US DSCSA – Misalignment Exceptions Business Scenarios

US DSCSA – Misalignment Exceptions Business Scenarios

Introduction:

The FDA, in collaboration Healthcare Distribution Alliance (HDA), has exercised enforcement discretion, extending the original deadline of November 27, 2023, by one year, now slated for implementation in 2024. Supply chain entities are leveraging this enforcement discretion to accelerate their compliance efforts, acknowledging that the extended deadline offers an opportunity to improve preparedness and strengthen strategies. The requirements of the Drug Supply Chain Security Act (DSCSA) are generally applicable to all transactions involving finished prescription drugs for human use, including the trading partners engaged in these transactions.

Key Requirements of US DSCSA:

1. Facilitating electronic data exchange with both direct and indirect trading partners.
2. Verification of suspect and illegitimate products.
3. Processing misalignment exceptions.
4. Implementing credentialing and authentication for trade partners.

A pressing issue for supply chain entities involves recognizing, understanding, and addressing misalignment exceptions. These exceptions occur when there's a discrepancy between the physical and virtual aspects of the supply chain. They specifically refer to situations in the supply chain where the transaction information (TI) mandated by US DSCSA doesn't perfectly match the physical products being exchanged.

Approximately 8 to 10 billion package-level transactions occur annually, making errors and discrepancies unavoidable. The process for handling exceptions must remain separate from that of investigating suspect products. An exception might trigger a suspect product investigation, but not necessarily so.

Participants: Manufacturers, wholesale distributors, and re-packagers must establish systems and processes to detect and mitigate misalignment exceptions related to the sale of physical products. Dispensers should have systems and processes to either:

1. Identify misalignment exceptions, or
2. Reconcile each physically saleable unit received with the corresponding TI.

When a misalignment exception is identified, the concerned package(s) should not undergo further transactions until the exception is comprehended and resolved. Trading partners must possess systems and processes to detect, understand, and address misalignment exceptions.

Exception Scenarios: The following business scenarios may lead to misalignment or exceptions:

1. No Data

Scenario 1.1: The wholesale distributor was sent the data, but the EPCIS file is not correct in content or format as prescribed in the GS1 EPCIS implementation guideline.

The wholesale distributor discovers upon receipt of the file that a manufacturer has sent an EPCIS file, but it cannot accept the EPCIS file because it is not formatted correctly. Numerous root causes result in this sort of exception scenario. Several are cited below.

1. Electronic Product Code (EPC) events out of the correct time stamp sequence can cause files to be rejected. For example, an aggregation event packing the drug packages to the case is time-stamped before the commission events of the packages go into that case.
2. Product vocabulary element attributes are missing or incorrect such as dosage form or strength.
3. An incorrect GS1-formatted Serialized Global Location Number (sGLN) was found in the file.

Scenario 1.2: The wholesale distributor receives data, but the Global Company Prefix (GCP) and/or GLN/sGLN are not found in the receiver’s master data.

• A manufacturer sends an EPCIS file to a distributor.
• Upon receiving an EPCIS file, the wholesale distributor determines that it does not have a GCP, GLN, or sGLN in its system that corresponds to a GLN or sGLN in the EPCIS file the manufacturer sent.

Scenario 1.3: The wholesale distributor receives the data, but the GTIN is not found in the receiver’s master data.

• A manufacturer sends an EPCIS file to a distributor.
• At receiving, the wholesale distributor determines that it does not have the GTIN(s) contained within the EPCIS file. The file may be rejected depending on how the wholesale distributor’s systems are configured.

Scenario 1.4: A wholesale distributor receives data, but there is a misalignment between the data received and the lot number and/or expiry encoded and successfully scanned in the two-dimensional data matrix bar code (2D bar code). This scenario covers incorrect data.

• Note that in this scenario, the GTIN and serial number on the package label match the EPCIS data.
• If the label is deemed to be incorrect, see scenario 4.1.

2. No Data

Scenario 2.1: A manufacturer sends an EPCIS file for a shipment, but there is a communication issue, and the file is not received by the wholesale distributor.

Scenario 2.2: A wholesale distributor receives a product, but the serial number is not found within any EPCIS file delivered and there is no purchase order or delivery number to reference.

• The wholesale distributor’s system will indicate an error at receiving. This scenario could arise when an unexpected shipment arrives as a mis-shipment or has come with other shipments from a manufacturer.
• The wholesale distributor will work with the manufacturer on the “surprise” shipment and resolution steps.

Scenario 2.3: A wholesale distributor receives a shipment in which the serial numbers are not found due to the wrong data being sent. There is a valid purchase order number to reference.

• The wholesale distributor’s system will indicate an error at receiving.
• This scenario assumes some data were received for the shipment and that this appears to be a serial number mismatch.
• This could also exist as a “data, no product” scenario discussed elsewhere.

Scenario 2.4: A wholesale distributor receives a product overage with a valid purchase order receipt in which the shipment references the purchase order.

• This scenario covers either an insufficient number of product identifiers or no product identifiers in the TI accompanying a shipment.

Scenario 2.5: A delivery was made to the right company, but to the wrong distribution center within that company. Note: This is not a DSCSA compliance issue. Because the delivery was made to the correct trading partner purchaser but the wrong facility within that company, the decision on how to handle this scenario should consider other regulatory, statutory, or business requirements.

Scenario 2.6: A delivery was made to the wrong wholesale distributor.

• Unlike scenario 2.5, this is a DSCSA compliance issue.
• The product was incorrectly delivered to a trading partner that did not order the product, and the shipment paperwork may confirm the mis-shipment. The person receiving the product often will not recognize the PO number with the delivery.

Scenario 2.7: A serial number is not found while a wholesale distributor is trying to pick, pack, and ship.

• This event signals the serial number was not sent in an EPCIS file from the manufacturer. This could be an aggregation error, or it could also indicate a mis-pick of the physical product shipped by the manufacturer.
• Where a product, no data exception is discovered during the distributor’s pick, pack, and ship process, the wholesaler may not be able to provide any useful information other than that the product identifier is not found in the distributor’s systems.

3. No Product

Scenario 3.1: The manufacturer sends data that includes products not received in a wholesale distributor shipment, resulting in a shortage.

• The wholesale distributor will discover that it received data but is a missing product, typically via a true shipment shortage. an internal receiving and/or other reconciliation process. The ASN and packing list confirm this.
• This may also include products lost in transit.

Scenario 3.2: A manufacturer sends data received by the distributor, but later the manufacturer cancels the shipment (in full or partially) or the carrier fails to deliver the product.

• This may occur when the manufacturer’s customer service contacts a wholesale distributor to cancel an order or change an order quantity. Note: Such changes should be made before the manufacturer ships the product.
• The carrier may have lost the product.

Scenario 3.3: A manufacturer sends data that are received by the wholesale distributor, but the shipment is refused because the product is deemed unsaleable.

• One example could be refusal due to damage to the product.
• Another example could be temperature excursions.

Scenario 3.4: A manufacturer sends data that are received by the wholesale distributor, but the shipment is refused even though it is saleable.

• Saleable product refused due to canceled or expired order.

Scenario 3.5: A manufacturer sends data for a shipment that is to be received by a wholesale distributor, but the shipment or partial shipment is stolen.

• A trading partner discovers the shipment is stolen in transit.
• Wholesale distributors may observe tampered parcels/pallets.

4. Packaging and Labelling

Scenario 4.1: A wholesale distributor scans a product at receiving or when preparing it for shipment that shows a mismatch between the product label and the transaction data that the manufacturer determines is a labeling issue.

This scenario is related to section 1, scenario 4.

Scenario 4.2: A wholesale distributor discovers when receiving a product or preparing it for shipment that the product has no Human Readable Interpretation (HRI) of the 2D bar code on the label (i.e., the GTIN, serial number, lot, and/or expiry are not included in the HRI).

• This product does not comply with the DSCSA and is unsaleable product.
• Note: This scenario assumes the product is covered under the DSCSA, is not grandfathered, and is not the subject of a temporary or permanent waiver, exception, or exemption.

Scenario 4.3: A wholesale distributor discovers during their operations that the Serialized Shipping Container Code (SSCC) is damaged, unusable, or missing. Note: This is not a DSCSA compliance issue; the DSCSA does not address the use or placement of the SSCC; the DSCSA requires that only covered drug packages and homogenous cases must bear product identifiers.

Scenario 4.4: A wholesale distributor receives a product or is preparing to ship it and is unable to read the 2D bar code because it will not scan, is encoded incorrectly, or has incomplete elements.

• Whether this problem with the 2D bar code is discovered at receiving or at pick, pack, and ship, the process will be the same.
• If a bar code is unreadable at the initially scanned packaging level, the bar code at the next lower package level may be readable.
• This may be a DSCSA compliance issue if, for example, any of the required elements of the product identifier (NDC, serial number, lot number, and expiry) are incorrect.

Scenario 4.5: A wholesale distributor discovers there is an aggregation error in the EPCIS data it received from the manufacturer.

• This might be discovered during receiving or inventory spot checking, most likely where a loose package was aggregated to one case in the data but was placed in another case and both cases were received by the distributor.
• This might also be discovered during loose picking when a package is already shown to have been shipped in a case because the case the package was aggregated to was already shipped.

5. Unavailable for Distribution: Product Is Recalled, Suspect or Illegitimate

Scenario 5.1: A wholesale distributor discovers a serial number or lot number is unavailable for distribution due to being recalled, suspect, or illegitimate.

Overall Takeaway in Exception Management:

• A well-planned receiving process aids in the early identification of exceptions during distribution, facilitating timely resolution.
• Collaborating with relevant stakeholders expedites exception resolution.
• Understanding supply chain business use cases assists in identifying ownership changes and potential exceptions.
• Adopting industry best practices to standardize data flow interoperability can reduce misalignment exception occurrences.

Reference:

1. EXCEPTIONS HANDLING GUIDELINES FOR THE DSCSA Version 2.0, October 2023
   https://dscsagovernance.org/wp-content/uploads/2023/03/Exception-Handling-Workshop-Report-.pdf
2. For additional information, visit DSCSAgovernance.org

How can CosmoTrace help?

CosmoTrace specializes in providing comprehensive support for managing DSCSA compliance exceptions, offering tailored strategies to streamline your processes and ensure regulatory compliance. Our expertise and customizable approach can help your organization navigate complex supply chain challenges with confidence and efficiency.

Disclaimer

This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just one possible interpretation of information available in the public domain or through membership organizations, and that interpretation is subject to change. This information does not constitute legal advice. Users must refer to the source material for the complete requirements and form their interpretation before making business decisions. Please use the references below to follow the updates at the source