Is Your Pharmacy Compliant with the EPA’s Hazardous Waste Pharmaceuticals Rule?

As the July 1, 2021 deadline approaches for states to adopt the EPA’s final rule on Hazardous Waste Pharmaceuticals, it’s important to ensure that your pharmacy has policies in place to remain compliant. The “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine” final rule (40 CFR Part 266 Subpart P) went into effect at a federal level in August 2019, but many states did not adopt the ruling at the time. According to the ruling, all states that do not require a statutory amendment have until July 1, 2021 to adopt Subpart P.

Definitions

A Hazardous Waste Pharmaceutical (HWP), as defined by the ruling, is a pharmaceutical that is a solid waste, as defined in CFR 261.2, and exhibits one or more of the following characteristics: ignitability, corrosivity, reactivity, or toxicity. A pharmaceutical, over-the-counter pharmaceutical, dietary supplement, or homeopathic drug is not a hazardous waste pharmaceutical if it is legitimately used/reused or reclaimed or, excluding prescription pharmaceuticals, has a reasonable chance of legitimate reuse or reclamation. The EPA has categorized hazardous pharmaceuticals into three classes: potentially creditable, non-creditable, and evaluated.

A potentially creditable HWP has a reasonable expectation to receive manufacturer credit, is in the original manufacturer’s packaging (recalls excluded) and is unexpired or less than one year past the expiration date.

Non-creditable HWPs consist of any prescription pharmaceutical that does not have a reasonable expectation of receiving manufacturer credit, and several conditions are included that could cause a product to fall into this category.

Evaluated HWPs are potentially creditable HWPs that have been evaluated by a reverse distributor to establish whether it is eligible for manufacturer credit.

A potentially creditable HWP may be returned to a reverse distributor, like Return Solutions; a non-creditable HWP may not be returned to a reverse distributor and must be handled at the healthcare facility as RCRA hazardous waste and sent to a Transportation, Storage, Disposal Facility (TSDF) licensed with EPA for the transportation, storage, and disposal of RCRA hazardous waste facility.

Shipping HWPs

Healthcare facilities and reverse distributors may use carriers, such as USPS, UPS, and FedEx for shipments of potentially creditable hazardous waste pharmaceuticals to and between reverse distributors, as long as personnel are present to receive and take control of the shipments upon arrival. EPA believes that carriers are able to provide safe shipment since these potentially creditable hazardous waste pharmaceuticals present low risk of release during transport. The reverse distributor must provide confirmation of receipt to the healthcare facility. Non-creditable and evaluated HWPs may not be shipped to a reverse distributor, and must be shipped to a licensed Treatment, Storage, and Disposal Facility (TSDF) via a hazardous waste transporter. A healthcare facility shipping non-creditable hazardous waste pharmaceuticals is not required to list all applicable hazardous waste numbers (i.e., hazardous waste codes) in Item 13 of EPA Form 8700-22 (hazardous waste manifest).  Instead, it must write only one waste code – the word “PHARMS” in Item 13.

Accumulation Time Limits

A healthcare facility may store non-creditable HWPs up to one year before shipping to a TSDF facility. Healthcare facilities may use one of three approaches to demonstrate the length of time that these are accumulated on site: mark the container label with the date that accumulation began, maintain an inventory system that identifies when HWPs began to be accumulated, or identify the earliest date of accumulation in a specific are designated for HWPs.

Exemptions

Hazardous waste pharmaceuticals that are also controlled substances, including but not limited to chloral hydrate, fentanyl sublingual spray, phenobarbital, testosterone gels, diazepam injectable are not regulated as RCRA hazardous waste, but are subject to the sewer ban. These items must be destroyed by a method that Drug Enforcement Administration has publicly deemed in writing to meet their non-retrievable standard of destruction, such as incineration. FDA-approved OTC patches, gums, and lozenges are no longer regulated as a hazardous waste. Residues in stock bottles, vials, ampules, syringes, and I.V. bags are considered hazardous waste, however no longer regulated as RCRA hazardous waste under certain conditions and may be disposed of in a normal trash receptacle. This includes warfarin.

Household waste pharmaceuticals collected in take-back programs, including pharmaceuticals collected during “Take-Back” events and pharmaceuticals placed into collection receptacles, kiosks, or cabinets located within the healthcare facility, like Return Solutions’ MedCollect cabinets, are not regulated as RCRA hazardous waste and must be destroyed by a method that Drug Enforcement Administration has publicly deemed in writing to meet their non-retrievable standard of destruction, such as incineration.

Options for VSQG Healthcare Facilities

As an independent pharmacy, you may fall under the Very Small Quantity Generator (VSQG) threshold, and in such case are not subject to this ruling. As a VSQG, you can opt in to Subpart P to streamline your HWP disposal process. A VSQG generates less than or equal to the following per month:

  • 100 kilograms (220 lbs) of non-acute hazardous waste; and
  • 1 kilogram (2.2 lbs) of acute hazardous waste; and
  • 100 kilograms (220 lbs) of any residue or contaminated soil, water, or other debris resulting from the cleanup of a spill, into or on any land or water, of any acute hazardous waste

If you are a VSQG and opt to manage HWPs under Subpart P, you must submit a notification to your state environmental agency or EPA Regional Administrator using the Site ID Form.

Sewer Prohibition

Even if you are a VSQG, the sewer prohibition portion of the rule applies to you. HWPs, including HWPs that are DEA controlled substances, may not be disposed of down the drain or by flushing. This prohibition is currently in effect in all states.

Managing HWPs In Your Pharmacy

If you are required or choose to manage HWPs under Subpart P, it’s important to work with a trusted and experienced reverse distributor, such as Return Solutions. We have published an infographic as well as a more detailed guide to HWPs if you would like more information. In addition to managing your potentially creditable HWPs, Return Solutions can take care of all pharmaceutical returns and non-hazardous waste destruction for your pharmacy.

About Return Solutions

Return Solutions offers the simplest and most efficient expired product returns process in the industry with the OneCheck Select program. Reclaim time spent tracking expired product return credits so you can focus on what matters most: your customers and your business. Return Solutions offers both on-site and mail-in options, and you receive a single check, for all credit due through OneCheck Select, within your choice of 10, 30, 60, or 90 days. Return Solutions also offers simple, cost-effective, and compliant disposal of unused consumer prescription medications starting at under $85 per month with the MedCollect program.

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