Please refer to DSCSA Updates and Readiness Check: Requirements for Dispensers and other Trading Partners for more information on DSCSA deadlines for Trading Partners and Dispensers.
The first major deadline of the DSCSA was January, 2015 which required manufacturers to print lot numbers on packaging of all prescription drugs, as well as supply chain partners to exchange 3T documents (transaction information, transaction history, and a transaction statement) at each transfer of liability. In order for pharmacies to comply with the new regulations, they were required to capture the 3T documentation and maintain these records for 6 years.
Since November 2017, all RX products in homogenous cases need to be serialized and compliant with the FDA’s SNI guidance. However, taking into account a lack of qualified vendors and insufficient industry readiness, enforcement of DSCSA serialization requirements were postponed for one year.
Subsequent DSCSA deadlines will impact repackagers (November 2018), wholesale distributors (November 2019) and dispensers (November 2020). From 2023, full unit level traceability including aggregation will be mandatory.
FDA published two final guidance documents on 09/20/2018 which you can find here:
In addition, FDA published draft guidance titled, “Product Identifiers Under the Drug Supply Chain Security Act—Questions and Answers” (Product Identifier Q&A Guidance), which is intended to clarify FDA’s interpretation of product identifier requirements, including as they relate to the linear barcode requirements under 21 CR 201.25. Comments on the draft guidance can be submitted to FDA (Docket No. FDA-2018-D-3175) until November 19, 2018.
Become familiar with the law
The Drug Supply Chain Security Act (DSCSA) outlines requirements for manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers (trading partners). Some requirements began in November 2014 and several key requirements began at various stages in 2015. The requirements, development of standards, and the system for product tracing will continue to be phased in until 2023. FDA will continue working with trading partners and other stakeholders to effectively implement the requirements.
Provide product tracing information (manufacturers, repackagers, wholesale distributors, and dispensers)
Lot-level product tracing: provide transaction information information, history, and statement. See DSCSA Implementation: Product Tracing Requirements for Dispensers–Compliance Policy (Revised) for additional information.
To assist manufacturers, repackagers, wholesale distributors, and dispensers to comply with the new product tracing requirements, FDA has published a draft guidance for industry, DSCSA Standards for the Interoperable Exchange of Information for Tracing of Human, Finished Prescription Drugs: How to exchange product tracing information.
- Accept ownership of product with applicable transaction information, transaction history, and transaction statements.
- If your trading partner does not provide the proper transaction documentation, work with your trading partner to promptly get the proper documentation and to minimize disruption in the supply chain.
Know how to handle suspect and illegitimate product (manufacturers, repackagers, wholesale distributors, and dispensers)
To assist manufacturers, repackagers, wholesale distributors, and dispensers to comply with the new verification requirements, FDA published the draft guidance for industry, Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.
- Establish systems to:
- Quarantine and investigate suspect product to determine if it is illegitimate.
- Notify FDA and immediate trading partners, if illegitimate product is found.
Confirm authorized trading partners (manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers)
Check with your trading partner directly to confirm they are authorized, or
- For manufacturers and repackagers, check FDA’s drug establishment registration database for registration;
- For wholesale distributors, third-party logistics providers and dispensers, you can check with your respective state authority to confirm licensure.
Note, third-party logistics providers are considered to be licensed under the DSCSA until the effective date of the third-party logistics provider licensing regulations issued by FDA, unless the third-party logistics provider is licensed by a state having a specific third-party logistics provider licensing program.
Report licensure (third-party logistics providers and wholesale distributors)
To assist third-party logistics providers and wholesale distributors to comply with the new reporting requirements, FDA published a draft guidance, Drug Supply Chain Security Act Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers. The draft guidance outlines the information that should be submitted to FDA, the timing of the submissions, a preferred format for the submissions, and a preferred method for reporting using FDA’s CDER Direct Electronic Submissions Portal.
The “Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act” Guidance Document exempts certain dispensers (like……. ) who “may lack the resources to provide product tracing information for these transactions” from the provision of “specific product tracing information“ to subsequent purchasers of a subscription drug. It also recognizes that “first responders may lack the resources to comply with certain requirements under section 582(d) of the FD&C Act, including receipt, capture and maintenance of product tracing information and verification.”
Here are links to a few webinars and documents regarding DSCSA compliance and implementation.
- Pharmacist webinar: FDA offers a free 45-minute continuing education course for pharmacists to help explain DSCSA requirements.
- Webinar: Annual Reporting Using CDER Direct: Technical Tips for Wholesale Drug Distributors and Third-Party Logistics Providers
- Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers
- Webinar: An Overview of FDA’s Guidance – Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification
- Overview of Product Tracing Requirements
- Overview of Wholesale Distributor and Third-Party Logistics Provider Requirements and Standards for Licensure
- Webinar: DSCSA Overview and Implementation