DSCSA
deadline
FDA to delay enforcement of DSCSA
requirements until November 2024
📍NEWS UPDATE: Drug Supply Chain Security Act: FDA delays Drug Supply Chain Security Act Deadline until November 2024
On August 25, 2023, the Food and Drug Administration (FDA) issued a compliance policy guidance on enhanced drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act.
Official document available here.
Since the enactment of DSCSA, the FDA understands that collaboration and alignment among trading partners and other stakeholders throughout the supply chain are critical for achieving interoperability under the DSCSA.
While FDA generally expects trading partners to have the systems and processes in place to meet these requirements as of November 27, 2023, it has been recognized that some technical and operational issues, including issues involving trading partners and other affected stakeholders, may not be fully resolved by that time.
This guidance is intended to provide clarity and flexibility to trading partners to help ensure continued patient access to prescription drugs as the supply chain transitions to the interoperable, electronic product tracing at the package level under the DSCSA.
The compliance policies in this guidance can help trading partners throughout the supply chain implement the requirements under section 582(g)(1) of the FD&C Act by accommodating the additional time that may be needed to implement, troubleshoot, and mature their systems and processes while supporting the continued availability of products to patients.
Until November 27 2024, FDA does not intend to take action to enforce section 582(g)(1)of the FD&C Act:
A)
The transaction information and the transaction statements as required under this section shall be exchanged in a secure, interoperable, electronic manner in accordance with the standards established under the guidance issued pursuant to paragraphs (3) and (4) of subsection (h), including any revision of such guidance issued in accordance with paragraph (5) of such subsection.
B)
The transaction information required under this section shall include the product identifier at the package level for each package included in the transaction.
C)
Systems and processes for verification of product at the package level, including the standardized numerical identifier, shall be required in accordance with the standards established under the guidance issued pursuant to subsection (a)(2) and the guidances issued pursuant to paragraphs (2), (3), and (4) of subsection (h), including any revision of such guidances issued in accordance with paragraph (5) of such subsection, which may include the use of aggregation and inference as necessary.
D)
The systems and processes necessary to promptly respond with the transaction information and transaction statement for a product upon a request by the Secretary (or other appropriate federal or state official) in the event of a recall or for the purposes of investigating a suspect product or an illegitimate product shall be required.
E)
The systems and processes necessary to promptly facilitate gathering the information necessary to produce the transaction information for each transaction going back to the manufacturer, as applicable, shall be required (i) in the event of a request by the Secretary (or other appropriate federal or state official), on account of a recall or for the purposes of investigating a suspect product or an illegitimate product, or(ii) in the event of a request by an authorized trading partner, in a secure manner that ensures the protection of confidential commercial information and trade secrets, for purposes of investigating a suspect product or assisting the Secretary (or other appropriate federal or state official) with a request described in clause (i).
F)
Each person accepting a saleable return shall have systems and processes in place to allow acceptance of such product and may accept saleable returns only if such person can associate the saleable return product with the transaction information and transaction statement associated with that product.
Furthermore, about point (B) FDA does not intend to take action to enforce this requirement with respect to product that is introduced in a transaction into commerce by the product’s manufacturer or repackager before November 27, 2024, and for subsequent transactions of such product through the product’s expiry.
FDA received several letters about actual readiness of pharma supply chain for compliance to DSCSA. A special mention to Healthcare Distribution Alliance (HDA) which represents primary pharmaceutical distributors.
FDA recognized a potential risk on forcing the original date and issued such compliance policy guidance.
FDA emphasized that this guidance is not intended to provide a justification for delaying efforts by trading partners to implement the enhanced drug distribution security requirements under section 582(g)(1) of the FD&C Act.
FDA strongly urges trading partners to continue their efforts to implement necessary measures to satisfy these enhanced drug distribution security requirements.
REQUIREMENTS
Drug Supply Chain Security Act
November 27th, 2023 *(see updates)., it is the FDA’s deadline for compliance with the Drug Supply Chain Security Act (DSCSA). The Drug Supply Chain Security Act (DSCSA), aims to protect the product and the patient in order to:
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Enhance the ability to help and protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful
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Improve detection and removal of potentially dangerous drugs from the drug supply chain
OVERVIEW
The situation
Serialization is mandatory by the FDA since 2017 and requires all players in the drug supply chain to adhere to the traceability requirements, serializing products and verifying the serial numbers.
Manufacturers were required to serialize and verify products at the secondary packaging level (SKU). Both individual units and shippers contained serialization data without any parent relationship between them. When the manufacturer, wholesalers or packager ships the products, it is required to transmit to trading partners the 3T documentation which includes the Transaction history (TH), the Transaction information (TI), and the Transaction statement (TS).
The whole current situation involves many manual operations with consistent risks of human errors, and this is the main reason why the current situation will be changed in November 2023 (see updates).with the introduction of modifications to enhance the current management of the supply chain.
Product tracing information
Enhancing the security of drugs supply chain
All the pharmaceutical stakeholders, both manufacturers and trading partners (re-packagers, distributors, wholesalers, and dispensers), will soon be required to have a secure interoperable track and trace solution in place to build a complete interoperable electronic system for tracking and identifying prescription drugs on sale in the US.
The hierarchical aggregation will make it possible to accurately identify the items in the supply chain and to detect any counterfeited product more easily. Aggregation will also provide a higher level of security and visibility of products into the drug supply chain, facilitating the exchange of data with trading partners.
This will allow trading partners to easily communicate the serialization information to their final customer; for the operators will be easier to access the list of all the serial numbers able with a single operation (e.g pallet’s label scanning)
Some examples of the packaging logistic unit involved
ENHANCED DRUG DISTRIBUTION SECURITY
What it is going to change
With the new requirements established by DSCSA, wholesalers and dispensers are required to implement interoperable and electronic tracing of products at the package level, exchanging data (product tracing information, TI and TS) between themselves. Additionally, if the distributors would like to resell a returned product, the manufacturer should be able to receive electronically a query to which respond promptly.
This can happen using systems that are fully capable to trace and verify the distributed products across the pharmaceutical distribution supply chain.
DSCSA Key requirements
How to be prepared
The minimum requirements to be ready can be summarized as follows:
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Setup of a complete all-in-one solution that assigns serial numbers to each product from individual units (cartons, bottles, vials, etc.) to upper levels (shippers/ pallets) and link them together in a hierarchical relationship
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Setup a software able to implement a reliable process and product transaction history
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Be able to handle various export file formats such as CSV, XML that complies with GS1 standards (e.g. EPCIS 1.2).
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Be able to handle various data exchange protocols such as SFTP
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Setup an interoperable tracing system software able to exchange 3T documentation
To build such an interoperable system capable to serialize, aggregate, and transmit electronical documentation, the experience of SEA Vision in cutting-edge track&trace software architecture is key.
Contact us for any questions at: marketing@seavision-group.com
A serialization and aggregation workstation on show
With the FDA’s deadline for compliance with the Drug Supply Chain Security Act (DSCSA) rapidly approaching, it is important for pharmaceutical manufacturers to find a way to comply with these regulations.
SEA Vision will be showcasing TrackPCA, a compact workstation designed to manage the serialisation of cartons and multi-level aggregation on cases and pallets all at once, allowing for quick and efficient compliance.
The skills and experience of SEA Vision in cutting-edge Track & Trace software architecture allow manufacturers to be ready in time for the DSCSA’s final deadline of November 27th, 2023 *(see updates). In fact, the station manages the printing and checking of the variable data and codes to serialise cartons; the presence of a built-in label printer allows parent-child aggregation to be performed up to the pallet level, and partial cases and pallets can also be managed.
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