---
kind: "section"
citation: "21 C.F.R. § 201.50"
title: "21"
number: "201.50"
heading: "Statement of identity."
url: "https://uscodex.org/cfr/21/201.50"
---

# §201.50. Statement of identity.

- (a) The label of prescription and insulin-containing drugs in package form shall bear as one of its principal features a statement of the identity of the drug.
- (b) Such statement of identity shall be in terms of the established name of the drug. In the case of a prescription drug that is a mixture and that has no established name, the requirement for statement of identity shall be deemed to be satisfied by a listing of the quantitative ingredient information as prescribed by [§ 201.10](/cfr/21/201.10.md).
- (c) The statement of identity of a prescription drug shall also comply with the placement, size and prominence requirements of [§ 201.10](/cfr/21/201.10.md).

## Notes

### Amendments

[40 FR 13998, Mar. 27, 1975, as amended at 63 FR 26698, May 13, 1998]

### Authority

Authority: 21 U.S.C. 321, 331, 343, 351, 352, 353, 355, 358, 360, 360b, 360ccc, 360ccc-1, 360ddd, 360ddd-1, 360ee, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.

### Source

Source: 40 FR 13998, Mar. 27, 1975, unless otherwise noted.

### Amendments

[40 FR 13998, Mar. 27, 1975, as amended at 63 FR 26698, May 13, 1998]