> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Information Collection Extension for Bar Code Labels
- URL: https://www.fdaweb.com/information-collection-extension-for-bar-code-labels/
- Published: 2018-10-31T12:00:00.000Z
- Updated: 2026-09-15T00:41:46.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142713

*Federal Register* notice: FDA is seeking comments on an information collection extension entitled “Bar Code Label Requirement for Human Drug and Biological Products” (OMB Control Number 0910-0537). In 2004, FDA issued a final rule that requires human drug product and biological product labels to have bar codes. Specifically, the final rule requires bar codes on most human prescription drug products and on over-the-counter drug products that are dispensed under an order and commonly used in health care facilities. It also requires machine-readable information on blood and blood components. For human prescription drug products and OTC drug products that are dispensed under an order and commonly used in health care facilities, the bar code must contain the national drug code number for the product. To view the notice, click [here](https://s3.amazonaws.com/public-inspection.federalregister.gov/2018-23910.pdf?ref=fdaweb.com).