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Environmental Update – Proposed Hazardous Waste Rule for Pharmaceuticals

Environmental Update

On August 31, 2015, the EPA proposed new regulations for the management of hazardous waste pharmaceuticals at healthcare facilities.  First and foremost, the proposed rule prohibits the flushing of any hazardous waste pharmaceutical into a sewer drain or toilet.  Many local municipalities have restricted the flushing of pharmaceuticals into the sewer; however, the new rule will create a federal prohibition on this practice.

The proposed rule applies to Healthcare Facilities and to a newly created designation – Pharmaceutical Reverse Distributors.  Healthcare facilities include entities that provide medical care, such as hospitals, doctor’s offices, dentist’s offices, health clinics, long-term care facilities, ambulance services, pharmacies and retailers of over-the-counter medications.  A Pharmaceutical Reverse Distributor is defined to include any person who receives and accumulates potentially creditable hazardous waste pharmaceuticals for a manufacturer’s credit.

The proposed rule defines Pharmaceutical Waste with a much boarder definition than that established by the Federal Food, Drug and Cosmetic Act.  The definition includes any prescription and non-prescription (over-the-counter) drugs, and expands the definition to include dietary supplements, residues in containers, personal protective equipment and cleanup waste from spills.  The definition does not include laboratory waste or sharps (needles and syringes) if the sharps are properly disposed of in a sharps container.

The proposed rule establishes two different mechanisms for the management of pharmaceutical hazardous waste depending on whether the waste is (1) potentially creditable or (2) non-creditable.  The good news is that regardless of the classification, the amount of the waste generated will not be counted toward whether the facility is considered to be a Large Quantity Generator or a Small Quantity Generator under existing RCRA laws.  This may allow many facilities to reduce their regulated status under RCRA.

If the waste is “potentially” creditable, meaning that the manufacturer will issue a credit to the generator for the unused pharmaceutical, the proposed rule significantly reduces the burden on the healthcare facility in managing this type of waste.  Under the proposed regulations, potentially creditable pharmaceuticals would be exempt from the accumulation time limits under RCRA (i.e. they can accumulate the pharmaceuticals more than 90 days), and they can accumulate the pharmaceuticals in non-hazardous waste designated areas provided that the container is labeled for potentially creditable hazardous waste pharmaceuticals.  Healthcare facilities may ship the potential creditable waste using a common carrier in compliance with the DOT requirements to a pharmaceutical reverse distributor provided that advance notice is provided and the reserve distributor provides notice or receipt, without the use of a RCRA waste manifest.

If the waste is non-creditable waste, the rules are a little more stringent.  First, the waste can be accumulated in a container suitable for the specific type of waste for up to one (1) year and without regard to quantity restriction under RCRA.  The container must be labeled as “Hazardous Pharmaceutical Waste.”  The waste must be shipped to a RCRA interim status or permitted facility as any other hazardous waste must be shipped using a manifest system and by an approved DOT transporter.

For Pharmaceutical Reverse Distributors, the proposed rule establishes storage and shipping requirements that are still less stringent than RCRA.  The Reverse Distributor must notify EPA that it is a reserve distributor.  It must store the pharmaceuticals in a secure area, must report any unauthorized shipment of waste to the facility, must make a determination within 21 days of arrival if the waste is “creditable” and may only accumulate the waste for a total of 90 days from the date of receipt.

Finally, the proposed rule provides conditional exemption for hazardous waste pharmaceuticals that are also DEA controlled substances, provided that the waste is properly disposed of under DEA regulations.

Comments on the proposed rule must be submitted to EPA by October 30, 2015.