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The Compliance Corner: The Designated Person—To Be or Not To Be?

Compliance Corner

The Compliance Corner

Michelle Woosley, PharmD., MBA, CM&AP, FACA
VP of Business Development/Senior Consultant

Welcome to Compliance Corner where I share insider inspection tips on common inspection findings, discuss hot topics, and address industry challenges.

The Designated Person—To Be or Not To Be?

I recently received a call from a colleague asking my opinion about becoming the designated person at the pharmacy where he works. He was concerned about the increased amount of responsibility he would take on as the Designated Person. His concern was justifiable. Let's face it—the list of responsibilities for a Designated Person(s) can seem daunting, especially for one person. What does it really mean to be the "DP"? Now that's the real question so let's get down to some real answers.

The USP standards don't clearly define the "who" or the "how" to be a designated person, but the "what" is perfectly clear. Just take a look at the list of responsibilities found in USP Chapter <795>, <797> and <800>. Every listed area relates back to quality management and oversight of compounding operations. Considering not every compounding pharmacy has the ability to stand up a Quality Team or implement a Quality Management System, I believe the USP's entire purpose for creating the Designated Person(s) role is to ensure SOMEONE in the pharmacy is identified as responsible for each of the key quality-related aspects of the pharmacy's compounding operations. And yes—this can (and probably should) be more than one person. Many pharmacies assign this role to the Pharmacist-In-Charge or the Pharmacy Manager.

Regardless of who or how many individuals are assigned to this role, here's some best practice tips on Designated Person(s).

Best Practice Tips for Designated Person(s)

1) Have a separate Designated Person(s) SOP that outlines the respective DP areas of responsibility for USP <797>, <795>, and <800> (or whichever is applicable).

Be sure to include the following in your SOP:

  • Identify which position(s) can be assigned to the role.
    • "The Pharmacist in Charge will function as the designated person."
    • "The Designated Person(s) will be assigned based on job title and areas of responsibility. This may include the PIC, training personnel, pharmacy technicians, and other qualified individuals."
  • If the pharmacy has more than one Designated Person, create a Lead DP role and indicate in the SOP the Lead Designated Person will assign one or more individuals to this role.
  • What qualifies someone to be a Designated Person(s)? Does the person have to be a pharmacist? Have a certain number of years of experience? Complete a specific training or certification? Include these details in the SOP as well and consider what type of qualifications best fit the needs of your pharmacy.

Until next time—Keep it Compliant!

Best Regards,
Michelle