Specialty Pharmacy (4.0) 4.0

PROD 3-2: Employee Safety

Submited by: Tom Goddard

The Basics

Under this standard, the pharmacy must take certain steps to ensure employee safety. Specifically, the pharmacy must make available to employees and train employees on how to use

  • Safety Data Sheets
  • Spill kits
  • Eye wash stations.

Now, if your pharmacy has conducted a risk assessment and has determined that there is zero risk of exposure to hazardous drugs and materials, it may be that only the Safety Data Sheets component of this standard applies to your pharmacy.

Management Tips

If you believe that the pharmacy may be excluded from the requirement for spill kits and eye wash stations, you should conduct an analysis that includes a determination of potential exposure to drugs (on the NIOSH or other list of hazardous drugs) or other hazardous materials.
We recommend that you consult USP 800 (see link, below) for guidance on how to conduct such a risk assessment and how to maintain a list of hazardous drugs.
One note -- eye wash stations that are self-contained meet the intent of element (c).

Accreditation Tips

Desktop Review

Submit a policy and procedure that both prescribes the availability and training in the three areas described in the standard, and describes in detail who is responsible for the fulfilling the requirements of this standard. If you have conducted a risk assessment that there is zero risk of exposure to hazardous drugs or materials, execute a signed attestation on the organization's letterhead that the pharmacy has conducted such a risk assessment and has concluded that there is zero such risk.

Validation Review

The URAC reviewer will observe the accessibility of safety data sheets, spill kits, and eye wash stations in the pharmacy.

  • Specialty Pharmacy (4.0) 4.0 / 05.19.2020


    Focus area

  • Specialty Pharmacy (4.0) 4.0 / 05.19.2020

    PROD 7-1: Compounding Requirements

    If the pharmacy engages in compounding, it must implement policies and procedures that ensure that the compounding activities meet both USP guidelines and applicable laws and regulations, whether state or federal. Those policies need to identify who is responsible for ensuring such compliance and how he/she/they are to do that. 

  • Specialty Pharmacy (4.0) 4.0 / 05.19.2020

    PROD 6-1: Machine and Equipment Maintenance

    The pharmacy must implement written policies and procedures that:ensure that all machines and equipment in the pharmacy are maintained according to both the guidelines provided by the manufacturers and any applicable regulations, andprovide for the documentation of the implementation of the processes dealing with cleaning, calibrating, and auditing of the machinery and equipment.The machinery and...