HDA Guidelines for Bar Coding in Pharmaceutical Supply Chain Available

The document serves as a resource on the use of GS1 system data structures and symbologies to comply with the Drug Supply Chain Security Act’s serialized product and data requirements.

Healthcare Distribution Alliance (HDA)

Apr 18th, 2022

Hda Barcode Guidelines 2021

Learn and apply the latest specifications and industry best practices for bar coding and labeling healthcare products with the newly updated HDA Guidelines for Bar Coding in the Pharmaceutical Supply Chain. Now available as a complimentary download from HDA’s website, the guidelines reflect the most comprehensive updates since 2017 and were developed with technical expertise from HDA’s Bar Code Task Force.

The document serves as a resource on the use of GS1 system data structures and symbologies to comply with the Drug Supply Chain Security Act’s (DSCSA) serialized product and data requirements. Detailed guidance is included on:

Shipping case bar code label format
Inner packs
The latest FDA and USP recommendations
Industry best practices for marking and placement of bar codes to be used in the U.S. pharmaceutical supply chain

As the DSCSA compliance deadline of November 27, 2023, approaches, download this free resource for new changes in terminology, additional information on GS1 standards, label examples for serialized, non-serialized product, and more.

Healthcare Distribution Alliance (HDA)

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2022 GS1 Connect: Adapt in San Diego, CA

Expand your professional network and gain new insights on supply chain excellence, June 7-9, 2022. Register by June 1.

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Unleashing QR Codes’ Potential in Healthcare

QR codes can link consumers and patients to dynamic engagement, education, authentication features and more. Here are 12 examples of how brand owners can unleash the potential of QR codes for life science and personal care applications.

Hda Barcode Guidelines 2021

HDA Guidelines for Bar Coding in Pharmaceutical Supply Chain Available

The document serves as a resource on the use of GS1 system data structures and symbologies to comply with the Drug Supply Chain Security Act’s serialized product and data requirements.

Hataali Wins U.S. Patent for Use in Personalized Medicines

The blockchain-based solution, which was awarded the 2021 Bionow Technical Service Award, now has a U.S. patent for use in advanced medicinal therapy products.

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2022 HDA PCSC Educational Seminar in April

The educational event will take place April in Whippany, NJ, and will feature expert-led presentations, live demonstrations, as well as a keynote from transportation experts.

Tyvek Pouches Now Available: In Stock & Ready to Ship

Tyvek Pouches Now Available: In Stock & Ready to Ship

Do you need sterile barrier pouches quickly to help cover low inventory? Don't let standard lead times slow you down. Expedited shipping is available with our Stock Pouch Program. Place your order.

Manufacturers are seeking to improve efficiency by increasing visibility into their operations.

Pharma Manufacturers Seek Visibility into Processes to Drive Efficiency

The rise of shorter, customized runs in the pharmaceutical industry has strained production capacity at many plants. To keep up with this demand, manufacturers are seeking to improve efficiency by increasing visibility into their operations.

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Future for Pharmaceutical Manufacturers Includes More Digitized Data Collection

While automation is driving physical changes to pharmaceutical production and packaging processes, another significant shift is occurring in the accumulation and use of data.

Antares Global Tracking System Software

Antares Vision Group Global Tracking System Software Has New Upgrades

Guarantees aggregation data integrity and optimizes serialization

Open Credentialing Initiative Closes U.S. DSCSA Compliance Gap

OCI invites pharmaceutical supply chain actors into its Early Adopter Program to trial the industry’s first compliance solution for U.S. DSCSA Authorized Trading Partner authentication.

TrakCel, Körber Providing Orchestration Within Manufacture of Therapies

TrakCel is launching a software integration that will allow customers of both companies to share data detailing manufacturing events and milestones between the two systems.

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2022 Distribution Management Conference (DMC) and Expo in Austin

Hosted by the Healthcare Distribution Alliance, the conference takes place Mar. 6 through 9. This year’s event will feature more than 30 breakout sessions on key distribution issues, including best practices for sending DSCSA-required data.

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Counting Down the Top 10 Articles of 2021 - #1: Serialization 101

Join us as we look back at the most-read Healthcare Packaging stories of 2021. At #1, we’re going back to basics with an introductory look at serialization, required by pharma and medical device regulations to defend against counterfeiting.

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Counting Down the Top 10 Articles of 2021 - #3: Benefits of RFID on Vial Labels

Join us as we look back at the most-read Healthcare Packaging stories of 2021. At #3, we cover ways that RFID benefits health systems, from the perspective of the manager of pharmacy operations at Allegheny Health Network.

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Counting Down the Top 10 Articles of 2021 - #5: Fresenius Kabi Implements RFID

Join us as we look back at the most-read Healthcare Packaging stories of 2021. At #5, we cover Fresenius Kabi’s journey to go above and beyond DSCSA requirements, with the support and standards of GS1 US.

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Counting Down the Top 10 Articles of 2021 - #9: Exchanging Pharma Master Data in 2021

Join us as we look back at the most-read Healthcare Packaging stories of 2021. At #9, we cover the exchange master data to meet DSCSA requirements with EPCIS (Electronic Product Code Information Services) files.

FDA Discusses Nov. 2023 DSCSA Future State

At the HDA Traceability Online Seminar (Nov. 1-3, 2021), FDA’s Connie Jung, RPh, talked about how DSCSA continues to transform the pharmaceutical supply chain to preserve drug safety and security.

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Inmar: MEDEX TRAYSAFE MOBILE

A 'lot and expiration-date tracing functionality' enables tracking of distributed inventory and identification of missing, misplaced, expired, and recalled medications.

For product traceability, outbound scanning alone is expected to increase labor by a minimum of 12 to 15% based on recent time studies, per Cardinal Health.

Will Labor Requirements Increase in Meeting DSCSA Milestones?

With many companies either facing or concerned about labor shortages in manufacturing, an expert from Cardinal Health notes that outbound scanning alone may require a 12 to 15% increase in headcount in their operations.

To meet DSCSA requirements, processes must be put into place to handle supply chain data exchange exceptions.

DSCSA and the Importance of Exception Management

At the HDA Traceability Online Seminar (Nov. 1-3, 2021) the topic of handling exceptions ranged from ‘in the weeds’ to the philosophical. Processes are still emerging for data issues, organizing quarantine, and more.

More in Traceability/Serialization

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2021 HDA Traceability Online Seminar Takes Place Nov. 1-3

Are you prepared to comply with the DSCSA by 2023? Supply chain stakeholders will convene to discuss the most pressing DSCSA-related topics with experts, including a presentation from FDA.

The Mini Manual Station supports small- and mid-sized aggregation needs.

Mini Manual Aggregation Station for Small- to Mid-Sized Production

Capable of supporting post-lot reworking operations in warehouses and distribution centers, the system is a fit for smaller producers looking to meet upcoming supply chain security requirements.

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Covectra: Enhanced Smart Label and Mobile Authentication

StellaGuard enhancements are designed to allow consumers to more easily and accurately identify, authenticate, and track genuine products and combat counterfeiting using their Android or Apple mobile device.

HDA Survey Offers Some Troubling DSCSA Prep Results

With just two years left to meet the Nov. 2023 DSCSA requirements, a readiness survey shows that there is much work to be done in drug supply chain traceability. 57% of manufacturers surveyed have no successful data connections in production environments.

New Packaging Report Highlights Need for Anti-Counterfeiting

An international trade body comments on a new report that paves the way to ‘significant’ opportunity and growth for packaging holography technologies.

Four DSCSA Guidances Were Released this Summer: Are You Up to Date?

Read what’s new on DSCSA regarding suspect and illegitimate product, product identifiers, and enhanced drug distribution security at the package level.

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Using GS1 Standards to Prepare for DSCSA in 2023

DSCSA requirements to exchange serialized transaction data between trading partners all the way through the supply chain will begin in 2023. GS1 standards allow for universal identification of a product’s history along the supply chain.

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Serialization and Aggregation Systems for Pharmaceuticals

Mettler-Toledo PCE launched the T60 Integrated 360 Series of solutions for serialization and aggregation of bottles and vials in the pharmaceutical sector, enhancing quality control and traceability of products with 360o image capture.

Are You Ready to Exchange Serialization Master Data?

Watch this Take Five video to learn how with limited time left to onboard, experts urge pharmaceutical manufacturers to begin testing and sharing traceability data via EPCIS files with distributors ASAP to meet DSCSA requirements.

Fraud is a serious issue for drug manufacturing, and pharmaceutical and medical device regulations using serialization have been mandated to defend against counterfeiting.

Summer Reading Series: Traceability Articles to Catch Up On

Skipping vacation this week? Using your free time to brush up on what you missed? From 'serialization 101' to advice on exchanging master data for DSCSA compliance, here are five articles on healthcare traceability.

Atlas Repackaging

Covectra: Enhanced Serialization Platform to Simplify the Repackaging of Pre-Serialized Products

New ATLAS Repackaging Component offers custom option to simplify the rework process and reduce production downtime for pharmaceutical manufacturers.

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AIM Revises RFID Standard for Healthcare Industry

AIM Standard 7351731 Offers Guidance Evaluating the Immunity of Medical Devices from Exposure to RFID.