CalRecycle Safety Regulations
The Pharmaceutical and Sharps Waste Stewardship Act Regulations were adopted on January 7, 2021 (Public Resources Code (PRC), section 42030 et seq. or Act) and require covered drug and sharps manufacturers to establish safe and convenient disposal options for pharmaceutical drug generated waste. The regulations also cover distributors, repackagers, owners or licensees of a trademark or brand and importers of “covered products” that are sold in or into the state. “Covered drug” means a drug, including a brand name or generic drug, sold, offered for sale, or dispensed in the State of California in any form. Exemptions include vitamins, supplements, cosmetics, biologics, devices, and veterinary drugs. Stewardship plans were due to CalRecycle by July 7, 2021, pending the California Board of Pharmacy review (PRC section 42032(a) – (b)).
Administrative penalties of $10,000 up to $50,000 per day may be imposed on entities that sell, offer for sale, or provide a covered product in violation of the Act or its Implementing Regulations. (PRC 42035.2(a) and CCR, sections 18975-18975.2)