New Pharmaceutical and Home-Generated Sharps Waste Rulemaking to Begin this Fall
Every year, Californians use hundreds of millions of medical sharps such as syringes and lancets, and they obtain hundreds of millions of medical prescriptions. Improperly disposed medications can threaten the environment, wildlife, waste handlers, and the public through water contamination, inadvertent needle sticks, and drug abuse. State lawmakers have offered a solution by passing Senate Bill 212 (Jackson, Chapter 1004, Statutes of 2018), the Pharmaceutical and Sharps Waste Stewardship Act.
Under SB 212, sharps and pharmaceutical waste will be regulated through a product stewardship program under which producers bear the physical and financial responsibility for proper end-of-life management of these products. The law requires the creation of a mail-back program for needles and the establishment of convenient collection receptacles for covered drugs. Covered drugs include brand name or generic drugs that are sold, offered for sale, or dispensed in California in any form, including prescription and nonprescription drugs approved by the FDA.
This fall, CalRecycle will begin the formal rulemaking process for the new law, which involves developing regulations for the safe and convenient collection and disposal options for home-generated pharmaceutical drugs and sharps. The department will set public comment periods and schedule public hearings for stakeholder input as part of the rulemaking process.
CalRecycle’s regulations must be in place by Jan. 1, 2021, and consumers can expect to see take-back programs in place in late 2022 or early 2023. Producers have until July 2021 to submit stewardship plans, first to the Board of Pharmacy and then to CalRecycle, that describe how their programs will work and meet the requirements of the law. The length of the approval process will depend on whether the submitted plans sufficiently meet all statutory and regulatory requirements.
Current state law (H&SC §118286) makes it illegal to dispose of home-generated sharps waste (hypodermic needles, pen needles, intravenous needles, lancets, and other devices that are used to penetrate the skin for the delivery of medications) in the trash or recycling containers, and requires that all sharps waste be transported to a collection center in a sharps container approved by the local enforcement agency. However, medical waste is still improperly disposed throughout the state. SB 212 aims to make proper disposal more convenient for Californians.
Stay informed by visiting CalRecycle’s SB 212 rulemaking webpage and subscribing to CalRecycle’s Pharmaceutical and Sharps Waste Stewardship Listserv.