From the U.S. House of Representatives Downloadable U.S. Code
[uscode.house.gov]
[Laws in effect as of January 5, 1999]

[CITE: 42USC300aa-28]

 
TITLE 42 - THE PUBLIC HEALTH AND WELFARE
    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
 
-HEAD-
    Sec. 300aa-28. Manufacturer recordkeeping and reporting
 
-STATUTE-
    (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) of this section 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.
 
-SOURCE-
    (July 1, 1944, ch. 373, title XXI, Sec. 2128, as added Pub. L.
    99-660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3777;
    amended Pub. L. 100-203, title IV, Sec. 4302(b)(1), Dec. 22, 1987,
    101 Stat. 1330-221.)
 
-COD-
                                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.
 
-MISC3-
                                 AMENDMENTS
      1987 - Subsec. (a). Pub. L. 100-203 substituted ''effective date
    of this subpart'' for ''effective date of this part''.
 
-SECREF-
                   SECTION REFERRED TO IN OTHER SECTIONS
      This section is referred to in section 300aa-33 of this title.