40 CFR 266.503, 40 CFR 266.509
Standards for healthcare facilities managing potentially creditable hazardous waste pharmaceuticals.
Definition – A prescription hazardous waste pharmaceutical that has a reasonable expectation to receive manufacturer credit.
Criteria: Undispensed prescription pharmaceutical in the manufacturer's original container with less than one year past expiration date.
Potentially Creditable HW Pharmaceuticals can be sent back to a Reverse Distributor (RD) for possible credit processing.
RECOMMONDATIONS - 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.
- Perform a hazardous waste determination (§ 266.503(a)) - A facility must determine whether or not the potentially creditable pharmaceutical is hazardous waste. HW Drugs
- HWP weight generated does not count towards your generator status.
- Container requirements - none
- Accumulation time limit - none
- Labeling requirements - none
- Spill response requirements - Facility must immediately contain all spills and manage the spill cleanup material as non-creditable hazardous waste.
- Procedure for shipping to Reverse Distributor (40 CFR 266.509).
- Ship via common carrier with ability to track.
- No hazardous waste manifest required.
- Follow DOT regulations (49 CFR part 171 through 180). You are shipping hazardous materials!
- RD provides you with written confirmation (paper or electronic) of receipt.
- Promptly contact RD if receipt confirmation is not within 35 calendar days of shipment and determine status of shipment.
- Maintain records for a minimum of 3 years and have readily available for inspection upon request (confirmation receipt from Reverse Distributor, shipping papers).
Reverse Distributor Impacts
- DO NOT SEND HAZARDOUS OTC to the Reverse Distributor - A Reverse Distributor is not allowed to accept OTC's that are hazardous. It is highly unlikely that the OTC falls in the category of having a reasonable chance of being used/reused or reclaimed when sending back to the Return Logistics Center unless you are a large retail chain.
- OK to send non-hazardous OTC to a reverse distributor for possible credit.
- Commingling Option - A facility has the option of commingling all potentially creditable hazardous and non-hazardous pharmaceutical waste streams together.
- In this specific instance, the facility does not need to make a hazardous waste determination.
- Once commingled, all contents are all subject to Subpart P regulations while they remain commingled. In other words, if commingling, then no OTC can go back to the Reverse Distributor as it is not known whether or not the commingled return contains hazardous waste OTC's.
- If commingling, every prescription and non-prescription pharmaceutical returned to the reverse distributor would need the date verified that is less than one year expired and in the original container and in an undispensed form.
- On average 95% of a drug formulary is non-hazardous, 5% hazardous.
- Potentially creditable hazardous waste pharmaceutical shipping standards apply to the entire shipment (§ 266.509).
- DOT shipping regulations apply to the return shipment
- Summary - Since on average only 5% of an average inventory is hazardous, it may be worth identifying those pharmaceuticals and follow the shipping procedures for shipping potentially creditable hazardous waste pharmaceuticals. Commingling may result in 1) less pharmaceuticals being sent back to the RD, 2) less pharmacy reimbursements (credits), 3) more solid waste left at the pharmacy for disposal.