News

All Eyes on Vendor Management

Michelle Woosley

Michelle Woosley — PharmD., MBA, CM&AP, FACA

VP of Business Development, Certified Mergers & Acquisitions Advisor

Compliance Corner
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All Eyes on Vendor Management

Last month, I virtually attended several Boards of Pharmacy meetings across the country. It is common for multiple compounding pharmacy license applications and/or renewals to appear on BOP agendas. These licenses are frequently being met with increased scrutiny by Board members, particularly when the pharmacy prepares and dispenses compounded GLP-1 products.

This is old news—right? Well, yes and no.

More recently—pharmacy oversight of vendor management has become a major area of focus and frequent line of questioning.

Questions that I have seen come up are:

  1. “Do you purchase your APIs from XXXX? Were you aware they have been issued a 483?”
  2. “Have you confirmed that the vendors the pharmacy purchases semaglutide and tirzepatide from are on the FDA’s Green List?”
  3. “Is the list your pharmacy provided to the Board the most updated list of vendors?”
  4. “Has your pharmacy completed a vendor checklist/on-site inspection of XXXX API vendor?”

Pharmacies should ensure they have a well-developed vendor management program that includes maintaining an accurate and current list of vendors, implements a process to verify at least every 12 months that all vendors are FDA-registered, and establishes quality control parameters within the vendor agreements. As a best practice, this should include an initial on-site facility visit, followed by additional site visits every two years.

Equally important is ensuring that whichever team or individuals are assigned to these tasks in the pharmacy stay informed on news reports, recalls, and FDA inspection outcomes that may negatively impact the pharmacy’s relationship with its vendors. Additionally, monitoring the so-called “Green List” (which isn’t an actual list) is critical when managing GLP-1 API sourcing.

Lastly, if your pharmacy is preparing to apply for a new state license or renew an existing one, be prepared to address these types of questions to demonstrate appropriate and effective oversight of vendor management practices to Boards of Pharmacy.


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