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Title 42 — The Public Health and WelfareRelease 119-73

§300aa–28 Manufacturer recordkeeping and reporting

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

Last updated Apr 6, 2026|Official source

Summary

Vaccine makers must keep detailed records for every batch made or licensed after December 22, 1987, when the vaccine is on the Vaccine Injury Table or is required by a State. They must record how each batch was made, processed, tested, repooled, or reworked, and note any big problems. If a safety test shows a likely or serious public health danger, the maker must report to the Secretary within 24 hours. The report must give the test date, vaccine type, batch identity, whether it was repooled or reworked (and the prior batches if so), full test results, and the tester’s name and address. A responsible company official must sign a statement saying the report is true. Makers must also keep and give the Secretary, on request, product distribution records by batch. If a maker intentionally destroys, changes, falsifies, or hides any required record or report, it can face a civil penalty up to $100,000 per occurrence, or a criminal fine of $50,000, or up to 1 year in jail, or both.

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 6, 2026

Release point: 119-73