[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR2.10]

[Page 16-17]
 
                        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.

[[Page 17]]

    (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 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]