[Title 21 CFR 1301.72]
[Code of Federal Regulations (annual edition) - April 1, 2002 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter II - DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE]
[Part 1301 - REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES]
[Sec. 1301.72 - Physical security controls for non-practitioners; narcotic]
[From the U.S. Government Printing Office]


21FOOD AND DRUGS92002-04-012002-04-01false1301.72Sec. 1301.72FOOD AND DRUGSDRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICEREGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES
Sec. 1301.72  Physical security controls for non-practitioners; narcotic 
treatment programs and compounders for narcotic treatment programs; 
storage areas.

    (a) Schedules I and II. Raw material, bulk materials awaiting 
further processing, and finished products which are controlled 
substances listed in Schedule I or II (except GHB that is manufactured 
or distributed in accordance with an exemption under section 505(i) of 
the FFDCA which shall be subject to the requirements of paragraph (b) of 
this section) shall be stored in one of the following secured areas:
    (1) Where small quantities permit, a safe or steel cabinet;
    (i) Which safe or steel cabinet shall have the following 
specifications or the

[[Page 36]]

equivalent: 30 man-minutes against surreptitious entry, 10 man-minutes 
against forced entry, 20 man-hours against lock manipulation, and 20 
man-hours against radiological techniques;
    (ii) Which safe or steel cabinet, if it weighs less than 750 pounds, 
is bolted or cemented to the floor or wall in such a way that it cannot 
be readily removed; and
    (iii) Which safe or steel cabinet, if necessary, depending upon the 
quantities and type of controlled substances stored, is equipped with an 
alarm system which, upon attempted unauthorized entry, shall transmit a 
signal directly to a central protection company or a local or State 
police agency which has a legal duty to respond, or a 24-hour control 
station operated by the registrant, or such other protection as the 
Administrator may approve.
    (2) A vault constructed before, or under construction on, September 
1, 1971, which is of substantial construction with a steel door, 
combination or key lock, and an alarm system; or
    (3) A vault constructed after September 1, 1971:
    (i) The walls, floors, and ceilings of which vault are constructed 
of at least 8 inches of reinforced concrete or other substantial 
masonry, reinforced vertically and horizontally with \1/2\-inch steel 
rods tied 6 inches on center, or the structural equivalent to such 
reinforced walls, floors, and ceilings;
    (ii) The door and frame unit of which vault shall conform to the 
following specifications or the equivalent: 30 man-minutes against 
surreptitious entry, 10 man-minutes against forced entry, 20 man-hours 
against lock manipulation, and 20 man-hours against radiological 
techniques;
    (iii) Which vault, if operations require it to remain open for 
frequent access, is equipped with a ``day-gate'' which is self-closing 
and self-locking, or the equivalent, for use during the hours of 
operation in which the vault door is open;
    (iv) The walls or perimeter of which vault are equipped with an 
alarm, which upon unauthorized entry shall transmit a signal directly to 
a central station protection company, or a local or State police agency 
which has a legal duty to respond, or a 24-hour control station operated 
by the registrant, or such other protection as the Administrator may 
approve, and, if necessary, holdup buttons at strategic points of entry 
to the perimeter area of the vault;
    (v) The door of which vault is equipped with contact switches; and
    (vi) Which vault has one of the following: Complete electrical 
lacing of the walls, floor and ceilings; sensitive ultrasonic equipment 
within the vault; a sensitive sound accumulator system; or such other 
device designed to detect illegal entry as may be approved by the 
Administration.
    (b) Schedules III, IV and V. Raw material, bulk materials awaiting 
further processing, and finished products which are controlled 
substances listed in Schedules III, IV, and V, and GHB when it is 
manufactured or distributed in accordance with an exemption under 
section 505(i) of the FFDCA, shall be stored in the following secure 
storage areas:
    (1) A safe or steel cabinet as described in paragraph (a)(1) of this 
section;
    (2) A vault as described in paragraph (a)(2) or (3) of this section 
equipped with an alarm system as described in paragraph (b)(4)(v) of 
this section;
    (3) A building used for storage of Schedules III through V 
controlled substances with perimeter security which limits access during 
working hours and provides security after working hours and meets the 
following specifications:
    (i) Has an electronic alarm system as described in paragraph 
(b)(4)(v) of this section,
    (ii) Is equipped with self-closing, self-locking doors constructed 
of substantial material commensurate with the type of building 
construction, provided, however, a door which is kept closed and locked 
at all times when not in use and when in use is kept under direct 
observation of a responsible employee or agent of the registrant is 
permitted in lieu of a self-closing, self-locking door. Doors may be 
sliding or hinged. Regarding hinged doors, where hinges are mounted on 
the outside, such hinges shall be sealed, welded or otherwise 
constructed to inhibit removal. Locking devices for such doors shall be

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either of the multiple-position combination or key lock type and:
    (a) In the case of key locks, shall require key control which limits 
access to a limited number of employees, or;
    (b) In the case of combination locks, the combination shall be 
limited to a minimum number of employees and can be changed upon 
termination of employment of an employee having knowledge of the 
combination;
    (4) A cage, located within a building on the premises, meeting the 
following specifications:
    (i) Having walls constructed of not less than No. 10 gauge steel 
fabric mounted on steel posts, which posts are:
    (a) At least one inch in diameter;
    (b) Set in concrete or installed with lag bolts that are pinned or 
brazed; and
    (c) Which are placed no more than ten feet apart with horizontal one 
and one-half inch reinforcements every sixty inches;
    (ii) Having a mesh construction with openings of not more than two 
and one-half inches across the square,
    (iii) Having a ceiling constructed of the same material, or in the 
alternative, a cage shall be erected which reaches and is securely 
attached to the structural ceiling of the building. A lighter gauge mesh 
may be used for the ceilings of large enclosed areas if walls are at 
least 14 feet in height,
    (iv) Is equipped with a door constructed of No. 10 gauge steel 
fabric on a metal door frame in a metal door flange, and in all other 
respects conforms to all the requirements of 21 CFR 1301.72(b)(3)(ii), 
and
    (v) Is equipped with an alarm system which upon unauthorized entry 
shall transmit a signal directly to a central station protection agency 
or a local or state police agency, each having a legal duty to respond, 
or to a 24-hour control station operated by the registrant, or to such 
other source of protection as the Administrator may approve;
    (5) An enclosure of masonry or other material, approved in writing 
by the Administrator as providing security comparable to a cage;
    (6) A building or enclosure within a building which has been 
inspected and approved by DEA or its predecessor agency, BND, and 
continues to provide adequate security against the diversion of Schedule 
III through V controlled substances, of which fact written 
acknowledgment has been made by the Special Agent in Charge of DEA for 
the area in which such building or enclosure is situated;
    (7) Such other secure storage areas as may be approved by the 
Administrator after considering the factors listed in Sec. 1301.71(b), 
(1) through (14);
    (8)(i) Schedule III through V controlled substances may be stored 
with Schedules I and II controlled substances under security measures 
provided by 21 CFR 1301.72(a);
    (ii) Non-controlled drugs, substances and other materials may be 
stored with Schedule III through V controlled substances in any of the 
secure storage areas required by 21 CFR 1301.72(b), provided that 
permission for such storage of non-controlled items is obtained in 
advance, in writing, from the Special Agent in Charge of DEA for the 
area in which such storage area is situated. Any such permission 
tendered must be upon the Special Agent in Charge's written 
determination that such non-segregated storage does not diminish 
security effectiveness for Schedules III through V controlled 
substances.
    (c) Multiple storage areas. Where several types or classes of 
controlled substances are handled separately by the registrant or 
applicant for different purposes (e.g., returned goods, or goods in 
process), the controlled substances may be stored separately, provided 
that each storage area complies with the requirements set forth in this 
section.
    (d) Accessibility to storage areas. The controlled substances 
storage areas shall be accessible only to an absolute minimum number of 
specifically authorized employees. When it is necessary for employee 
maintenance personnel, nonemployee maintenance personnel, business 
guests, or visitors to be present in or pass through controlled 
substances storage areas, the registrant shall provide for adequate

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observation of the area by an employee specifically authorized in 
writing.

[36 FR 18730, Sept. 21, 1971, as amended at 37 FR 15919, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, l973]

    Editorial Note: For Federal Register citations affecting 
Sec. 1301.72, see the List of CFR Sections Affected, which appears in 
the Finding Aids section of the printed volume and on GPO Access.