42 U.S.C. § 300aa–28: Manufacturer recordkeepin…

Summary

Vaccine makers must keep detailed records for every batch, lot, or other quantity of any vaccine on the Vaccine Injury Table or required by a State law or rule that was made or licensed after December 22, 1987. They must record how each batch was made, processed, tested, repooled, or reworked and note any major problems. If a safety test shows a likely or serious public health hazard, the maker must tell the Secretary within 24 hours. That report must give the test date, vaccine type, batch or lot identity, whether it came from repooling or reworking (and the earlier batch identities if so), the full test results, and the name and address of the person who ran the test. The report must include a signed statement from a responsible company official saying it is true and complete. Makers must also keep and give product distribution records by batch or lot when the Secretary asks. If anyone intentionally destroys, changes, fakes, or hides those required records or reports, they face penalties. They can be fined up to $100,000 per occurrence, or fined $50,000 and/or jailed for up to 1 year. The penalty applies to the person who did it, the person who ordered it, and the vaccine maker they work for. Each wrongful act is treated as a separate occurrence.

Title 42, §300aa–28

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

(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.

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”.

§300aa–28 Manufacturer Recordkeeping and Reporting

Summary

Title 42, §300aa–28

Notes & Related Subsidiaries

Editorial Notes

Effective Date

Effective Date

Amendments

Effective Date

Effective Date

Citations & Metadata