October 15, 2015

Summary of Pharmaceutical Waste Management Proposal

On September 25, 2015, EPA proposed standards for hazardous waste pharmaceuticals generated and managed in the healthcare industry. [80 FR 58014] If finalized, the management standards will be codified in a new Subpart P to Part 266. The proposed rule would regulate two different entities: 1) healthcare facilities, and 2) reverse distributors, as discussed below.

Healthcare facilities

Healthcare facilities would include hospitals, surgical centers, health clinics, physicians’ offices, optical and dental providers, chiropractors, long-term care facilities, ambulance services, coroners, medical examiners, and pharmacies. Such facilities would be subject to two different sets of standards when managing hazardous waste pharmaceuticals, based on whether they are “potentially creditable” or not. Potentially creditable hazardous waste pharmaceuticals would be pharmaceuticals that 1) have the potential to receive manufacturer’s credit, 2) are unused or un-administered, and 3) are unexpired or are less than one year past expiration date.

Potentially creditable hazardous waste pharmaceuticals

The proposed rule would allow healthcare facilities to continue sending potentially creditable hazardous waste pharmaceuticals to reverse distributors, provided they meet a few requirements. These requirements would primarily include standards to ensure their proper delivery, although no manifest would be required. The agency believes that creditable pharmaceuticals are less likely to be released to the environmental and so has decided not to impose specific management standards during their accumulation (e.g., no accumulation time limits, no container labeling, etc.).

Non-creditable hazardous waste pharmaceuticals

There would be a long list of requirements applicable to the management of non-creditable hazardous waste pharmaceuticals, similar to the standards for traditional hazardous wastes managed at a small quantity generator:

• Notification as a healthcare facility would be required using EPA’s site identification form (EPA Form 8700-12);
• A hazardous waste determination would be required, but no waste codes would have to be identified;
• A one-year onsite accumulation time limit would apply;
• Containers would be subject to RCRA-like standards (e.g., they must be structurally sound, compatible with their contents, closed, labeled with the words “Hazardous Waste Pharmaceuticals,” etc.);
• The facility would have to train its employees to a level similar to small quantity generators;
• The land disposal restrictions would apply; and
• A hazardous waste manifest would be required to ship the wastes.

Reverse distributors

Reverse distribution facilities that receive and manage potentially creditable hazardous waste pharmaceuticals would have their own set of requirements under Part 266, Subpart P. They would be similar to those applicable to traditional hazardous wastes managed at a large quantity generator:

• Notification as a reverse distributor would be required using EPA’s site identification form (EPA Form 8700-12).
• A current inventory of all onsite hazardous waste pharmaceuticals would be required, including pharmaceutical name and quantity.
• A 90-day onsite accumulation time limit would apply (including the 21-day evaluation period noted below).
• A contingency plan per Part 265, Subpart D would be required.
• Reporting and recordkeeping would be required, including unauthorized waste reporting.
• An evaluation of potentially creditable pharmaceuticals would be required within 21 days of arrival at a reverse distributor. The evaluation would determine whether the pharmaceuticals are destined for 1) further evaluation or verification of manufacturer’s credit, or 2) an offsite TSD facility. The following requirements would apply to the management of hazardous waste pharmaceuticals destined for an offsite TSD facility:
• Containers would be accumulated in a designated area and would be subject to RCRA-like standards (e.g., they must be in good condition, compatible with their contents, closed, inspected weekly, labeled with the words “Hazardous Waste Pharmaceuticals,” etc.).
• The facility would have to train its employees to large quantity generator standards in §265.16.
• The land disposal restrictions would apply.
• Containers would have to be labeled with applicable hazardous waste codes prior to offsite shipment, and a hazardous waste manifest would be required to ship the wastes.

Other key requirements

The following additional requirements are part of the September 2015 pharmaceutical proposal:

• Sewer ban—EPA is proposing a ban on the sewering of all hazardous waste pharmaceuticals, including those managed at conditionally exempt small quantity generators (CESQGs). The sewer ban is the only part of the proposed rule that would be promulgated under HSWA authority and, therefore, would be effective in all 50 states on the effective date of any final rule.
• Controlled substances—The agency is proposing to conditionally exempt hazardous waste pharmaceuticals that are controlled substances from all RCRA regs if they are being 1) managed in compliance with all applicable DEA regulations, and 2) combusted in a municipal or hazardous waste combustor.
• Empty containers—The agency is proposing to exempt pharmaceutical unit-dose and dispensing containers from hazardous waste management if they 1) have a capacity of no more than 1 liter or 1,000 pills, and 2) have been completely dispensed. This exemption would apply to P-listed drugs in addition to their nonacute counterparts. Dispensing syringes and any remaining residues would not be regulated as hazardous waste if the syringes 1) have been used to administer the pharmaceutical to a patient, and 2) are placed in a sharps container and managed under state and federal medical waste regulations.
• Nicotine wastes—EPA is looking at two options for amending the P075 listing for “Nicotine & salts” in §261.33(e). The first option would be to exempt all nicotine-containing smoking cessation products (e.g., nicotine patches, gums, and lozenges), but not e-cigarettes, from the listing. The second option would be to exempt all products containing less than or equal to 3% nicotine from the P075 listing, similar to the P-listings for warfarin and zinc phosphide.

EPA has provided a summary of the proposed rule and answers to frequent questions. Comments on the proposal must be received by November 24, 2015.

 

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