U.S. Requirement for Traceability of Drugs: The Drug Supply Chain Security Act (DSCSA) FDA/CDER/Office of Compliance Office of Drug Security, Integrity and Response Connie Jung, Ph.D. FDA/Office of Global Operations/India Office Jay Jariwala Global GS1 Healthcare Conference November 5, 2019 New Delhi, India
Disclaimer The content here is intended only to provide a summary and general overview. It is not intended to be comprehensive nor does it constitute legal advice. Additional Resources Updates and links to FDA documents or notices summarized in this presentation can be found on the DSCSA webpage on FDA’s website. 2 www.fda.gov
Commissioner of Food and Drugs Office of the Chief Counsel Center for Center for Center for Center for Drug Biologics Office of Center for Center for Devices and Food Safety Evaluation Evaluation Veterinary Tobacco Regulatory Radiological & Applied and and Affairs Medicine Products Health Nutrition Research Research (Simplified organizational representation)
Office of Global Policy and Strategy Office of Global Policy and Strategy Office of Trade, Office of Diplomacy Office of Global Mutual Recognition, and Partnerships Operations and Intl. Arrangements Latin America Office China Office India Office Europe Office www.fda.gov 4
Office of Global Policy and Strategy www.fda.gov 5
CDER’s Office of Compliance Center for Drug Evaluation and Research Office of Compliance Office of Office of Drug Office of Office of Office of Unapproved Security, Program & Manufacturing Scientific Drugs and Integrity, & Regulatory Quality Investigations Labeling Response Operations Compliance 6 www.fda.gov
Pharmaceutical Supply Chain Maintaining integrity from manufacturer to patient(s) • Who touches the product? • Where are the vulnerabilities? • What are the threats? Protect the product Protect the patient 7 www.fda.gov
8 www.fda.gov
Threats to the Pharmaceutical Supply Chain Unscrupulous players Illegitimate product • Distribute illegitimate product Counterfeit, diverted, stolen, intentionally adulterated, • Don’t maintain quality of the product subject to a fraudulent transaction, or otherwise unfit for • Don’t maintain security or integrity of the supply chain distribution that would result in serious adverse health (examples: are not authorized or do business with consequences or death to humans entities that are not authorized) Weakness in the drug supply chain can be anywhere 9 www.fda.gov
Overview of the DSCSA Drug Supply Chain Security Act (DSCSA) adds new sections in the Federal Food, Drug and Cosmetic Act (FD&C Act): • 581 – Definitions Drug Quality • 582 – Requirements (product and Security tracing, product identification, Act verification) • 583 – Standards for licensure of Title I: The Title II: Drug wholesale distributors (WDD) Compounding Supply Chain • 584 – Standards for licensure of Quality Act Security Act third-party logistics providers (3PLs) • 585 – Uniform national policy WDD and 3PL Product Licensing and Tracing Standards 10 www.fda.gov
DSCSA Goals 1. Implement an interoperable, electronic tracing of products at the package level by 2023 that will: Enable prompt Use product Enable secure response to identifiers to Improve tracing of suspect and verify product efficiency of product at the illegitimate at the package recalls package level products level when found 2 . Establish national standards for licensure for wholesale distributors and third-party logistics providers 11 www.fda.gov
How DSCSA protects patients Prevent harmful drugs from entering the supply chain. Detect harmful drugs if they enter the supply chain. Respond rapidly when harmful drugs are found. 12 www.fda.gov
The DSCSA Path Electronic, Product Interoperable Verification System Product (down to (product tracing Identification package level) down to (Serialization) 2019+ Product package level) 2017-2018 Tracing & 2023 Verification 3PL & Authorized Wholesale Trading Distributor Partners reporting to 2015 Licensure standards for 3PLs FDA and wholesale distributors 2014-2015 13 www.fda.gov
Products • What’s covered: – Prescription drug in finished dosage form for administration to a patient without further manufacturing (such as capsules, tablets, lyophilized products before reconstitution) • What’s not covered: ‒ Blood or blood components intended for transfusion ‒ Radioactive drugs or biologics ‒ Imaging drugs ‒ Certain IV products ‒ Medical gas ‒ Homeopathic drugs ‒ Lawfully compounded drugs Refer to the definition for “product” in section 581(13) of the FD&C Act for specific information regarding exceptions. 14 www.fda.gov
Transactions • Involve transfers of product where a change of ownership occurs • Excludes: – Intracompany distributions – Distribution among hospitals under common control – Public health emergencies – Dispensed pursuant to a prescription – Product sample distribution – Blood and blood components for transfusion – Minimal quantities by a licensed pharmacy to a licensed practitioner – Certain activities by charitable organizations – Distributions pursuant to a merger or sale – Certain combination products – Certain medical kits – Certain IV products – Medical gas distribution – Approved animal drugs Refer to the definition for “transaction” in section 581(24) of the FD&C Act for specific information regarding exclusions . 15 www.fda.gov
Trading Partners under DSCSA Manufacturers Repackagers Wholesale Distributors (WDDs) Dispensers (primarily Pharmacies) Third-party logistics providers (3PLs) 16 www.fda.gov
Key Requirements* Authorized Trading Verification Partners DSCSA Product Product Tracing Identification (Serialization) *The requirements under section 582 of the FD&C Act apply to manufacturers, repackagers, wholesale distributors, and dispensers (pharmacies). 17 www.fda.gov
Authorized Trading Partner Requirement Manufacturers Wholesale and Distributors Dispensers Repackagers and 3PLs • Have valid • Have valid State • Have valid State registration with license or Federal FDA license and • Check respective compliance with • Check FDA’s drug state authorities reporting establishment requirements current registration site • Check FDA’s database WDD/3PL (DECRS) database Trading partners must be authorized! 18 www.fda.gov
FDA’s Drug Establishment Current Registration Site (DECRS) • DECRS publishes currently registered establishments (facilities) which manufacture, prepare, propagate, compound or process drugs that are commercially distributed in the U.S. or offered for import to the U.S. • For DSCSA purposes, check DECRS for valid registration by manufacturers and repackagers 19 www.fda.gov
Wholesale Distributor and 3PL Reporting Database • Reporting licensure to FDA started in 2014 for 3PLs and in 2015 for wholesale distributors • Single national database • Self reported information by Wholesale Distributors and 3PLs • Search capability (by facility name, type, State, or license) • File download capability 20 www.fda.gov
Product Tracing Requirement •When buying, only accept prescription drugs with product tracing information: • Transaction Information (TI) Receive • Transaction History (TH) • Transaction Statement (TS) •Generate and provide product tracing information with each transaction if you Provide sell a prescription drug to another trading partner •Respond to a request for information, in the event of a recall or to investigate a Respond suspect or illegitimate product Store •Store product tracing information you receive for at least 6 years Return •Return product to the trading partner that you bought the drug from 21 www.fda.gov
Definitions: Transaction Information, History, and Statement Transaction Information (TI): Transaction Statement (TS): A statement, • in paper or electronic form, that the entity Proprietary or established name or names of the product; transferring ownership in a transaction— • Strength and dosage form of the product; • Is authorized as required under DSCSA; • • National Drug Code number of the product; Received the product from a person that is • authorized as required under DSCSA; Container size; • • Received transaction information and a Number of containers; transaction statement from the prior owner of • Lot number of the product; the product, as required under the law; • Date of the transaction; • Did not knowingly ship a suspect or illegitimate • Date of the shipment, if more than 24 hours after product; the date of the transaction; and • Had systems and processes in place to comply • Business name and address of the person from with verification requirements under the law; whom and to whom ownership is being • Did not knowingly provide false transaction transferred. information; and Transaction History (TH ): A statement in • Did not knowingly alter the transaction history. paper or electronic form, including the transaction information for each prior transaction going back to the manufacturer of the product. 22 www.fda.gov
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