal as it was approved by the department under this section, or 38 each covered manufacturer or group of covered manufacturers must 39 identify a new program operator to develop a new program proposal. 40 p. 5 2SHB 1161.SL The department must accept new proposals from potential program 1 operators for a minimum of four months from the date the department 2 is notified of the program operator intending to cease operations, or 3 until a proposal is approved by the department. The department may 4 approve a proposal if it meets the requirements in subsection (2) of 5 this section and the applicant pays the appropriate fee established 6 by the department under RCW 69.48.120. The department must approve or 7 reject proposals received using the process described in subsection 8 (3) of this section. 9 (b) If there is a single approved drug take-back program, and 10 that program operator leaves the program and participating 11 manufacturers do not identify a program operator to take over the 12 approved program as provided in (a) of this subsection, all covered 13 manufacturers must participate in a new approved drug take-back 14 program as soon as one is approved.15 (9) If there is more than one approved drug take-back program, 16 and a program operator for a drug take-back program leaves the 17 program for any reason and the covered manufacturers participating in 18 that program fail to identify a new entity to take over operations of 19 the existing program without a break in program services as described 20 in subsection (8)(a) of this section, those manufacturers must 21 immediately join an existing approved drug take-back program.22 (10) A covered manufacturer may change the approved drug take-23 back program it participates in but the covered manufacturer must 24 maintain continuous participation in an established drug take-back 25 program and may not leave an approved program until it transfers 26 participation to an approved drug take-back program that has begun 27 drug collection.28 (11) The department shall make all proposals submitted under this 29 section available to the public and shall provide an opportunity for 30 written public comment on each proposal. 31 (12)(a) All program operators must collaborate to present a 32 consistent statewide drug take-back system for residents to ensure 33 that all state residents can easily identify, understand, and access 34 services provided by any approved drug take-back program. The 35 department may identify or clarify in rule additional requirements 36 for coordination or performance amongst program operators, if 37 necessary, to ensure consistent operation of the drug take-back 38 program. Requirements may include, but are not limited to: Consistent 39 drop box appearance and signage; consistent messaging in education 40 p. 6 2SHB 1161.SL and outreach; and consistent metrics included in operator annual 1 reports as required in RCW 69.48.100 to ensure the department can 2 accurately analyze the data. 3 (b) Failure to comply with these requirements may result in 4 enforcement action against a program operator as authorized under RCW 5 69.48.110.6 Sec. 4. RCW 69.48.070 and 2018 c 196 s 7 are each amended to 7 read as follows: 8 (1) A drug take-back program must develop and provide a system of 9 promotion, education, and public outreach about the safe storage and 10 secure collection of covered drugs. This system may include signage, 11 written materials to be provided at the time of purchase or delivery 12 of covered drugs, and advertising or other promotional materials. At 13 a minimum, each program must: 14 (a) Promote the safe storage of legend drugs and nonlegend drugs 15 by residents before secure disposal through a drug take-back program;16 (b) Discourage residents from disposing of covered drugs in solid 17 waste collection, sewer, or septic systems; 18 (c) Promote the use of the drug take-back program so that where 19 and how to return covered drugs is widely understood by residents, 20 pharmacists, retail pharmacies, health care facilities and providers, 21 veterinarians, and veterinary hospitals; 22 (d) Establish a toll-free telephone number and website 23 publicizing collection options and collection sites and discouraging 24 improper disposal practices for covered drugs, such as flushing them 25 or placing them in the garbage; 26 (e) Prepare educational and outreach materials that: Promote safe 27 storage of covered drugs; discourage the disposal of covered drugs in 28 solid waste collection, sewer, or septic systems; and describe how to 29 return covered drugs to the drug take-back program. The materials 30 must use plain language and explanatory images to make collection 31 services and discouraged disposal practices readily understandable to 32 all residents, including residents with limited English proficiency;33 (f) Disseminate the educational and outreach materials described 34 in (e) of this subsection to pharmacies, health care facilities, and 35 other interested parties for dissemination to covered entities;36 (g) Work with authorized collectors to develop a readily 37 recognizable, consistent design of collection receptacles, as well as 38 clear, standardized instructions for covered entities on the use of 39 p. 7 2SHB 1161.SL collection receptacles. The department may provide guidance to 1 program operators on the development of the instructions and design; 2 and 3 (h) Annually report on its promotion, outreach, and public 4 education activities in its annual report required by RCW 69.48.100.5 (2) If more than one drug take-back program is approved by the 6 department, the programs must coordinate their promotional activities 7 to ensure that all state residents can easily identify, understand, 8 and access the collection services provided by any drug take-back 9 program. Coordination efforts must include providing residents with a 10 single toll-free telephone number and single website to access 11 information about collection services for every approved program , 12 including presenting all available collection sites, mail-back 13 distribution locations, and take-back events to ensure residents are 14 able to access the most convenient method of collection, regardless 15 of the program operator, and must manage requests for prepaid, 16 preaddressed mailing envelopes from covered entities and from retail 17 pharmacies as provided in RCW 69.48.060(3)(e). 18 (3) Pharmacies and other entities that sell medication in the 19 state are encouraged to promote secure disposal of covered drugs 20 through the use of one or more approved drug take-back programs. Upon 21 request, a pharmacy must provide materials explaining the use of 22 approved drug take-back programs to its customers. The program 23 operator must provide pharmacies with these materials upon request 24 and at no cost to the pharmacy. 25 (4) The department, the health care authority, the department of 26 social and health services, the department of ecology, and any other 27 state agency that is responsible for health, solid waste management, 28 and wastewater treatment shall, through their standard educational 29 methods, promote safe storage of prescription and nonprescription 30 drugs by covered entities, secure disposal of covered drugs through a 31 drug take-back program, and the toll-free telephone number and 32 website for approved drug take-back programs. Local health 33 jurisdictions and local government agencies are encouraged to promote 34 approved drug take-back programs. 35 (5) The department: 36 (a) Shall conduct a survey of covered entities and a survey of 37 pharmacists, health care providers, and veterinarians who interact 38 with covered entities on the use of medicines after the first full 39 year of operation of the drug take-back program, and again every two 40 p. 8 2SHB 1161.SL years thereafter. Survey questions must: Measure consumer awareness 1 of the drug take-back program; assess the extent to which collection 2 sites and other collection methods are convenient and easy to use; 3 assess knowledge and attitudes about risks of abuse, poisonings, and 4 overdoses from drugs used in the home; and assess covered entities' 5 practices with respect to unused, unwanted, or expired drugs, both 6 currently and prior to implementation of the drug take-back program; 7 and 8 (b) May, upon review of results of public awareness surveys, 9 direct a program operator for an approved drug take-back program to 10 modify the program's promotion and outreach activities to better 11 achieve widespread awareness among Washington state residents and 12 health care professionals about where and how to return covered drugs 13 to the drug take-back program. 14 Sec. 5. RCW 69.48.120 and 2018 c 196 s 12 are each amended to 15 read as follows: 16 (1)(a) ((By July 1, 2019, the )) The department shall: Determine 17 its costs for the administration, oversight, and enforcement of the 18 requirements of this chapter, including , but not limited to, a fee 19 for proposal review, and the survey required under RCW 69.48.200; 20 pursuant to RCW 43.70.250, set fees at a level sufficient to recover 21 the costs associated with administration, oversight, and enforcement; 22 and adopt rules establishing requirements for program operator 23 proposals. 24 (b) The department shall not impose any fees in excess of its 25 actual administrative, oversight, and enforcement costs. The fees 26 collected from each program operator in calendar year 2020 and any 27 subsequent year may not exceed ten percent of the program's annual 28 expenditures as reported to the department in the annual report 29 required by RCW 69.48.100 and determined by the department.30 (c) Adjustments to the department's fees may be made annually and 31 shall not exceed actual administration, oversight, and enforcement 32 costs. Adjustments for inflation may not exceed the percentage change 33 in the consumer price index for all urban consumers in the United 34 States as calculated by the United States department of labor as 35 averaged by city for the twelve-month period ending with June of the 36 previous year. 37 (d) The annual fee set by the department shall be evenly split 38 amongst each approved program operator.39 p. 9 2SHB 1161.SL (e) The department shall collect annual operating fees from each 1 program operator by October 1, 2019, and annually thereafter.2 (f) Between the effective date of this section and January 1, 3 2024, the department shall collect a nonrefundable one-time fee of 4 $157,000 for review of proposals from each potential program operator 5 applicant as provided in RCW 69.48.050.6 (2) All fees collected under this section must be deposited in 7 the secure drug take-back program account established in RCW 8 69.48.130. 9 Sec. 6. RCW 43.131.423 and 2018 c 196 s 26 are each amended to 10 read as follows: 11 The authorization for drug take-back programs created in chapter 12 196, Laws of 2018 and chapter . . ., Laws of 2021 (sections 1 through 13 5 of this act) shall be terminated on January 1, 2029, as provided in 14 RCW 43.131.424. 15 Sec. 7. RCW 43.131.424 and 2018 c 196 s 27 are each amended to 16 read as follows: 17 The following acts or parts of acts, as now existing or hereafter 18 amended, are each repealed, effective January 1, 2030:19 (1) RCW 69.48.010 and 2021 c . . . s 1 (section 1 of this act) & 20 2018 c 196 s 1;21 (2) RCW 69.48.020 and 2018 c 196 s 2; 22 (((2))) (3) RCW 69.48.030 and 2018 c 196 s 3; 23 (((3))) (4) RCW 69.48.040 and 2018 c 196 s 4; 24 (((4))) (5) RCW 69.48.050 and 2021 c . . . s 3 (section 3 of this 25 act) & 2018 c 196 s 5; 26 (((5))) (6) RCW 69.48.060 and 2018 c 196 s 6; 27 (((6))) (7) RCW 69.48.070 and 2021 c . . . s 4 (section 4 of this 28 act) & 2018 c 196 s 7; 29 (((7))) (8) RCW 69.48.080 and 2018 c 196 s 8; 30 (((8))) (9) RCW 69.48.090 and 2018 c 196 s 9; 31 (((9))) (10) RCW 69.48.100 and 2018 c 196 s 10;32 (((10))) (11) RCW 69.48.110 and 2018 c 196 s 11;33 (((11))) (12) RCW 69.48.120 and 2021 c . . . s 5 (section 5 of 34 this act) & 2018 c 196 s 12; 35 (((12))) (13) RCW 69.48.130 and 2018 c 196 s 13;36 (((13))) (14) RCW 69.48.140 and 2018 c 196 s 14;37 (((14))) (15) RCW 69.48.150 and 2018 c 196 s 15;38 p. 10 2SHB 1161.SL (((15))) (16) RCW 69.48.160 and 2018 c 196 s 16;1 (((16))) (17) RCW 69.48.170 and 2018 c 196 s 17;2 (((17))) (18) RCW 69.48.180 and 2018 c 196 s 18;3 (((18))) (19) RCW 69.48.190 and 2018 c 196 s 19; and4 (((19))) (20) RCW 69.48.200 and 2018 c 196 s 20.5 Passed by the House March 8, 2021. Passed by the Senate April 11, 2021. Approved by the Governor May 3, 2021. Filed in Office of Secretary of State May 3, 2021. --- END --- p. 11 2SHB 1161.SL