§ 207.81. What registration and listing information will FDA make available for public disclosure?
223 words·~1 min read·
/us/cfr/t21/s§ 207.81·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Except as provided in paragraphs
(b)and
(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, § 207.49, § 207.53, § 207.54, or § 207.57.
(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 as the basis upon which it has been determined that a particular drug is not subject to section 505 or 512 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) for which the registrant makes a valid assertion of confidentiality under § 20.61 of this chapter or other provision of law, or
(3)Drug listing information obtained under § 207.33(d)(3), § 207.49(a)(9) and (12), § 207.53(b) and (c), or § 207.54(a) or (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)of this section.