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How to Notify the FDA of a Illegitimate Product

Christian Souza

Steps for FDA Notification

One of the questions we get at TrackTraceRx is, “how do I notify the FDA if i discover a counterfeit product within my supply chain?”

The DSCA section 582(h)(2) requires the FDA to issue guidance to aid trading partners in identifying a suspect product. Let’s first identify what the FDA considers a suspect product.

a – is potentially counterfeit, diverted, or stolen.

b – is potentially intentionally adulterated such that the product would result  in serious adverse health consequences or death to humans.

c – is potentially the subject of a fraudulent transaction.

d – appears otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans.

Pretty clear guidelines for you to classify a product as a suspect product. Once you have determined that the product is a suspect product, here is what you need to do next.

Quarantine

Quarantine the product and conduct an investigation to determine if the product is a illegitimate product.

The DSCSA defines a illegitimate product as:

a – counterfeit, diverted, or stolen.

b – intentionally adulterated such that the product would result in a serious adverse health consequences or death to humans.

c – is the subject of a fraudulent transaction.

d – appears otherwise unfit for distribution such that the product would be reasonable likely to result in a serious adverse health consequences or death to humans.

Identification of a Suspect Product

Trading partners must have systems in place that enables them to start investigating a suspect product either by determining that the product is suspect or by a request from the FDA. The trading partner must then quarantine the product and work with their respective trading partners within the supply chain. Here are some best practices you should follow to identify a suspect product:

1. Exercise vigilance

2. Maintain awareness about suspicious activity

3. Look our for potential threats to your supply chain

4. Devote attention and effort to detect suspect products

Product Sourcing:

Receiving sales offers from a new trading partner or unknown source unwilling to provide a transaction history with the product being purchased.

Suspicious Appearance, label misspellings or not following usual color, font and images. Also packages that are missing key information such as a lot number and a different identification number rather than the National Drug Code (NDC)

Trading partners should closely examine the package and look for signs that is has been opened, broken seal, damaged, repaired and altered. Trading partners should also look for missing information such as a lot number, lot identification, NDC or strength of drug.

“Once you have identified that a product is “illegitimate”, the trading partner has 24 hours to notify the FDA and their respective trading partners.”

Notifying the FDA

Once you have identified that a product is “illegitimate”, the trading partner has 24 hours to notify the FDA and their respective trading partners.

Trading partners should have a system in place that can automatically send out a notification to the FDA (like the TrackTraceRx Portal). If not, the trading partner will have to perform this manually by accessing the FDA’s web site: http://www.accessdata.fda.gov/scripts/cder/email/drugnotification.cfm and follow the instructions to construct their own form. (The form on the FDA web site is only a draft.)

Trading partners will then have to create and manually fill out a form (roughly four pages long). This form will include:

Pay attention to the FDA form

Type of Notification:

This form will require initially that you identify what type of report this is:

a – Initial notification – first notification to the FDA of an illegitimate product or product with a high risk of illegitimacy.

b – Follow-up Notification – subsequent notification to FDA, related to an initial notification already submitted to the FDA.

c – Request for Termination – request for consultation with the FDA to terminate a notification of an illegitimate product or production with a high risk illegitimacy.

Classification of Notification:

Counterfeit – A product in your possession or control is determined to be counterfeit.

Diverted – A product in your possession or control is determined to be counterfeit.

Stolen – A product in your possession or control is determined to be a stolen product.

Intentional adulteration – A product in your possession or control is intentionally adulterated such that use of the product would result in serious adverse health consequences or deaths to humans.

Unfit for distribution – A product in your possession or control appears otherwise unfit for distribution such that use of the product would be reasonably likely to result in serious adverse health consequences or death to humans.

Fraudulent transactions – A product in your possession or control is the subject of a fraudulent transaction.

Description of Product:

A description of the illegitimate product will need to be added. The following description will need to be added such as, Generic name, Trade name, Drug use, Drug description, Strength, Dosage form, Quantity, NDC, Serial, Lot, and Expiration.

Company and Facility Information

The Company name of the Trading partner and address will need to be provided that is responsible for the product or for the notification. A unique identifier for the facility should be provided. For now, the only identifier that the FDA accepts is A D-U-N-S number. If the facility does not have a D-U-N-S number then this field should be left blank. A D-U-N-S number can be obtained for no cost from Dun & Bradstreetfor free.

The name of the person needs to also be reported that submitted the notification. This person will also need to provide their email and telephone information.  Finally, a category for the company needs to be submitted. This category will need to be one of the following:

Manufacturer, Wholesale distributor, Dispenser, Repackager.

Emailing the FDA

Once the form is complete, the Trading partner will have to email the form to DrugNotifications@fda.hhs.gov

Free DSCSA Evaluation

With the deadline fast approaching, contact TrackTraceRx today to receive a free evaluation of your DSCSA current policy and procedures. This free consultation will allow you to have a piece of mind that you are following the correct procedures in order to meet ALL DSCSA requirements. TrackTraceRx will also provide you with a FREE Standard Operating Procedure (SOP) template which is required by the DSCSA during a FDA inspection.

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