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.

  • Core 3.4 / 06.29.2020

    CORE 40 - Health Literacy

    This standard, a new, experimental standard, suggests that your organization should have policies and procedures that address health literacy. In this context, the meaning of health literacy is, "The degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate decisions regarding their health." The three suggested...

    READ FULL POST
  • Core 3.4 / 06.29.2020

    CORE 39 - Consumer Satisfaction

    This short standard requires that your organization have a mechanism to collect information about your consumers' satisfaction.This often is done in the form of customer satisfaction surveys, consumer complaints, and sometimes even focus groups. Find out what your organization does -- it's likely more than one mechanism.

    READ FULL POST
  • Core 3.4 / 06.29.2020

    CORE 38 - Consumer Safety Mechanism

    One of the most important of the URAC standards is this one, which requires that the organization have processes to respond quickly to urgent situations that threaten consumers' well-being.Even though the standard speaks of "a mechanism", the reality is that it requires a system of mechanisms dealing with the full array of urgent situations that are likely to confront the applicant. You can see th...

    READ FULL POST
Top