# Prescription Drug Product Labeling; Medication Guide Requirements
> **Food and Drug Administration** · Final rule. · Published 1998-12-01 · Effective 1999-06-01 · 63 FR 66378
## Document
- **Document number:** 98-31627
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 63 FR 66378
- **CFR reference:** 21 CFR 201
- **Publication date:** 1998-12-01
- **Effective date:** 1999-06-01
- **HHS docket:** Docket No. 93N-0371
## Abstract

The Food and Drug Administration (FDA) is establishing requirements for the distribution of patient labeling for selected prescription human drug and biological products used primarily on an outpatient basis. The agency is requiring the distribution of patient labeling, called Medication Guides, for certain products that pose a serious and significant public health concern requiring distribution of FDA-approved patient medication information. The intent of this action is to improve public health by providing information necessary for patients to use their medications safely and effectively. FDA believes that this program will result in direct improvements in the safe and effective use of prescription medications.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1998/12/01/98-31627/prescription-drug-product-labeling-medication-guide-requirements)
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