Drug Supply Chain Security Act (DSCSA): Are the Required Data Elements in the Data Matrix for 2017 Consistent with Previous Guidance Document on SNI?

The data elements are consistent with Standardized Numerical Identifier (SNI).  SNI guidance discussed GS1 standards by stating you can use GS1 standards to generate what the FDA considers an SNI.  The DSCSA refers to SNI in the draft guidance, which is a direct reference to SNI guidance from 2010.  On another related topic that sometimes causes confusion, the SNI guidance allowed for additional attributes to be encoded in the barcode if desired (such as Lot and Expiry), there is no conflict at all between the SNI guidance document.

The USDM Life Sciences Track & Trace Solutions and Services team will help you assess, plan and execute the changes and enhancements necessary to meet these regulations. Our team of experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to foreign medical agency databases for pharmaceutical tracking. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.

Drug Supply Chain Security Act (DSCSA): What Deadlines Occur Between 2017 and 2023?

Requirements for wholesale distributers, repackagers and pharmacies will take effect on a staggered basis between 2017 and 2023.  There aren’t many requirements for manufacturers after 2017, except to work with the FDA and the rest of the industry to figure out what will happen in 2023 with the shift to a new type of security system. However, as a practical matter, there will likely be a lot of work done to continue to improve and streamline all these new processes, adopt additional automations, and begin preparations internally to do the necessary implementations that are coming in 2023.

The USDM Life Sciences Track & Trace Solutions and Services team will help you assess, plan and execute the changes and enhancements necessary to meet these regulations. Our team of experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to foreign medical agency databases for pharmaceutical tracking. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.

Drug Supply Chain Security Act (DSCSA): How Do I Parse Data from Barcodes to Pull Only the Data I Want to Capture?

In the GS1 standards, there are very specific rules that help you determine how to parse the data that you want to capture into your information systems. For example, if you wanted to only capture the GTIN and Serial number but the barcode carried the Lot and Expiry also, you would scan the barcode, capture the entire data string, use the GS1 General Specifications to determine which Application Identifiers (AI) carry the desired data, determine how the string of data is terminated for each piece of data, then apply that logic in your information system to select only the data elements you wish to capture. Some AIs are fixed length, some are variable length. The variable length AIs are terminated either using a ‘separator character’ such as a Function1 or the end of string character (when that AI is the last AI in the string).

The USDM Life Sciences Track & Trace Solutions and Services team will help you assess, plan and execute the changes and enhancements necessary to meet these regulations. Our team of experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to foreign medical agency databases for pharmaceutical tracking. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.

Does the Drug Supply Chain Security Act (DSCSA) Have Guidance for Requests for Verification?

The guidance does mention creating a system for manufacturers to respond to verification requests. But, there is no specific mention of what “system” means.  System may simply mean standard operating procedures or business processes. To be clear, it does not necessarily mean ‘computerized system’. The verification process in the short term may look like the processes used to fulfill the Florida ePedigree requirements.  In those situations, the verification process involves phone support from the manufacturer, and the manufacturer has an internal capability to access information quickly without relying on an IT analyst to create and generate report data.

The USDM Life Sciences Track & Trace Solutions and Services team will help you assess, plan and execute the changes and enhancements necessary to meet these regulations. Our team of experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to foreign medical agency databases for pharmaceutical tracking. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.

Does the Drug Supply Chain Security Act (DSCSA) Support Product Returns and Resales?

When a wholesaler receives inventory returns from a pharmacy for credit, a wholesaler can determine whether the product is still saleable.  As long as there is nothing wrong with the product, the wholesaler is able to resell the product.  But, wholesalers (starting in November 2017) must submit a request for verification from the manufacturer.

The USDM Life Sciences Track & Trace Solutions and Services team will help you assess, plan and execute the changes and enhancements necessary to meet these regulations. Our team of experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to foreign medical agency databases for pharmaceutical tracking. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.

Drug Supply Chain Security Act (DSCSA): What Data Exchange Formats Will be Acceptable to Trading Partners?

Electronic Data Interchange (EDI) is the most commonly accepted electronic data exchange format by trading partners. Electronic Product Code Information Service (EPCIS) is another electronic format.  However, it appears that only a small number of companies will use EPCIS.  You should consider whether large wholesalers are willing to accept EPCIS before deciding on a data exchange format.  Not all large wholesalers have indicated they will accept EPCIS.  Another option to consider is an electronic invoice, which is an electronic method of transferring data from an invoice.  But, wholesalers may try to dissuade you from using electronic invoices to carry data such as lot numbers, transaction statements and other data required by the DSCSA due to complexities of pulling that data out of this format for further use.

The USDM Life Sciences Track & Trace Solutions and Services team will help you assess, plan and execute the changes and enhancements necessary to meet these regulations. Our team of experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to foreign medical agency databases for pharmaceutical tracking. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.

Drug Supply Chain Security Act (DSCSA): Is Aggregation Necessary?

Aggregation is not an explicit or implied requirement of the DSCSA. There is no requirement forcing companies to know which serial numbers are inside a particular case. However, aggregation does have non-regulatory value to manufacturers. What makes aggregation controversial in the DSCSA is the term “verification.” What does “verification” mean, how is it going to be interpreted in future FDA guidance, and how is it going to be interpreted by customers? One question that remains unanswered is if a customer receives a case of a product along with serial numbers for each item in the case and later it is discovered that one of the listed serial numbers is not in the case, are they somehow liable because of the term “verification”?

The USDM Life Sciences Track & Trace Solutions and Services team will help you assess, plan and execute the changes and enhancements necessary to meet these regulations. Our team of experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to foreign medical agency databases for pharmaceutical tracking. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.