USP General Chapter <800> Compliance Toolkit and Resources for Psychiatric Facilities

The U.S. Pharmacopeial Convention (USP) has issued USP General Chapter <800> Hazardous Drug Handling in Healthcare Settings describing practice and quality standards for handling hazardous drugs (HDs) to promote patient safety, worker safety, and environmental protection. The applicable HDs is based on the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings (see 2016 edition). Handling HDs includes, but is not limited to, the receipt, storage, compounding, dispensing, administration, and disposal of sterile and nonsterile products and preparations. AAPP has developed a toolkit consisting of peer-reviewed assessments of risk for 125+ formulations that are commonly found at psychiatric facilities. Save hundreds of hours of staff time researching, documenting, and reviewing safety procedures that balance safety with patient needs. 

Toolkit Plan and Pricing

The toolkit is available for $250/facility ($400 for non-members) for the first calendar year, with access through December 31. Continued access to the toolkit costs $100/facility/year after the first calendar year ($200 for non-members) to receive any new or updated risk assessment forms and/or to make changes to the facility formulation details. Licenses should be purchased using the account that will be the primary administrator for the project. Purchasing departments should authorize the appropriate staff member to purchase via online credit card using the button below; if a purchase order is needed from their facility, for assistance.

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The AAPP USP <800> Compliance Toolkit

AAPP has developed a compliance toolkit that will assist entities who store prepare, transport, or administer psychiatric drugs that are considered to hazardous. The toolkit includes:

Does USP <800> apply to you?

This chapter applies to all healthcare personnel who handle HD preparations and all entities which store, prepare, transport, or administer HDs (e.g., pharmacies, hospitals and other healthcare institutions, patient treatment clinics, physicians' practice facilities, or veterinarians' offices). Personnel who may potentially be exposed to HDs include, but are not limited to: pharmacists, pharmacy technicians, nurses, physicians, physician assistants, home healthcare workers, veterinarians, and veterinary technicians.

Since many psychiatric drugs are considered hazardous, this includes psychiatric inpatient facilities, ICF-IDD inpatient facilities, mental health clinics, nursing homes and some extent rehab facilities.

What does USP <800> require you to do?

By December 1, 2019, entities that handle HDs must incorporate the standards in this chapter into their occupational safety plan. The entity's health and safety management system must, at a minimum, include:

  • Engineering controls
  • Competent personnel
  • Safe work practices
  • Proper use of appropriate Personal Protective Equipment (PPE)
  • Policies for HD waste segregation and disposal

The USP 800 chapter was originally scheduled to go into effect July 1, 2018. However, it was delayed to December 1, 2019. State boards of pharmacy will be implementing these regulations as well.