Bill: HB 1047 — 2017
Protecting the public's health by creating a system for safe and secure collection and disposal of unwanted medications (Peterson)
Creates a system for safe and secure collection and disposal of unwanted medications.
SUMMARY OF 1ST SUBSTITUTE COMPARED TO ORIGINAL BILL
(1) Modifies the timelines for wholesalers to provide a list of manufacturers to the DOH and removes the requirement that the DOH post a list of manufacturers on its website; (2) extends the deadline for submitting program proposals; (3) specifies locations where a program may locate collection sites and requires program operators to service collection sites; (4) requires programs to provide explanatory materials and, upon request, mailers to pharmacies, requires programs' biennial survey to assess covered entities' practices, changes the deadline for program operators to submit an initial report, and encourages (rather than requires) local agencies to promote approved programs; (5) expands the prohibition on point-of-sale and point-of-collection fees, changes the timeframe for the DOH to set and collect fees, and removes provisions related to an annual fee divided among programs; (6) provides penalties for wholesalers and pharmacies and specifies that the DOH may not prohibit the sale of a drug; (7) limits the time period for enforcing a grandfathered ordinance to 18 months and prohibits local laws requiring certain entities to collect and dispose of covered drugs; (8) modifies the deadline for the DOH report to the Legislature, adds the requirement that the DOH report evaluate the impact of approved programs on certain outcomes, and adds the requirement that the statewide program of poison and drug information survey residents; and (9) modifies several definitions, adds a legislative finding, and makes several technical corrections.
HOUSE STRIKER AMENDMENT
(1) Clarifies that the intent of the legislature is to establish a single, uniform, statewide system of regulation for drugtake back programs. (2) Defines "administer" and "mail-back distribution location," and limits the definition of "covered drug" to exclude a number of products that were previously excluded from the definition of "drug" and specifically excludes emptied injector products, emptied medical devices, and exposed needles or sharps. (3) Requires program operators to submit program proposals by July 1, 2019, rather than October 1, 2019. (4) Allows covered manufacturers in a drug take-back program to apportion the costs as the manufacturers determine, rather than according to sales revenue in Washington state. (5) Limits the fees the Department of Health (Department) can collect from program operators to the actual costs of administration, oversight, enforcement, and starting in 2020 to 10% of the total program costs. Limits adjustments to the fees for inflation to not exceed the percentage change in the consumer price index for all urban consumers averaged by city, in the previous year. (6) Increases the time limit for a program operator to initiate operation of an approved drug take-back program to 180 days from 90 days, and provides 90 days for a program operator to submit a revised proposal that was rejected by the Department instead of 60 days. (7) Requires program operators to notify the Department of substantial changes to the program and 15 days prior to the change, rather than notification of any substantive change 30 days in advance. For changes that are not substantive, the program operator must notify the Department seven days in advance, instead of 15 days. Program operators must notify the department of any changes in ownership or contact information for participating covered manufacturers within 90 days, instead of 30 days. (8) Requires drug take-back program collection systems to provide reasonably convenient access and that there must be a collection site for each population center plus an additional site for every 50,000 residents instead of every 20,000 residents. (9) Allows a program operator to establish mail-back distribution locations or hold periodic collection events instead of requiring periodic collection events. (10) Clarifies that the alternative collection methods of mailback programs and periodic events may only be conducted to the extent permissible under state and federal laws. (11) Removes the requirement on program operators to conduct a survey on consumer awareness, the use of the collection methods, and knowledge of the risks of abuse and overdose and places the responsibility on the Department. (12) Changes the date the annual report must be submitted to July 1st instead of April 1st. (13) Requires program operators submit within 30 days of the annual period of operation the total amount, by weight, of covered drugs collected from each collection site during the prior year. (14) Limits the Department's enforcement authority by only allowing the Department to require a person or entity to engage in or refrain from engaging in certain activities that pertain to the chapter. (15) Reduces the time period in which a county may enforce a grandfathered ordinance after an approved drug take-back program begins operating and a manufacturer in compliance with a grandfathered ordinance is considered in compliance with the statelaw for purposes of that county, from 18 months to 12 months. Clarifies that after the 12-month period that all local laws regarding drug take-back programs are preempted. (16) Requires the Department to utilize an academic institution that is not an agency of the state in evaluation of the impact of the drug take-back program. (17) Subjects the authorization for drug take-back programs to the sunset review process, terminating the authority on January 1, 2029. (18) Increases dates in the bill by one year, and makes a technical change to reflect legislation enacted in 2017.
SENATE COMMITTEE (Health & Long Term Care) STRIKER AMENDMENT
(1) Excludes private label distributors, repackagers, and certain nonprofit corporations from the definition of covered manufacturer and clarifies that the act preempts all existing and future local laws related to drug take-back or similar programs.
SENATE FLOOR AMENDMENTS
Clarifies that a qualifying nonprofit health care corporation is not considered a drug manufacturer for the purposes of the act if it only packages and supplies drugs to its facilities for clinical use.
Hearing Date: Monday, February 19, 2018 -- 10:00 am
WA State Legislature Link:
http://app.leg.wa.gov/billsummary?BillNumber=1047&Year=2017 (opens a new browser tab)
|UW Medicine||Governor Signature||2018-02-19|