40 CFR Part 266 Subpart P
Some definitions have been simplified and are not exactly as they appear in the CFR.
- CAA - Centralized Accumulation Area
- CESQG - Conditionally Exempt Small Quantity Generator
- CFR – Code Of Federal Regulations
- DEA – Drug Enforcement Administration
- DOT – Department Of Transportation
- EPA – Environmental Protection Agency
- HW - Hazardous Waste
- HWP - Hazardous Waste Pharmaceutical
- LQG – Large Quantity Generator
- LTCF – Long Term Care Facility
- NRT - Nicotine Replacement Therapy
- NCHWP - Non-Creditable Hazardous Waste Pharmaceuticals
- OTC - Over-The-Counter
- PCHWP - Potentially Creditable Hazardous Waste Pharmaceuticals
- RCRA – Resource Conservation and Recovery Act of 1976
- RD - Reverse Distributor
- RLC - Reverse Logistics Center
- SQG – Small Quantity Generator
- UD - Unit dose
- VSQG – Very Small Quantity Generator
- Biennial report (BR) – report that LQG’s are required to fill out every other even numbered year.
- Dual waste – Waste pharmaceutical that is hazardous and also has a biological component.
- Generator - Person whose act or process produces hazardous waste or whose act first causes a hazardous waste to become subject to RCRA.
- Hazardous waste pharmaceuticals (HWP) – Pharmaceuticals that are considered RCRA hazardous by the EPA. Excluded are non-prescription pharmaceuticals that have a reasonable expectation of being used/reused or reclaimed.
- Healthcare facilities (HF) – Any person that is lawfully authorized to provide patient care to humans or animals. Or, facility that sells or dispenses OTC or prescription drugs.
- Household waste pharmaceutical – A pharmaceutical waste generated by a consumer household and is therefore not regulated under Subpart P due to an EPA exemption.
- Long term care facility (LTCF) - Licensed entity that provides assistance with activities of daily living, including managing and administering pharmaceuticals to one or more individuals at the facility.
- Non-creditable hazardous waste pharmaceutical (NCHWP) – Pharmaceutical waste that is RCRA hazardous and does not have the potential for manufacturer credit.
- Non-hazardous waste pharmaceutical – A pharmaceutical that is not RCRA hazardous, therefore is not regulated under Subpart P. State and or local regulations may apply for the proper disposal.
- Non-pharmaceutical hazardous waste – A RCRA hazardous waste that does not meet the definition of pharmaceutical. RCRA regulations continue to apply to this waste stream.
- Pharmaceutical – Any drug or dietary supplement for use by humans or animals. Examples include: OTC, prescription, dietary supplements, homeopathic drugs, compounded drugs, electronic nicotine delivery systems and liquids, investigational drugs, drugs container residue from non-empty containers, contaminated personal protective equipment, clean up material from pharmaceutical spills. Does not include used sharps, medical waste or dental amalgams.
- Potentially creditable hazardous waste pharmaceutical (PCHWP) – Prescription pharmaceutical waste that is RCRA hazardous and that has the potential for manufacturer credit (Undispensed, in original manufacturer container and less than one year expired.
- Reverse distribution – Reverse flow of prescription and non-prescription pharmaceuticals.
- Reverse distributor (RD) - Anyone that that receives PCWHP's (prescription) for the purposes of facilitating or verifying manufacturer credits . Depending on functions performed, this could include forward distributors (Drug Wholesalers and Distributors), Drug Manufacturers and 3PL's.
- Reverse logistics - Reverse flow of nonprescription pharmaceuticals and other unsold retail items.
- Reverse logistics centers (RLC) - Facilities that receive nonprescription pharmaceuticals and other unsold retail items.
- Shipper - Party (e.g. HCF) that prepares and offers a shipment to be transported by a carrier.
- Ultimate Users - DEA term to define consumers of DEA controlled substances.
- Unauthorized waste – Waste sent to a reverse distributor that it is not authorized to receive.
- Unit dose containers – Hold a single dose of a pharmaceutical (e.g., blister packs, cups, wrappers, packets)
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