The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published guidance for companies submitting a Manufacturing Authorisation application or variation on...06 January 2017
EPA Proposed Rule: Management Standards for Hazardous Waste Pharmaceuticals
The Proposed Rule applies to waste “pharmaceuticals” that are: (1) hazardous (i.e., those waste pharmaceuticals that meet the current definition of a hazardous waste under RCRA); and (2) generated by healthcare-related facilities. Importantly, EPA proposes to define “pharmaceutical” to include not only prescription drugs, but also OTCs, dietary supplements, residues of pharmaceuticals remaining in containers, contaminated personal protective equipment, and clean-up material from the spills of pharmaceuticals. The Proposed Rule provides a conditional exemption for hazardous waste pharmaceuticals that are regulated as controlled substances by the Drug Enforcement Agency (“DEA”).
Although the Proposed Rule addresses numerous areas of interest to the regulated industry, the following five key topics are likely to be of broad interest:
- Creditable vs. Non-Creditable. The Proposed Rule sets forth different management standards applicable to potentially creditable and non-creditable hazardous waste pharmaceuticals generated at healthcare facilities. Potentially creditable hazardous waste pharmaceuticals must have the potential to receive manufacturer’s credit, and must be (1) unused or un-administered, and (2) unexpired or less than one year past their expiration date. Under the proposal, these potentially creditable pharmaceuticals would be subject to relaxed on-site management requirements, and could be sent to a pharmaceutical reverse distributor via a common carrier, without the need for a waste manifest. Non-creditable hazardous waste pharmaceuticals would be subject to management requirements similar to current small quantity generator requirements. When shipped off-site, they would need to be transported as hazardous wastes, with an accompanying hazardous waste manifest, and must be transported to and disposed of by a TSDF. However, unlike most other hazardous wastes, non-creditable hazardous waste pharmaceuticals could be accumulated for up to one year.
- Point of Generation. Under the proposed rule, products that are not potentially creditable are considered hazardous wastes at the health care facility. In addition, EPA proposes to abandon its longstanding position that pharmaceuticals sent to a reverse distributor for a credit evaluation are not waste. Instead, under the Proposed Rule, the point of generation is the point at which the healthcare facility decides to send the product to the reverse distributor. These provisions would appear to make it impossible for retailers to donate or liquidate unsold OTCs through reverse distribution because these products must be managed as waste at either the health care facility (for non-creditable products) or the reverse distributor (for creditable products).
- Standards for Reverse Distributors. EPA’s Proposed Rule also sets forth new standards applicable to the accumulation of hazardous waste pharmaceuticals by pharmaceutical reverse distributors. The proposed accumulation standards for pharmaceutical reverse distributors are similar to RCRA’s existing standards for large quantity generators (“LQGs”), with the addition of new inventory and tracking requirements.
- Regulation of Long-Term Care Facilities. Under EPA’s previous RCRA interpretation, long-term care facilities were able to rely upon the household waste exemption to manage waste pharmaceuticals that would otherwise be hazardous wastes. The Proposal would prohibit long-term care facilities from using this exemption for any of the wastes generated in their facility, even those generated by and that remain under the control of patients or residents in the long-term care facility.
- Container Residues. The Proposed Rule contains different management standards for different types of containers: (1) unit-dose containers and dispensing bottles and vials; (2) dispensed syringes; and (3) other containers and delivery devices.
- Ban on Sewer Disposal. EPA is proposing an industry-wide sewer ban in which healthcare facilities and pharmaceutical reverse distributors would be prohibited from disposing of hazardous waste pharmaceuticals down the toilet or drain.
EPA will accept comments on the Proposed Rule through November 24, 2015.
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