Being Prepared for Track and Trace: DSCSA 101 Susanne Somerville, Founder The LinkLab Eric Garvin, Founder, The LinkLab Brian Daleiden, VP Industry Marketing and Co-Founder, TraceLink
Objective of Today s Webinar Overview of DSCSA: What is required for Manufacturers, Distributors, and Dispensers How does the EU law differ from what we have to do in the US? Checklist / Questions for your Packager Checklist / Questions for your 3PL Partner Checklist / Questions for your Serialization System Partner Key factors to make your project successful Q&A
DSCSA Overview JANUARY 1, 2015 Trade with authorized trading partners Provide transaction information to trading NOVEMBER 27, 2020 DISPENSER partners Quarantine and investigate suspect products Identify and remove illegitimate products, and notify FDA and trading partners NOVEMBER 27, 2018 REPACKAGER NOVEMBER 27, 2023 Participate in electronic package-level traceability system NOVEMBER 27, 2019 WHOLESALE DISTRIBUTOR NOVEMBER 27, 2017 MANUFACTURER Serialize with unique product identifier Provide transaction information to trading partners in electronic format Respond to verification requests from trading partners Verify unique product identifier of suspected products at package level Verify the unique product identifier of returned products intended for resale
DSCSA Key Definitions Manufacturer, Wholesale Distributor Manufacturer Holds an application approved under section 505 of the Public Service Health Act (NDA, ANDA) Holds a license issued under section 531 of the Public Service Health Act (BLA) If product not subject to an approved application or license, the person who manufactured the product A co-licensed partner of the application holder, license holder or product manufacturer An affiliate of the application/license holder or colicensed partner Wholesale Distributor A person that engages in wholesale distribution (distribution of a drug to a person other than a consumer or patient, or receipt of a drug by a person other than a consumer or patient) Excludes: (following not considered a wholesale distribution transaction) Distribution of a drug by the manufacturer of a drug Intra-company distribution of a drug between members of an affiliate or within a manufacturer Distribution of a drug among hospitals / health care entities under common control Distribution by a licensed retail pharmacy to a licensed practitioner Dispensing of a drug Authorized 3PL where 3PL does not take ownership Distribution of a drug to an authorized repackager that takes ownership and repacks Facilitating distribution of a drug by providing administrative services (orders, payments) Transportation of a drug by a common carrier that does not take ownership Distribution for emergency medical reasons (NOT INCLUDING DRUG SHORTAGES)
DSCSA Key Definitions Repackager, 3PL, Exclusive Distributor, Dispenser Repackager A person who owns or operates an establishment that repacks and re-labels a product or package for: Further sale Distribution without a further transaction 3PL A company that provides/coordinates warehousing of product but: Does not take ownership [of the product] Does not have responsibility to direct the sale or disposition of a product Exclusive Distributor A wholesale distributor that purchases the product from the manufacturer and is the sole distributor of that product for the US market Dispenser Retail or hospital pharmacy Group of chain pharmacies under common ownership that DO NOT act as a wholesale distributor Other persons authorized to dispense or administer prescription drugs (long-term healthcare facilities with pharmacy operations, etc.) Affiliated warehouses or DCs of such pharmacies under common ownership that DO NOT act as a wholesale distributor
DSCSA Key Definitions Product, Package and Case Product Prescription drug in finished dosage form for administration to a patient without substantial further manufacturing E.g. capsules, tablets, lyophilized products before reconstitution [but NOT API or Intermediates] Excludes: Blood products or components intended for transfusion Radioactive drugs and biological products (regulated by the NRC or a State) Imaging drugs Intravenous products (fluid replenishment, calorie replacement, dialysis solutions, sterile water, etc.) Medical gasses Homeopathic drugs Drugs compounded (in compliance with sec 503A or sec 503B) Package Smallest individual saleable unit of product for distribution by a manufacturer or repackager intended for individual sale to the dispenser of such product Homogeneous Case Sealed case containing only product with a Single NDC and a Single Lot
DSCSA Serialization Requirements Establishing Unique Identity at the Saleable Unit Manufacturer Repackager Wholesale Distributor Dispenser (2017) (2018) (2019) (2020) Manufacturer (Nov. 2017) Repackager (Nov. 2018) Wholesale Distributor (Nov. 2019) Dispenser (Nov. 2020) Serialization (Unit) Apply 2D DataMatrix NDC, Serial Number Lot, Expiry Date Apply 2D DataMatrix NDC, Serial Number Lot, Expiry Date Serialization (Case) (sealed homogeneous) Apply 2D DataMatrix or Linear Apply 2D DataMatrix or Linear Aggregation Not DSCSA legal requirement Potential trade requirement Not DSCSA legal requirement Potential trade requirement Not DSCSA legal requirement Potential trade requirement Saleable Returns Verify product identifier for sealed homogeneous case or saleable units before resale Verify product identifier for sealed homogeneous case or saleable units before resale Verify product identifier for sealed homogeneous case or saleable units before resale Buy/Sell May only buy serialized product May only sell serialized product May only buy serialized product May only sell serialized product May only buy serialized product May only sell serialized product Archival Store serialization data for 6 years past transaction date Store serialization data for 6 years past transaction date Store repackaged product source product assoc. for 6 years
DSCSA Verification Requirements Verifying Transaction and Product Information Regulation Date Requirements Request for Information Jan 2015 (M, R, W) July 2015 (Dispenser) If receive request for information from government official in the event of a recall or suspect product investigation: Provide TH, TI, TS for requested products in one (1) business day (not to exceed 48 hrs.) [dispensers have 2 business days] Verification 2015 (all) If receive verification request from gov t official in suspect product investigation or if company determines it has suspect product: Conduct investigation in coordination with trading partners; quarantine such product Validate TH, TI of identified products Verification (enhanced) Request for Verification 2017-2020 (M, R, W, D) If receive verification request from gov t official in suspect product investigation or if company determines it has suspect product: Verify product identifier/sni of identified products Dispensers: verify lot number, verify SNI of 3 packages or 10%, whichever is greater 2017 (M) 2018 (R) If receive request for verification of drug product from supply chain participant (direct OR indirect trading partners): Verify product identifier/sni of the products queried against product identifier/sni affixed by manufacturer/repackager Notify trading partner of results within 24 hours Notification 2015 (all) Notify gov t officials of cleared product subject to investigation Notify FDA and all immediate trading partners if determine a product in their possession or control is illegitimate (w/in 24 hours) Manufacturers: Notify FDA and Immediate trading partners if reason to believe at high risk of possession of illegitimate product Notify trading partners of investigation termination Archive 2015 (all) Archive suspect product investigation and illegitimate product documentation for 6 years past investigation closure M: Manufacturer R: Repackager W: Wholesale Distributor D: Dispenser
EU Falsified Medicines Directive Serialization, Reporting and Verification Model Pharma Manufacturer (MAH) Wholesaler Wholesaler Pharmacy Patient Product Flow Report Product Master Data and Serialized Pack Data Risk Based Verification Verification at Point of Dispense DEADLINE: February 9, 2019 Serialization (saleable unit) Government reporting Verification Upload Data Verify Unique Identity European Hub National System
Checklist / Questions for your Packager Have you managed EPCIS events before? What lessons did you learn on your path to accomplish this? How will you manage aggregation? What has been your error rates with serialization, and how are you handling correcting errors? What serialization systems have you integrated with? What are your lessons learned from setting up data transfers with Manufacturers and 3PLs?
Checklist / Questions for your 3PL / Warehouse Operations Do you have serialization management processes in place? What systems do you use? What serialization systems have you integrated with? Have you managed EPCIS events before? What lessons did you learn on your path to accomplish this? How will you manage aggregation and disaggregation? Who will be responsible for verification responses 3PL or Manufacturer?
Checklist / Questions for your Serialization (EPCIS) System Vendor Describe your implemented network What choices do I have for private tenancy vs a multi-tenant solution? How can I manage system updates and the associated validation? How will I use the system to respond to verification checks? What is your roadmap for providing services for serialization in other regions of the world (EU, Turkey, China, Brazil, etc.)?
Key Factors for a Successful Project Clear Team structure, along with understood roles and responsibilities Clear and understood decision makers Know who needs to be informed Clear requirements documented: User Requirements Specification for serialization system, agreed to by the broader team (so new requirements don t sneak in later) Standards Document (compilation of all numbering structures, artwork specifications, system standards to ensure all parties understand what is being implemented) Understanding of the change management needs, even if your company is small Training, SOPs, etc. Don t invent things if you don t need to Follow lead of vendors you have chosen
Q&A
Additional DSCSA Educational Resources 50 Must-Know Terms to Decipher Serialization (link) Serialization: Where to Begin (link) 2016 Global Drug Supply, Safety and Traceability Report (link) Infographic: Serialization Plans and Concerns (link)
DSCSA Tracing Requirements Tracing Changes of Drug Ownership Manufacturer Wholesale Distributor Dispenser TI TS TI TI Receive for each drug product: Transaction History + Transaction Information + Transaction Statement TH, TI, TS data elements and structure vary depending on product source and transaction history DSCSA does not define the data exchange method for this compliance documentation Compliance documentation must be archived for 6 years past date of transaction TS Transaction History (TH) Transaction Information (TI) Transaction Statement (TS) Single document starting with manufacturer Each change of ownership (TI) going back to the manufacturer Electronic or paper (initially) Electronic required from manufacturer in 2017 NDC Product Name Strength, Dosage Form Container Size, Number of Containers Lot Number (optional in certain scenarios) Transaction Date (optional in scenarios) Shipment Date (optional in scenarios) Transfer From Party Transfer To Party Wholesaler Contact Information (for Drop Ship) Statements attesting that party selling product Is authorized and registered Received product from authorized Received TI, TS from the prior owner Did not knowingly ship suspect or illegitimate product Had systems and processes in place to comply with verification requirements Did not knowingly provide false trans. info Did not knowingly alter the transaction history
The DSCSA Compliance Data Varies by the Path the Product Takes Through the Supply Chain Direct Purchase Distribution from Manufacturer Manufacturer TH Wholesale Dist. TH Dispenser TI TS TI (-Lot) TS (DPS) Secondary Wholesale Distribution Manufacturer TH Wholesale Dist, TH Wholesale Dist. TH (WD) Dispenser TI TI (-Lot) TI TS TS (DPS) TS(rDPS) TH Drop Shipment Manufacturer TI(+Drop) Wholesale Dist. Dispenser TS Transaction History Transaction Information Transaction Statement TH Transaction History (full back to Manufacturer) TI Transaction Information (full) TS Transaction Statement (normal) TH (WD) Transaction History (starts w/ initial Wholesaler) TI (-Lot) Transaction Information (w/o Lot, Trans Date) TS (DPS) Transaction Statement (+ Direct Purchase Statement*) TI(+Drop) Transaction Information (w/ WD contact info) TS(rDPS) Transaction Statement (+ received DPS) *Note: Transaction Statement including statement of direct purchase from the manufacturer, repackager or excl. dist.
US DSCSA vs. EU FMD Compliance Requirement US EU Products Product Scope Rx (all) Rx (all) OTC (high risk) Special Requirements Exemptions Exemptions, Per-country Rx Participation Supply Chain Stakeholders Mfg, Wholesaler, Repackager, Dispenser Mfg, Wholesaler, Parallel Importers, Dispenser Serialization Serial Number Format GS1 GS1 Product Code NDC (GTIN wraps) GTIN, National Product Code Packaging Levels Secondary, Tertiary Secondary Data Elements (in secondary barcode) Randomization NDC Lot Expiry Date Serial # GTIN/NTIN/National Code Lot Expiry Date Serial # Natl. Reimbursement (opt) (1:10,000) Aggregation Business/trade requirement? Business/trade requirement? Special Requirements GTIN used to convey NDC Multi-pack Traceability Supply Chain Traceability Data Exchange with Who? Supply Chain Partners
US DSCSA vs. EU FMD Compliance Requirement US EU Compliance Reporting Type Suspect/Illegitimate Product Master Data, Sales Pack Format TBD XML Data Exchange and Access Manual Integrated, Portal Product Master Data Product Pack Data (serialization info) Serial Number Decommissioned Special Reports Request for Information Recall Verification Type Suspect/Illegitimate Product Dispensation Risk-based (supply chain) Info Verified TH / TI Product Identifier Product Identifier
Four Key Challenges to Master for DSCSA Network Connect all internal sites, external CMOs / 3PLs, trade partners for serialization and serialized product events and serialization inquiries Scale Manage a potential 1,000x increase in data storage and a 10,000x increase in transaction events compared to lot-level product distribution Compliance Rapidly comply to evolving regulatory, standards and partner requirements while maintaining validation of systems Ensure Supply Ensure all products supplied from all sites can be supplied to meet diverse channel and trade partner requirements in your target markets