---
kind: "section"
citation: "21 C.F.R. § 200.51"
title: "21"
number: "200.51"
heading: "Aqueous-based drug products for oral inhalation."
url: "https://uscodex.org/cfr/21/200.51"
---

# §200.51. Aqueous-based drug products for oral inhalation.

- (a) All aqueous-based drug products for oral inhalation must be manufactured to be sterile.
- (b) Manufacturers must also comply with the requirements in [§ 211.113(b)](/cfr/21/211.113.md?p=b) of this chapter.

## Notes

### Amendments

[65 FR 34089, May 26, 2000]

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 358, 360e, 371, 374, 375.

### Source

Source: 40 FR 13996, Mar. 27, 1975, unless otherwise noted.

### Amendments

[65 FR 34089, May 26, 2000]