FDA Aligns with Pharmacists in Ensuring Integrity of Drug Supply Chain | ASPL 2024

In order to maintain the integrity of the US drug supply chain, it’s the shared goal of pharmacists, manufacturers, and regulators to focus on protecting all pharmaceutical products, and ultimately the patient receiving those products, from harm. From enforcement actions and warning letters to new programs furthering the organization’s mission, the FDA is working around the clock with several supply chain contributors to ensure safety and security within US pharmacies.

“We need to make sure that our federal requirements, layered with our state requirements, maintain the integrity of the pharmaceutical supply chain to protect the product and ultimately protect the patient. That's what all of our goals are. We all have a common goal,” said Leigh Verbois, PhD, Director of the Office of Drug Security, Integrity, and Response at the FDA.¹

Verbois gave a presentation detailing what pharmacists should know about the FDA’s key rules and regulations. | image credit: Anny Art / stock.adobe.com

At the American Society of Pharmacy Law’s 50th Developments in Pharmacy Law Seminar, Verbois gave a presentation detailing what pharmacists should know about the FDA’s key rules and regulations like the Drug Supply Chain Security Act (DSCSA), FDA warning letters, and the act of combatting counterfeit drugs as a whole.

READ MORE: How DSCSA Serves as the Drug Supply Chain’s Lead Investigator | ASPL 2024

Verbois started her presentation by giving the audience some background on the FDA office she works for. While the FDA has various responsibilities regarding the drug supply chain, Verbois’ focus is on the FDA’s Center for Drug Evaluation and Research (CDER). Within the CDER, she works in the Office of Compliance, with the mission of shielding patients from “poor-quality, unsafe, and ineffective drugs through proactive compliance strategies and risk-based enforcement actions.”¹

Regarding the enforcement actions her office is so familiar with, Verbois touched on the DSCSA. Representing the organization who enforces the statute, she discussed how the DSCSA is like a tool belt for pharmacists, regulators, and supply chain entities alike to recognize and flag suspicious inventory.

“DSCSA outlines steps to have an interoperable electronic tracing of products at the package level to ensure that those packages were distributed throughout the United States with identity and tracing for certain prescription products. It enhanced ability to protect consumers from exposure to counterfeit, stolen, contaminated, or otherwise harmful products, ensuring that we all had additional tools in our tool belt to determine if those products were counterfeit, stolen, contaminated, or otherwise harmful,” continued Verbois.¹

Enacted in 2023, all stakeholders impacted by the DSCSA had 10 years to understand provisions under the law before it officially went into effect in 2023. In the meantime, FDA has delivered over 20 guidance documents to help individuals prepare and has even issued an exemption period for smaller dispensers needing more time to comply with the requirements. That exemption will be lifted in November 2026, when the law will go fully into effect for all parties involved with the drug supply chain.

Among other requirements, the DSCSA is designed to hold supply chain actors to the highest of standards, from understanding the 4 product identifiers on every pill bottle to only working with authorized trading partners. While the DSCSA is the FDA’s most notable legislation within the pharmacy industry, it’s not the only statute that upholds the integrity of the drug supply chain. Verbois also mentioned 582(g)(1) of the Federal Food, Drug, and Cosmetic Act, touching on data and the safe and secure exchange of information.

“In 582(g)(1), there's requirement that any information must be exchanged in a secure, interoperable manner. It should include the product identifiers at the package level. For verifications, it should be at the package level. You must promptly respond to information and properly facilitate a gathering if a federal or state official asks for that information and you must be able to associate the saleable return with the transaction information or the transaction statement,” she said.¹

After laying out the rules and regulations FDA is enforcing to ensure a safer supply chain, Verbois pivoted to some real-world examples of entities failing to do their due diligence. One instance was in June of 2023 when FDA sent a warning letter to wholesale distributing company Safe Chain. They were notified that they had inadequate verification systems and were working with unauthorized trading partners.

“FDA cited 4 DSCSA violations in the warning letter. They didn't have systems in place to be in compliance with the verification requirements. They were conducting transactions with trading partners that were not authorized. They did not maintain records of suspect product investigations and they didn't respond to notifications of illegitimate product,” said Verbois.¹

According to her, these 4 actions were significant violations of the DSCSA and it was the first warning letter FDA issued under the newly enacted statute. Authorized trading partners operating under the DSCSA have had 10 years to understand the law’s requirements. But with less than a year since implementation, it seems associated parties are still struggling to meet all requirements.

“We don't take this mission lightly. We work really hard to identify the solutions that we need to bring to the table, to be proactive, to prevent the introduction of products into the US drug supply chain. And we work across our entire office to identify how we can do that,” she concluded.¹

Check out more of our ASPL 2024 coverage here.

Are you ready to elevate your pharmacy practice? Sign up today for our free Drug Topics newsletter and get the latest drug information, industry trends, and patient care tips, straight to your inbox.

Reference

1. Verbois L. FDA Presentation. Presented at: 2024 Developments in Pharmacy Law Seminar; November 7-10, 2024; Phoenix, AZ.