Retail Overview and Status of EPA Pharmaceutical Waste Rule

On February 22, 2019, the U.S. Environmental Protection Agency (EPA) signed the final rule “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine,” also known as the Pharm ule. The rule applied immediately to states without an authorized Resource Conservation and Recovery Act (RCRA) program, while states that do have an authorized RCRA program are expected to adopt the full regulations by July 1, 2021, unless they require a statutory amendment, in which case they must adopt the full regulations by July 1, 2022. This article gives an overview of the current status of the Pharm Rule adoption by states.
Management and Handling of Pharmaceutical Waste
The Pharm Rule sets standards for the handling of hazardous waste pharmaceuticals. This rule applies to retailers and others defined as healthcare facilities and reverse distributors that "generate and manage hazardous waste pharmaceuticals" and not to pharmaceutical manufacturers. The term "healthcare facility" is fairly broad and in addition to treatment facilities it includes "any person that is lawfully authorized to … distribute, sell, or dispense pharmaceuticals, including over-the-counter pharmaceuticals, dietary supplements, homeopathic drugs, or prescription pharmaceuticals." As a result, health clinics and retailers of pharmaceuticals are affected by the rule. 
Retailers defined as health care facilities or reverse distributors should consider compiling an inventory of the products, substances, and materials in their facilities, to determine if any of their pharmaceuticals qualify as hazardous waste pharmaceuticals. In addition, health care facilities or reverse distributors should review their current procedures for handling and disposing of waste pharmaceuticals, including unwanted or expired pharmaceuticals.

According to the EPA, as of January 21, 2021, states where the Pharm rule is currently in effect are Alabama, Alaska, Arizona, Colorado, Delaware, Florida, Georgia, Illinois, Iowa, Kentucky, New Jersey, North Carolina, Ohio, Oklahoma, Pennsylvania, South Dakota, Utah, Virginia, Washington, West Virginia and Wisconsin. Minnesota is phasing in the regulations, with certain parts effective now, and plans to fully adopt in 2022.

P075 Listing for Nicotine

EPA acknowledged common sense by excluding "patches, gums and lozenges that are FDA-approved over-the-counter nicotine replacement therapies" from the P075 acutely hazardous listing in the final rule. Importantly, the Agency did not re-classify these items as non-acutely hazardous wastes, but rather excluded them from RCRA regulation entirely.  However, this exclusion from RCRA does not include e-cigarettes, e-liquids, or prescription nicotine replacement therapies. 

According to the EPA, as of January 21, 2021, the exemption for over-the-counter nicotine replacement therapies has been adopted in the following states: Alabama, Alaska, Arizona, Colorado, Delaware, Florida, Georgia, Hawaii, Illinois, Iowa, Kentucky, Minnesota, New Hampshire, New Jersey, North Carolina, Oklahoma, Pennsylvania, South Dakota, Virginia, Washington and West Virginia.

New York issued an enforcement discretion letter allowing use of the amended listing. In the remaining states, over-the-counter nicotine replacement therapies continue to be regulated as P075-listed hazardous waste.
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