BEING PREPARED FOR TRACK AND TRACE: DSCSA 101 - SUSANNE SOMERVILLE, FOUNDER THE LINKLAB ERIC GARVIN, FOUNDER, THE LINKLAB BRIAN DALEIDEN, VP ...
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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 NOVEMBER 27, 2023
• Quarantine and investigate suspect products • Participate in electronic
• Identify and remove illegitimate products, and package-level
notify FDA and trading partners NOVEMBER 27, 2018 – REPACKAGER 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 resaleDSCSA Key Definitions
Manufacturer, Wholesale Distributor
Manufacturer Wholesale Distributor
• Holds an application approved under section 505 • A person that engages in wholesale distribution (distribution of a
of the Public Service Health Act (NDA, ANDA) drug to a person other than a consumer or patient, or receipt of a
drug by a person other than a consumer or patient)
• Holds a license issued under section 531 of the
Public Service Health Act (BLA)
• Excludes: (following not considered a wholesale distribution transaction)
• If product not subject to an approved application • Distribution of a drug by the manufacturer of a drug
or license, the person who manufactured the • Intra-company distribution of a drug between members of an affiliate or within a
manufacturer
product • Distribution of a drug among hospitals / health care entities under common control
• A co-licensed partner of the application holder, • Distribution by a licensed retail pharmacy to a licensed practitioner
license holder or product manufacturer • Dispensing of a drug
• Authorized 3PL where 3PL does not take ownership
• An affiliate of the application/license holder or co- • Distribution of a drug to an authorized repackager that takes ownership and repacks
licensed partner • 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 Dispenser
• A person who owns or operates an establishment • Retail or hospital pharmacy
that repacks and re-labels a product or package for: • Group of chain pharmacies under common
• Further sale
• Distribution without a further transaction ownership that DO NOT act as a wholesale
distributor
3PL • Other persons authorized to dispense or
• A company that provides/coordinates warehousing administer prescription drugs (long-term
of product but: healthcare facilities with pharmacy operations,
• Does not take ownership [of the product] etc.)
• Does not have responsibility to direct the sale or disposition of
a product • Affiliated warehouses or DCs of such pharmacies
under common ownership that DO NOT act as a
Exclusive Distributor wholesale distributor
• A wholesale distributor that purchases the product
from the manufacturer and is the sole distributor of
that product for the US marketDSCSA Key Definitions
Product, Package and Case
Product Package
• Prescription drug in finished dosage form for • Smallest individual saleable unit of product for
administration to a patient without substantial further distribution by a manufacturer or repackager intended for
manufacturing individual sale to the dispenser of such product
• E.g. capsules, tablets, lyophilized products before Homogeneous Case
reconstitution [but NOT API or Intermediates]
• Sealed case containing only product with a Single NDC
• Excludes: and a Single Lot
• 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)DSCSA Serialization Requirements
Establishing Unique Identity at the Saleable Unit
Manufacturer Repackager Wholesale Distributor Dispenser
(2017) (2018) (2019) (2020)
Manufacturer Repackager Wholesale Distributor Dispenser
(Nov. 2017) (Nov. 2018) (Nov. 2019) (Nov. 2020)
Serialization (Unit) Apply 2D DataMatrix Apply 2D DataMatrix
• NDC, Serial Number • NDC, Serial Number
• Lot, Expiry Date • Lot, Expiry Date
Serialization (Case) Apply 2D DataMatrix or Linear Apply 2D DataMatrix or Linear
(sealed homogeneous)
Aggregation Not DSCSA legal requirement Not DSCSA legal requirement Not DSCSA legal requirement
Potential trade requirement Potential trade requirement Potential trade requirement
Saleable Returns Verify product identifier for sealed Verify product identifier for sealed homogeneous case or Verify product identifier for sealed
homogeneous case or saleable units saleable units before resale homogeneous case or saleable units
before resale before resale
Buy/Sell May only buy serialized product May only buy serialized product May only buy serialized product
May only sell serialized product May only sell serialized product May only sell serialized product
Archival Store serialization data for 6 years past Store serialization data for 6 years past transaction date
transaction date Store repackaged product – source product assoc. for 6 yearsDSCSA Verification Requirements
Verifying Transaction and Product Information
Regulation Date Requirements
Request for Jan 2015 (M, R, W) If receive request for information from government official in the event of a recall or suspect product investigation:
Information July 2015 (Dispenser) • 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 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:
(enhanced) • Verify product identifier/SNI of identified products
• Dispensers: verify lot number, verify SNI of 3 packages or 10%, whichever is greater
Request for 2017 (M) If receive request for verification of drug product from supply chain participant (direct OR indirect trading partners):
Verification 2018 (R) • 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: DispenserEU Falsified Medicines Directive
Serialization, Reporting and Verification Model
Pharma Manufacturer (MAH) Wholesaler Wholesaler Pharmacy Patient
Product Flow
Verification at
Risk Based Point of Dispense DEADLINE: February 9, 2019
Report Product Verification
Master Data and Serialization (saleable unit)
Serialized Pack Data
Government reporting
Verification
Upload Data Verify Unique Identity
European Hub National SystemChecklist / 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 chosenQ&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
TI
TS
TI
TS
• 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
Transaction History (TH) Transaction Information (TI) Transaction Statement (TS)
Single document starting with manufacturer • NDC Statements attesting that party selling product
• Product Name • Is authorized and registered
Each change of ownership (TI) going back to the • Strength, Dosage Form • Received product from authorized
manufacturer
• Container Size, Number of Containers • Received TI, TS from the prior owner
• Lot Number (optional in certain scenarios) • Did not knowingly ship suspect or illegitimate
Electronic or paper (initially) product
• Transaction Date (optional in scenarios)
• Electronic required from manufacturer in 2017
• Shipment Date (optional in scenarios) • Had systems and processes in place to comply
with verification requirements
• Transfer From Party
• Did not knowingly provide false trans. info
• Transfer To Party
• Did not knowingly alter the transaction history
• Wholesaler Contact Information (for Drop Ship)The DSCSA Compliance Data Varies by the Path the
Product Takes Through the Supply Chain
Manufacturer TH Wholesale Dist. TH Dispenser
Direct Purchase TI TI (-Lot)
Distribution from TS TS (DPS)
Manufacturer
Manufacturer TH Wholesale Dist, TH Wholesale Dist. TH (WD) Dispenser
Secondary Wholesale
TI TI (-Lot) TI
Distribution
TS TS (DPS) TS(rDPS)
TH
TI(+Drop) Wholesale Dist. Dispenser
Manufacturer
Drop Shipment 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 TI (-Lot) Transaction Information TS (DPS) Transaction Statement (+ Direct Purchase Statement*)
(starts w/ initial Wholesaler) (w/o Lot, Trans Date)
TI(+Drop) Transaction Information TS(rDPS) Transaction Statement (+ received DPS)
(w/ WD contact info)
*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, National Product Code
(GTIN wraps)
Packaging Levels Secondary, Tertiary Secondary
Data Elements NDC GTIN/NTIN/National Code
(in secondary barcode) Lot Lot
Expiry Date Expiry Date
Serial # Serial #
Natl. Reimbursement (opt)
Randomization ✓(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 PartnersUS 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 IdentifierFour Key Challenges to Master for DSCSA
Network Scale
Connect all internal sites, external Manage a potential 1,000x
CMOs / 3PLs, trade partners for increase in data storage and a
serialization and serialized 10,000x increase in transaction
product events and serialization events compared to lot-level
inquiries product distribution
Compliance Ensure Supply
Rapidly comply to evolving Ensure all products supplied from
regulatory, standards and partner all sites can be supplied to meet
requirements while maintaining diverse channel and trade partner
validation of systems requirements in your target
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