
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 23, 2000]
[Document not affected by Public Laws enacted between
  January 23, 2000 and December 4, 2001]
[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
 
Sec. 300aa-28. Manufacturer recordkeeping and reporting


(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.

(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.)

                          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''.

                  Section Referred to in Other Sections

    This section is referred to in section 300aa-33 of this title.
