1 Year Subscription: USP 800 Policy & Procedure Templates

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1 Year Subscription: USP 800 Policy & Procedure Templates

895.00

USP 800 Hazardous Drugs (HDs) will become effective on December 1, 2019. The time to prepare for compliance is now.

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 Pharmacy

  3. Hazardous Drug Handling – Sterile Compounding Pharmacy

By making this purchase, you are subscribing to receive these three documents as well as receive them again with any updates within 12 months from date of purchase by contacting Bula.

Note: The $895 price is per pharmacy permit. Your purchase will not be finalized and you will not receive access to the USP 800 documents until we have verified and confirmed your organization’s size and market.

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Don’t compound? USP 800 may still impact you.

It’s a misconception that USP 800 applies only to compounding. Do you dispense any Estrogens or Warfarin, for example? Both appear on the NIOSH list, which determines if a drug is hazardous. Therefore the USP 800 standards apply to handling. USP 800 includes the handling of any hazardous drug - from the opening of the shipping box it is delivered in to handing it over to a patient.

Contact us to for more information.


Outline of the USP 800 Templates:

Hazardous Drug Handling – General Pharmacy / No 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

 

Hazardous Drug Handling – NonSterile Compounding Pharmacy

  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



Hazardous Drug Handling – Sterile Compounding Pharmacy

  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 pharmacies and the implementation of good business practices. Now 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 — which will soon be mandatory.

Receiving the templates after your purchase:

After your purchase, Bula will confirm your organization’s size and market. Upon positive confirmation, Bula will email the three USP 800 documents to the email address specified. These templates are Word documents, so that revisions and updates are simple.

Note: It is the customer's responsibility to contact Bula during the 12-month subscription to request the templates again or any updates. 

This 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. This template and all others in this manual, are designed to comply with federal law however, some states 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.