[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR2.10]
[Page 50-51]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 2 GENERAL ADMINISTRATIVE RULINGS AND DECISIONS--Table of Contents
Subpart A General Provisions
Sec. 2.10 Examination and investigation samples.
(a)(1) When any officer or employee of the Department collects a
sample of a food, drug, or cosmetic for analysis under the act, the
sample shall be designated as an official sample if records or other
evidence is obtained by him or any other officer or employee of the
Department indicating that the shipment or other lot of the article from
which such sample was collected was introduced or delivered for
introduction into interstate commerce, or was in or was received in
interstate commerce, or was manufactured within a Territory. Only
samples so designated by an officer or employee of the Department shall
be considered to be official samples.
(2) For the purpose of determining whether or not a sample is
collected for analysis, the term analysis includes examinations and
tests.
(3) The owner of a food, drug, or cosmetic of which an official
sample is collected is the person who owns the shipment or other lot of
the article from which the sample is collected.
(b) When an officer or employee of the Department collects an
official sample of a food, drug, or cosmetic for analysis under the act,
he shall collect at least twice the quantity estimated by him to be
sufficient for analysis, unless:
(1) The amount of the article available and reasonably accessible
for sampling is less than twice the quantity so estimated, in which case
he shall collect as much as is available and reasonably accessible.
(2) The cost of twice the quantity so estimated exceeds $150.
(3) The sample cannot by diligent use of practicable preservation
techniques available to the Food and Drug Administration be kept in a
state in which it could be readily and meaningfully analyzed in the same
manner and for the same purposes as the Food and Drug Administration's
analysis.
(4) The sample is collected from a shipment or other lot which is
being imported or offered for import into the United States.
(5) The sample is collected from a person named on the label of the
article or his agent, and such person is also the owner of the article.
(6) The sample is collected from the owner of the article, or his
agent, and such article bears no label or, if it bears a label, no
person is named thereon.
In addition to the quantity of sample set forth in this paragraph, the
officer or employee shall, if practicable, collect such further amount
as he estimates will be sufficient for use as trial exhibits.
(c) After the Food and Drug Administration has completed such
analysis of an official sample of a food, drug, or cosmetic as it
determines, in the course of analysis and interpretation of analytical
results, to be adequate to establish the respects, if any, in which the
article is adulterated or misbranded within the meaning of the act, or
otherwise subject to the prohibitions of the act, and has reserved an
amount of the article it estimates to be adequate for use as exhibits in
the trial of any case that may arise under the act based on the sample,
a part of the sample, if any remains available, shall be provided for
analysis, upon written request, by any person named on the label of the
article, or the owner thereof, or the attorney or agent of such person
or owner, except when:
(1) After collection, the sample or remaining part thereof has
become decomposed or otherwise unfit for analysis, or
(2) The request is not made within a reasonable time before the
trial of any case under the act, based on the sample to which such
person or owner is a party. The person, owner, attorney, or agent who
requests the part of sample shall specify the amount desired. A request
from an owner shall be accompanied by a showing of ownership, and a
request from an attorney or agent by a showing of authority from such
person or owner to receive the part of
[[Page 51]]
sample. When two or more requests for parts of the same sample are
received the requests shall be complied with in the order in which they
were received so long as any part of the sample remains available
therefor.
(d) When an official sample of food, drug, or cosmetic is the basis
of a notice given under section 305 of the act, or of a case under the
act, and the person to whom the notice was given, or any person who is a
party to the case, has no right under paragraph (c) of this section to a
part of the sample, such person or his attorney or agent may obtain a
part of the sample upon request accompanied by a written waiver of right
under such paragraph (c) from each person named on the label of the
article and owner thereof, who has not exercised his right under such
paragraph (c). The operation of this paragraph shall be subject to the
exceptions, terms, and conditions prescribed in paragraph (c) of this
section.
(e) The Food and Drug Administration is authorized to destroy:
(1) Any official sample when it determines that no analysis of such
sample will be made;
(2) Any official sample or part thereof when it determines that no
notice under section 305 of the act, and no case under the act, is or
will be based on such sample;
(3) Any official sample or part thereof when the sample was the
basis of a notice under section 305 of the act, and when, after
opportunity for presentation of views following such notice, it
determines that no other such notice, and no case under the act, is or
will be based on such sample;
(4) Any official sample or part thereof when the sample was the
basis of a case under the act which has gone to final judgment, and when
it determines that no other such case is or will be based on such
sample;
(5) Any official sample or part thereof if the article is
perishable;
(6) Any official sample or part thereof when, after collection, such
sample or part has become decomposed or otherwise unfit for analysis;
(7) That part of any official sample which is in excess of three
times the quantity it estimates to be sufficient for analysis.
[42 FR 15559, Mar. 22, 1977, as amended at 63 FR 51299, Sept. 25, 1998]
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