The EPA Final Rule on Hazardous Waste Pharmaceuticals (Subpart P) and Amendment to the P075 Listing for Nicotine
The Final Rule of the Environmental Protection Agency (EPA), under 40 CFR 266 subpart P on the management of hazardous waste pharmaceuticals became effective on August 21, 2019.
The rule was effective immediately in AK, FL, IA, KY, NJ, PA, VA and Puerto Rico.
States that do not require legislation have until July 1, 2021 to adopt the rule, states that do require a legislative change in order to adopt the rule are given until July 1, 2022 to adopt.
As a result, the effective dates have varied by state. It's very important to understand that until your state adopts the rule, the current hazardous waste regulations are applicable.
The exception to state adoption is the ban on flushing. This requirement was proposed under the Hazardous and Solid Waste Amendments. Requirements implemented under this authority became effective in all states on August 21, 2019.
See below Stericycle’s state adoption map and matrix that gives further details on unique state adoptions of the rule as well as forecasted dates of adoption. Click image to download.
The USP does not enforce regulations. However, USP’s drug standards do influence and can be adopted by regulatory bodies including the Food and Drug Administration (FDA), state pharmacy boards and accrediting agencies such as Joint Commission.
Stericycle monitors all federal and state regulations affecting your regulated waste management. If Stericycle is servicing your facilities’ pharmaceutical waste and you are following the Stericycle Waste Acceptance Policy, you are compliant with waste management regulations and current USP 800
standards concerning disposal. Be aware:
USP 800 is not a new set of regulations concerning pharmaceutical waste but rather new protocols for safe handling of pharmaceuticals in the clinical or pharmaceutical workplace.
Pharmaceutical waste will continue to be handled in accordance with EPA requirements, NIOSH guidelines, and individual state regulations.
Stericycle strives to ensure our customers stay OSHA compliant, including with OSHA’s Hazard Communication Standard
For the safety of your employees and to stay compliant with the OSHA Hazard Communication Standard, you must keep an updated Hazard Communication Program (HCP). The USP 800 recommends only two additions: A written plan that describes how the USP 800 standard will be implemented and a provision that personnel of reproductive capability must confirm in writing that they understand the risks of handling HDs. Among other rules of the Hazard
Communication Standard, your HCP still needs to include:
All containers of hazardous chemicals must be labeled, tagged, or marked with the identity of the material and appropriate hazard warnings
Entities must have an SDS for each hazardous chemical they use (29 CFR 1910.1200)
Entities must ensure that the SDSs for each hazardous chemical used are readily accessible to personnel during each work shift and when they are in their work areas
Personnel who may be exposed to hazardous chemicals when working must be provided information and training before the initial assignment to work with a hazardous chemical, and also whenever the hazard changes.
USP 800 states that “handling HDs includes, but is not limited to, the receipt, storage, compounding, dispensing, administration, and disposal.” USP 800 refers primarily to transport and disposal within the healthcare facility but the standard does reflect Stericycle’s longstanding recommendations as well as our Waste Acceptance Policy regarding HD wastage generated from chemotherapy.
Transport <800>, 11.3
“HDs that need to be transported must be labeled, stored, and handled in accordance with applicable federal, state, and local regulations. HDs must be transported in containers that minimize the risk of breakage or eakage. Pneumatic tubes must not be used to transport any liquid HDs or any antineoplastic HDs because of the potential for breakage and contamination. When shipping HDs to locations outside the entity, the entity must consult the Transport Information on the SDS. The entity must ensure that labels and accessory labeling for the HDs include storage instructions, disposal instructions, and HD category information in a format that is consistent with the carrier’s policies.”
Disposal <800>, 11.4
“All personnel who perform routine custodial waste removal and cleaning activities in HD handling areas must be trained in appropriate procedures to protect themselves and the environment to prevent HD contamination. isposal of all HD waste, including, but not limited to, unused HDs and trace-contaminated PPE and other materials, must comply with all applicable federal, state, and local regulations.” Note: Disposal of all HD waste (including unused and unusable HDs) must comply with all applicable federal, state, and local regulations. Because USP 800 is not a regulation, and USP does not have jurisdiction over waste disposal, the standard defers to federal, state, and local regulations for waste disposal. This means that EPA regulations need to be followed for disposal of HDs that are also hazardous wastes. Some states also regulate waste that previously contained HDs or was used to administer HDs, in those states’ regulated medical waste regulations; this waste is often referred to as “trace chemotherapy” waste.
The Final Rule bans the flushing (also called “sewering”) of all hazardous waste pharmaceuticals, regardless of generator type. This ban does not affect nonhazardous pharmaceuticals. However, the EPA discourages flushing of any pharmaceuticals. See Stericycle’s infographic on the effects pharmaceutical waste has on the environment.
There are only a few controlled substances that are hazardous waste. These few drugs are conditionally exempted from hazardous waste regulations when managed in compliance with DEA regulations and incinerated at an authorized facility.
1.Stock, dispensing, and unit dose containers — this includes vials, blister packs, and dispensing bottles (not to exceed 1 liter or 10,000 pills). These items are considered empty when their contents have been removed by normal means and are not regulated as hazardous waste, even if they held P-listed wastes.
2. Syringes — syringes are considered empty and not regulated as hazardous waste pharmaceuticals when the plunger has been fully depressed. The empty syringe should be managed under applicable federal, state, and local requirements for medical waste and sharps.
3. Intravenous bags (IVs) — fully administered IV bags are considered empty and/or those that meet the current definition of RCRA empty.
4. Other containers, including delivery devices — this includes items such as inhalers, nebulizers, ointments, gels, and creams. These items are also considered empty when the current definition of RCRA empty is met.
Yes. The EPA amended the current listing for acutely hazardous nicotine and salts (P075) designating that FDA-approved, over-the-counter nicotine replacement therapies such as patches, gums and lozenges are no longer considered acutely hazardous waste.
This new exception applies to all generators of hazardous waste, not just healthcare facilities as it is outside of subpart P. Other nicotine containing products such as prescription replacement therapies and e-cigarettes are not excluded from the P075 listing and are still regulated as such. There is no requirement or timeline for state adoption.
Stay aware of your state's progress and potentially unique adoption of the Final Rule. It is very important to understand that all current RCRA regulations are being enforced until your state adopts. It is recommended that facilities potentially impacted by the Final Rule review the regulations.
To view the Final Rule and for additional information visit the EPA website.
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