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

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

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

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

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

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)

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

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

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.”

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 – http://www.accessdata.fda.gov/scripts/cder/email/drugnotifiaction.cfm 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

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 – http://www.accessdata.fda.gov/scripts/cder/email/drugnotifiaction.cfm 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

Illegitimate / High Risk of Illegitimacy Product Notification Terminating Notification Trading partner responsible for making notification must request for termination Access FDA’s Web page – http://www.accessdata.fda.gov/scripts/cder/email/drugnotifiaction.cfm 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

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