FDA Posts Draft Guidance on Due Diligence and Product Notifications in Pharma Supply Chain
The Food and Drug Administration posted a draft guidance on identification of suspect product in pharmaceutical supply chains and subsequent notifications to FDA, as required by the Drug Supply Chain Security Act. Beginning on Jan. 1, 2015, “trading partners” as defined by the 2013 law must notify FDA when they come across “illegitimate product.” The draft guidance includes scenarios that should raise red flags for supply chain participants, as well as due diligence activities that should be undertaken and the procedure for submitting and terminating notifications when illegitimate product is found. Comments on the draft guidance are due Aug. 11, according to a concurrent Federal Register notice (here).
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The notification requirements apply to “trading partners,” defined as the “manufacturer, repackager, wholesale distributor or dispenser.” It does not include third-party logistics providers (3PLs), but FDA “encourages 3PLs to follow the recommendations in this guidance to the extent relevant to the 3PL’s operations,” it said.
(FDA says its draft guidances do not create legal requirements, but only describe FDA’s “current thinking on a topic.” They should only be viewed as recommendations unless specific legal requirements are cited, it said.)
Notification Requirements Begin on Jan. 1, 2015
Under the Drug Supply Chain Security Act, which became law in November 2013 (see 13121725), trading partners must quarantine a product and conduct an investigation whenever they find that they are in possession or control of a “suspect product.” Suspect product includes potentially counterfeit, stolen, intentionally adulterated, fraudulent, or dangerous pharmaceuticals. If the trading partner finds that the suspect product is actually “illegitimate product” -- product that is actually counterfeit, stolen, intentionally adulterated, fraudulent, or dangerous -- it must notify FDA within 24 hours of making its notification. Manufacturers must also notify their immediate trading partners within 24 hours. These requirements take effect Jan. 1, 2015.
Some Scenarios Heighten Drug Supply Chain Risks
Certain scenarios “significantly increase” the risk of suspect product entering the pharmaceutical supply chain, said FDA. As such, supply chain participants should be on the lookout for the following situations:
Trading partners and product sourcing. Purchasing from new sources, an unknown source found on the internet, and purchasing from sources that are known to have dealt in suspect products in the past. Also, receiving unsolicited sales offers from unknown sources.
Market concerns. Products that are in high demand or have high sales volumes or prices, as well as product that has previously been found to be illegitimate or has been subject to an FDA counterfeit or cargo theft alert.
Product appearance. Misspellings or non-standard labels, foreign terms or identification systems, missing information, missing anti-counterfeit technologies, or signs of poor quality in the product itself.
Supply Chain Should Exercise Due Diligence to Find Suspect Product
In order to catch suspect product as soon as possible before it enters commerce, pharmaceutical supply chain participants should exercise due diligence, said FDA. Supply chain participants should discuss with each other any observations, questions, or concerns they have on whether a drug is suspect. They should also be in contact with the government for help when additional expertise is necessary. In addition, supply chain members should use the following strategies for identifying suspect product on their own:
- Beware of offers that are too good to be true.
- Closely examine the package and transport container to look for signs it has been compromised or tampered with or comes from an unexpected source.
- Closely examine the label on the package or the label on the individual retail unit to see if it is missing information, has been altered, includes misspelled words, is in a foreign language, or has other issues like bubbling on the surface of a label, a strange product name, or lot numbers that don’t match.
Form 3911 Used to Notify FDA of Illegitimate Product, Terminate Notifications
Once a “trading partner” has determined that a product is illegitimate, they must notify FDA starting on Jan. 1, 2015. FDA will provide information on its website (here) on how that notification should be made. FDA Form 3911 will be used to provide information about the entity initiating the notification, the illegitimate product, and a description of the circumstances that led to the notification.
“Trading partners” must also have systems in place to terminate a notification beginning in 2015, said FDA. They should use the same Form 3911 for termination, and include an explanation of what has taken place or what information has become available to make the notification no longer necessary. FDA will then review the request and consult with the “trading partner”, it said. FDA must respond to the termination request before the trading partner notifies other trading partners that a notification is terminated. That should happen within 10 days, although FDA may tell the trading partner it needs additional time, it said. Expedited review may be requested, said FDA.
Once FDA has provided its “consultation response” and the trading partner “determines that the notification is no longer necessary,” the trading partner who requested termination must “promptly notify” immediate trading partners that the notification has been terminated. Means of communication may include posting to the company website, sending an email, or mailing or faxing a letter.
(See FDA’s draft guidance for a draft Form 3911 and draft instructions for completing the form.)