# Bar Code Label Requirement for Human Drug Products and Biological Products
> **Food and Drug Administration** · Final rule. · Published 2004-02-26 · Effective 2004-04-26 · 69 FR 9120
## Document
- **Document number:** 04-4249
- **Category:** hospital-facility
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 69 FR 9120
- **CFR reference:** 21 CFR 201
- **Publication date:** 2004-02-26
- **Effective date:** 2004-04-26
- **HHS docket:** Docket No. 2002N-0204
## Abstract

The Food and Drug Administration (FDA) is issuing a new rule to require certain human drug and biological product labels to have bar codes. The bar code for human drug products and biological products (other than blood, blood components, and devices regulated by the Center for Biologics Evaluation and Research) must contain the National Drug Code (NDC) number in a linear bar code. The rule will 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 rule also requires the use of machine-readable information on blood and blood component container labels to help reduce medication errors.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2004/02/26/04-4249/bar-code-label-requirement-for-human-drug-products-and-biological-products)
---
*AI Analytics · CC0 1.0*