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Pharmacy Returns Solutions & Resources Q&A | U.S. Environmental Protection Agency


Q. What is the Hazardous Waste Pharmaceutical Final Rule and what does it do?

On February 22, 2019, EPA finalized the new Resource Conservation and Recovery Act (RCRA) regulations for managing hazardous waste pharmaceuticals. The final rule consists of three primary components:

1.) Amends the hazardous waste listing for nicotine (Waste Code P075) such that FDA-approved over-the-counter nicotine patches, gums, and lozenges will no longer be considered hazardous waste when discarded.

2.) Creates new Subpart P in 40 CFR Part 266 (“Subpart P”), which contains new regulations that have been tailored specifically to the healthcare sector (including pharmacies and retail stores that sell pharmaceuticals) to improve the management of hazardous waste pharmaceuticals and thereby enhance protection of human health and the environment. Subpart P addresses the regulatory status of prescription pharmaceuticals going through reverse distribution and non- prescription pharmaceuticals going through reverse logistics.

3.) Establishes EPA’s Reverse Logistics Policy, which addresses the regulatory status under RCRA of all other unsold retail items going through reverse logistics.

This final rule provides solutions to many of the hazardous waste management issues facing healthcare facilities, including retail stores that sell pharmaceuticals. Healthcare workers and retail pharmacy employees are often unfamiliar with RCRA hazardous waste management requirements, leading to inadvertent mismanagement of hazardous waste pharmaceuticals as municipal waste or medical waste. Subpart P streamlines the hazardous waste regulations for these wastes, reduces the compliance burden on healthcare personnel and healthcare facilities, and ensures that more hazardous waste pharmaceuticals are managed properly. Subpart P provides a practical system for the management of hazardous waste pharmaceuticals that is easier to comply with than the industry-oriented hazardous waste generator regulations. Accordingly, EPA encourages healthcare facilities to manage their non-hazardous pharmaceutical waste under the final rule, along with their hazardous waste pharmaceuticals, which will keep more pharmaceuticals out of municipal waste landfills and sewers.


Q. Who is affected by Subpart P of this final rule?

Healthcare facilities (including retail pharmacies) and reverse distributors will follow these new, tailored standards for managing their hazardous waste pharmaceuticals.

Subpart P does not apply to pharmaceutical manufacturers (unless they act as reverse distributors), production facilities, or other generators of hazardous waste pharmaceuticals (e.g., farms or ranches). Those facilities remain subject to all other applicable hazardous waste regulations.

In addition, the amendment to the P075 hazardous waste listing for nicotine applies to anyone (i.e., not just healthcare facilities or reverse distributors) who generates or manages discarded FDAapproved over-the-counter nicotine replacement therapies (i.e., patches, gums, and lozenges).

Finally, the sewering prohibition in Subpart P is effective on August 21, 2019. This is the one provision in Subpart P that applies to ALL healthcare facilities and reverse distributors, including healthcare facilities that are classified as Very Small Quantity Generators (VSQGs). VSQG healthcare facilities are not required to comply with the other provisions of Subpart P.


Q. How will discarded over-the-counter nicotine replacement therapies be regulated?

This final rule exempts FDA-approved over-the-counter nicotine replacement therapies (i.e., nicotine patches, gums, and lozenges) from the RCRA Hazardous Waste Code P075 for nicotine. Thus, under the federal hazardous waste regulations, generators (e.g., retail stores, hospitals) may discard these wastes as nonhazardous. EPA recommends, however, that facilities take steps to prevent unauthorized access to the waste containers, dumpsters, etc., to prevent illicit diversion (i.e., dumpster diving). Nicotine continues to be a listed acute hazardous waste with the waste code P075, so any nicotine waste, other than nicotine patches, gums, and lozenges, is still regulated as P075 acute hazardous waste (e.g., liquid nicotine in electronic cigarettes, nicotine pesticides).


Q. What benefits does EPA expect from the new management standards for hazardous waste pharmaceuticals in Subpart P?

Subpart P protects human health and the environment by improving compliance at healthcare facilities (including hospitals, clinics, and retail stores with pharmacies) and reverse distributors that generate and manage hazardous waste pharmaceuticals. Specifically, the rule decreases the risk of illicit diversion of unused prescription hazardous waste pharmaceuticals by requiring basic tracking of these pharmaceuticals from healthcare facilities to reverse distributors.

Subpart P will reduce the negative impacts caused by hazardous waste pharmaceuticals that enter the environment through flushing down the sink or toilet, and is projected to prevent the flushing of 1,600 to 2,300 tons of hazardous waste pharmaceuticals annually.


Q. What is the definition of healthcare facility under Subpart P of the final rule?

In Subpart P of the final rule, a healthcare facility is defined as any person who is lawfully authorized to:

(1) provide 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

(2) distribute, sell, or dispense pharmaceuticals, including overthe-counter pharmaceuticals, dietary supplements, homeopathic drugs, or prescription pharmaceuticals. This definition includes, but is not limited to, wholesale distributors, third-party logistics providers that serve as forward distributors, military medical logistics facilities, hospitals, psychiatric hospitals, ambulatory surgical centers, health clinics, physicians’ offices, optical and dental providers, chiropractors, long-term care facilities, ambulance services, pharmacies (including long-term care and mail-order), retailers of pharmaceuticals, veterinary clinics, and veterinary hospitals.

This definition does not include pharmaceutical manufacturers, reverse distributors, or reverse logistics centers.


Q. What is the definition of pharmaceutical under Subpart P of the final rule?

In Subpart P of the final rule, pharmaceutical is defined as: any drug or dietary supplement for use by humans or other animals; any electronic nicotine delivery system (e.g., electronic cigarette or vaping pen); or any liquid nicotine (e-liquid) packaged for retail sale for use in electronic nicotine delivery systems (e.g., pre-filled cartridges or vials).

This definition includes, but is not limited to, dietary supplements, as defined by the Federal Food, Drug and Cosmetic Act; prescription drugs, as defined by 21 CFR 203.3(y); over-the-counter drugs; homeopathic drugs; compounded drugs; investigational new drugs; pharmaceuticals remaining in non- empty containers; personal protective equipment contaminated with pharmaceuticals; and clean-up material from spills of pharmaceuticals.

This definition does not include dental amalgam or discarded needles (“sharps”).


Q. Which pharmaceuticals are considered hazardous waste?

A solid waste is considered hazardous waste if it meets a hazardous waste listing or exhibits a hazardous waste characteristic described in title 40 of the Code of Federal Regulations Part 261. It is the generator’s responsibility to determine whether the waste that they generate is hazardous under RCRA.

There are approximately 30 commercial chemical products listed on the P and U hazardous waste lists (see 40 CFR §261.33) that have pharmaceutical uses; however, this number does not completely represent the total number of brand name pharmaceuticals that may actually be listed hazardous wastes when discarded.

Waste pharmaceuticals may also be hazardous because they exhibit one or more of the four characteristics of hazardous waste: ignitability, corrosivity, reactivity, and toxicity.


Q. What is the difference between Reverse Distribution and Reverse Logistics?

Subpart P adopts the terminology commonly used in the industry. “Reverse distribution” is used to refer to the reverse flow of prescription pharmaceuticals. Unused prescription pharmaceuticals are sent to reverse distributors to determine if they are eligible to receive manufacturer credit. Because they are not redistributed by the reverse distributor for reuse, the prescription pharmaceuticals are considered waste at the healthcare facility before they are sent to a reverse distributor. That said, these wastes have value in the form of potential manufacturer credit, which has allowed EPA to take a more tailored and flexible regulatory approach for this particular type of hazardous waste pharmaceuticals.

“Reverse logistics” is used to refer to the reverse flow of nonprescription pharmaceuticals and other unsold retail items. Reverse logistics centers evaluate whether items can be sold on the secondary market, donated or recycled. If non-prescription pharmaceuticals and other unsold retail items have a reasonable expectation of being legitimately used/reused (e.g., sold or donated) or reclaimed, then they can be sent to a reverse logistics center without being considered waste at the healthcare facility. On the other hand, if the non-prescription pharmaceutical or other unsold retail item does not have a reasonable expectation of being legitimately used/reused or reclaimed (e.g., it is broken or leaking), then it is considered a waste at the healthcare facility and may not be sent to a reverse logistics center. If the waste is a hazardous waste pharmaceutical, then the healthcare facility must manage the non-prescription hazardous waste pharmaceutical under the new Subpart P regulations for pharmaceuticals. Other unsold retail items that are considered hazardous waste (i.e., non-pharmaceutical hazardous waste) at the healthcare facility must be managed under the existing applicable hazardous waste regulations.


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Returns & Waste Services (Pharmaceutical/Medical)