TBT BSN | Notification

Notification Detail :: G/TBT/N/USA/37

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

Bar Code Label Requirement for Human Drug Products and Blood  (34 pages, in English)

Objective

Product Covered

Human Drug Products and Blood (ICS 13)

Document Notification

Link to ePing

HSCODE

ICSCODE

13 - ENVIRONMENT. HEALTH PROTECTION. SAFETY

Keywords

Labelling

Specific Regions

Description

The Administration is proposing a new rule that would require certain human drug product labels and biological product labels to have bar codes.  The bar code for human drug products and biological products (other than blood and blood components) would contain the National Drug Code number in a linear bar code. The purposed rule would help reduce the number of medication errors in hospitals and other health care settings by allowing health care professionals to use bar code scanning equipment to verify that the right drug (in the right dose and right route of administration) is being given to the right patient at the right time.  The proposed rule would also require the use of machine-readable information on blood and blood component container labels to help reduce medication errors.

Notified Document

Link to Notification

EN:File here

FR:File here

ES:File here

Status Active

No	#	Comment By	Title	Comment Date	File

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Notification Detail :: G/TBT/N/USA/37

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