Independent pharmacies are facing a new level of scrutiny—and this time, it’s coming directly from a major pharmaceutical manufacturer.

Gilead Sciences, the maker of leading HIV medications such as Biktarvy and Descovy, has begun reporting pharmacies to numerous State Boards of Pharmacy, alleging that certain pharmacies may have unknowingly purchased and dispensed counterfeit versions of its products. These reports come on the heels of an ongoing federal lawsuit in which Gilead alleges that over 85,000 bottles of counterfeit HIV drugs were distributed through a complex black-market network of suppliers, distributors, and, ultimately, pharmacies.

Why This Matters to Independent Pharmacies

Pharmacies often serve as the final checkpoint in the drug distribution chain. When counterfeit medications enter the market, pharmacies are the ones left exposed—both legally and reputationally—regardless of whether they were knowingly involved.

In the Gilead case, pharmacies that purchased from seemingly legitimate secondary wholesalers are now under state investigation because they dispensed medications later identified as counterfeit. While the manufacturers’ intent may be to safeguard patient safety, their strategy of reporting directly to regulators puts pharmacies squarely in the crosshairs.

This development serves as a wake-up call for independent pharmacies to:

Reassess sourcing protocols. If you’re purchasing medications from non-primary wholesalers or secondary suppliers, you need airtight due diligence processes and documentation.

Vet suppliers rigorously. Ensure every distributor is VAWD/NABP-accredited and compliant with the Drug Supply Chain Security Act (DSCSA).

Document everything. Purchase orders, pedigree records, invoices, and chain-of-custody documents must be meticulously maintained.

Seek legal guidance early. If your pharmacy is notified by a manufacturer or Board of Pharmacy, engage counsel immediately to control the narrative and avoid unnecessary sanctions and to ensure you understand all rights afforded in a Board of Pharmacy administrative proceeding. 

The Legal Landscape Is Changing

Gilead’s decision to proactively notify State Boards of Pharmacy signals a shift in manufacturer enforcement strategy. Traditionally, counterfeit drug investigations centered on upstream actors—rogue wholesalers and suppliers. Now, the focus is extending downstream to pharmacies.

Many pharmacies may be unknowingly pulled into regulatory investigations or civil litigation simply for having purchased from non-traditional or discounted sources. Unfortunately, good faith isn’t always a defense when regulators come knocking.

What You Can Do Now

Pharmacists and pharmacy owners should take a proactive approach:

Conduct an internal audit of all purchase activity for high-risk drugs, particularly HIV, oncology, and specialty medications.

Review contracts and sourcing relationships for any gaps in indemnification or compliance responsibilities.

Work with experienced legal counsel to prepare a compliance and response strategy in case you receive an inquiry from a manufacturer or regulator.
Educate your staff. Counterfeit drugs don’t always look fake. Your team should know what red flags to watch for in product packaging, NDC discrepancies, and shipping patterns.

We Help Pharmacies Navigate These Challenges

At our firm, we represent pharmacies targeted by manufacturers and PBMs alike. We’ve defended pharmacies under investigation for counterfeit drug purchases, helped them respond to State Board of Pharmacy inquiries, and built compliance programs that stand up to scrutiny.

If your pharmacy has received a notice from Gilead—or if you’re concerned about your sourcing practices—it’s critical to act fast. The best time to protect your business is before an investigation begins.

Bottom Line:

Gilead’s reports to State Boards of Pharmacy are a warning shot to the entire pharmacy industry. Independent pharmacies must stay vigilant, document sourcing thoroughly, and prepare a legal defense strategy in advance.

If you’re not sure where your risk lies, now is the time to find out.