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Hazardous Waste Pharmaceuticals Proposed Rule

8th October 2015

On September 25, 2015, the U.S. Environmental Protection Agency (EPA) published a proposed rule titled “Management Standards for Hazardous Waste Pharmaceuticals” in the Federal Register. 80 Fed. Reg. 58,014. Comments on the proposed rule must be received by EPA on or before November 24, 2015.

The proposed rule adds a new subpart P to 40 CFR Part 266 to address hazardous waste pharmaceuticals that are generated or managed by healthcare facilities and pharmaceutical reverse distributors. One of the purposes of the rule is to impose controls on the current practice of sending expired, unused, or un-administered pharmaceuticals that also are hazardous wastes to reverse distributors who then determine what if any credit the healthcare facilities will receive for those pharmaceuticals. Another purpose of the rule is to reduce the amount of pharmaceuticals disposed of through sewer systems.

The proposed rule includes a number of new terms including “hazardous waste pharmaceutical” which is defined as a pharmaceutical that is a solid waste pursuant to 40 CFR 261.2 that either is a listed hazardous waste or a characteristic hazardous waste. Examples of listed hazardous waste pharmaceuticals include arsenic trioxide (P012), smoking cessation products with nicotine as the sole active ingredient (P075), pharmaceuticals with greater than 0.3% warfarin (and salts) as the sole active ingredient (e.g., Coumadin) (P001), streptozotocin (U206), and pharmaceuticals with less than or equal to 0.3% warfarin (and salts) as the sole active ingredient (U248).

“Hazardous waste pharmaceuticals” are then divided into three groups – potentially creditable hazardous waste pharmaceuticals, non-creditable hazardous waste pharmaceuticals, and evaluated hazardous waste pharmaceuticals. A “potentially creditable hazardous waste pharmaceutical” is defined as:

(1) A hazardous waste pharmaceutical that has the potential to receive manufacturer’s credit and is: (i) [u]nused or un-administered; and (ii) [u]nexpired or less than one year past expiration date.
(2) The term does not include “evaluated hazardous waste pharmaceuticals,” residues of pharmaceuticals remaining in containers, contaminated personal protective equipment, and clean-up material from the spills of pharmaceuticals.

A “non-creditable hazardous waste pharmaceutical” is defined as “a hazardous waste pharmaceutical that is not expected to be eligible for manufacturer’s credit.” An “evaluated hazardous waste pharmaceutical” is defined as “a hazardous waste pharmaceutical that was a potentially creditable hazardous waste pharmaceutical but has been evaluated by a pharmaceutical reverse distributor to establish whether it is eligible for manufacturer’s credit and will not be sent to another pharmaceutical reverse distributor for further evaluation or verification.”

The proposed rule only applies to hazardous waste pharmaceuticals generated or managed by two types of entities – healthcare facilities and pharmaceutical reverse distributors. The rule defines a “healthcare facility” as:

(1) Any person that: (i) [p]rovides preventative, diagnostic, therapeutic, rehabilitative, maintenance or palliative care, and counseling, service, assessment or procedure with respect to the physical or mental condition, or functional status, of a human or animal or that affects the structure or function of the human or animal body; or (ii) [s]ells or dispenses over-the-counter or prescription pharmaceuticals.
(2) This definition includes, but is not limited to, hospitals, psychiatric hospitals, ambulatory surgical centers, health clinics, physicians’ offices, optical and dental providers, chiropractors, long-term care facilities, ambulance services, coroners and medical examiners, pharmacies, long-term care pharmacies, mail-order pharmacies, retailers of over-the-counter medications; and veterinary clinics and hospitals.

A “pharmaceutical reverse distributor” is defined as “any person that receives and accumulates potentially creditable hazardous waste pharmaceuticals for the purpose of facilitating or verifying manufacturer’s credit. Any person, including forward distributors and pharmaceutical manufacturers, that processes pharmaceuticals for the facilitation or verification of manufacturer’s credit is considered a pharmaceutical reverse distributor.”
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Posted in Blog by securedmedwaste

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