King County, Washington Enacts Pharmaceutical Take-Back Program
On June 20, 2013, the King County, Washington Board of Health passed the Secure Medicine Return Rule and Regulation (“SMRRR”) establishing a product stewardship program to collect and safely dispose of unwanted household medicines. The law requires drug manufacturers to fund and implement a drug collection and disposal program. Leftover, expired, and unneeded drugs must be collected from residents free-of-charge at drop boxes located at retail pharmacies and law enforcement offices. Drug producers must transport the medicines in accordance with federal and state laws for disposal at permitted incineration facilities.
King County is located in the western part of Washington state and encompasses Seattle. According to the 2010 census, King County has almost two million residents and is the fourteenth most populous county in the United States. King County is the second jurisdiction to pass a mandatory pharmaceutical product stewardship law in the U.S. The first was Alameda County, California, which passed a similar law last year. The Pharmaceutical Research and Manufacturers of America and other trade groups have filed a lawsuit in federal court challenging the constitutionality of the Alameda County law.
Under the SMRRR, all drugs used by county residents, including prescription, non-prescription (over the counter), brand name, and generic drugs are covered and must be accepted for collection. Legally prescribed controlled substances, such as OxyContin, Vicodin, Valium, Ritalin, and stimulants, are covered. (As discussed below, the U.S. Drug Enforcement Agency (“DEA”) is currently developing regulations to expand options for disposal of controlled substances). Cosmetics, herbal-based remedies, homeopathic drugs, sunscreen, medicated shampoos, vitamins, supplements, pet pesticides, medical devices, and pharmaceutical waste from businesses are notcovered.
The SMRRR imposes many new requirements on pharmaceutical producers. The law defines a “producer” as “a manufacturer engaged in the manufacture of a covered drug sold in or into King County.” Producers must develop and implement stewardship plans that provide convenient and equal access to all residents, promote the program to residents, and finance the program.
Stewardship Plans. The SMRRR defines plan standards but allows drug producers to develop their own stewardship plans. Every covered producer must participate in the “standard” plan or may propose an “independent” plan; both plan types must meet system standards and receive approval from Public Health – Seattle & King County (“Public Health”).
Convenient & Equitable Access. One central standard of the law is convenient and equitable access for all residents. Therefore, any retail pharmacy or law enforcement agency that volunteers to serve as a drop-off site must be included in the collection system to ensure as many locations as possible. Collectors may offer their offices and/or businesses as collection sites voluntarily, but producers are also allowed to incentivize participation through compensation or other means. Producers must serve areas lacking a minimum number of collection sites by holding periodic collections or operating mail-back programs. Home-bound or disabled residents must be provided with pre-paid return mailers.
Program Promotion. Drug producers are required to promote safe storage of medicines and the return system to residents, pharmacists, retailers, and health professionals. Producers must provide materials to pharmacies, health care facilities, and others as well as operate a website and a toll-free number. They must work with collectors to develop clear instructions on use of secure drop boxes and to create a readily recognizable, consistent drop box design.
Costs. Drug producers are responsible for the costs relating to collection supplies, pre-paid mailers, collection events, drug transportation, drug disposal, program monitoring, evaluation, and administration. The Local Hazardous Waste Management Program of King County is responsible for providing up to 400 secure drop boxes and assisting with program promotion.
Within six months of adoption of the law (by December 20, 2013), producers must notify Public Health of their intent to participate in the standard plan or form an independent plan. Within nine months of adoption of the law (by March 20, 2014), producers must notify Public Health of a designated plan “operator,” notify all potential collection sites, and provide a process for forming agreements between the plan and collection sites. Within a year of adoption of the law (June 20, 2014), producers must submit a proposed plan. After plan approval, producers then have three months to begin operation. Once implemented, producers must report annually to Public Health on the number of pounds of drugs collected and the effectiveness of promotion efforts. In years one, five, and nine, producers must also report the results of a survey given to residents to assess program awareness and convenience.
Oversight & Enforcement
Public Health will oversee the program to ensure compliance and safety. The agency will also review producer plans, monitor plan operations, conduct inspections as needed, and review reports. Public Health may assess civil penalties of up to $2,000 per day for failure to comply with the law. Oversight costs will be recovered through annual operating fees from producers.
Related Federal Developments
DEA is currently developing regulations which are intended to expand options for disposal of controlled substances by ultimate users. Current law restricts return of controlled substances to law enforcement drop-off sites or collection events. As authorized by the 2010 Secure and Responsible Drug Disposal Act, DEA issued a proposed rule in December 2012 which would allow users to dispose of unwanted controlled substances through take-back events, mail-back programs, or collection receptacles located at DEA-registered locations. Collection and disposal programs could be operated by law enforcement or certain authorized collectors (registered manufacturers, distributors, reverse distributors, and retail pharmacies). The public comment period closed in February 2013 and DEA has not provided an anticipated date for the final rule. Because the rule will likely simplify collection of controlled substances through pharmaceutical take-back programs, local or state programs may be expected to follow closely after DEA’s final rule is published.
The U.S. Environmental Protection Agency (“EPA”) is currently developing regulations to address pharmaceutical disposal at healthcare facilities. Many pharmaceutical wastes are subject to regulation as hazardous wastes under the federal Resource Conservation and Recovery Act (“RCRA”). In an effort to reduce applicable RCRA requirements, in 2008 EPA proposed classifying hazardous pharmaceutical wastes as “universal wastes.” EPA since decided not to finalize its 2008 proposal, and is now developing a proposal for new standards for the management and disposal of hazardous waste pharmaceuticals that are generated by healthcare-related facilities. This proposal is currently expected to be issued in August 2013.