Securing the Supply Chain Through Interoperability and Vigilance

Justin Macy, PharmD, JD, director of innovation at the National Association of Boards of Pharmacy (NABP), and Andrew Funk, director of member relations and government affairs at NABP, presented a session at the Total Pharmacy^® Solutions Summit detailing the final steps for compliance with the Drug Supply Chain Security Act (DSCSA). Describing the decade-long implementation as a "relay race" that began with manufacturers, they emphasized that the final milestone for small dispensers is fast approaching this November.

Although DSCSA is often viewed as a regulatory burden, Macy and Funk illustrated its necessity through harrowing case studies of supply chain failures. One significant example involved a patient buyback scheme for the HIV medication bictegravir/emtricitabine/tenofovir (Biktarvy), where people purchased used bottles, filled them with rocks or antipsychotic medications, and reintroduced them into the supply chain through "fly-by-night" wholesalers. Another case highlighted counterfeit semaglutide (Ozempic) found in the supply chain during a period of high demand and shortage, which contained nonsterile needles and resulted in patient harm. These examples underscore that the DSCSA’s primary goal is protecting public health by ensuring the legitimacy of every drug package.

The 4 Pillars of Dispenser Readiness

Macy and Funk organized the path to compliance into 4 buckets for pharmacies to address:

• Authorized trading partners: Pharmacies must verify that they only transact with manufacturers, repackagers, and wholesale distributors that are appropriately licensed by the state and registered with the FDA.
• Serialized transaction data: As of 2023, the industry has shifted from lot-level tracking to serialized data, where every individual bottle is a unique item with its own serial number. Dispensers must ensure these data are stored and retrievable for at least 6 years.
• Suspect and illegitimate product investigations: Pharmacies must have processes to identify “suspect products”—those they have reason to believe are counterfeit or diverted—and escalate to "illegitimate" if there is credible evidence.
• Policies and procedures (P&Ps): State boards of pharmacy prioritize P&P adherence. P&Ps are the operational instructions that ensure a pharmacy can handle a regulatory inquiry or a product investigation even in the absence of the manager.

Key Takeaways From the Presentation

• Entities with fewer than 25 full-time equivalent employees—pharmacies or technicians—have a compliance deadline of November 2026.
• Traditional paper-based transaction histories have gone away. Pharmacies must now be able to put the chain of ownership back together using serialized electronic data.
• Dispensers should be wary of unsolicited sales offers, products in shortage offered by new sources, or packaging with typos, unusual adhesive residue, or the smell of solvents.
• If a product is determined to be illegitimate, the dispenser has 24 hours to notify the FDA using Form 3911.

To facilitate the communications required by DSCSA, NABP developed Pulse, a digital platform that serves as connective tissue between regulators and trading partners. Pulse allows dispensers to perform product verifications for free, enabling them to scan a barcode and instantly ask a manufacturer whether the serial number is valid. This tool is designed to streamline investigations and ensure that even small pharmacies can meet high-technology regulatory standards without significant cost barriers.

A Call for Operational Alignment

The experts concluded with a reminder that compliance must be integrated into daily workflows. Funk noted that when inspectors see a disconnect between written policies and actual operations, it sets the stage for broader regulatory concerns. Macy and Funk suggested that floating or relief pharmacists should be familiar with the pharmacy's specific P&Ps and ensure that every order is evaluated for legitimacy at the point of receipt. They urged dispensers to finalize their training and utilize available free resources as the November deadline nears to ensure pharmacists are ready to protect their patients from an increasingly complex global threat landscape.