More than five years after being initially proposed, the Environmental Protection Agency’s (EPA’s) rule entitled “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine” was published in the Federal Register on February 22, 2019 1 and became effective August 21, 2019. It is codified in the federal regulations under 40 CFR 266, Subpart P (Subpart P).
Subpart P comprises standards for the management of hazardous waste pharmaceuticals (HWP) generated at healthcare facilities as well as reverse distributors engaged in managing nonprescription pharmaceutical product returns. HWP was already regulated under EPA’s hazardous waste management regulations; but Subpart P was particularly designed by EPA to simplify the management and disposal of HWP and to decrease the compliance burden for healthcare facilities.
Although Subpart P is meant to simplify compliance procedures, like other federal regulations it is complicated and difficult to navigate. The following is a brief summary of Subpart P and some of its most important requirements. It is not intended to cover each and every requirement in detail but to inform and encourage healthcare facilities to dig deeper into its requirements and to initiate compliance activities as may be necessary.
Effective Dates and Compliance Deadlines
Although Subpart P became effective on August 21, 2019, the ban on HWP sewer disposal was the only part that came into effect in all states. A few states were given until July 1, 2021 to adopt it, while most other states were granted until July 1, 2022 to do so. However, a number of states have already initiated measures to adopt the rule well in advance of EPA’s deadlines, thereby making it important for healthcare facilities to monitor regulatory adoption plans in their respective states.
Applicability
Subpart P applies to healthcare facilities that manage HWP as well as reverse distributors that help healthcare facilities receive credit from unused, no-longer-needed prescription pharmaceuticals. Pharmaceuticals are defined as “any drug or dietary supplement for use by humans or other animals,” and include prescription drugs, over-the-counter (OTC) drugs, investigational other drugs, and other listed items. It exempts FDA-approved OTC nicotine replacement therapies – such as patches, gums and lozenges.
Purpose of Subpart P
Prior to Subpart P, all facilities generating HWP were subject to the hazardous waste management standards in the Resource Conservation Recovery Act (RCRA). However, compliance with RCRA standards was exceptionally difficult for most healthcare facilities, because thousands of pharmaceutical products are typically on site at any time and facility staff – such as nurses, physicians, pharmacy workers, etc. – rarely had the expertise or time to make necessary hazardous waste determinations and implement mandatory compliance procedures.
Waste is defined as hazardous under RCRA if included on a listing of hazardous waste types or if it exhibits specific characteristics. RCRA compliance requirements vary according to monthly hazardous waste generation rates with the most difficult being for Large Quantity Generators (LQGs) or facilities that generate 1,000 kg/month or more of hazardous waste or only one kg (2.2 lb)/month or more of “acute” hazardous waste. There are about 30 acutely listed products – identified as P-listed U-listed waste – having pharmaceutical uses at most healthcare facilities. The disposal of unusable quantities of such products are often much greater than one kg/month, thereby making many healthcare facilities subject to the onerous requirements for LQGs. Subpart P eliminated the requirement to count acutely hazardous pharmaceutical wastes in monthly generation quantities such that most healthcare facilities are no longer categorized as LQGs, becoming subject to much less stringent compliance standards.
Subpart P Categories
Subpart P classifies HWP into two categories with differing requirements for each – namely “Potentially Creditable Hazardous Waste Pharmaceuticals” (PCHWP) and “Non-Creditable Hazardous Waste Pharmaceuticals” (NCHWP):
- PCHWPs are those having reasonable expectation to receive manufacturers’ credit via reverse distribution; but they must be unused, undispensed, in original packaging, and less than a year past expiration date.
- NCHWPs are those not having a reasonable expectation to be legitimately reused/reclaimed and are not eligible for reverse distribution. They include unusable pharmaceutical products, compounded drugs, residues in empty pharmaceuticals containers, refused dispensed pharmaceuticals, and other listed items.
Highlights of Subpart P Standards for Healthcare Facilities
Notification
A one-time notification form is required to inform the state agency and/or EPA of operations under Subpart P rules. Facilities not required to submit a biennial report for other hazardous waste must notify within 60 days of the rule going into effect.
Training
Personnel managing NCHWP must be thoroughly familiar with proper procedures during both normal operations and emergencies.
Hazardous Waste Determinations
Facilities must determine whether a disposed pharmaceutical is HWP and either a PCHWP or NCHWP.
Commingling
Hazardous and non-hazardous waste pharmaceuticals may be accumulated in the same container.
HWP Containers
- Labeling: NCHWP containers must be labeled with “Hazardous Waste Pharmaceuticals.” No labeling requirements for PCHWP containers.
- Container Standards: Containers must be structurally-sound, undamaged, and not leaking. They must remain closed and secured as to prevent unauthorized opening.
- Accumulation Time: NCHWP containers limited to onsite storage for a maximum of one year. No accumulation limit for PCHWP containers.
Shipping Manifests
Manifests and licensed hazardous waste transporters are required for NCHWP but not for PCHWP.
Sewer Discharge Ban
Prohibits the disposal of HWP in sinks discharging to a municipal sewer system. As such, triple-rinsing of “RCRA empty” HWP is no longer acceptable.
Regulatory Support from HETI
To reiterate, it is important for healthcare facilities to monitor not only EPA’s compliance deadline but also regulatory adoption plans in their respective states.
HETI’s staff continually reviews new and proposed changes to regulations and standards to make sure we have current knowledge of compliance and environmental issues. We have extensive experience in supporting our clients through a comprehensive range of regulatory support and other services. In addition, HETI staff has extensive, comprehensive experience in providing environmental compliance services to hundreds of healthcare facilities nationwide – particularly including the management and disposal of healthcare wastes of all types.