Richard Sieg, Regulatory Counsel, Inmar
On February 25, 2015, Senate Bill 423 was introduced in the California Legislature. This Bill seeks to amend the California Medical Waste Management Act (MWMA) to streamline retail options for managing, discarding and recycling over the counter (OTC) products and dietary supplements. A hearing scheduled for April 15, 2015, was cancelled at the request of the author; it appears that a hearing on this Bill may take place as early as June or July.
For those who manage OTC items or supplements in California, you are probably aware of the current challenges associated with the management of these items under the current agency interpretations. First, anything with “drug facts” placed on the packaging must be managed as a pharmaceutical waste. This means saline solution that is 99% water, but its packaging lists “drug facts,” must be managed as pharmaceutical waste in California.
Historically, there have been interpretations of California law that would have pulled items with “supplement facts” on the label under the MWMA’s authority as well. The current interpretation of the law appears to be that those consumer products would not fall within the confines of the MWMA, but may be interpreted as hazardous waste because of aquatic toxicity. The settlement agreements with retailers typically include funds for a District Attorney initiative to test supplements for aquatic toxicity.
The Bill in its current form (Legislative website checked on May 3, 2015) would specifically exclude OTCs and dietary supplements from the definition of pharmaceutical waste if the item meets all of the following:Is offered for sale without a prescriptionIs labeled with information entitled “Drug Facts” or “Supplement Facts” in accordance with the Federal Food, Drug, and Cosmetic ActIs characterized and managed under either the hazardous waste or solid waste rulesWith respect to an OTC human or veterinary drug, is not disposed of on land within the state
We are also expecting that, in its final form, the Bill would adjust the California Health and Safety Code’s hazardous waste provisions to expressly allow retailers to return non-saleables (non-leaking, household consumer products in their original packaging) to reverse distributors for consolidation, credit evaluation, etc., and eliminate uncertainty regarding whether certain types of returned products require disposal at the retail store.
Language under consideration would enable the retail industry to enjoy the full benefits of reverse distribution, including economies of scale, financial reconciliation, waste minimization and management of products and wastes by regulatory experts, with respect to all non-leaking household consumer products moving through the reverse supply chain.
We encourage our partners in both the Supply Chain and Healthcare Networks to monitor the progress of California Senate Bill 423 and to support its passage. We believe this legislation better balances the unique challenges faced by the retail sector with the actual, minimal risks posed by the reverse distribution of retail products.ContactRichard Sieg with questions or comments.