21 USC 364a - Adverse events

U.S Code last checked for updates: Apr 29, 2024

§ 364a.

Adverse events

(a)

Serious adverse event reporting requirements

(b)

Submission of reports

(1)

Serious adverse event report

(2)

New medical information

(3)

Consolidation of reports

(c)

Exemptions

(d)

Contact information

(e)

Maintenance and inspection of adverse event records

(1)

Maintenance

(2)

Inspection

(A)

In general

(B)

Authorized person

For purposes of this paragraph, the term “authorized person” means an officer or employee of the Department of Health and Human Services who has—

(i)

appropriate credentials, as determined by the Secretary; and

(ii)

been duly designated by the Secretary to have access to the records required under this section.

(f)

Fragrance and flavor ingredients

(g)

Protected information

A serious adverse event report submitted to the Secretary under this section, including any new medical information submitted under subsection (b)(2), or an adverse event report, or any new information, voluntarily submitted to the Secretary shall be considered to be—

(1)

a safety report under section 379v of this title and may be accompanied by a statement, which shall be a part of any report that is released for public disclosure, that denies that the report or the records constitute an admission that the product involved caused or contributed to the adverse event; and

(2)

a record about an individual under section 552a of title 5 (commonly referred to as the “Privacy Act of 1974”) and a medical or similar file the disclosure of which would constitute a violation of section 552 of such title 5 (commonly referred to as the “Freedom of Information Act”), and shall not be publicly disclosed unless all personally identifiable information is redacted.

(h)

Effect of section

(1)

In general

(2)

Personally identifiable information

Notwithstanding any other provision of law, personally-identifiable information in adverse event reports provided by the Secretary to any health, food, or drug officer or employee of any State, territory, or political subdivision of a State or territory, shall not—

(A)

be made publicly available pursuant to any State or other law requiring disclosure of information or records; or

(B)

otherwise be disclosed or distributed to any party without the written consent of the Secretary and the person submitting such information to the Secretary.

(3)

Use of reports

(4)

Rule of construction

(June 25, 1938, ch. 675, § 605, as added Pub. L. 117–328, div. FF, title III, § 3502, Dec. 29, 2022, 136 Stat. 5848.)

cite as: 21 USC 364a