FDA recommends EPCIS for DSCSA drug traceability

Happy Independence Day!

After many years of uncertainty, FDA has (finally!) recommended that trading partners use the Electronic Product Code Information Services (EPCIS) standard to provide and maintain the data associated with transaction information and transaction statements.

Prior regulations and guidance were less specific; only mandating that standards of interoperable exchange “shall comply with a form and format developed by a widely recognized international standards development organization.”

With this guidance, FDA is more specific:

  1. Solution providers possess processes and capabilities that enable the exchange product tracing information
  2. Electronic approaches have evolved and become more affordable and accessible to a wider range of trading partners
  3.  FDA is specifically interpreting the enhanced drug distribution security interoperability requirements to encompass the ability to securely exchange, capture, and maintain electronic transaction information and transaction statements accurately, efficiently, and consistently among trading partners

Furthermore, FDA recommends that trading partners use the Electronic Product Code Information Services (EPCIS) standard to provide and maintain the data associated with transaction information and transaction statements. FDA cites the following reasons for this decision:

  1. EPCIS is a global GS1 standard that allows trading partners to capture and share information about products as they are transacted through the supply chain.
  2. EPCIS can support and enable electronic and interoperable interfaces used by trading partners to ensure compliance with DSCSA
  3. EPCIS is compatible with a range of different technological approaches.
  4. Industry stakeholders have championed EPCIS as a suitable standard to adopt for the enhanced drug distribution security requirements.

To achieve compliance with enhanced drug distribution security interoperability requirements trading partners should make a collaborative effort to follow accepted, industry application standards such as GS1 EPCIS.

Gateway Checker, as a certified GS1 Conformance Testing Service is a leading provider of tools, techniques and technologies that verifies and validates EPCIS content, schema, and structure.

Gateway can quickly and effectively assess DSCSA conformance and traceability readiness.

Contact us for a Readiness Assessment.

Download the Guidance: DSCSA Standards for Interoperable Exchange

EPCIS (Electronic Product Code Information Services) is a standard developed by GS1. For more information see https://www.gs1.org/standards/epcis

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Getting Ready: Drug Traceability

As the community prepares for the GS1 Connect 2021: Digital Edition conference next week, the FDA issued new guidance to further enhance the security of prescription drugs in the supply chain. This guidance is intended to assist trading partners in complying with the law and achieving a safer, more secure, and more trusted drug supply chain.

The Drug Supply Chain Security Act (DSCSA), enacted by Congress on November 27, 2013, outlines steps to build an electronic, interoperable system to identify and trace U.S. prescription drugs. The regulation has a ten-year horizon with requirements and applicable standards unfolding in several phases.

As the industry struggles to meet specific milestones, FDA periodically delays regulatory enforcement. Six months ago, FDA surprised many by delaying enforcement of salable returns verification by an additional three years, until November 27, 2023.

New guidance on enhanced drug distribution security establishes an integrated view of drug traceability requirements, commonly referred to as the “enhanced system.” In this guidance, FDA makes clear that salable return verification should be considered an integrated capability of enhanced verification, as opposed to developing separate processes and systems dedicated just to salable returns verification.

For the first time, the FDA clarifies the enhanced system requirements and provides recommendations on system attributes necessary for enabling secure tracing of product at the item level. The FDA establishes a blueprint for a comprehensive approach to drug traceability and sharpens the focus on specific aspects (e.g. aggregation, inference, physical security, data and system security, errors and other discrepancies) deemed important to implementing a robust enhanced system envisioned under DSCSA.

November 2023 seems far away; do I need to worry?

Traceability requires that an extensive amount of item-level information be captured and exchanged at each ownership change. Successfully establishing traceability therefore requires each trading partner within the drug supply network to connect and exchange drug product information.

Most wholesalers are looking for the majority of their customers to be onboarded in the first half of 2023. Realistically, most industry trading partners have 18 months from today to get connected and share item-level transaction record information, consistent with DSCSA data content requirements and GS1 application standards.

Expect the onboarding process to be delayed the longer one waits to engage with trading partners. According to industry surveys, only 10-20% of the manufacturers are currently connected to their trading partners, which means sharing scarce resources with hundreds of companies and thousands of products. Recognize that few onboardings succeed initially, many require multiple iterations, so plan accordingly. What seemed to be off into the future, is now around the corner.

Since the FDA expects the product tracing information to be true, accurate, and complete, consider Gateway Checker’s conformance certification and establishing an automated approach to drug traceability integrity.

To learn more about how Gateway Checker is testing and certifying traceability conformance, join our virtual presentation An Automated Approach to Drug Traceability Readiness at GS1 Connect 2021: Digital Edition, taking place June 8-10, 2021. You will lean about an automated solution that can achieve accurate, rapid, robust and reliable connectivity with minimal errors, conformance to accepted standards, and identify gaps in preparedness.

We look forward to assisting the pharmaceutical industry on its path to traceability and we hope you will journey with us! If you like what you read, please share our newsletter and invite others to subscribe.

Click on the links below for additional information:

Gary Lerner,
President and Founder
Gateway Checker

Enhanced Drug Distribution Security at the Package Level under DSCSA

On June 3, 2021, the FDA provided new guidance to further enhance the security of prescription drugs in the U.S. supply chain. To help stakeholders understand the emerging DSCSA requirements FDA published four guidance documents (June 3, 2021) to assist trading partners in complying with the law and achieving a safer, more secure, and more trusted drug supply chain.

Three of the published documents either finalize or revise guidance on suspect product and product identifiers. From an industry participant perspective there is not much new as most of the content has already been published.  See: FDA provides new guidance to further enhance the security of prescription drugs

The fourth guidance, Enhanced Drug Distribution Security at the Package Level under DSCSA, is new and brings into focus the interoperable, electronic, package level product tracing systems, and processes required by section 582(g) of the F D & C act which go into effect on November 27, 2023.

For the first time FDA clarifies the enhanced system requirements and provides recommendations on system attributes necessary for enabling secure tracing of product at the item level. FDA establishes a blueprint for a comprehensive approach to drug traceability and sharpens the focus on specific aspects (e.g. aggregation, inference, physical security, data and system security, errors and other discrepancies) deemed important to implementing a robust enhanced system envisioned under DSCSA.

The new guidance on enhanced drug distribution security establishes an integrated view of drug traceability requirements, commonly referred to as the “enhanced system.” In this guidance FDA makes clear that salable return verification should be considered an integrated capability of enhanced verification, as opposed to developing separate processes and systems dedicated just to salable returns verification.

Furthermore, FDA expects the product tracing information to be true, accurate, and complete.  Consider Gateway Checker’s conformance certification and establishing an automated approach to drug traceability integrity to ensure continuous content verification.

Some content of the guidance represents more specific or new requirements that trading partners need to consider when making plans to support the Enhanced System.

Enhance System Elements

The FDA mandated the use of product identifiers to verify the product at the package level and enable prompt response when suspect and illegitimate products were found.

DSCSA included a ten-year timeline culminating in the building of “an electronic, interoperable system to identify and trace prescription drugs as they are distributed in the United States.”

DSCSA “Enhanced System” requires trading partners to exchange drug product tracing information (TI) and a transaction statement (TS) whenever there is a transaction that involves a drug product change of ownership.

The inclusion of both a TI and a TS represents a Transaction Record (TR).  Per the DSCSA, this information, the Transaction Record, must be exchanged in electronic form.

In short, the enhanced drug distribution security aspect of DSCSA mandates the exchange of a Transaction Record it each change of ownership.

Specifically referenced in this guidance, the Enhanced System includes the following:

(A) the exchange of transaction information and transaction statements in a secure, interoperable, electronic manner;

(B) transaction information that includes the data elements of 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;

(D) systems and processes necessary to promptly respond with the relevant transaction information and transaction statement for a product upon request by FDA 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;

(E) systems and processes necessary to promptly facilitate the gathering of the information necessary to produce the transaction information for each transaction going back to the manufacturer upon request by FDA 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, or upon request of an authorized trading partner for the purposes of investigating a suspect product or an illegitimate product or assisting FDA or other appropriate Federal or State official with a request; and

(F) systems and processes to associate a saleable return product with its applicable transaction information and transaction statement to allow a trading partner to accept the returned product.

Other aspects of the Enhanced System requiring further review and scrutiny:

  • Physical Security Features – FDA recommends the use of security features on shipping units (such as homogeneous cases or pallets) of product to help indicate when product may have been tampered with, previously unsealed, or damaged, rendering it suspect.
  • A trading partner should only use inference when it receives pallets or homogeneous cases with aggregated data if the integrity of the unit is intact—in other words, the tamper-evident tape or wrap, or other security seal, has not been broken. If the receiving trading partner determines that the product is suspect, it should not use inference for the aggregated data.
  • Although under section 582(k) of the FD&C Act the requirement to provide and receive transaction history sunsets November 27, 2023, the enhanced system must include the ability to promptly facilitate the gathering of information necessary to produce the transaction information for each transaction going back to the manufacturer.
  • The enhanced system should permit only an authorized trading partner to request relevant data related to a product the authorized trading partner sold or purchased
  • The Selling Trading Partner Should Ensure that the Transaction Information and Transaction Statement Accurately Reflect the Product it Sells to a Purchasing Trading Partner
  • The product tracing information that will be provided to the purchasing trading partner in an electronic format should be checked to ensure that it accurately reflects the product that will be physically shipped.
  • A purchasing trading partner should undertake reconciliation upon physical receipt of the product and then before selling the product to help confirm the veracity of the inbound and outbound transactions.
  • If a wholesale distributor, dispenser, or repackager purchases product and identifies a potential clerical error or other discrepancy in the product tracing information it received, that trading partner should FDA expects the product tracing information to be true, accurate, and complete. resolve the error or discrepancy within 3 business days.
  • Examples of how trading partners may resolve errors:
    • The selling trading partner may provide new and revised product tracing information that reflects the products received by the purchasing trading partner.
    • The selling trading partner may provide new product tracing information only for the extra product received by the purchasing trading partner.
    • Either trading partner may use internal resources for identifying trading partners and their contact information to fill in such gaps in product tracing information received.

Click Here to review the DSCSA Enhanced System guidance

FDA In Brief: FDA provides new guidance to further enhance the security of prescription drugs in the U.S. supply chain

June 03, 2021

The following quote is attributed to Donald D. Ashley, J.D., Director of the Office of Compliance for FDA’s Center for Drug Evaluation and Research

“Ensuring the quality of prescription drugs and safeguarding the integrity of pharmaceutical distribution are crucial roles the FDA plays in protecting the health of the American public. Illegitimate and unsafe products must be kept out of the U.S. drug supply chain.

Since 2013, when the FDA began phasing in new requirements added by the Drug Supply Chain Security Act (DSCSA), we have helped create a supply chain that is better at preventing and detecting the introduction of illegitimate products. The new requirements can also enable stakeholders and the FDA to respond rapidly when such products are found.

To help our stakeholders understand these requirements, we are issuing guidance documents intended to assist trading partners in complying with the law and achieving a safer, more secure and more trusted drug supply chain. We are also soliciting feedback for further improving the way our drug supply chain operates within the DSCSA framework. We view these guidance recommendations as an important part of implementing the robust enhanced system envisioned under DSCSA.

We look forward to continuing open conversations on DSCSA-related issues and providing future guidance to stakeholders as part of our efforts to protect American patients and the drug supply chain we all rely on.”

Additional Information

  • Today, the U.S. Food and Drug Administration is finalizing two guidance documents and making available two draft guidance documents to help ensure that prescription drugs are identified and traced properly as they move through the supply chain. These guidance documents lay out the FDA’s recommendations for how to comply with applicable DSCSA requirements, including those for enhanced drug distribution security at the package level that go into effect in November 2023.
  • As part of the DSCSA, manufacturers and repackagers are required to put a product identifier on drug packages. This includes the product national drug code (NDC), serial number, lot number and expiration date on each package and homogenous case of product, in human- and machine-readable form. The machine-readable form is generally a two-dimensional data matrix barcode. Industry questions are clarified in the final guidance, Product Identifiers Under the Drug Supply Chain Security Act, Questions and Answers.
  • Additionally, the final guidance Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification is intended to aid certain trading partners in identifying a suspect product and specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain. The guidance also describes how trading partners should notify the FDA of illegitimate product and sets forth a process for terminating notifications of illegitimate product in consultation with the FDA. In addition, this guidance describes when manufacturers should notify the FDA of a high risk that a product is illegitimate. This guidance responds to comments from stakeholders to clarify certain points and finalizes the remaining draft portion of the otherwise final guidance for industry, Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification issued in December 2016.
  • The revised draft guidance, Definitions of Suspect Product and Illegitimate Product for Verification Obligation under DSCSA, lays out the FDA’s current understanding of terms used to define “suspect” and “illegitimate” products. These include “counterfeit,” “diverted,” “stolen,” “fraudulent transaction” and “unfit for distribution.” In response to comments received from stakeholders, this draft guidance revises the March 2018 draft guidance.
  • The new draft guidance, Enhanced Drug Distribution Security at the Package Level under DSCSA, is intended to assist supply chain stakeholders, particularly trading partners, with requirements for enhanced drug distribution security at the package level that go into effect on November 27, 2023. This guidance provides recommendations on the system attributes necessary for enabling the secure tracing of product at the package level.
  • Congress enacted the Drug Supply Chain Security Act on November 27, 2013. DSCSA outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. Additionally, DSCSA directs the FDA to establish national licensure standards for wholesale distributors and third-party logistics providers and requires these entities to report licensure and other information to the FDA annually.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

We Will Be Presenting at This Year’s GS1 Connect Conference

GS1 Connect 2021 Digital Edition: Move Beyond Supply Chain Challenges
Date: June 8-10, 2021 (Register by June 3, 2021)
Website: https://gs1connect.gs1us.org/

Session 701: An Automated Approach to Drug Traceability Readiness
Speaker: Gary Lerner President Gateway Checker Corporation
Conference Track: Tech

This presentation will examine enhanced drug distribution security requirements and what it means for industry participants from an information exchange perspective. In short, the enhanced drug distribution security aspect of DSCSA mandates the exchange of a transaction record it each change of ownership.

By 2023, U.S. pharmaceutical manufacturers will need to send serialized data, along with shipped product, to meet DSCSA traceability requirements. However, assessing drug traceability readiness can be inexact, time-consuming, and resource intensive. To achieve accurate, rapid, robust, and reliable connectivity with minimal errors, conformance to accepted standards is essential and can identify gaps in preparedness and inform compliance planning. Join this session to hear about an automated solution that can evaluate pharmaceutical manufacturers’ readiness.

  • What information must be captured and exchange?
  • What standards exist to support this?
  • What are the challenges?
  • How can an automated approach more effectively assure drug traceability readiness?

Gary Lerner, founder of Gateway Checker, is an accomplished architect of supply integrity solutions. An expert in item-level serialization, Gary has developed successful supply chain and channel integrity solutions for nearly 100 leading brands around the world, serving the needs of pharmaceutical, medical device, packaged food, electronics and apparel manufacturers. Over the past 18 years, he has worked with more than 60 leading brands, serving the needs of pharmaceutical, medical device, packaged food, electronics, consumer, and apparel manufacturers. He has been actively involved in facilitating FDA regulatory compliance and enabling supply network interoperability. Gary is an active participant in medical device and pharmaceutical GS1 industry initiatives, starting in 2010. A member of the GS1 Healthcare industry workgroup, Gary helped to craft the Implementation Guidelines for Applying GS1 Standards for DSCSA and Traceability, published in 2016.

More about GS1 Connect 2021: Move Beyond Supply Chain Challenges

Join innovators and business leaders at this year’s supply chain conference as they identify breakthrough possibilities for the future.

Gain insights from industry peers, innovators, and industry leaders on:

  • Meeting shifting consumer demands with complete and accurate data
  • Driving engaging customer experience through unique identification
  • Enabling end-to-end supply chain visibility using GS1 Standards
  • Connecting digital and physical supply chains through technology
  • How to drive supply chain innovation, agility, and resilience in a COVID-19 world

https://gs1connect.gs1us.org/