Specialty Pharmacy (4.0) 4.0

PROD 7-1: Compounding Requirements

Submited by: Tom Goddard

The Basics

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. 

Management Tips

About the only way to fail to meet this standard is to write the policy in terms that are too general. Get clear about who is in charge of compliance for compounding and what resources will be used in the process.

Accreditation Tips

Desktop Review
Submit either the compounding policy that addresses compliance with USP and regulatory requirements or a signed attestation on company letterhead that explains that the pharmacy does not do compounding.
Validation Review
The URAC reviewer will observe the area of the pharmacy set aside for compounding.

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