We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » HEALTH CARE PROVIDERS EXPRESS CONCERN ABOUT BAR CODE RULE

HEALTH CARE PROVIDERS EXPRESS CONCERN ABOUT BAR CODE RULE

April 27, 2006

How the FDA defines a hospital for the purpose of its rule requiring bar codes on drug labels is a key question affecting health care providers and drug manufacturers' ability to comply with the rule, a hospital official says.

The FDA's rule, "Bar Code Label Requirement for Human Drug Products and Biological Products," became effective April 26. The rule requires that drugs and biologic products distributed in hospitals include bar codes that contain at least the drug's National Drug Code (NDC) number. The NDC identifies the drug's labeler, product details and trade package size. Such labels are meant to avoid misapplication of drugs or use of the wrong drugs by hospital staff through the use of bar codes to transmit dosing data and the names of these products.

The agency issued a Federal Register notice providing common questions about the rule and the FDA's views on these topics. But the document does not go far enough in answering how the agency defines the term "hospital" for the purposes of the rule, Steven Goulet, the pharmacy informatics coordinator for St. Joseph's Mercy Health System told FDAnews. Goulet is also a member of the Auto-ID and Barcode Task Force for the Healthcare Information and Management Systems Society. The task force is currently assessing the rule to determine how to comply with it.

Whether ambulatory care settings, such as nursing homes, and behavioral care facilities are considered hospitals and must comply with the rule is uncertain and one of the "more ambiguous and gray areas" for both health care providers and industry, Goulet said. Health care providers and industry must be sure, he added, what's expected of them before investing in the bar code labeling and the equipment to read these labels.

Questions about the agency's enforcement of the rule are also an issue for industry, said Ken Kleinberg, senior director for global healthcare at Symbol Technologies. This uncertainty makes it difficult to predict the rate of compliance within industry, he said.

The Federal Register notice is available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/05d-0202-gdl0002.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/05d-0202-gdl0002.pdf).

(http://www.fdanews.com/did/5_83/)

KEYWORDS FDAnews Drug Daily Bulletin

Upcoming Events

  • 10Mar

    FDA Drug GMP Facility Inspections During the Pandemic

  • 16Mar

    Pharmaceutical Naming Regulation: Understanding the Latest Developments

  • 18Mar

    Pharmaceutical Postmarket Surveillance: Latest Developments in the Era of COVID-19

  • 23Mar

    Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

  • 30Mar

    Data Integrity for GMP/Postmarket Professionals: Core Requirements, Expectations and Challenges

  • 06Apr

    Medical Device Cybersecurity: Understand the Latest Developments

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • UKflag.jpg

    UK Study Says Single Shot of Pfizer/BioNTech Vaccine Significantly Lessened Asymptomatic Infections

  • emergency use authorization approved

    Eurofins Receives FDA Emergency Authorization for Over-the-Counter COVID-19 Test

  • FDA clears text

    Vetex Medical’s Thrombectomy Catheter Cleared by FDA

  • 100Bills_flatmoney.gif

    Merck Purchases Rights to Debiopharm’s Xevinapant for More Than $1 Billion

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing