republic-os/legal/us/code/title-42/chapter-6a/section-300aa-28.md

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LegalText	42 U.S.C. § 300aa–28	Manufacturer recordkeeping and reporting	us	united_states_code	code_section	42	THE PUBLIC HEALTH AND WELFARE	6A	PUBLIC HEALTH SERVICE	300aa–28	42 U.S.C. § 300aa–28	current	119-100	2026-06-26	official	https://uscode.house.gov/download/releasepoints/us/pl/119/100/xml_usc42@119-100.zip	/us/usc/t42/s300aa–28	data/legal/raw/us/code/title-42/usc42.xml	d468240ee599b3441dce26a365ed84b60522cf9269e231cd5a8e26901fc71bfc	644321055a08eb1f260a6a3e31ac157fa024756abf612a9fd6857e7e400cf24e	7fe9874672716d53256f28e64d42384fff55ae0132d50134a66edc62aa76102f	2026-07-04	official	legal us-code

42 U.S.C. § 300aa–28 - Manufacturer recordkeeping and reporting

Text

(a) General rule Each vaccine manufacturer of a vaccine set forth in the Vaccine Injury Table or any other vaccine the administration of which is mandated by the law or regulations of any State, shall, with respect to each batch, lot, or other quantity manufactured or licensed after December 22, 1987—

(1) prepare and maintain records documenting the history of the manufacturing, processing, testing, repooling, and reworking of each batch, lot, or other quantity of such vaccine, including the identification of any significant problems encountered in the production, testing, or handling of such batch, lot, or other quantity,

(2) if a safety test on such batch, lot, or other quantity indicates a potential imminent or substantial public health hazard is presented, report to the Secretary within 24 hours of such safety test which the manufacturer (or manufacturer’s representative) conducted, including the date of the test, the type of vaccine tested, the identity of the batch, lot, or other quantity tested, whether the batch, lot, or other quantity tested is the product of repooling or reworking of previous batches, lots, or other quantities (and, if so, the identity of the previous batches, lots, or other quantities which were repooled or reworked), the complete test results, and the name and address of the person responsible for conducting the test,

(3) include with each such report a certification signed by a responsible corporate official that such report is true and complete, and

(4) prepare, maintain, and upon request submit to the Secretary product distribution records for each such vaccine by batch, lot, or other quantity number.

(b) Sanction Any vaccine manufacturer who intentionally destroys, alters, falsifies, or conceals any record or report required under paragraph (1) or (2) of subsection (a) shall—

(1) be subject to a civil penalty of up to $100,000 per occurrence, or

(2) be fined $50,000 or imprisoned for not more than 1 year, or both.

Such penalty shall apply to the person who intentionally destroyed, altered, falsified, or concealed such record or report, to the person who directed that such record or report be destroyed, altered, falsified, or concealed, and to the vaccine manufacturer for which such person is an agent, employee, or representative. Each act of destruction, alteration, falsification, or concealment shall be treated as a separate occurrence.

(July 1, 1944, ch. 373, title XXI, § 2128, as added Pub. L. 99–660, title III, § 311(a), Nov. 14, 1986, 100 Stat. 3777; amended Pub. L. 100–203, title IV, § 4302(b)(1), Dec. 22, 1987, 101 Stat. 1330–221.)

Notes

Editorial Notes

Codification In subsec. (a), “December 22, 1987” substituted for “the effective date of this subpart” on authority of section 323 of Pub. L. 99–660, as amended, set out as an Effective Date note under section 300aa–1 of this title.

Amendments1987—Subsec. (a). Pub. L. 100–203 substituted “effective date of this subpart” for “effective date of this part”.