In March, the FDA finalized its guidance on how to consider potentially dangerous products. The release can help trading partners across the pharmaceutical supply chain achieve verification requirements for DSCSA, where trading partners must have processes in place to identify, report, and dispose of potentially dangerous products.
The guidance helps determine whether a product should be considered "suspect" or "illegitimate" as they appear in the Federal Food, Drug, and Cosmetic Act -- thus determining how they ought to be dealt with -- by interpreting several terms for security threats. The guidance notes that while its list of definitions can't account for every scenario that trading partners may encounter, it describes the most common ones.
We've assembled a rundown of these definitions -- take a look!
Counterfeit is interpreted to mean a product that wrongly shows, or is labeled with, the trademark, trade name, or likeness of trading partners other than those involved in its creation, packaging, and distribution.
Diverted product is described as one that left the U.S. pharma supply chain, but was brought back into it via a transaction with a trading partner. Similarly, this applies to product labeled for sale in a non-U.S. market, yet brought into the U.S. supply chain through a transaction.
(It's important to note that this applies to any way a product might leave the supply chain, including having been removed by a trading partner for other reasons, or having already been dispensed to a patient.) However, the guidance also includes counter-examples where a product could enter the U.S. supply chain yet not be deemed "diverted." These include a trading partner's surveillance activities, FDA actions to address drug shortages, and the FDA's Emergency Use Authorization.
Stolen is used to define products -- whether the entire product, or just packaging or contents -- that are taken without permission at any point in the supply chain. The guidance notes that this should not apply to products that may be lost or missing under other circumstances, and points readers to its 2021 Enhanced Security guidance, which addresses "aggregation errors and other discrepancies."
Fraudulent transaction applies when T3 data (Transaction Information, Transaction History, and Transaction Statement) contains intentionally falsified information. Again, the FDA urges caution on how this is used, noting that such instances may not be immediately evident, and that clerical errors or other discrepancies may be to blame.
Unfit for distribution is meant to refer to drugs whose sale would violate the FD&C Act, given evidence that the product is dangerous: altered, adulterated, recalled, damaged, expired, and so on. Misbranded products that could harm a user are covered here as well.
Throughout, the guidance encourages pharma trading partners to follow their policies and procedures for investigating products to make these determinations. Given that we're just a few months from the final DSCSA enforcement deadline, this shows the FDA is working from the understanding that everyone in the industry has been using the long DSCSA implementation period to prepare: every company needs a solid playbook to make these decisions and follow up with partners and the FDA itself.
Don't assume that everyone on your team will handle these scenarios optimally without well-constructed and tested SOPs. Logistical issues and sensitivities vary from company to company, and you'll want processes that are a good fit for your workflows and are easily repeatable. Time pressure will be a factor, and reliability in your internal procedures can add speed and reduce uncertainty in supply chain operations.