On February 22, EPA published new rules for management of hazardous waste pharmaceuticals that will affect healthcare facilities, including hospitals, clinics, dentist offices, nursing care facilities, veterinary clinics, outpatient care centers, pharmacies and drug stores, even supermarkets, that generate, accumulate, or otherwise handle prescription pharmaceuticals. The rule becomes effective six months from the publication date, or on August 21, 2019.
Some pharmaceuticals are regulated as hazardous waste under the Resource Conservation and Recovery Act (RCRA) when discarded. The new rule creates a regulatory program – part 266 subpart P in Chapter 40 of the Code of Federal Regulations – for the management of hazardous waste pharmaceuticals by healthcare facilities (including veterinary) and reverse distributors (e.g., of unused or expired drugs).
Healthcare facilities and reverse distributors will manage their hazardous waste pharmaceuticals under this new set of sector-specific standards rather than the regulations that apply to hazardous waste generators, generally. Manufacturers of pharmaceuticals, however, cannot use these alternative standards, except for their reverse distribution activities.
As you may have guessed from the headline, the new rules prohibit the disposal of hazardous waste pharmaceuticals down the drain(!). This ban on flushing drugs down the drain applies to all regulated facilities, even “very small quantity generators” of hazardous waste.
The rule definition of a “pharmaceutical” includes, but is not limited to, dietary supplements; prescription drugs; over-the-counter drugs; homeopathic drugs; pharmaceuticals remaining in non-empty containers; personal protective equipment contaminated with pharmaceuticals; and clean-up material from spills of pharmaceuticals. The definition specifically excludes dental amalgam and sharps.
The rule redefines how a container for hazardous waste pharmaceuticals is considered “RCRA empty,” addressing bottles, vials, ampules and unit-dose containers (e.g., packet, cup, blister-pack, delivery device), as well as syringes, IV bags and other container types.
The new rule contains provisions for notification by facilities subject to the rule, personnel training, hazardous waste determination, requirements for accumulation time, containers and labeling, compliance with land disposal restrictions, shipment manifesting and recordkeeping.
It eliminates the dual regulation of RCRA hazardous waste pharmaceuticals that are also Drug Enforcement Administration (DEA) controlled substances by finalizing a conditional exemption. The new subpart maintains the household hazardous waste exemption for pharmaceuticals collected during pharmaceutical take-back programs and events, while ensuring their proper disposal. The rulemaking also codifies EPA’s prior policy on the regulatory status of nonprescription pharmaceuticals going through reverse logistics.
Note that the final rule does not add pharmaceuticals to the hazardous waste listings or expand the hazardous waste characteristics to include additional pharmaceuticals.
EPA is also taking two actions aside from adding part 266 subpart P.
- First, EPA is finalizing an amendment to the P075 acute hazardous waste listing of nicotine and salts to exclude certain U.S. Food and Drug Administration (FDA) approved over-the-counter nicotine replacement therapies.
- Second, in the preamble to this final rule, EPA establishes a policy on the regulatory status of unsold retail items that are not pharmaceuticals and are managed via reverse logistics.
As noted, the new rules take effect on August 21, 2019. The ban on sending these wastes to sewer applies in all states at that time. States authorized to administer the federal hazardous waste regulations must amend their programs to adopt the more stringent parts of the rule – which as determined by EPA includes all of subpart P – and have additional time to do so. Notably, Florida has added pharmaceuticals to its Universal Waste program; since the state program is less stringent than these new rules, Florida will have to remove hazardous waste pharmaceuticals from its universal wastes listing and regulate them in accordance with the new rules.
Please contact us for assistance with any hazardous waste management issues or challenges!