Regulatory Focus™ > News Articles > How Can Companies Avoid and Report Counterfeit Drugs? FDA Explains in New Guidance

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Posted 10 June 2014 | By Alexander Gaffney, RAC

How Can Companies Avoid and Report Counterfeit Drugs? FDA Explains in New Guidance


The US Food and Drug Administration (FDA) has released a new draft guidance document detailing how companies, acting under a law passed in 2013, can better protect the safety of the pharmaceutical supply chain.


The law in question is the Drug Quality and Security Act, a law passed in November 2013 with two purposes: to change how compounded pharmaceutical products are regulated, and to better protect the US pharmaceutical supply chain. The latter provision, also known as the Drug Supply Chain Security Act (DSCSA), was originally intended to be in the Food and Drug Administration Safety and Innovation Act of 2012, but was scrapped when legislators couldn't agree on the details of some of its most important provisions.

Once passed, the DSCSA essentially implemented what is known as a pharmaceutical "track and trace" system, so named because it requires manufacturers to label products with tracking numbers (allowing them to be tracked), and allowing any suspect product to be traced back to its point of origin into the system by mandating strict record-keeping requirements.

The DSCSA establishes a system in which all prescription drug packages will need to carry a serial number (reflecting the manufacturing lot) within four years, with unit-level (i.e. package) numbering coming into effect 10 years thereafter.

That number and other information would be recorded each time a drug was passed through the pharmaceutical supply chain, such as from a drug manufacturer to a wholesaler or a wholesaler to a retailer. If a counterfeit medicine was introduced into the supply chain, it would therefore be easier to determine its point of entry by examining the records of each entity.

As Focus has written in the past, while the law covers most pharmaceutical products, it does not cover all of them, such as over-the-counter non-prescription drugs.

FDA has already begun implementing portions of the DSCSA. In February 2014, it released one of the first documents related to the law in the Federal Register, explaining that it wanted feedback on the interoperability of DSCSA transaction standards, which is critical to how information will be shared between members of the supply chain.

New Guidance

Now the agency is out with its second document o

n the DSCSA, a guidance document entitled, DSCSA Implementation: Identification of Suspect Product and Notification.

In short, the document explains some of the elements intended to actually protect consumers from counterfeit, suspect or adulterated drugs found within the supply chain. Under Section 582 of the Federal Food Drug and Cosmetic Act, companies will, as of January 2015, need to have systems in place to quarantine suspect products and conduct prompt investigations regarding their authenticity.

FDA's guidance goes into various "specific scenarios that would significantly increase the risk of suspect products entering the pharmaceutical distribution supply chain and makes recommendations to assist trading partners in identifying and making determinations about suspect product as soon as practicable," it explains.

For example, one section of the guidance outlines actions that may be associated with a higher risk of suspect products entering the supply chain, like purchasing from a new trading partner, receiving unsolicited sales offers, purchasing drugs on the Internet and purchasing products from sources that are themselves suspect (e.g. won't turn over transaction records).

Supply chain entities should also be cognizant that certain products also are naturally more prone to counterfeiting and diversion. For example, drugs that are in high demand, are experiencing shortages, have recently been reported stolen or are expensive may be popular targets for improper entry into the supply chain.

The guidance then goes on to list some actions which should raise the suspicions of purchasing companies, like drugs available at a "too-good-to-be-true" price, drugs contained in tampered packaging, or drugs with obviously fake packaging.

Notification Procedures

But the above factors should already be well known to those in charge of a company's supply chain. So what happens when a company actually finds a suspect product—what should it do then?

As FDA's guidance explains, the company should immediately notify FDA at the following page on its website and submit a Form FDA 3911, which is attached to the guidance for reference.

Once the problem is resolved, companies should file an attachment to that form indicating that no further action is necessary. FDA will not automatically grant this termination, however. As the agency explains:

"FDA interprets the DSCSA’s requirement for trading partners to “mak[e] a determination, in consultation with the Secretary, that a notification is no longer necessary”7 323 to require that trading partners provide the Agency with an opportunity to provide its expert views and advice on proposed terminations of notifications. Therefore, a trading partner must wait until FDA responds to the termination request before the trading partner notifies other trading partners that a notification is terminated."

FDA did indicate that it may speed up requests in some instances, such as to help alleviate potential drug shortages.

The guidance is open for comment for the next 60 days.


DSCSA Implementation: Identification of Suspect Product and Notification

Federal Register Notice


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