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Title 42, The Public Health and WelfareRelease 119-73not60

§300aa–28 Manufacturer Recordkeeping and Reporting

Title 42 › Chapter 6A— PUBLIC HEALTH SERVICE › Subchapter XIX— VACCINES › Part 2— National Vaccine Injury Compensation Program › Subpart c— assuring a safer childhood vaccination program in united states › § 300aa–28

Last updated Apr 5, 2026|Official source

Summary

Vaccine makers must create and keep detailed records for every batch, lot, or other quantity made or licensed after December 22, 1987 for vaccines on the Vaccine Injury Table or those required by state law. Records must show how the product was made, tested, processed, repooled, or reworked and note any major problems. If a safety test shows a likely serious public health danger, the maker must tell the Secretary within 24 hours and give the test date, vaccine type, batch ID, whether it was repooled or reworked (and from which batches), full test results, and who ran the test. Each report must include a signed statement from a company official saying it is true. Makers must also keep and give, on request, distribution records by batch or lot number. If a maker intentionally destroys, changes, fakes, or hides any required record or report, they can face up to a $100,000 civil penalty per incident, or a $50,000 fine and/or up to 1 year in jail.

Full Legal Text

Title 42, §300aa–28

The Public Health and Welfare, Source: USLM XML via OLRC

(a)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)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.

Legislative History

Notes & Related Subsidiaries

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.

Amendments

1987—Subsec. (a). Pub. L. 100–203 substituted “

Effective Date

of this subpart” for “

Effective Date

of this part”.

Reference

Citations & Metadata

Citation

42 U.S.C. § 300aa–28

Title 42, The Public Health and Welfare

Last Updated

Apr 5, 2026

Release point: 119-73not60