1. Identification of Suspect Product and Notification
DSCSA Implementation
Identification of Suspect Product and Notification

2. Agenda
Background
Drug Supply Chain Security Act
Identifying Suspicious Product / Product with High Risk of Illegitimacy
Scenarios
Recommendations
Notification of Illegitimate Products / Products with High Risk of Illegitimacy
FDA Notification Scenarios
Notification to FDA
Notification Process for Terminating Notification

3. Background Drug Supply Chain Security Act (DSCSA)
Signed into law on November 27th 2013
FDA required to issue guidance assisting trading partners
Identifying suspect product
Terminating notifications
Suspect / Illegitimate product – definition
Potentially counterfeit, diverted, or stolen
Intentionally adulterated – result in serious health consequences
Subject to fraudulent transaction
Appears unfit for distribution – result in serious health consequences

4. Identifying Suspicious / High Risk of Illegitimate Products
Scenarios
Trading Partners and Product Sourcing
Purchasing from a source new to trading partner
Receiving unsolicited sales offer from unknown source
Internet purchasing from unknown source
Purchasing from a source that a trading partner believes engaged in questionable/suspicious business practices
Partner involved in transactions where illegitimate products was sold/delivered
Partner has history of false transaction histories/pedigrees (incomplete info./misspelled words)
Partner is reluctant to provide transaction history or is not done in a timely manner
Partner provides incomplete/suspicious T3 data

5. Identifying Suspicious / High Risk of Illegitimate Products
Scenarios
Supply/Demand History/Value of Product
High demand for product in U.S. market
Higher demand products – potential/perceived relationship to public health or emergencies
Example – antiviral drugs
High sales volumes or prices for product
Price offering that is “too good to be true”
Previously/currently being counterfeited or diverted
Previously/currently subject to shortage
Previously/currently subject of illegitimate product notification
Previously/currently subject to FDA counterfeit/cargo theft alert

6. Identifying Suspicious / High Risk of Illegitimate Products
Scenarios
Product Appearance
Suspicious package (case or tote) appearance
Label – misspellings/different from standard label (color, font, images)
Package exhibits unusual/excessive adhesive residue
Contains foreign identification features (replacing the expected National Drug Code (NDC))
Missing information – lot number or expiration date
Security/anti-counterfeiting technologies missing – normally featured on FDA-approved products
Easily visible to the eye – holograms, color shifting inks, neckbands, watermarks
Finished dosage appears suspicious
Shape/color, unusual imprint, odor, poor quality (chips/cracks to coatings, smeared or unclear ink imprints)

7. Identifying Suspicious / High Risk of Illegitimate Products
Recommendations
Product offered for sale at a extremely low price – “too good to be true”
Examine package and transport container (case or tote)
Signs of being compromised
Package or container has changed since the last shipment of that product type
Product inserts missing, don’t match product, or suspicious
Examine label on the package and if applicable the saleable unit
Any missing/incorrect information? (lot #, NDC, strength, lot ID, Rx only symbol, misspelled words)
Altered product information – smudged print, print difficult to read
Bubbling in the surface of a label
Foreign language – little or no English provided and or used to describe lot number

8. Identifying Suspicious / High Risk of Illegitimate Products
Recommendations (cont.)
Examine label on the package and if applicable the saleable unit
FDA-approved drug label differs from the product name
Product name for a foreign version of the drug is used
Product transported in a case or tote – not expected under the circumstance
Lot #’s and expiration dates on product differ from outer container

9. Illegitimate / High Risk of Illegitimacy Product Notification
FDA Notification - Scenarios
Manufacturer determines or is notified by the FDA/trading partner that there is a high risk, has substantial reason to believe an immediate trading partner has possession of illegitimate product
Example: “Manufacturer learns that its product has been stolen or diverted in the United States while not in its possession or control, and the manufacturer has reason to believe that an immediate trading partner might have the stolen product or diverted product in its possession.”
Manufacturer determines or is notified by the FDA/trading partner that the product has inherently high risks that increase the likelihood of illegitimate product entering the supply chain.
Example: “Manufacturer learns from a foreign regulatory authority that one of its products has been counterfeited in a another country, and that some of that product is on a cargo ship destined for the United States for delivery to a wholesale distributor.”
Manufacturer determines or is notified by the FDA/trading partner that “other high risks determined by the FDA guidance subsection 582(h)” exist with the product.
Example: “A manufacturer learns that a licensed practitioner is administering an oncology drug to patients that purports to have been manufactured by that manufacturer, but the manufacturer determines that there is a high risk that the drug is counterfeit.”

10. Illegitimate / High Risk of Illegitimacy Product Notification
Notification to FDA - (within 24 hours after determining illegitimate/high risk)
Process to Notify FDA of Illegitimate Products
Access FDA’s Web page –
Follow instructions for accessing FORM FDA 3911 (Appendix 1)
Submit Form FDA 3911 using method provided
FDA to acknowledge receipt of notification – incident number to be assigned
Notify all immediate trading partners – reason to believe they may also possess drug

11. Illegitimate / High Risk of Illegitimacy Product Notification
Notification to FDA
Process to Notify FDA of product with High Risk of Illegitimacy
Access FDA’s Web page –
Follow instructions for accessing FORM FDA 3911 (Appendix 1)
Submit Form FDA 3911 using method provided
FDA to acknowledge receipt of notification – incident number to be assigned
Notify all immediate trading partners – reason to believe they may also possess drug
If product is found illegitimate:
Follow-up notification explaining classification update referencing incident number of original notification
If product is not found to be illegitimate
Submit request for termination to the FDA

12. Illegitimate / High Risk of Illegitimacy Product Notification
Terminating Notification
Trading partner responsible for making notification must request for termination
Access FDA’s Web page –
Follow instructions for accessing FORM FDA 3911 (Appendix 1)
Submit Form FDA 3911 using method provided
FDA will review the request/consult with trading partner
Intends to respond within 10 business days – may be request for additional time to respond
Post FDA consultation response/trading partner determines notification is no longer required
Promptly notify immediate trading partners that notification has been terminated

13. Questions

14. THANK YOU