40 CFR 266.502, 40 CFR 266.508
Standards for healthcare facilities managing non-creditable hazardous waste pharmaceuticals
Definition - A prescription hazardous waste pharmaceutical that does not have a reasonable expectation to receive credit - or - A nonprescription hazardous waste pharmaceutical that does not have a reasonable expectation to be legitimately used/reused or reclaimed. Examples include: drugs sold on a non-returnable basis, damaged, samples, repackaged drugs, investigational drugs, residues of pharmaceuticals in empty containers, contaminated PPE, expirations dating greater than one year, pharmaceuticals refused by a patient, etc.
Do not send non-creditable hazardous waste pharmaceuticals back to a Reverse Distributor!
RECOMMENDATIONS - if operating under Subpart P
- Facility notification to EPA – Site Identification Form
- The healthcare facility is to notify their regional EPA that they are operating under Subpart P.
- An EPA ID will be issued if one does not already exist for your facility.
- You do not need to list EPA waste codes (Box 10B)
- A copy of notification must be kept on file.
- OK to indicate notification on your Biennial Report (if you are a LQG). If the facility is not required to submit a biennial report, then they must notify EPA within 60 days of the new regulations going into effect or the facility becoming subject to Subpart P.
- Generator to identify HW Pharmaceuticals (§ 266.502(c)) - Facility "must determine whether that pharmaceutical is a hazardous waste pharmaceutical"... Do not need to identify HW codes (e.g, D001, U010, P001, etc.). However, the HW disposal vendor will likely need the specific EPA Waste Codes in order to set up disposal profiles.
- Optional – A facility can manage all their non-creditable pharmaceuticals, including non-hazardous as hazardous waste pharmaceuticals and make no hazardous waste determinations. However, managing all non-creditable pharmaceuticals as hazardous would result in no non-creditable pharmaceuticals being returned to the Reverse Distributor (see below flow chart). Additionally, the HW disposal vendor would likely need the specific EPA Waste Codes in order to set up disposal profiles.
- Pharmaceutical waste weight does not count towards generator status. Refer to Generator Status Determination
- Non-Creditable HWP Criteria for prescription pharmaceuticals: HWP (Rx) not in its original container (or) Dispensed (or) Greater than 1 year of expiration (or) a non-RCRA empty container (or) refused by patient.
- Non-Creditable HWP Criteria for non-prescription pharmaceuticals: HWP (Non-Rx) that does not have a reasonable expectation of being used/reused or reclaimed. Most non-prescription hazardous waste drugs will likely be non-creditable unless you are a large retail chain.
- Container and storage requirements.
- Structurally sound container (not damaged or leaking)
- Compatible wastes in same container. However, additional safety requirements if incompatible wastes are commingled together.
- Closed container
- Contents secured to prevent unauthorized access (via location and or type of storage container)
- Container requirement - UNSUITABLE FOR INCINERATION
- EPA is requiring any HWP's that are unsuitable for incineration (e.g., Arsenic Trioxide - P012) to be segregated in a separate container and labeled with the appropriate hazardous waste codes.
- An accurate pharmaceutical waste characterization is needed to let the HW disposal vendor know what waste codes are affected.
- Check with your HW disposal vendor to verify.
- Label on container to read "Hazardous Waste Pharmaceuticals".
- Hazardous waste codes are not required.
- Options for documenting start accumulation time:
- Mark container (Start Accumulation Date: _______)
- Maintain an inventory system
- Identify in accumulation area earliest date of hazardous waste generation
- One year accumulation time limit.
- No extensions granted - FOR ANY REASON - Make sure you plan well in advance for any and all possible scenarios that would cause a delay in getting your waste shipped out in time. Consider shipping out nine (9) months from the start accumulation date.
- Applies to personnel that manages hazardous waste pharmaceuticals.
- Performance based - Staff must be familiar with waste handling and emergency procedures specific to their job responsibilities.
- Land Disposal Restrictions Apply
- This is typically handled through the hazardous waste disposal vendor (LDR paperwork and compliance)
- Refer to 40 CFR Part 268.
- The generator is ultimately and legally responsible for the hazardous waste they generate and dispose (cradle to grave). It is essential that the hazardous waste codes of the pharmaceuticals be accurate.
- Keep track of all record keeping for a period of at least 3 years (manifests, exception reports, test results, waste determinations). Time period extended if under EPA investigation or if requested by the EPA.
- Records must be kept onsite and readily available for inspector request.
- Shipping requirements
(40 CFR 266.508)
- DOT regulations apply (packaging, labeling, placarding, manifests). 49 CFR Parts 172(E), 172(D), 173, 178, 180
- Hazardous waste manifest and licensed hazardous waste transporter required.
- Hazardous waste transporter and disposal facility have additional requirements to comply with.
- Generally the hazardous waste transporter is familiar with the DOT shipping requirements.
- Healthcare facility (generator) is to receive signed manifests back from the disposal facility within 60 days. Generator is to notify Regional EPA Administration if this does not happen. This is referred to as an exception report.
Rejected shipments - In the highly unlikely event that a hazardous waste shipment is sent back to the healthcare facility, additional regulations apply. Refer to § 266.502(h) for more information.
- If generator is required to fill out a Biennial Report (BR), they do not need to include their non-creditable HW generation,
- If generator does not receive a copy of the UHWM within 60 days from the designated facility, additional regulations and reporting apply. Refer to 266.502(i).
- If a shipment is rejected from the designated facility and sent to an alternate facility and the generator does not receive a copy of the UHWM within 60 days from the alternate facility, additional regulations and reporting apply.
- Spill response - Contain immediately and manage appropriately under Subpart P regulations.