• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Manufacturing
    • Packaging
    • Development
    • Compliance
    • Top 25
    • Directory
    • Microsites
    • Events
    • More
  • Magazine
  • News
  • Manufacturing
  • Packaging
  • Development
  • Compliance
  • Top 25
  • Directory
  • Microsites
  • Events
  • Current / Back Issue
    Features
    Editorial
    Columns
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Subscribe Now
    Advertise Now
    Top Features
    Pharmaceutical Packaging Technology

    Elemental Impurities: The Time Has Come

    Continuous vs. Batch Production

    2018: The evolution of pharmaceutical packaging

    Formulation Development Trends
    Breaking News
    Online Exclusives
    Industry News
    Collaborations & Alliances
    Promotions & Moves
    Trials & Filings
    Financial Reports
    Bio News & Views
    Custom Sourcing News
    Packaging & Tracking
    CRO News
    Live From Shows
    Top News
    InClinica Names BD Manager

    SCHOTT Introduces syriQ BioPure

    Heritage Pharma Makes Leadership Changes

    JLL and Water Street Acquire Triplefin

    WuXi AppTec Opens Laboratory Testing Facility in NJ
    APIs
    Aseptic Processing
    Cleaning Validation
    Clinical Trial Materials
    Cytotoxics and High Potency Manufacturing
    Equipment
    Excipients
    Extractables and Leachables
    Facilities
    Fill/Finish
    Lyophilization
    Parenterals
    Process Development
    Process Validation
    Risk Management
    Scale-up/ Technology Transfer
    Solid Dosage/ Creams/ Ointments

    WuXi AppTec Opens Laboratory Testing Facility in NJ

    Arcinova Receives £1.5M Innovate UK Grant

    Vetter Welcomes Illinois Governor

    Sterling Pharma Invests £6M To Expand Offerings

    PhoenixMD, STA Enter Manufacturing Agreement
    Capsules
    Cold Chain Management
    Injectables
    Logistics
    Serialization
    Solid Dosage / Semi-solids
    Supply Chain
    Vials

    INTERPHEX: Adents Showcases Cloud-Based Serialization Solution

    Almac Group Expands Packaging Capabilities

    Catalent Bolsters Clinical Supply Capabilities

    West, Stevanato Group Enter Ompi EZ-fill Alliance

    Pharmaceutical Packaging Technology
    Analytical Services
    Bioanalytical Services
    Bioassay Developement
    Biologics, Proteins, Vaccines
    Biosimilars
    Chemistry
    Clinical Trials
    Drug Delivery
    Drug Development
    Drug Discovery
    Formulation Development
    Information Technology
    Laboratory Testing
    Methods Development
    Microbiology
    Preclinical Outsourcing
    R&D
    Toxicology

    WuXi AppTec Opens Laboratory Testing Facility in NJ

    ICON, Intel Enter Pharma Analytics Platform Pact

    AMRI Renews NIH Contract

    Sterling Pharma Invests £6M To Expand Offerings

    PhoenixMD, STA Enter Manufacturing Agreement
    Filtration & Purification
    GMPs/GCPs
    Inspections
    QA/QC
    Regulatory Affairs
    Validation

    Blockchain: The Next Big Trend in BioPharma?

    Emergent Completes Market Authorization

    Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle: ICH Q12

    LSNE Expands Capabilities and QC Laboratory Space

    Evotec Launches Drug Development Service
    Companies
    Categories
    Corporate Capabilities
    Add New Company
    Contract Service Directory Companies
    Symbiosis Pharmaceutical Services

    iuvo BioScience

    Almac Group

    Legacy Pharmaceutical Packaging

    Rockledge Pharmaceutical Manufacturing, LLC
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    Alcami
    Webinars
    Live From Shows
    • Magazine
      • Current / Back Issue
      • Features
      • Editorial
      • Columns
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
      • Enewsletter Archive
      • Digital Edition
    • Directory
      • Companies
      • Categories
      • Corporate Capabilities
      • Add Your Company
    • Manufacturing
      • APIs
      • Aseptic Processing
      • Cleaning Validation
      • Clinical Trial Materials
      • Cytotoxics and High Potency Manufacturing
      • Equipment
      • Excipients
      • Extractables and Leachables
      • Facilities
      • Fill/Finish
      • Lyophilization
      • Parenterals
      • Process Development
      • Process Validation
      • Risk Management
      • Scale-up/ Technology Transfer
      • Solid Dosage/ Creams/ Ointments
      • cGMP Manufacture
    • Packaging
      • Capsules
      • Cold Chain Management
      • Injectables
      • Logistics
      • Serialization
      • Solid Dosage / Semi-solids
      • Supply Chain
      • Vials
    • Development
      • Analytical Services
      • Bioanalytical Services
      • Bioassay Developement
      • Biologics, Proteins, Vaccines
      • Biosimilars
      • Chemistry
      • Clinical Trials
      • Drug Delivery
      • Drug Development
      • Drug Discovery
      • Formulation Development
      • Information Technology
      • Laboratory Testing
      • Methods Development
      • Microbiology
      • Preclinical Outsourcing
      • R&D
      • Toxicology
    • Compliance
      • Filtration & Purification
      • GMPs/GCPs
      • Inspections
      • QA/QC
      • Regulatory Affairs
      • Validation
    • Top 25 Pharma & BioPharma
      • Top 20 Pharma & BioPharma
      • Top 10 BioPharma Companies
    • Breaking News
    • Online Exclusives
    • Slideshows
    • Experts Opinions
    • Surveys
      • Outsourcing Survey
      • Salary Survey
    • Glossary
    • Videos
    • White Papers
    • Infographics
    • Supplier Microsite
      • Companies
      • News Releases
      • Posters
      • Brochures
      • Services
      • Videos
      • Case Study
      • White Papers
    • Contract Pharma Conference
      • Contract Pharma Conference
      • Speakers
      • Exhibitors
      • Agenda
      • Conference Sessions
    • Events
      • Industry Events
      • Live from Show Events
      • Webinars
    • Classifieds / Job Bank
      • Classifieds
      • Job Bank
    • About Us
      • About Us
      • Contact Us
      • Advertise With Us
      • Privacy Policy
      • Terms of Use
    Online Exclusives

    FDA Holds Track & Trace Workshop

    Confusion, anxiety reign as Agency talks tagging

    Related CONTENT
    • Complying with Track and Trace
    • Drug Packaging Serialization
    • Track & Trace Update
    • What's the Worst That Could Happen?
    • Packaging Serialization Update
    Stephen Barlas02.15.11
    FDA Holds Track & Trace Workshop

    Confusion, anxiety reign as Agency talks tagging

    By Stephen Barlas

    Drug company executives displayed both confusion and anxiety over emerging federal drug tagging efforts discussed at a workshop hosted by the Food and Drug Administration in Washington on February 15. The meeting — Determination of System Attributes for the Tracking and Tracing of Prescription Drugs — was held to give the FDA input on standards it is required to develop on drug package authentication, interoperability, verification and data management. The requirement was contained in the Food and Drug Administration Amendment Acts of 2007.

    That law includes no deadline for publication of final FDA standards, but the FDA is being pressured by a 2015 California deadline that manufacturers provide an item level e-pedigree for half their drugs going into the state. Ginny Herold, the executive officer of the California Board of Pharmacy, appeared at the FDA workshop via video. She said California law would be pre-empted if Congress passes a federal trace and trace requirement. “We need a federal solution,” she said. “But I am not sure when that will happen.”

    There have been bills introduced in Congress that would give the FDA authority to not just establish standards, but force pharmaceutical companies to track and trace their products. But those bills have not moved in past sessions, and there is no indication that they will move in 2011 or 2012.

    There was confusion based on Ms. Herold’s comments that the California “e-Pedigree” and “track and trace” are equivalent terms. Connie Jung, senior policy advisory in the FDA office of pharmacy affairs, later noted, “They are not the same thing.”

    A McKesson executive complained that while the FDA was focusing on track and trace standards, California only required tracing. He asked, “Why are you ratcheting up the requirement?”

    Ilisa Bernstein, acting deputy director of the office of compliance at the Center for Drug Evaluation and Research (CDER), answered that the agency is only publishing standards, not requiring tracing or tracking, at least not yet. She added that when the agency started working on track and trace in 2003, it expected — based on input from industry — to have a national system up and running by 2007. She added, ruefully, “It has been painfully slow and we hope to kick it up a gear or two.”

    Asked whether the FDA could mandate track and trace — as opposed to publishing standards — in the absence of a congressional grant of authority, she declined to respond.

    Stephen Barlas is a contributing writer for Contract Pharma. He can be reached at sbarlas@verizon.net.
    Related Searches
    • Methods Development
    • Pharma
    • contract pharma
    Suggested For You
    So You Think You Know  All About Excipients? So You Think You Know All About Excipients?
    CROs & Next-Gen  Drug Development CROs & Next-Gen Drug Development
    Edge Pharmacy Services Investing $1.5 Million in Facility Expansion Edge Pharmacy Services Investing $1.5 Million in Facility Expansion
    Aseptic Manufacturing Trends Roundtable Aseptic Manufacturing Trends Roundtable
    Elemental Impurities: A Virtual Company Perspective Elemental Impurities: A Virtual Company Perspective
    Reality and Un-Reality:  Continuous Processing in Pharmaceutical Manufacturing Reality and Un-Reality: Continuous Processing in Pharmaceutical Manufacturing
    DCAT Week DCAT Week '17 Q&A: API Market Trends
    Precision Medicine Precision Medicine
    Q BioMed in Cancer Development Pact Q BioMed in Cancer Development Pact
    Emergent BioSolutions Reports Third Quarter and Nine Months 2016 Financial Results Emergent BioSolutions Reports Third Quarter and Nine Months 2016 Financial Results
    Packaging Serialization Update Packaging Serialization Update
    What What's the Worst That Could Happen?
    Track & Trace Update Track & Trace Update
    Drug Packaging Serialization Drug Packaging Serialization
    Complying with Track and Trace Complying with Track and Trace

    Related Online Exclusives

    • Capsules | Excipients | GMPs/GCPs | Industry News | Inspections | Process Development | Regulatory Affairs | Solid Dosage/Semi-solids

      Molecular Profiles Hosts Bioavailability Event

      Biannual event attracts scientists, executives
      Gil Roth 02.11.14

    • APIs | Capsules | Extractables and Leachables | Facilities | Fill/Finish | GMPs/GCPs | Industry News | Inspections | Lyophilization | Process Development | QA/QC | Regulatory Affairs | Serialization | Supply Chain | Validation

      FDA Publishes Report on GDUFA

      First-year goals met
      Gil Roth 02.05.14

    • CRO News | GMPs/GCPs | Inspections | Process Development | Regulatory Affairs

      PAREXEL Creates Customized Biopharm Unit

      Q&A with Ubavka DeNoble, M.D. about small and mid-size company needs
      Kristin Brooks 11.06.13


    • APIs | Aseptic Processing | Capsules | Cleaning Validation | Clinical Trial Materials | Extractables and Leachables | Facilities | Fill/Finish | GMPs/GCPs | Industry News | Inspections | Lyophilization | Process Development | QA/QC | Regulatory Affairs | Serialization | Solid Dosage/Semi-solids | Supply Chain | Validation

      European Medicines Agency Reveals New Structure

      EMA reorganizes to cover drugs' lifecycles
      Gil Roth 09.16.13

    • Aseptic Processing | Capsules | Extractables and Leachables | Facilities | Fill/Finish | GMPs/GCPs | Inspections | Lyophilization | Parenterals | Process Development | QA/QC | Regulatory Affairs | Serialization | Solid Dosage/Semi-solids | Supply Chain | Validation | Vials
      West Pharmaceutical Services Q&A

      West Pharmaceutical Services Q&A

      We talk with West CEO Don Morel about the company's 90th anniversary
      Gil Roth 07.11.13

    • Capsules | Collaborations & Alliances | Excipients | Extractables and Leachables | Facilities | Fill/Finish | GMPs/GCPs | Lyophilization | Parenterals | Process Development | Scale-up/Technology Transfer | Solid Dosage/Semi-solids | Vials
      Halo/Altus Q&A

      Halo/Altus Q&A

      Halo's CEO discusses his recent formulation partnership
      Gil Roth 06.12.13


    • Collaborations & Alliances | CRO News | GMPs/GCPs | Process Development
      Quintiles Q&A

      Quintiles Q&A

      Discussing a new partnership with Merck Serono
      Kristin Brooks 06.05.13

    • Extractables and Leachables | Facilities | GMPs/GCPs | Process Development | QA/QC | Validation

      Build an Architecture for Control Documents

      Accelerate your QMS development
      Craig Wylie, PA Consulting 06.05.13

    • Capsules | Cleaning Validation | Extractables and Leachables | Facilities | Fill/Finish | GMPs/GCPs | Inspections | Lyophilization | Process Development | Process Validation | QA/QC | Solid Dosage/Semi-solids | Validation | Vials

      Manufacturing Equipment Trends

      Industry perspective from suppliers and manufacturers
      Kristin Brooks, Associate Editor 03.07.12


    • Aseptic Processing | Capsules | Extractables and Leachables | Facilities | Fill/Finish | GMPs/GCPs | Lyophilization | Process Development | QA/QC | Validation

      Newsmakers: John Bertagnolli of Jubilant HollisterStier

      How do you manage client expectations during an expansion?
      Gil Roth 10.19.11

    • Bio News | Process Development

      BIO 2011 Wrapup

      Video interviews from the world's biggest biotech show
      Gil Roth 07.20.11

    • Injectables | Lyophilization | Process Development | Vials

      Jubilant News for Hollister-Stier

      Jubilant News for Hollister-Stier By Joanna Cosgrove In what’s been billed as the largest overseas acquisition in contract manufacturing sector by an Indian company, Hollister-Stier Laboratories LLC, a Spokane, WA-based contract manuf…
      Joanna Cosgrove 05.04.07

    Breaking News
    • InClinica Names BD Manager
    • SCHOTT Introduces syriQ BioPure
    • Heritage Pharma Makes Leadership Changes
    • JLL and Water Street Acquire Triplefin
    • WuXi AppTec Opens Laboratory Testing Facility in NJ
    View Breaking News >
    CURRENT ISSUE

    April 2018

    • Pharmaceutical Packaging Technology
    • Elemental Impurities: The Time Has Come
    • Continuous vs. Batch Production
    • 2018: The evolution of pharmaceutical packaging
    • Formulation Development Trends
    • Changing Dynamics: The CDMO market in focus
    • Contract BioManufacturing in China: Creating a New Segment
    • View More >

    Copyright © 2018 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.