The Environmental Protection Agency (EPA) outlines in the Code of Federal Regulations, CFR 40, standards such as Part 266 regarding the Management of Specific Types of Hazardous Waste Management Facilities with Subpart P relating specifically to Hazardous Waste Pharmaceuticals. The final rule titled the Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine was published in the Federal Register in February of 2019.
This final rule prohibits all facilities that are subject to the rule from sewering hazardous pharmaceutical waste with a goal of making the nation’s surface and drinking water healthier and safer. This final rule protects the environment and human health and should reduce the amount of hazardous waste pharmaceuticals that enter our waterways by up to 2,300 tons each year, while establishing streamlined, cost-saving standards for healthcare facilities.
EPA Subpart P Adoption Dates – 40 CFR Part 266
40 CFR Part 266, Subpart P addresses the hazardous solid waste pharmaceuticals and required management which is mandatory for all healthcare facilities. This includes facilities that are Small Quantity Generators (SQG), Large Quantity Generators (LQC) and Reverse Distributors (RD).
The effective date of the final rule went into effect on 8/21/2019 for the states of Alaska and Iowa and will go into effect for the remaining states as the states adopt the ruling. Healthcare facilities were required to adhere to the nationwide sewer ban on hazardous waste pharmaceuticals effective 8/21/2019. It is not an option for states to not adopt Subpart P although states can choose to adopt regulations that are more stringent.
Each state can, however, choose whether or not to adopt the nicotine exemption as that part is less stringent. The Nicotine amendment applies to delisting of nicotine patches, gum and lozenges per P075. States like Michigan and Florida that have allowed pharmaceuticals to be handled as universal waste will not be allowed to do so any longer, and the ban on sewering or disposing of hazardous pharmaceutical waste down the drain is banned in all states.
EPA 40 CFR Part 266 subpart P has a state adoption deadline of 7/1/21 if there is no state legislation and a deadline of 7/1/22 if there is state legislation required.
What Facilities Does 40 CFR 266 Subpart P Apply To?
40 CFR, Part 266, Subpart P applies to anywhere pharmaceuticals are administered or sold. The regulations are enforceable and apply to the storage, transportation, and handling of hazardous waste pharmaceuticals that healthcare facilities generate. Facilities impacted by Subpart P include:
- Healthcare facilities and clinics
- Specialty and psychiatric hospitals
- Hospital pharmacies
- Dental offices
- Veterinary facilities and clinics
- Veterinary pharmacies
- Physician’s offices
- Drug wholesalers
- Drug compounders
- Skilled nursing facilities
- Hospice facilities
- Optical providers
- Ambulatory services
- Grocery stores and supermarkets
- Reverse distributors
All of these types of facilities must adhere to Subpart P of Part 266, CFR 40 and implement a safe and compliant drug disposal system. Rx Destroyer™ is a pharmaceutical waste disposal system that begins to quickly neutralize medications on contact through chemical digestion, which is a DEA compliant method of drug destruction. By utilizing Rx Destroyer™ in your facility you can help to maintain compliance to federal regulations set forth by the EPA and the DEA.
C2R Global is the manufacturer and patent holder of Rx Destroyer™, offering easy to use drug disposal products to facilities in a variety of settings. Rx Destroyer™ is available in various sizes to meet the needs of a wide range of facilities. Contact us to learn more about safe and efficient pharmaceutical waste disposal.