Due Diligence

This is a list of questions a provider should ask a compounding pharmacy before approving them. It is not a “Hartley” driven questionnaire. Rather, its intent is to educate.

All questions are intended to be open-ended in order to provide the opportunity for the provider to learn more. We welcome your questions and invite your on-site inspections.

How many years’ experience does your facility/team have in sterile compounding?

In regards to your sterile compounding staff . . .

Do you have an employee training and evaluation program in compliance with USP <797> / Board of Pharmacy? Please describe.
What are your policies and procedures for hand washing, gowning, and gloving?
Does your staff perform media fills in compliance with USP <797>?

Is your sterile compounding pharmacy accredited by an acknowledged sterile compounding association?

Do you have a set of policies and procedures, or checks and balances, to guide the sterile compounding process? Please describe.

Do you have adequate space for compounding sterile products?

Do you have a dedicated, separate, and contained sterile preparation area?

In regards to the United States Pharmacopoeia (USP) guidelines for the sterile preparation area . . .

What is the air quality classification of your IV hoods or Laminar Air Flow Workbenches? Please explain what this means to you.
How often are your sterile preparation rooms and IV hoods certified?

In regards to your environmental monitoring . . .

Will you describe this process?
Do you test for air microbial bioburdens? How often?
Do you test for particulates in the air? How often?
Do you perform surface and fingertip microbial testing? How often?

In regards to the cleaning and disinfection program for your sterile environment . . .

Will you describe this process?
How often is it employed?

What is your delivery process?

Do you perform in-house auditing to expose discrepancies in prescriptions and billing?

Do you provide access to a clinical support team who can help with formulation questions and other clinical concerns?

Do you have at least five (5) references who may be contacted to testify to the quality of your products and satisfaction of your customer service?

Do you have a network of health professionals for referrals regarding additional needs?