New Requirements on FDA Notification of Suspected Illegitimate Products To Begin January 1, 2015

FDA issued a Draft Guidance, entitled Drug Supply Chain Security Act Implementation:  Identification of Suspect Product and Notification (here) which describes the proper means of notification of FDA by trading partners of the potential suspect products.  The requirements under the Drug Supply Chain Security Act (DSCSA) will kick in on January 1, 2015 and also requires firms to identify other immediate trading partners of their suspicion.  The Guidance defines trading partners as manufacturers, repackagers, wholesalers or dispensers and requires the notice to be given to FDA within 24 hours of identifying a suspect product.

Under the Guidance a “[S]uspect product is defined in section 581 of the FD&C Act as a product for which there is reason to believe it (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; or (D) appears otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans.” 

The Guidance provides example of scenarios that trading partners should pay attention to in alerting them to a possible suspect product from other trading partners or product sourcing options; cautions firms to be wary of supply history, value of the product; and appearance of the product.  Some passages from the Guidance can be found below. 

Be alert for offers of product for sale at a very low price or one that is “too good to be true” 

  • Closely examine the package and the transport container (such as the case or tote):- To look for signs that it has been compromised (e.g., opened, broken seal, damaged, repaired, or altered).
  • To see if it has changed since it was last received for an unexplained reason (e.g., a notification about the change from the manufacturer has not been received)
  • To see if product inserts are missing or do not correspond to the product.
  • For shipping addresses, postmarks, or other materials indicating that the product came from an unexpected foreign entity or source.

Closely examine the label on the package, or the label on the individual retail unit, if applicable, for: 

  • Any missing information, such as the lot number or other lot identification, NDC, or strength of the drug
  • Any altered product information, such as smudged print or print that is very difficult to read.
  • Misspelled words.
  • Bubbling in the surface of a label.
  • Lack of an Rx symbol.
  • Foreign language with little or no English provided.
  • Foreign language that is used to describe the lot number
  • A product name that differs from the name of the FDA-approved drug.
  • A product name that is the product name for a foreign version of the drug.
  • A product that is transported in a case or tote, when not expected under the circumstances.
  • Lot numbers and expiration dates on product that do not match the lot 256 numbers and expiration dates of its outer container. 

The Guidance also describes how to notify FDA of the suspect product, indicated that the product should be quarantined until the investigation is complete and, if the product is found not to actually be a problem product, how to notify the FDA of the termination of the notification.

So get ready – here is something else that the supply chain must being doing on the first of the year to aid in further securing the entire supply chain.  It is everyone’s business to assure that only legitimate and non-tampered with products ultimately reach the consumer.