[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR5.31]

[Page 65-66]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 5_DELEGATIONS OF AUTHORITY AND ORGANIZATION--Table of Contents
 
              Subpart B_General Redelegations of Authority
 
Sec. 5.31  Enforcement activities.

    (a) Designated officers and employees of the Food and Drug 
Administration who have been issued the Food and Drug Administration 
official credentials consisting of Form FDA-200A, Identification Record, 
and Form FDA-200B, Specification of General Authority, are authorized:
    (1) To conduct examinations, inspections, and investigations; to 
collect and obtain samples; to have access to and to copy and verify 
records as authorized by law; to make seizures of items under section 
702(e)(5) of the Federal Food, Drug, and Cosmetic Act (the act) (21 
U.S.C. 372 (e) (5)); and to supervise compliance operations for the 
enforcement of the act, the Fair Packaging and Labeling Act (15 U.S.C. 
1451-1461), the Federal Caustic Poison Act (44 Stat. 140b; see also 
Public Law 86-613, section 19, formerly section 18), the Import Milk Act 
(21 U.S.C. 141-149), the Filled Milk Act (21 U.S.C. 61-64), and sections 
351 and 361 of the PHS Act (42 U.S.C. 262 and 264).
    (2) To administer oaths and affirmations under section 1 of the act 
of January 31, 1925 (Ch. 124, 43 Stat. 803); sections 12 to 15 of 
Reorganization Plan No. IV, effective June 30, 1940; and Reorganization 
Plan No. 1 of 1953, effective April 11, 1953.
    (b) Any officer or employee of the Food and Drug Administration who 
has been designated by the Commissioner of Food and Drugs (Commissioner) 
to conduct examinations, investigations, or inspections under the act 
relating to counterfeit drugs and issued the Food and Drug 
Administration Official Credential consisting of Form FDA-200D, Special 
Authority for Criminal Investigators, is authorized to do the following:
    (1) As set forth under section 702(e)(1) through (e)(5) of the act 
(21 U.S.C. 372(e)(1)-(e)(5)):
    (i) Carry firearms;
    (ii) Serve and execute search warrants and arrest warrants;
    (iii) Execute seizure by process issued under libel under section 
304 of the act (21 U.S.C. 334);

[[Page 66]]

    (iv) Make arrests without warrant for an offense under the act with 
respect to counterfeit drugs if the offense is committed in the presence 
of the criminal investigator or, in the case of a felony, if the 
investigator has probable cause to believe that the person so arrested 
has committed, or is committing, such offense; and
    (v) Make, prior to the institution of libel proceedings under 
section 304(a)(2) of the act (21 U.S.C. 334(a)(2)), seizures of drugs or 
containers or of equipment, punches, dies, plates, stones, labeling, or 
other things, if they are, or the criminal investigator has reasonable 
grounds to believe that they are, subject to seizure and condemnation 
under section 304(a)(2) of the act.
    (2) Perform such other functions under the act, or any other law, as 
the Commissioner may prescribe.
    (3) To administer oaths and affirmations under section 1 of the act 
of January 31, 1925 (Ch. 124, 43 Stat. 803); sections 12 to 15 of 
Reorganization Plan No. IV, effective June 30, 1940; and Reorganization 
Plan No. 1 of 1953, effective April 11, 1953.
    (c) Any officer or employee of the Food and Drug Administration who 
has been designated by the Commissioner to provide specialized law 
enforcement support involving criminal investigations under the act, and 
other duties as assigned by the Commissioner, and issued the Food and 
Drug Administration Official Credential consisting of Form FDA-200E, 
Special Authority for Criminal Investigative Specialists, is authorized 
to receive information as to all matters relating to such act and 
regulations issued under the act.
    (d) These officials may not further redelegate these authorities.