[Code of Federal Regulations]
[Title 21, Volume 9]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1316.03]

[Page 173-174]
 
                         TITLE 21-FOOD AND DRUGS
 
   CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1316_ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES
--Table of Contents
 
                  Subpart A_Administrative Inspections
 
Sec. 1316.03  Authority to make inspections.

    In carrying out his functions under the Act, the Administrator, 
through his inspectors, is authorized in accordance with sections 510 
and 1015 of the Act (21 U.S.C. 880 and 965) to enter controlled premises 
and conduct administrative inspections thereof, for the purpose of:
    (a) Inspecting, copying, and verifying the correctness of records, 
reports, or other documents required to be kept or made under the Act 
and regulations promulgated under the Act, including, but not limited 
to, inventory and other records required to be kept pursuant to part 
1304 of this chapter, order form records required to be kept pursuant to 
part 1305 of this chapter, prescription and distribution records 
required to be kept pursuant to part 1306 of this chapter, records of 
listed chemicals, tableting machines, and encapsulating machines 
required to be kept pursuant to part 1310 of this chapter, import/export 
records of listed chemicals required to be kept pursuant to part 1313 of 
this chapter, shipping records identifying the name of each carrier used 
and the date and quantity of each shipment, and storage records 
identifying

[[Page 174]]

the name of each warehouse used and the date and quantity of each 
storage.
    (b) Inspecting within reasonable limits and to a reasonable manner 
all pertinent equipment, finished and unfinished controlled substances, 
listed chemicals, and other substances or materials, containers, and 
labeling found at the controlled premises relating to this Act;
    (c) Making a physical inventory of all controlled substances and 
listed chemicals on-hand at the premises;
    (d) Collecting samples of controlled substances or listed chemicals 
(in the event any samples are collected during an inspection, the 
inspector shall issue a receipt for such samples on DEA Form 84 to the 
owner, operator, or agent in charge of the premises);
    (e) Checking of records and information on distribution of 
controlled substances or listed chemicals by the registrant or regulated 
person (i.e., has the distribution of controlled substances or listed 
chemicals increased markedly within the past year, and if so why);
    (f) Except as provided in Sec. 1316.04, all other things therein 
(including records, files, papers, processes, controls and facilities) 
appropriate for verification of the records, reports, documents referred 
to above or otherwise bearing on the provisions of the Act and the 
regulations thereunder.

[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 51 FR 5319, Feb. 13, 1986; 55 FR 50827, Dec. 11, 1990; 60 
FR 32465, June 22, 1995]