In September 2018, California enacted the Pharmaceutical and Sharps Waste Stewardship law, which requires covered entities to provide for the safe and convenient collection, transportation and disposal of “covered drugs” (which includes both prescription and over-the-counter drugs sold or dispensed in California) and home-generated sharps waste (which includes hypodermic needles, lancets and other such items sold in California). On January 7, 2021, the regulations implementing the stewardship law became effective (the law and regulations are herein referred to as the “Stewardship Law”). These regulations provided additional details about the obligations of covered entities and triggered key compliance deadlines, some of which are quickly approaching. The Stewardship Law has broad applicability for manufacturers, retail pharmacies, and potentially for distributors and other entities in the distribution chain of covered products sold in California, regardless of whether such entities otherwise have connections to the state.
Covered Entities
The Stewardship Law obligates covered entities—which include manufacturers but can in certain circumstances also include distributors, repackagers, trademark holders or importers of covered products sold in California—to establish and implement a stewardship program to promote the safe end-of-life disposition of these items. While retail pharmacies are not “covered entities” under the Stewardship Law, pharmacies play a key role under the law and are subject to their own obligations, as further described below.
Stewardship Plan
On or before July 7, 2021, covered entities must submit to California’s Department of Resources Recycling and Recovery (CalRecycle) a proposed stewardship plan meeting the requirements of the Stewardship Law. The Stewardship Law establishes parallel sets of obligations for covered drugs and home-generated sharps, respectively.
Covered Drugs—The stewardship plan submission for covered drugs must include, among other things, initial and ongoing budget information and processes and policies to ensure the safe collection, tracking and management of covered drugs through ultimate disposal. The stewardship program must identify a minimum of five geographically distributed collection sites per county (typically expected to be retail pharmacies) or one authorized collection site per 50,000 people, whichever is greater, and establish a mail-back program or alternative collection program for homebound consumers and in counties that do not have the minimum number of collection sites.
The Stewardship Law requires retail pharmacies to “make a reasonable effort” to serve as authorized collection sites of covered drugs. In counties with too few covered drug collection sites, retail pharmacies may be required to establish as authorized collection points a minimum of “one location or 15 percent of its store locations, whichever is greater, in the county.” Pharmacies acting in such capacity are also subject to additional obligations, including recordkeeping and reporting requirements.
Home-Generated Sharps—The stewardship plan submission for home-generated sharps must include, among other things, a demonstration of adequate funding for all costs of implementing the program and provision for handling, transport and disposal of covered products at no cost to the end user. The home-generated sharps stewardship plan must be accomplished primarily through a mail-back program, although supplemental collection receptacles may be established in compliance with the Stewardship Law.
Stewardship plans for both covered drugs and home-generated sharps include requirements for education and outreach to the public, including through printed and electronic means.
The Stewardship Law is the country’s most comprehensive law governing the ultimate disposition of drugs and home-generated sharps. Like many prior California regulatory initiatives, the Stewardship Law has implications that stretch far beyond the state’s borders. If you have questions or would like additional information, please contact Matt Dombroski at mdombroski@manatt.com.