USP 800 Basic Overview
What is USP 800?
USP, or United States Pharmacopeia, is a scientific non-profit organization that sets standards for the quality, purity, and potency of medicines, dietary supplements, and other healthcare products. Technically, it is not a governing body, yet the FDA recognizes it as an official compendium, meaning its standards are enforceable by law. USP 800 was published in 2016 and helps healthcare facilities protect their workers, patients, and the environment from exposure to hazardous drugs.
Which Drugs Does USP 800 Cover?
Any hazardous drug is a risk; however, they all have different forms of accepted disposal for various drugs. Things to considerer when assessing the risk of the drug:
- Type of Hazardous Drug (e.g., antineoplastic, non-antineoplastic, reproductive risk only)
- Dosage form
- Risk of exposure
- Packaging
- Manipulation
To minimize occupational exposure, document containment strategies and/or work practices, review the documentation at least once every 12 months.
What are the guidelines regarding the transportation and disposal of Hazardous Pharmaceutical waste?
Transportation
- Hazardous drugs (HDs) transportation is in accordance with applicable federal, state, and local regulations.
- HDs transports in containers that minimize the risk of breakage or leakage.
- Pneumatic tubes shall have no usage in transport any liquid HDs or any antineoplastic HDs.
- When shipping HDs to locations outside the entity, the entity must consult the Transport Information on the SDS.
- Labels and accessory labeling for the HDs must include storage instructions, disposal instructions, and HD category information in a format that is consistent with the carrier’s policies.
Disposal
- All personnel who perform routine custodial waste removal and cleaning activities in areas where hazardous materials (HDs) handles in training in appropriate procedures to protect themselves and the environment from HD contamination.
- Disposal of all HD waste, including unused HDs, trace-contaminated personal protective equipment (PPE), and other materials, must comply with all applicable federal, state, and local regulations.
Conclusion
The USP 800 is not a new set of regulations, but finding and adhering to its regulations is challenging for all waste-producing companies. To best deal with your hazardous pharmaceutical waste, consult an expert that consistently deals with these regulations and products. MedPro Disposal is a disposal company that can help you identify and dispose of your hazardous pharma waste!
800 HAZARDOUS DRUGS—HANDLING IN HEALTHCARE SETTINGS (uspnf.com)