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Medication - Sterile Compounding - Supervision of Compounding Activities

The United States Pharmacopeia (USP) 797 refers to a 'designated person' as the individual to 'supervise all compounding activities'. Does The Joint Commission require this individual to be a pharmacist?

Any examples are for illustrative purposes only.
No. The Designated Person (DP) referenced in the USP 797 chapter is responsible for development of standard operating procedures, training, maintaining an appropriate physical environment and ensuring compliance with the chapter.  The Joint Commission will survey to the USP 797 requirement for the DP, which the organization has deemed qualified through education, training, and competency to serve in this role.

A pharmacist is responsible for supervising all compounding, packaging, and dispensing of drugs and biologicals except in urgent situations in which a delay could harm the patient or when the product's stability is short.  Additionally, all compounding, packaging, and dispensing of drugs and biologicals must be performed in accordance with state and federal law and regulation. This requirement is based on the CMS Conditions of Participation. 
Manual: Hospital and Hospital Clinics
Chapter: Medication Management MM
This page was last updated on September 26, 2023
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