How Pharmacies Should Prepare as the DSCSA Stabilization Period Ends
As the end of the DSCSA stabilization period approaches, Scott Mooney, vice president of distribution operations at McKesson, discussed what pharmacists should consider to be prepared.
The Drug Supply Chain Security Act (DSCSA) was enacted more than a decade ago. Most DSCSA requirements went into effect on November 27, 2023. According to the FDA, those DSCSA provisions “outline[s] steps to achieve an interoperable and electronic way to identify and trace certain prescription drugs at the package level as they move through the supply chain. This helps prevent harmful drugs from entering the US drug supply chain, detect harmful drugs if they do enter the supply chain and enable rapid response to remove harmful drugs from the supply chain to protect patients.”1
But late last August, the FDA announced a 1-year extension—termed a “stabilization period”—to enable the industry to implement, troubleshoot and mature their electronic interoperable systems. Now, pharmacists are required to educate themselves on these DSCSA requirements and be prepared when the November 27, 2024, stabilization period ends.
As the stabilization period draws to a close, Scott Mooney, vice president of distribution operations at McKesson, shared some insights into the stabilization period during a session at McKesson ideaShare 2024. “[The federal government] wanted us to mature the systems that we have, perfect the systems that we have, so that when we go live on November 27th, everything works as it’s supposed to,” Mooney said.
Originally introduced in 2013, DSCSA has experienced a long road to implementation. | image credit: Yevhen / stock.adobe.com
Originally introduced in 2013, DSCSA has experienced a long road to implementation, with changes and exemptions introduced throughout the past 10 years. In early June 2024, the FDA granted another exemption, this one for smaller dispensers, granting more time to comply with soon-to-be enforced DSCSA requirements. Systems for these small dispensers that were intended to go live on November 27, 2024—following the 1-year stabilization period—now have a compliance deadline of November 27, 2026. These small dispensers have been defined by the FDA as organizations with fewer than 25 pharmacists and technicians.2
But despite these delays, Mooney and McKesson are working to educate pharmacists on DSCSA serialization requirements ahead of November 27, 2024.
Mooney detailed 3 specific areas of these pending and existing DSCSA obligations and how they are designed to keep the drug supply chain safe and secure from suspect medications.
“There [are] several key parts to the act,” Mooney told Drug Topics. “Only buy from authorized trading partners, which is the first foundation. There is the data piece, but also equally important for independent pharmacies is suspect and illegitimate drug investigations. [Pharmacists] have to know how to do that, and they have to know how to document that well."
It's important for all pharmacists to work with authorized distributors and manufacturers. Unauthorized businesses can slip through the cracks, but it is ultimately up to the pharmacists to ensure all drugs they purchase are coming from authorized distributors with proper licensing to distribute in their respective states, which has been a legal requirement since 2014.2
Unlike their familiarity with the requirement to vet business partners, pharmacists may be less familiar with the requirements around capturing and tracking all DSCSA data. This tracking can be executed by pharmacy owners themselves, or through third-party solution vendors. According to Mooney, the switch to global location numbers can ensure that both pharmacists and the FDA are able to keep track of every interaction a drug has experienced within the supply chain.2
The third area of DSCSA that Mooney discussed deals with suspect or illegitimate drugs.
“[This] is probably the most misunderstood thing going on in the independent pharmacy space at the moment. And that is that you as a pharmacy [should] have a suspect and illegitimate drug policy in your pharmacy and [should] conduct investigations when you see a product that doesn't look right,” Mooney said.2 “If you're accustomed to a product coming in and it normally has a green cap on it, and all of a sudden, you get a light blue cap on it, that might be an indication that there's something wrong with that product. Before you use that for a patient, you [should] make sure that's a legitimate drug.”
He suggested that every independent pharmacist should have a detailed policy regarding suspect and illegitimate drugs that may come into their pharmacy; these types of policies can be executed with the help of the National Community Pharmacists Association and local board of pharmacy guidance.
Ultimately, DSCSA is designed to help pharmacists “create the data so you can make better informed decisions, because that's really the ultimate thing,” Mooney said.2 “Even if you have the data, if you don't meaningfully use the data, it didn't change anything. But if you're a pharmacy buying products and your product or data [doesn’t look right], you're questioning it, you can now track it back to the manufacturer to make sure it didn't come through an illegitimate market.”
Click here to check out more of our coverage from McKesson ideaShare 2024.
References
1. Drug Supply Chain Security Act (DSCSA). FDA. Reviewed June 18, 2024. Accessed June 25, 2024. https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa
2. Mooney S. Pharma Talk: DSCSA: how McKesson is helping you prepare. Presented at McKesson ideaShare 2024; June 23-26, 2024; New Orleans, LA.
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