This insider’s guide to understanding new U.S. federal requirements helps make sense of package serialization in light of the Drug Quality and Security Act of 2013 for prescription track-and-trace accountability.
In the United States, the Drug Quality and Security Act of 2013 (DQSA) was signed into law on November 27, 2013 as Public Law 113-54. Title II of the legislation is referred to as the Drug Supply Chain Security Act (DSCSA) and establishes new federal requirements for traceability. The law preempts equivalent state requirements and ensures consistency throughout the US drug supply chain with respect to serialization and traceability in the life sciences supply chain.
On May 8-9, 2014, the Food and Drug Administration (FDA) conducted an industry workshop with key life sciences supply chain stakeholders. This workshop was part of the FDA process for developing guidance on transaction reporting. Under the new law the guidance is required before November 27, 2014 for implementation before January 1, 2015 – just 21 business day apart.
The new U.S. federal law requires a transaction document (TD) beginning on January 1, 2015 and serialization of all prescription products by manufacturers by November 27, 2017. The TD is a document, initially in paper or electronic form, constructed by the entity selling the prescription controlled products and provided to the new owner. It contains transactional information and history and several statements to certify compliance with the law. A system to fully secure the exchange of prescription drug and biologic products is expected by 2023 under the law.
Change of ownership and transaction details
The “transaction statement” (TS) part of the TD communicates that the entity transferring ownership in a transaction; (A) is authorized (an authorized distributor of record) as required under the Drug Supply Chain Security Act; (B) received the product from a person that is authorized as required under the Drug Supply Chain Security Act; (C) received transaction information and a transaction statement from the prior owner of the product; (D) did not knowingly ship a suspect or illegitimate product; (E) had systems and processes in place to comply with verification requirements, (F) did not knowingly provide false transaction information; and (G) did not knowingly alter the transaction history.
Also under the law, “transaction information” (TI) must be exchanged and contains ten details, including: (A) the proprietary or established name or names of the product; (B) the strength and dosage form of the product; (C) the National Drug Code number of the product; (D) the container size; (E) the number of containers; (F) the lot number of the product; (G) the date of the transaction; (H) the date of the shipment, if more than 24 hours after the date of the transaction; (I) the business name and address of the person from whom ownership is being transferred; and (J) the business name and address of the person to whom ownership is being transferred.
For those entities in the supply chain who receive finished prescription drug or biologic products they must include “transaction history” (TH) including the transaction information for each prior transaction going back to the manufacturer of the product.
After November 27, 2017, the TD, including the TS, TH and TI is required in electronic form and transaction information may include the SNI for suspect product investigations defined under the law.
The law requires all saleable items and their sealed homologous shipper case to be uniquely serialized for all prescription drugs traded in the US after November 27, 2017. A full transaction pedigree will be defined by the FDA prior to the required implementation in November 2023.
The law also requires manufacturers to trade with only authorized distributors of record (ADR) who have valid up-to-date state licensing and to implement a system to support suspect product verification. The suspect product verification rules require the manufacturer to investigate suspect product notification and report relevant TD to the FDA. In June 2014 the FDA released draft guidance for suspect product investigations under the new law.
To comply with serialization, prior to the November 2017 deadline for manufacturers, packaging will need to be adapted to include new serialization information and a logistics data carrier (a symbol that can be scanned with a device) containing the item identity (often using the GS1 Global Trade Item Number or GTIN), serial number, packaging lot number, expiration date. This will need to be completed in time to ensure all inventory is flushed and only serialized goods are available for trade by the deadline.
The relationship of serialized contents to serialized containers, such as serialized saleable unit cartons to their serialized shipping cases, may be recorded or electronically aggregated to simplify the handling of serialized goods. This allows inferring the serialization information of the contents from transaction documents and avoid opening cases and scanning all items as the goods move between locations. This is a common practice in other industries where goods are sold and the serialized contents are recorded in electronic Advanced Shipping Notices (ASN) transaction documents, including in the consumer electronics and machine parts industries. While this is not required by the law until 2023, those handling goods in the supply chain may require it to effectively handle and trade the goods and so that they can comply with the suspect product investigation requirements under the new law.
GS1 (www.gs1.org) is a preeminent global standards organization for encoding point-of-sale and logistics information and machine-readable data carriers used in commerce throughout the world. US FDA guidance released in March 2010 for standardized numeric identifiers (SNI) in life sciences defines how to serialize drug and biologic products and supports the optional use of GS1 standards. The only symbol approved by GS1 for life sciences serialization is the GS1 DataMatrix 2-dimentional (2D) barcode, which is also defined under the law for saleable items.
GS1 Healthcare US (www.gs1us.org), responsible for GS1 standards in the U.S., is revising its 2013 GS1 Healthcare US Implementation Guideline to support the DSCSA requirements. The new version 1.2 is expected in September 2014.
A common method for sharing serialization information and serialized content-to-container relationships with trading partners is to use electronic data interchange (EDI). An emerging standard is electronic product code (EPC) information services (EPCIS) from GS1, which is less widely accepted in life sciences at the time of this writing but will likely emerge as a preferred standard in the next few years.
Leading wholesalers have stated they will require DSCSA TD as EDI Advanced Shipping Notices (ASN) and have provided requirements to their suppliers. The Healthcare Distribution Management Association (HDMA) and Pharmaceutical Distribution Security Alliance (PDSA) have released guidance on EDI for the DSCSA.
EPCIS standards are evolving
GS1 EPCIS records events associated with an item as it moves through an organization and the supply chain. EPCIS is also used to record the aggregated relationship of serialized items sealed in a serialized container, such as the saleable items in a shipper case. The EPCIS also define communications between systems, including the use of web services. EPCIS standards are being evolved to allow groups of products identified with a GTIN to be tracked using the packaging LOT number and quantity instead of a serial number to comply with the DSCSA.
In addition to complying with regulatory needs, serialization offers benefits found by other industries that have serialized goods to improve supply chain intelligence and control. These benefits include tighter control of incentives and chargebacks, authentication of goods in the supply chain, control of illegal diversion by leveraging sales information of uniquely identified goods, and more. Serialization may also be used as a market differentiator to build consumer confidence in the authenticity of products.
While the cost of serializing and encoding machine readable symbols is largely a cost bore by the manufacturer, serialization also provides new traceability capabilities for supply chain participants, including distributors, pharmacies and hospitals. They may wish to capture the serial number of products they sale or dispense in an effort to reconcile returns or facilitate recalls by knowing the recipient.
Companies may wish to leverage the experience and lessons learned from subject matter experts to avoid pitfalls and expedite the deployment of solutions for serialization. Companies may wish to seek assistance from those with a demonstrated track record of independence from specific solution providers and those who analyze the business needs independent of bias toward specific business solutions.
About the author
William Fletcher is the managing partner of Pharma Logic Solutions, LLC (www.pharma-logic.com). He has personally assisted 24 leading life-sciences manufacturers and global logistics companies to develop strategy, user requirement specification (URS), vendor selection, system design, implementation, testing and GxP validation for serialization and traceability regulations. He is a Certified GS1 Professional credentialed by GS1 US, longstanding member of Project Management Institute (PMI) and trained on SAP Aii/OER v7.1. His experience and lessons learned help facilitate compliance with the DSCSA and avoid wasting time. His background spans more than 32 years in supply-chain logistics systems, packaging execution system (PES), healthcare and life sciences. More is available at www.linkedin.com/in/williamfletcher.