California’s Drug and Sharps Takeback Bill Triggers Statewide Obligations

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All entities selling drugs and sharps in California should be aware of California’s pharmaceutical and sharps waste stewardship bill, SB 212, which recently passed both houses of the state Legislature. It currently sits on the Governor’s desk awaiting signature. SB 212 requires manufacturers of sharps and pharmaceuticals to create and fund a statewide take-back program covering prescription and OTC drugs. If a manufacturer is not located in the state, responsibility shifts down the chain to the wholesale distributor, then repackager, followed by the owner or licensee of the trademark, and lastly the importer. While these covered entities are likely to participate through a stewardship organization with a plan approved by CalRecycle, they also have the option to participate individually or as a group. Covered entities should begin to identify their compliance strategy now, as penalties for a failure to participate can reach $10,000 per day; $50,000 per day for intentional, knowing or reckless violations.

SB 212 also triggers obligations for retail pharmacies, as 15% of such stores must serve as collection sites for pharmaceuticals, unless the retail pharmacy already operates a voluntary collection program. The sharps program, by contrast, is a pre-paid mail-back program.

Work on SB 212 started after the Alameda County ordinance passed. Notably, SB 212 will preempt local stewardship programs effective on or after April 18, 2018, which is a benefit to entities managing compliance obligations in the 12 local California jurisdictions requiring manufacturers to manage drug and sharps waste.