---
kind: "section"
citation: "21 C.F.R. § 207.81"
title: "21"
number: "207.81"
heading: "What registration and listing information will FDA make available for public disclosure?"
url: "https://uscodex.org/cfr/21/207.81"
---

# §207.81. What registration and listing information will FDA make available for public disclosure?

- (a) Except as provided in paragraphs [(b)](#b) and [(c)](#c) of this section, the following information will be available for public disclosure, upon request or at FDA's discretion:
  - (1) All establishment registration information, and
  - (2) After a drug is marketed, information obtained under [§ 207.33](/cfr/21/207.33.md), [§ 207.49](/cfr/21/207.49.md), [§ 207.53](/cfr/21/207.53.md), [§ 207.54](/cfr/21/207.54.md), or [§ 207.57](/cfr/21/207.57.md).
- (b) Unless such information is publicly available or FDA finds that confidentiality would be inconsistent with protection of the public health, FDA will not make publicly available:
  - (1) Any information submitted under [§ 207.55](/cfr/21/207.55.md) as the basis upon which it has been determined that a particular drug is not subject to section [505](/cfr/21/505.md) or [512](/cfr/21/512.md) of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act,
  - (2) The names of any inactive ingredients submitted under [§ 207.49(a)(4)](/cfr/21/207.49.md?p=a-4) for which the registrant makes a valid assertion of confidentiality under [§ 20.61](/cfr/21/20.61.md) of this chapter or other provision of law, or
  - (3) Drug listing information obtained under [§ 207.33(d)(3)](/cfr/21/207.33.md?p=d-3), § [207.49(a)(9)](/cfr/21/207.49.md?p=a-9) and [(12)](/cfr/21/207.49.md?p=a-12), § [207.53(b)](/cfr/21/207.53.md?p=b) and [(c)](/cfr/21/207.53.md?p=c), or § [207.54(a)](/cfr/21/207.54.md?p=a) or [(c)](/cfr/21/207.54.md?p=c).
- (c) FDA may determine, in limited circumstances and on a case-by-case basis, that it would be consistent with the protection of the public health and the Freedom of Information Act to exempt from public disclosure specific information identified in [paragraph (a)](#a) of this section.

## Notes

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 360b, 371, 374, 381, 393; 42 U.S.C. 262, 264, 271.

### Source

Source: 81 FR 60212, Aug. 31, 2016, unless otherwise noted.