# Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
> **Food and Drug Administration** · Final rule. · Published 2003-12-11 · Effective 2004-06-08 · 68 FR 69009
## Document
- **Document number:** 03-30641
- **Category:** fda-drug
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 68 FR 69009
- **CFR reference:** 21 CFR 314
- **Publication date:** 2003-12-11
- **Effective date:** 2004-06-08
- **HHS docket:** Docket No. 2000N-1652
## Abstract

The Food and Drug Administration (FDA) is amending its regulations governing the format in which certain labeling is required to be submitted for review with new drug applications (NDAs), certain biological license applications (BLAs), abbreviated new drug applications (ANDAs), supplements, and annual reports. The final rule requires that certain labeling content be submitted electronically in a form that FDA can process, review, and archive. Submitting the content of labeling in electronic format will simplify the drug labeling review process and speed up the approval of labeling changes.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2003/12/11/03-30641/requirements-for-submission-of-labeling-for-human-prescription-drugs-and-biologics-in-electronic)
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