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California’s Revised Pharmaceutical Waste Handling Law – AB 1442

On September 28, 2012, Governor Brown announced the signing of AB 1442, which has potentially important implications for entities handling pharmaceutical items, including pharmacies, retailers, groceries, hospitals, medical clinics, and other such facilities which handle pharmaceutical and over-the-counter (OTC) drugs.  AB 1442 comes at a time when increased attention is being paid to the disposition and handling of these pharmaceutical items both in California and nationally, including the EPA’s recently renewed efforts to establish standards for the handling and disposal of hazardous waste pharmaceuticals.

The law amends California’s Medical Waste Management Act (MWMA) to provide relief from some of the MWMA’s onerous requirements pertaining to the handling of certain pharmaceutical items (which, as explained below, includes prescription and over-the-counter drugs). This includes requirements that, as interpreted by California enforcement authorities, had the practical effect of limiting the ability of entities handling pharmaceutical items to send certain of these items into reverse distribution for credit and liquidation, refurbishing, repurposing, or other responsible reprocessing, as opposed to disposal.

Specifically, enforcement authorities have typically interpreted the MWMA and other applicable laws as requiring regulated entities to determine whether a pharmaceutical item is a waste. Because the waste determination process is nuanced and the potential legal consequences of mischaracterizing a waste item as non-waste are severe, many regulated entities understandably take the conservative approach of disposing of many pharmaceutical items as waste at the store level, even where such items could have reasonably been sent through reverse distribution for credit and/or for a non-waste disposition. Based on our communications with multiple individuals involved in drafting the bill, AB 1442 is intended to at least partially address these concerns. The most salient components of AB 1442 include the following:

1.  AB 1442 defines “pharmaceutical waste,” which was previously undefined under the MWMA, as “any pharmaceutical, as defined in [the MWMA], that is a waste, as defined in [California Health and Safety Code Sec.] 25124.” The MWMA continues to define “pharmaceutical” as any prescription or over-the-counter drug, excluding any such drug that is regulated pursuant to the federal Resource Conservation and Recovery Act (“RCRA”) or the California Radiation Control Law.  Accordingly, because the provisions described below apply only to pharmaceuticals and pharmaceutical waste as defined by the MWMA, the benefits of AB 1442 do not extend to any prescription or over-the-counter items that would be RCRA-hazardous waste if disposed.

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