EPA Proposed Rule for Pharmaceutical Hazardous Waste Management

Pharmaceutical Pills















On September 25, 2015, the Environmental Protection Agency (EPA) published a proposed rule (80 FR 58013-58092) to revise the regulations for the management and disposal of hazardous waste pharmaceuticals and tailor them to address the specific compliance issues at hospitals, pharmacies, and healthcare related facilities face.
 

Significant Proposed Revisions

EPA is proposing to add a new subpart titled “Standards for the Management of Specific Hazardous Wastes and Specific Types of Hazardous Waste Management Facilities” under 40 CFR 266, Subpart P.  40 CFR 266, Subpart P is tailored for the management of hazardous waste pharmaceuticals at healthcare facilities and pharmaceutical reverse distributors.

If finalized, the regulations in 40 CFR 266, Subpart P will be MANDATORY requirements for the management of hazardous waste pharmaceuticals at healthcare facilities and pharmaceutical reverse distributors regardless of their RCRA generator category (e.g., small quantity generators and large quantity generators will be required to manage their hazardous waste pharmaceuticals in compliance with the regulations in 40 CFR 266, Subpart P.)
 
Hazardous waste pharmaceuticals would include, but would not be limited to: dietary supplements, prescription drugs, over-the-counter drugs, residues in containers, personal protective equipment contaminated with pharmaceuticals, and clean-up material from spills of pharmaceuticals
 
If this final rule is finalized as proposed facilities that generate hazardous waste pharmaceuticals and non-pharmaceutical hazardous would be required to manage their wastes under two different regulations.  The hazardous waste pharmaceuticals would be regulated under 40 CFR 266, subpart P and the non-pharmaceutical wastes would be regulated under the CESQG, SQG, or LQG regulations depending on the facilities generator status for non-pharmaceutical wastes.
 
Hazardous waste pharmaceuticals would NOT count towards a generators status (e.g., CESQG, SQG, LQG).
 
The disposal of hazardous waste pharmaceuticals down a toilet or drain will be PROHIBITED at Healthcare Facilities.
 
A Healthcare Facility would be allowed receive hazardous waste pharmaceuticals from an off-site CESQG healthcare facility without the use of a hazardous waste manifest of having a permit as long as the receiving healthcare facility supplies pharmaceuticals to the CESQG healthcare facility and certain conditions are met.
 
The proposed rule would create two categories of pharmaceutical hazardous wastes: (A) potentially creditable hazardous waste pharmaceuticals and (B) non-creditable hazardous waste pharmaceuticals. 
 

Potentially Creditable Hazardous Waste Pharmaceuticals

A potentially creditable hazardous waste pharmaceutical must have the potential to receive manufacturer’s credit, be unused, and be unexpired or less than one year past the expiration date.  The potentially creditable hazardous waste pharmaceuticals must be shipped to a pharmaceutical reverse distributor.  The hazardous waste pharmaceuticals would be considered a solid waste but there would be no accumulation time limits, container requirements, or labeling requirements.  A hazardous waste manifest would not be required for shipment but advance notification and delivery confirmation would be required.  In addition, a common carrier (e.g., USPS, UPS, FedEX, etc.) could be used for shipment.
 

Non-Creditable Hazardous Waste Pharmaceuticals

There are no satellite accumulation or storage are requirements other than the containers must be in good condition and compatible with the wastes placed in the container and the container must be marked with the words “Hazardous Waste Pharmaceutical.”  Hazardous waste pharmaceuticals may be stored on-site for up to one year.  A hazardous waste manifest must be used for shipment, but no waste codes are required and the words “hazardous waste pharmaceuticals” MUST be entered into the “Special Handling and Additional Information” section of the manifest (Box #14). 
 
Household hazardous waste pharmaceuticals collected at household hazardous waste collection events would be exempt from the proposed 40 CFR 266, Subpart P regulations, but would be required to be disposed/destroyed at a permitted or interim status hazardous waste incinerator, or a small or large municipal waste combustor.
 
Hazardous waste pharmaceuticals that are also DEA Controlled Substances would be conditionally exempt from the hazardous waste regulations as long as the DEA Controlled Substances shipping requirements and the wastes are combusted at a permitted or interim status hazardous waste incinerator or a municipal solid waste combustor.
 

Comments Due

Comments on this proposed rule must be submitted to EPA on or before December 24, 2015.
 
In addition to comments on the proposed revisions to the management standards for hazardous waste pharmaceuticals, EPA is seeking comment on the regulation of additional pharmaceuticals as hazardous wastes including creating a single hazardous waste listing for all discarded pharmaceuticals that are hazardous wastes. 
 
EPA is also seeking comment on potentially excluding FDA-approved over-the-counter nicotine-containing smoking cessation products from the P075 listing.  EPA is NOT proposing to exclude e-cigarettes from the P075 listing.
 

Link

The link below will allow you to view/print this proposed rule.
 
http://www.gpo.gov/fdsys/pkg/FR-2015-09-25/pdf/2015-23167.pdf