# Tamper-Evident Packaging Requirements for Over-the-Counter Human Drug Products
> **Food and Drug Administration** · Final rule. · Published 1998-11-04 · Effective 1998-12-04 · 63 FR 59463
## Document
- **Document number:** 98-29388
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 63 FR 59463
- **CFR reference:** 21 CFR 211
- **Publication date:** 1998-11-04
- **Effective date:** 1998-12-04
- **HHS docket:** Docket No. 92N-0314
## Abstract

The Food and Drug Administration (FDA) is amending its regulations on tamper-resistant packaging to require that all over-the- counter (OTC) human drug products marketed in two-piece, hard gelatin capsules be sealed using a tamper-evident technology; to change the term ``tamper-resistant'' in the labeling of all OTC drug products to ``tamper-evident;'' and to specify that the required OTC drug product labeling statement must refer to all packaging features used to comply with the tamper-evident packaging requirements, including those on the secondary package, the immediate container or closure, and any capsule sealing technologies used. FDA is taking this action as a result of its continuing review of the potential public health threat posed by product tampering and to improve consumer protection by addressing specific vulnerabilities in the OTC drug market.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1998/11/04/98-29388/tamper-evident-packaging-requirements-for-over-the-counter-human-drug-products)
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