In response to the increasing threat of illegitimate and counterfeit drugs entering the U.S. pharma supply chain, the Food & Drug Administration (FDA) passed the Drug Supply Chain Security Act in 2013, obliging manufacturers to report suspicious drugs to the agency. The FDA was required to publish a guidance no later than 180 days after the enactment of the DSCSA, so the one released on December 8, 2016, is “a little” overdue, but welcome. It is an edit of the draft published back in 2014, with improved readability and a new section on “High Risk of Illegitimacy Notifications” that they seek comments for. You can find the FDA DSCSA Guidance on “Identification of Suspect Product and Notification” here.
Who Should Read It
Everyone in the drug supply chain. From drug manufacturers, wholesalers, repackagers, & dispensers to online pharmacies, clinics, hospitals and individual practitioners.
The fact that its draft was published two years ago may prompt some companies to take it lightly – bad idea. The guidance is as important as escalating its provisions to every company standard operating procedures. Your employees, too, must be familiar with its provisions. Otherwise, you run the risk of violating the law without realizing it, so make sure you study the new guidance in depth to know your obligations and the procedures for investigating, reporting and terminating the notification of an illegitimate product.
1. DSCSA requires that the trading partners that identify a suspect product quarantine it during the investigation. If the trading partner determines a product is illegitimate, they must notify their trading partners that might have received the product and the FDA. Illegitimate can be either of the following – stolen, diverted, counterfeit, the subject of a fraudulent transaction, intentionally diverted, or otherwise unfit for distribution.
The new section “for comments purposes” requires manufacturers to notify the FDA and their trading partners within 24 hours after identifying or receiving a notification from the FDA that a product poses a high risk of illegitimacy in the following cases:
a) the trading partner believes there is a high risk a product in an immediate trading partner’s possession is illegitimate;
b) there is a high risk of an illegitimate product entering the U.S. drug distribution & supply chain;
c) “other high risk” (pursuant to subsection 582(h)). A manufacturer is recommended, not required though, to notify FDA only.
The FDA describes specific examples for each of these scenarios and a list of circumstances that may lead to them. The agency points out manufacturers may learn about high-risk products from their employees, trading partners, the FDA itself or other regulatory authorities even “when a product may not be in the manufacturer’s possession or control.”
Therefore, the FDA obliges manufacturers to notify the agency of a high-risk product even if the manufacturer is not in possession or control of the product, and provides examples for such scenarios. This obligation is notable as it is significantly broader than other obligations of the trading partners that typically have to be in possession or control of the suspect product to initiate an investigation and notification process.
Third-party logistics providers are not defined as “a trading partner” by the guidance. Therefore, they are not required (but encouraged) to notify the FDA if a situation arises.
2. In order to help companies identify scenarios that increase the risk of a suspect product entering the U.S. supply chain, the guideline outlines several areas where trading partners must be particularly diligent. These include:
- buying from new suppliers
- purchasing from a source that previously engaged in suspicious activity
- purchasing online from unknown sources
- when receiving an unsolicited offer from an unknown source
- when the price is too low for a specific product
and other common sense scenarios. Overall, a transaction that has an increased risk might involve suspiciously low prices, particularly high-in-demand products, drugs subject to a shortage, or those previously counterfeited or diverted, or have a questionable appearance.
3. The FDA recommends for the trading partners to share observations and concerns regarding a suspect product with their partners and seek law enforcement and regulatory authorities help. This is necessary to expedite identification of a suspect product and the following investigation.
Once the suspect product is determined to be illegitimate, a trading partner must notify the FDA and its immediate trading partners of the findings. The FDA will provide an online form on its web page for the companies to fill out.
Note: the guidance goes into detail describing the process of termination of the notification. Companies would have to go back to their submitted notification web form, describe the product & the notification they issued. The companies then need to describe the actions, or the new information, that justify the termination of the notification.
Of special note is that the FDA considers this procedure of termination of notification to be binding, and requires the trading partners to “provide the Agency with an opportunity to provide its expert views and advice.”
Therefore, a trading partner must first receive the response from the FDA to their termination request, and only then notify its trading partners of the termination. The agency sets a 10-business-day period it takes for responding. Only when the company receives a response from the FDA can it notify its trading partners of termination. FDA made minor changes to the Form FDA 3911 and edited the instructions for completing it.
Finally, beginning November 2017, pharmaceutical manufacturers must mark their produce with a National Drug Code (NDC), expiration date, serial number, lot number in the machine- and human-readable formats.
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