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• Today, the U.S. Food and Drug Administration is finalizing two guidance documents and making available two draft guidance documents to help ensure that prescription drugs are identified and traced properly as they move through the supply chain.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.

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/

FDA is issuing new guidance for immediate implementation in accordance with 21 CFR 10.115(g)(2).

FDA is concerned that large volume of saleable returns coupled with the challenges of establishing reliable and robust technology may disrupt the distribution of prescription drugs in the United States.

FDA does not intend to take action against wholesale distributors who do not, prior to November 27, 2023, verify the product identifier prior to further distributing returned product. This is a 3-year delay from the current date of enforcement.

FDA also does not intend to take action against dispensers who do not verify the product identifiers of suspect product as required by DSCSA before November 27, 2023.

Instead the FDA believes that the delay in enforcement will allow manufacturers, repackagers, wholesale distributors and dispensers to focus resources and efforts on implementing secure, interoperable, electronic tracing of products at the package level.

“We envision that, along with other enhanced drug distribution security requirements, wholesale distributors can increase their efficiency by incorporating the saleable return verification requirements into the enhanced verification required by 2023 instead of developing separate processes or infrastructures.”

This delay does not affect other aspects of DSCSA. Manufacturers are still obligated to conduct product verification according to section 582(b)(4)(C) of the FD&C Act upon receiving a request for verification from an authorized wholesale distributor.  Furthermore, a wholesale distributor may engage in transactions involving a product only if such product is encoded with a product identifier.

Please contact us if you have additional questions on this policy and the impact on DSCSA deliverables.

Gary Lerner, president and founder of Gateway Checker and expert on supply chain integrity, will be discussing the future of pharmaceutical traceability at the GS1 Connect virtual conference, taking place June 16-17, 2020. Gary, together with Jeff Denton of AmerisourceBergen, will present “Bridging the Gap to Pharmaceutical Traceability” as an On Demand session, which will be available throughout the two-day event.

During their session, Gary and Jeff will explore how the drug industry as a whole is adjusting to the requirements outlined in the Drug Supply Security Act of 2013 and what companies can do today to prepare for the new traceability standards that will be required by 2023. These requirements aim to help the FDA understand what product is in the supply chain, where it has been, where it is going, and who is handling it; and to ensure that only legitimate, safe products end up on the market.

Currently, much of the data collected along the drug supply chain is either inadequate or not interoperable according to accepted industry guidelines. Many organizations have developed their own proprietary solutions or workarounds that don’t play well together. Gary will address how agreeing upon and employing a “common language” across the pharmaceutical industry is vital in preparing for the upcoming regulations and requirements.

FREE Registration for GS1 Connect is open through Friday, June 12 at gs1connect.gs1us.org.

About Gateway Checker

Gateway Checker provides software to help the pharmaceutical industry quickly, accurately and thoroughly ensure data accuracy and integrity about the products moving through the drug supply chain. Gateway Checker is a GS1 Certified Conformance Testing Service, and can attest to full conformance with the GS1 US Rx EPCIS traceability requirements.

About GS1 Connect

GS1 Connect is an annual event hosted by GS1 US for the purpose of bringing trading partners together to network and learn about the value of using standards-based business processes and best practices for optimum efficiencies in managing the supply and demand sides of their value chain. Due to COVID-19, this year’s event will be virtual.

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