---
kind: "section"
citation: "21 C.F.R. § 206.1"
title: "21"
number: "206.1"
heading: "Scope."
url: "https://uscodex.org/cfr/21/206.1"
---

# §206.1. Scope.


This part applies to all solid oral dosage form human drug products, including prescription drug products, over-the-counter drug products, biological drug products, and homeopathic drug products, unless otherwise exempted under [§ 206.7](/cfr/21/206.7.md).


## Notes

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 355, 371; 42 U.S.C. 262.

### Source

Source: 58 FR 47958, Sept. 13, 1993, unless otherwise noted.