USP <800> (Hazardous Drugs) is Coming Soon & Applies to More Businesses Than You Might Think.

Effective date: December 1, 2019!

The time to prepare for compliance is now!

“USP General Chapter <800> is relevant to all healthcare personnel who handle HD preparations and all entities that store, prepare, transport, or administer HDs … ” (FAQs).

This includes:

  • Pharmacists

  • Technicians

  • Nurses

  • Physicians

  • Physician assistants

  • Home healthcare workers

  • Veterinarians

  • Veterinary technicians

  • Clinics

  • Hospitals

  • Long-term care facilities

  • Half-way houses

  • Skilled nursing facilities

  • Anyone who stores HDs, anyone who may come in contact with HDs

So, your organization doesn’t compound?

It’s a misconception that USP 800 applies only to compounding.
Do you dispense any Estrogens or Warfarin, for example?


Description of USP <800>

"USP General Chapter <800> provides standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients and the environment.

The National Institute for Occupational Safety and Health (NIOSH) considers a drug to be hazardous if it exhibits one or more of the following characteristics in humans or animals: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, or structure and toxicity profiles of new drugs that mimic existing hazardous drugs.

USP General Chapter <800> describes requirements including responsibilities of personnel handling hazardous drugs; facility and engineering controls; procedures for deactivating, decontaminating and cleaning; spill control; and documentation. These standards apply to all healthcare personnel who receive, prepare, administer, transport or otherwise come in contact with hazardous drugs and all the environments in which they are handled" (USP General).


The USP <800> Policies and Procedures Templates

Bula helps you prepare to maintain compliance by offering the following three USP 800 Policies and Procedures templates:

  1. Hazardous Drug Handling – General Pharmacy / No Compounding

  2. Hazardous Drug Handling – NonSterile Compounding

  3. Hazardous Drug Handling – Sterile Compounding


  1. Purpose

  2. Scope

  3. Definitions

  4. Safety Requirements

  5. Procedure

    1. Hazard communication program

    2. Occupational safety program

    3. Designation of HD areas

    4. Receipt

    5. Handling and dispensing finished dosage forms

    6. Nonsterile compounding

    7. Sterile compounding

    8. Labeling, packaging and transport

    9. Administering

    10. Environmental monitoring

    11. Disposal

    12. Spill control

    13. Medical surveillance

  6. References

  7. Attachments

  1. Purpose

  2. Scope

  3. Definitions

  4. Safety Requirements

  5. Procedure

    1. Hazard communication program

    2. Occupational safety program

    3. Designation of HD areas

    4. Receipt

    5. Handling and dispensing finished dosage forms

    6. Nonsterile compounding

    7. Sterile compounding

    8. Labeling, packaging and transport

    9. Administering

    10. Environmental monitoring

    11. Disposal

    12. Spill control

    13. Medical surveillance

  6. References

  7. Attachments

  1. Purpose

  2. Scope

  3. Definitions

  4. Safety Requirements

  5. Procedure

    1. Hazard communication program

    2. Occupational safety program

    3. Designation of HD areas

    4. Receipt

    5. Handling and dispensing finished dosage forms

    6. Nonsterile compounding

    7. Sterile compounding

    8. Labeling, packaging and transport

    9. Administering

    10. Environmental monitoring

    11. Disposal

    12. Spill control

    13. Medical surveillance

  6. References

  7. Attachments


The importance of these templates

Written policies and procedures are a must for well-managed organizations and the implementation of good business practices – including maintaining legal compliance. Now Bula clients can complete their manual that documents their procedures, outlines their business requirements, helps them comply with legal requirements, and clarifies expectations with these NEW USP 800 templates.


Bula’s templates are reviewed and updated annually. Due to the dynamic nature of the pharmacy industry, changes may require Bula to make modifications between annual update cycles. These templates are designed to comply with federal law, however some states may have requirements that differ from federal law. We advise consulting a local attorney familiar with your state’s laws to determine if any changes are required to meet state-specific laws.


References

USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings. (n.d.). Retrieved from https://www.usp.org/compounding/general-chapter-hazardous-drugs-handling-healthcare

FAQs: <800> Hazardous Drugs—Handling in Healthcare Settings. Retrieved from https://www.usp.org/frequently-asked-questions/hazardous-drugs-handling-healthcare-settings

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