Overview of proposed Secure Medicine Return Rule & Regulation
The King County Board of Health's Subcommittee on Secure Medicine Return has recommended a Rule and Regulation (R&R) establishing an industry-funded product stewardship model to collect and safely dispose of unwanted household medicines from residents of the county.
Overview of the proposed secure medicine return system
Residents will be encouraged to bring leftover, expired, and unneeded medicines to secure drop boxes in retail pharmacies or law enforcement offices throughout the county. These collection sites will participate voluntarily, and if a medicine drop-off site is not available in a specific area then periodic collection events or pre-paid return mailers will be provided. Pre-paid return mailers can be requested for residents who are home bound or disabled. Drop-off site locations and other collection services will be promoted to the community through a toll-free telephone line, a website, and print materials.
Collected medicines will be securely handled, transported and disposed of according to federal and state laws, including policies of the Drug Enforcement Administration and the Washington State Board of Pharmacy. The drugs will be destroyed at properly permitted high temperature incineration facilities.
Drug producers selling medicines for residential use in or into King County are required to finance and provide the secure medicine return system. Residents cannot be required to pay a fee for secure medicine return when they purchase medicines or return them. Public Health - Seattle & King County (Public Health) will oversee the drug producers' medicine return system to ensure safety and compliance with the R&R.
Medicines accepted for return
- Prescription and non-prescription (over-the-counter) medicines that residents use in their homes, or in other residential settings. Includes medicines in any form: pills, liquids, creams; and includes legally prescribed controlled substances, such as OxyContin, Vicodin, Valium, Ritalin, and stimulants.
- Current DEA regulations restrict return of controlled substances to law enforcement drop-off sites or collection events; however, new regulations the DEA is developing will authorize drug manufacturers, retail pharmacies and others to operate drop-off and mail-back programs.
- Not accepted for return: over-the-counter drugs that are regulated as cosmetics, e.g. toothpaste, sunscreen, medicated shampoos; vitamins and supplements; and pharmaceutical waste from businesses.
Operation of the system by drug producers
- The proposed R&R defines requirements and standards, but allows drug producers to develop their own stewardship plan for providing an efficient medicine return system.
- Every drug producer selling medicines for residential use in or into the county must participate in the "standard" stewardship plan. If a producer or group of producers prefers to form a different partnership, they may propose an "independent" plan. Both the standard plan and the independent plan must meet system requirements and standards, and be approved by Public Health before initiating operations.
- If multiple stewardship plans are approved, the plans must coordinate their promotional activities to ensure residents can easily understand and use the collection services of any plan.
- Timing of program implementation: drug producers must submit a proposed stewardship plan no later than 12 months after the R&R is enacted; and must begin operation of the stewardship plan no later than 3 months after plan approval by Public Health.
System requirements & standards
- The primary collection method will be secure drop boxes at retail pharmacies and law enforcement offices.
- The R&R defines a "service convenience goal" to ensure convenient and equitable access for all residents. Any retail pharmacy or law enforcement agency that volunteers to be a drop-off site must be included in the collection system to ensure as many drop-off sites as possible. Any areas lacking a minimum number of drop-off sites will be served through periodic collection events and/or through mail-back programs.
- Prepaid, preaddressed mailers can be requested for home bound or disabled residents.
- Collectors may offer to serve as a collector voluntarily, or may agree to serve in exchange for incentives or payment offered by the drug producers.
- Handling of all drugs must conform to all applicable federal and state laws and regulations, including those of the Drug Enforcement Administration and the Washington State Board of Pharmacy.
- Collected medicines must be disposed of at a properly permitted hazardous waste facility, unless permission is granted to use a large municipal waste combustion facility (e.g. Waste-to-Energy facilities) because of cost or logistical barriers. Use of alternative disposal technologies that provide superior environmental and human health protection may also be approved.
Promotion and evaluation requirements
Promotion: Drug producers are required to promote safe storage of medicines and how to use the medicine return system to residents, pharmacists, retailers, and health professionals; provide materials to pharmacies, health care facilities, and others; and provide a website and a toll-free number. Drug producers must work with collectors to develop clear instructions on use of secure drop boxes and a readily recognizable, consistent drop box design.
Evaluation: Drug producers must report annually on the pounds of medicines collected, annually evaluate the effectiveness of program promotion, and conduct a survey of residents to measure awareness and program convenience after the first program year, and again at years five and nine.
LHWMP will develop template educational materials for use by pharmacies, law enforcement, health care providers and local governments, and provide targeted education to key populations.
Drug producers are responsible for:
- Costs of collection supplies for drop-off sites, prepaid mailers, and any collection events.
- Costs of transporting collected medicines (including law enforcement escort if required), and final disposal at approved high temperature incineration facilities.
- Costs of program promotion and evaluation, as well as administrative costs.
- Payment of fees to Public Health to reimburse costs of plan review and annual oversight.
Collectors participate voluntarily and provide in-kind staff time at drop-off sites.
The Local Hazardous Waste Management Program in King County is responsible for costs of:
- Providing up to 400 secure drop boxes for the standard stewardship plan. Drug producers participating in the standard plan are responsible for any additional drop boxes or maintenance costs, and producers operating an approved independent plan must provide all drop boxes.
- Assisting with program promotion (see description above).
Oversight and enforcement
- Public Health will oversee the program to ensure compliance and safety.
- Public Health oversight authority includes: review and approval of the stewardship plan(s) from drug producers, monitoring of plan operations, inspections as needed, review and approval of substantive changes to the approved stewardship plan(s), and review of annual reports.
- Drug producers who are not in compliance with the R&R are subject to written warnings and civil penalties of up to $2,000 per day.
- Public Health oversight costs will be recovered through plan review and annual operating fees from producers.