[Code of Federal Regulations]
[Title 21, Volume 9]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1301.73]

[Page 38]
 
                         TITLE 21-FOOD AND DRUGS
 
   CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES--Table of Contents
 
Sec. 1301.73  Physical security controls for non-practitioners; 
compounders for narcotic treatment programs; manufacturing and 
compounding areas.

    All manufacturing activities (including processing, packaging and 
labeling) involving controlled substances listed in any schedule and all 
activities of compounders shall be conducted in accordance with the 
following:
    (a) All in-process substances shall be returned to the controlled 
substances storage area at the termination of the process. If the 
process is not terminated at the end of a workday (except where a 
continuous process or other normal manufacturing operation should not be 
interrupted), the processing area or tanks, vessels, bins or bulk 
containers containing such substances shall be securely locked, with 
adequate security for the area or building. If such security requires an 
alarm, such alarm, upon unauthorized entry, shall transmit a signal 
directly to a central station protection company, or local or state 
police agency which has a legal duty to respond, or a 24-hour control 
station operated by the registrant.
    (b) Manufacturing activities with controlled substances shall be 
conducted in an area or areas of clearly defined limited access which is 
under surveillance by an employee or employees designated in writing as 
responsible for the area. ``Limited access'' may be provided, in the 
absence of physical dividers such as walls or partitions, by traffic 
control lines or restricted space designation. The employee designated 
as responsible for the area may be engaged in the particular 
manufacturing operation being conducted: Provided, That he is able to 
provide continuous surveillance of the area in order that unauthorized 
persons may not enter or leave the area without his knowledge.
    (c) During the production of controlled substances, the 
manufacturing areas shall be accessible to only those employees required 
for efficient operation. When it is necessary for employee maintenance 
personnel, nonemployee maintenance personnel, business guests, or 
visitors to be present in or pass through manufacturing areas during 
production of controlled substances, the registrant shall provide for 
adequate observation of the area by an employee specifically authorized 
in writing.

[36 FR 18731, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 
l973 and amended at 39 FR 37984, Oct. 25, 1974]