CLIENT ADVISORY: Drugs are hazardous to your…drinking water and budget: New EPA standards for wasting and managing pharmaceuticals go into effect this month

Introduction 

Attention hospitals, physician offices and nursing homes: there is a new regulatory requirement for drug disposal, requiring new standards, paperwork, and training for many facilities. The new rule published by the Environmental Protection Agency (EPA), effective on August 21, 2019, updates the regulation of pharmaceuticals as hazardous waste by healthcare facilities and reverse distributors. Many health care facilities that distribute, sell, or dispense pharmaceuticals will need to be ready to implement the new rule.

The EPA has regulated hazardous and pharmaceutical waste through the Resource Conservation and Recovery Act (RCRA) for over forty years.[1] This client advisory will describe the facilities that need to comply with the regulations and summarize some of the updated regulations, including key provisions in bold. The full adopted regulation can be located here.[2]

The Final Rule implements three primary changes in how hazardous waste pharmaceuticals are managed:

  1. Unused or expired pharmaceuticals that are sent to an off-site reverse distributor will be regulated as hazardous waste under the RCRA while still at the health care facility;
  2. To prevent contamination of drinking water and the environment, hazardous waste pharmaceuticals are banned from being disposed of down a drain or in a toilet; and
  3. Containers that held hazardous waste pharmaceuticals can now be considered “empty” more easily and no longer considered hazardous waste.

Facilities Governed by the Regulations

All healthcare facilities and reverse distributors[3] are potentially subject to this final rule. Any healthcare facility that generates more than 100 kg of hazardous waste per calendar month or more than 100 kg of any residue or debris resulting from the cleanup of a spill of any acute hazardous waste per calendar month is subject to the regulations and must manage all hazardous waste pharmaceuticals generated at their facility under the provisions of Part 266 Subpart P.[4] This will include nearly, if not all, hospitals and nursing facilities.

Notably, before the Final Rule, the management of hazardous waste at long-term care facilities were excluded from RCRA requirements and treated the same as hazardous waste at residential households. Because the EPA considers nursing facilities more akin to hospitals, the new rule makes it clear that management of hazardous waste at nursing facilities will now be subject to RCRA requirements. Still excluded from RCRA requirements are group homes, independent living communities, assisted living facilities, and the independent and assisted living portions of continuing care retirement communities. 

All reverse distributors will be subject to Part 266 Subpart P for the management of their hazardous waste pharmaceuticals, including any reverse distributors that were previously considered Very Small Quantity Generators (“VSQGs”) under Part 262.[5] VSQGs maintain their conditional exemption and remain mostly exempt from Part 266 Subpart P.[6] However, they have the ability to opt into Part 266 Subpart P and comply with those provisions in lieu of their conditional exemption in Part 262.[7] All healthcare facilities, including Long Term Care Facilities ("LTCFs") and VSQGs, will be subject to the prohibition on disposing of hazardous waste pharmaceuticals in a drain or toilet.[8]

If a LTCF has no more than 20 beds, the presumption is that it is a VSQG, so it does not have to demonstrate the amount of hazardous waste it generates on a monthly basis.[9] If the EPA Regional Administrator wants the LTCF to operate under Subpart P, they must show that a LTCF with no more than 20 beds produces hazardous waste in amounts exceeding the VSQG limits.[10] Conversely, a LTCF with more than 20 beds must show that it generates hazardous waste below the VSQG limits to be considered a VSQG.[11]

Hazardous Waste Pharmaceuticals Covered by the Regulation

In general, the rule applies to hazardous pharmaceutical waste. To be a hazardous pharmaceutical waste, a substance must be a “pharmaceutical,” must be “solid waste,” and must be listed as hazardous waste under EPA lists or exhibit a characteristic of a hazardous waste.

The definition of “Pharmaceuticals” is broad, including dietary supplements, prescription drugs, over-the-counter drugs, homeopathic drugs, compounded drugs, investigational new drugs, personal protective equipment contaminated with pharmaceuticals, and clean-up material from spills of pharmaceuticals. “Solid waste,” despite the term, means any “discarded” material that is not otherwise excluded by the regulations—including liquids, semi-solid, or gaseous material. Generally, “discarded” material is anything that a facility has decided to discard, and must be managed appropriately at that time. Finally, solid wastes that are pharmaceuticals are considered hazardous waste under RCRA if they include chemicals included on EPA lists or exhibit one of four characteristics of hazardous waste: ignitability, corrosivity, reactivity, and toxicity. Facilities will need to review the regulations and EPA lists closely to determine if they generate hazardous waste pharmaceuticals.

In a significant shift from current regulations, over-the-counter nicotine replacement therapies are no longer considered hazardous waste under the RCRA.

Standards for Facilities that Manage Non-Creditable Pharmaceuticals

The above rules generally apply to potentially creditable hazardous waste pharmaceuticals[12] and non-creditable hazardous waste pharmaceuticals. Healthcare facilities that manage non-creditable hazardous waste pharmaceuticals subject to these regulations will need to submit Site ID Form (EPA Form 8700-12) to the EPA that the facility will operate under this regulation.[13] Healthcare facilities that produce non-creditable pharmaceutical solid wastes can either determine whether each item is a listed or characteristic hazardous waste subject to Subpart P or treat all non-creditable pharmaceuticals as non-creditable hazardous waste pharmaceuticals.[14] The healthcare facility must comply with the land disposal restrictions when it generates non-creditable hazardous waste pharmaceuticals.[15] A healthcare facility may accumulate hazardous waste pharmaceuticals at a 90-day or 180-day central accumulation area if the facility has one but they do not have to comply with central or satellite accumulation area regulations.[16] RCRA regulations will not apply to pharmaceuticals managed under a federally mandated or voluntary recall until they are going to be partially or fully destroyed, nor will they be applied to pharmaceuticals being kept as a result of an investigation or judicial proceeding or order.[17] Healthcare facilities may accumulate hazardous waste pharmaceuticals on site for one year while reverse distributors can do so for 180 days.[18]

Spilled non-creditable hazardous waste pharmaceuticals and the materials used to clean up these spills are required to be managed and contained as non-creditable hazardous waste pharmaceuticals.[19] Non-creditable hazardous waste pharmaceuticals must be stored in structurally sound containers that prevent leaks or spills due to reasonably foreseeable conditions that are compatible with the waste they store. When accumulating on site, they must be labeled with “Hazardous Waste Pharmaceuticals.”[20] If incompatible hazardous waste pharmaceuticals are placed in the same container, the container cannot have the potential to endanger human health and the environment.[21] If a facility closes or shuts down hazardous waste pharmaceutical operations, the reverse distributor must remove containers of both evaluated and potentially creditable hazardous waste pharmaceuticals from the facility.[22]

A reverse distributor requires a RCRA permit or interim status if it does not meet the permitting exemption set out in §266.510 “if it disposes of or treats hazardous waste on site or if it accepts manifested hazardous waste from off-site.”[23] Reverse distributors must keep an inventory of on-site potentially creditable and evaluated hazardous waste pharmaceuticals and must evaluate and inventory each potentially creditable hazardous waste pharmaceutical within 30 days of receipt.[24] The inventory must be updated and available for inspection and kept for as long as the facility is subject to Subpart P.[25] If the facility meets these inventory requirements because of other regulatory requirements, they do not need to provide a separate inventory to satisfy this subpart.[26] The 180-calendar day period the hazardous waste pharmaceuticals can accumulate on-site at a reverse distributor begins after evaluation.[27] There must be an inspection of the on-site accumulation area every seven days, which must be recorded.[28]

Prescription pharmaceuticals going through reverse distribution will be considered solid waste at the healthcare facility.[29] Conversely, nonprescription pharmaceuticals and other unsold retail items for which there is a reasonable expectation of legitimate use, reuse or, reclamation will not be considered solid waste.[30] The household hazardous waste exemption is preserved and pharmaceuticals collected in take-back programs will be exempted as long as they are not disposed in a drain or toilet and are destroyed by an accepted method of destruction.[31]

A healthcare facility must train employees so they are familiar with proper handling and emergency procedures that pertain to their responsibilities during day-to-day operations and emergencies.[32] Reverse distributors must train those that handle evaluated waste pharmaceuticals and these trainings must meet the same federal classroom and on the job training requirements that Large Quantity Generators must meet.[33]

Management of Residues in Pharmaceutical Containers

New § 266.507 replaces the old guidance on how residues of hazardous waste in pharmaceutical containers, and the pharmaceutical containers, are to be disposed of.[34] A container previously holding hazardous waste pharmaceuticals will be considered empty and will not be regulated as hazardous waste if the pharmaceuticals have been removed from the container using common practices of removal.[35] To avoid regulation as hazardous waste, the container previously holding the hazardous waste pharmaceuticals must meet the specific emptying requirements for that container in the new regulations.[36] For example, a syringe is considered empty if the plunger is fully depressed and the contents were administered to a patient, injected into a different delivery device, or emptied into a hazardous waste collection container.[37]  If the container does not meet these qualifications, then the container and the pharmaceutical must be placed in a container that is managed and disposed of as a non-creditable hazardous pharmaceutical waste. [38]

Shipping Standards

All shipments of non-creditable hazardous waste pharmaceuticals must comply with applicable DOT pre-transportation conditions for packaging, labeling, marking, and manifests.[39] Additionally, although hazardous waste codes are not required on the manifest, the PHARMS code is required in Item 13 for shipments to Treatment, Storage, and Disposal Facilities (“TSDFs”).[40] Healthcare facilities can accept non-creditable hazardous waste pharmaceuticals from an off-site VSQG without a permit or without having an interim status only if: the facilities are under the control of the same person “or has a contractual or other documented business relationship between the facilities where the receiving healthcare facility supplies pharmaceuticals to the VSQG healthcare facility.”[41] A healthcare facility or reverse distributor cannot import hazardous waste pharmaceuticals without a RCRA permit or interim status allowing it to accept off-site hazardous waste and without complying with the requirements in Part 262 Subpart H.[42] Similarly, a healthcare facility cannot export hazardous waste pharmaceuticals unless they comply with the export requirements of the same subpart.[43]

Potentially creditable hazardous waste pharmaceuticals can only be transferred three times before being transported to TSDFs. The three possible transfer types are: “(1) A healthcare facility may send potentially creditable hazardous waste pharmaceuticals to a reverse distributor . . . ; (2) the first reverse distributor may send the potentially creditable hazardous waste pharmaceuticals to another reverse distributor. . . ; and (3) the second reverse distributor can only send the potentially creditable hazardous waste pharmaceuticals on to a reverse distributor that is a manufacturer.”[44] If a reverse distributor receives a shipment of unauthorized waste, the facility must accept the shipment and manage it in compliance with all applicable regulations.[45] The facility must submit an unauthorized waste report to the EPA Regional Administrator, and facility that sent the waste, within 45 days.[46]

Conclusion

The new EPA rule makes numerous changes to the standards for management of hazardous waste pharmaceuticals. The final rule is extensive so the changes outlined in this Client Advisory should not be considered exhaustive and, if you need advice concerning these new management standards, you may contact our firm to get the best possible fact-specific advice. Should you have any questions concerning the updated regulations, please contact Peter Mellette, Nathan Mortier, Harrison Gibbs, Elizabeth Dahl, or Scott Daisley at Mellette PC.

This client advisory is for general educational purposes only. It is not intended to provide legal advice specific to any situation you may have. Individuals desiring legal advice should consult legal counsel for up-to-date and fact-specific advice.

[1] EPA History: Resource Conservation and Recovery Act, EPA, https://www.epa.gov/history/epa-history-resource-conservation-and-recovery-act.

[2] https://www.govinfo.gov/content/pkg/FR-2019-02-22/pdf/2019-01298.pdf.

[3] Reverse distributor means any person that receives and accumulates prescription pharmaceuticals that are potentially creditable hazardous waste pharmaceuticals for the purpose of facilitating or verifying manufacturer credit. Id. at 5941.

[4] See 84 Fed. Reg. 5855, 5941 (Feb. 22, 2019).

[5] 84 Fed. Reg. 5857 (Feb. 22, 2019).

[6] Id. at 5858.

[7] Id.

[8] Id. For purposes of RCRA, LTCF means a licensed entity that provides assistance with activities of daily living, including managing and administering pharmaceuticals to one or more individuals at the facility. This definition includes, but is not limited to, hospice facilities, nursing facilities, skilled nursing facilities, and the nursing and skilled nursing care portions of continuing care retirement communities. Id. at 5941.

[9] Id. at 5891.

[10] Id.

[11] Id.

[12] Potentially creditable hazardous waste pharmaceutical means a prescription hazardous waste pharmaceutical that has a  reasonable expectation to receive manufacturer credit and is—

(1) In original manufacturer packaging (except pharmaceuticals that were subject to a recall);

(2) Undispensed; and

(3) Unexpired or less than one year past expiration date.

Note that this does not include nonprescription pharmaceuticals including, but not limited to, over-the-counter drugs, homeopathic drugs, and dietary supplements. Id. at 5941.

[13] Id. at 5868.

[14] Id. at 5871.

[15] Id. at 5943.

[16] Id. at 5872.

[17] Id. at 5861, 5862.

[18] See id. at 5876 and 5921.

[19] Id. at 5881.

[20] Id. at 5873, 5857.

[21] Id. at 5873.

[22] Id. at 5924.

[23] Id. at 5932.

[24] Id. at 5925.

[25] Id.

[26] Id. at 5947.

[27] Id. at 5927.

[28] Id. at 5928.

[29] Id. at 5933.

[30] Id.

[31] Id. at 5945.

[32] Id. at 5869.

[33] Id. at 5928.

[34] Id. at 5905.

[35] Id.

[36] Id. at 5903-5908.

[37] Id. at 5906.

[38] See, e.g., Id. at 5908.

[39] Id. at 5909.

[40] Id.

[41] Id. at 5886.

[42] Id. at 5915.

[43] Id.

[44] Id. at 5926.

[45] Id. at 5924.

[46] Id.

Categories: Client Advisory