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

The Drug Supply Chain Security Act (DSCSA) was created to serve as a regulatory law used to track, and more importantly, trace the safe and secure buying and selling of prescription medications. While it is more of an ownership-level law than it is a shipping law, the DSCSA was designed for supply chain entities to have a collaborative and detailed database of all prescription drug transactions.

“And if you think about how the law works from a functional perspective, from an operational perspective, it's really more of a trace law than it is a track-and-trace. It's really about retrospective and being able to see and get the bottle of rocks and figure out information going backwards, not necessarily the other way around,” said Justin Macy, PharmD, JD, Director of Innovation with the National Association of Boards of Pharmacy.¹

At the American Society of Pharmacy Law’s 50th Developments in Pharmacy Law Seminar, pharmacy law experts gave a presentation titled “Regulatory, Industry and Legal Perspectives on the Future of the DSCSA.” Macy started the session by discussing an instance where, prior to DSCSA, bad actors within the supply chain manipulated prescription drugs, eventually leading to rocks appearing in the packaging for an HIV medication.

Pharmacy law experts gave a presentation titled “Regulatory, Industry and Legal Perspectives on the Future of the DSCSA.” | image credit: Рудой Максим / stock.adobe.com

READ MORE: How Pharmacies Should Prepare as the DSCSA Stabilization Period Ends

Explaining how exactly it happened, Macy said that a patient would buy prescriptions from a pharmacy, sell the bottle back to the pharmacy or a solutions company to then clean it, falsify transaction history to show that the prescription has been properly distributed, and finally, the bottle is sold back to the distributor who then sends it out to pharmacies nationwide. This simple process ultimately ended in a $250 million-plus lawsuit toward pharmacies for their lack of due diligence, an occurrence that is intended to be fully thwarted with the inception of the DSCSA.¹

Enacted in 2013, the DSCSA requirements were set to go into effect on November 27, 2023, after 10 years of deliberation and preparation for authorized trading partners (ATPs).² But in July 2024, dispensers with 25 or less employees were given a 2-year exemption for their DSCSA requirements, extending to November 27, 2026.

With over 10 years of the DSCSA’s history behind us but at least a 5-year road ahead of discussing the law in constant conversations, Macy and his colleagues dove deep into the statute and what exactly pharmacists need to be prepared for DSCSA rollout. Macy started by discussing the importance of both product tracing and product verification.

First, product verification is the simple way of collecting and storing prescription drug data to then be monitored by the proper regulators and drug supply chain entities. Product verification includes the prescription’s National Drug Code, lot number, expiration date, and serial number. “A product verification is a trading partner or regulator taking that information, calling the manufacturer, contacting them, and saying, ‘Hey, are these 4 product identifiers the thing you intended to put on a bottle, and is it still a good bottle?’” said Macy.¹

Product tracing, on the other hand, is a bit more of an involved aspect of the DSCSA, according to Macy. Tracing is the investigative tool fueled by the DSCSA to ensure all products are safe and continue to be safe even after they move from a manufacturer to a patient.

“Imagine a regulator contacts a trading partner and says, ‘I would like to know everyone you previously transacted with on this product, or this serial number for this product,’ providing all that TI data that you previously had, and being able to do it. They then can ask everyone else in the supply chain, ‘Can you recreate that transaction history, but this time, validate it?’ Because the transaction of the buyer and the seller should match,” he continued.¹

Next, Macy’s colleague, Jenni Wai, RPh, MBA, Chief Pharmacist with the State of Ohio Board of Pharmacy, discussed what ATPs and dispensers can look out for when it comes to suspect or illegitimate products. “Now these red flags are very apparent to note. They come in questionable containers, excessive adhesive residues, even foreign identification numbers, missing information,” she said. “I can tell you that from the compliance side, enforcement side, counterfeit drugs and illegitimate drugs do surface quite often in our drug supply chain.”

Wai highlighted the utmost importance of keeping pharmacy staff trained and educated on flagging illegitimate products. She also expressed the importance of documentation throughout the drug supply chain as well as the authorization of trading partners. While the DSCSA is a complex new look at regulatory standards within the drug supply chain, its checks and balances are designed to ensure all patients are receiving their care from the appropriate sources.

“When it comes to dispensers, and I can even tell you that as a state regulator, it really hasn't hit home to us until probably a couple of years ago when we were like, ‘Wait, what's DSCSA?’ We're still learning about DSCSA. What's all the requirements? So, a lot of cooperation, collaboration, and solution-finding is important here,” concluded Wai.¹

Check out more of our ASPL 2024 coverage here.

Pharmacy practice is always changing. Stay ahead of the curve: Sign up for our free Drug Topics newsletter and get the latest drug information, industry trends, and patient care tips, straight to your inbox.

References

1. Macy J, Wai J, Smith CR. Regulatory, industry and legal perspectives on the future of the DSCSA. Presented at: 2024 Developments in Pharmacy Law Seminar; November 7-10, 2024; Phoenix, AZ.

2. DSCSA compliance policies establish 1-year stabilization period for implementing electronic systems. News Release. FDA. August 30, 2023. Accessed November 12, 2024. https://www.fda.gov/drugs/drug-safety-and-availability/dscsa-compliance-policies-establish-1-year-stabilization-period-implementing-electronic-systems