Earlier this year the EPA published a final rule to standardize how healthcare facilities and reverse distributors handle hazardous waste pharmaceuticals. The new “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine” rule will be listed in 40 CFR Part 266. The regulation provides streamlined processes for safe management of pharmaceutical waste, including prohibiting draining pharmaceuticals as a disposal method, as well as uniformity on how Resource Conservation and Recovery Act (RCRA) applies to the healthcare sector. The rule also reduces overlapping regulations (e.g., DEA, FDA, etc.).
The provisions apply to healthcare facilities, including hospitals, clinics, pharmacies, long-term care facilities, as well as reverse distributors that handle pharmaceuticals considered hazardous waste.
A Little Background
Hazardous waste pharmaceuticals are currently regulated under RCRA (40 CFR Part 262) with accumulation, manifesting, and disposal limits. Historically, these requirements have been complex and difficult for healthcare workers to follow. The new rule will aim to provide increased flexibility for some requirements to facilitate compliance.
In addition, the current regulation allows sewer disposal of pharmaceuticals, including hazardous waste, under RCRA. In September 2015, the EPA issued a proposed rule to regulate waste disposal and minimize environment and human health impacts. The final rule promulgates the 2015 proposed rule with some modifications.
What You Should Know
EPA will implement RCRA Part 266, Subpart P in replacement of Part 262 to provide flexibility for certain requirements. For potentially creditable hazardous waste pharmaceuticals (i.e., unsold/unused pharmaceuticals that can likely be returned to the manufacturer), there will be no accumulation limits, container standards, or labeling requirements. Non-creditable hazardous waste pharmaceuticals will have a one-year accumulation limit, minimum container standard, and labeling requirements.
Other key changes include:
- A ban on sewer disposal of hazardous waste pharmaceuticals
- Removing U.S. Food and Drug Administration (FDA)-approved over the counter nicotine replacement therapies (e.g., nicotine patches, gums, lozenges) from P075 listing
- A conditional exemption for Drug Enforcement Administration (DEA)-controlled substances
- New requirements for notification, personnel training, reporting, and recordkeeping
This final rule becomes effective in Iowa, Alaska, Indian Country, and US territories (except Guam) on August 21, 2019. Other states have until July 1, 2021 or 2022 (depending on the State Constitution) to adopt the rule. However, the ban of sewer disposal will be applicable nationwide on August 21, 2019.
If you have questions about which steps you should take next to comply with the new rule, please contact our experts.
Rajib Sinha, P.E.
Regional Initiatives Manager