Sec. 31.
Physical security controls for nonpractitioners: Storage
Areas.
(a) Schedules I and II
[856 IAC 2-2-2 and
856 IAC 2-2-3] . Raw
materials, bulk materials awaiting further processing, and finished products
which are controlled substances listed in Schedule I or II
[856 IAC 2-2-2 or
856 IAC 2-2-3] shall be
stored in one of the following secure storage areas:
(1) Where small quantities permit, a safe or
steel cabinet.
(i) Which safe or steel cabinet
shall have 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.
(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
Indiana Board of Pharmacy or the Drug Enforcement Administration may
approve.
(2) A vault
constructed before, or under construction on October 1, 1973, which is of
substantial construction with a steel door, combination or key lock, and an
alarm system; or
(3) A vault
constructed after October 1, 1973:
(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
"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 Indiana Board of Pharmacy or the Drug Enforcement Administration 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
Indiana Board of Pharmacy or the Drug Enforcement
Administration.
(b) Schedules III, IV, and V
[856 IAC 2-2-4 T
856 IAC 2-2-6] . Raw
materials, bulk materials awaiting further processing, and finished products
which are controlled substances listed in Schedules III, IV, and V
[856 IAC 2-2-4 T
856 IAC 2-2-6] shall be
stored in one of the following secure storage areas:
(1) Where small quantities permit, a safe
which complies with the requirements set forth in paragraph (a)(1) of this
section;
(2) A vault which complies
with the requirements set forth in either paragraph (a)(2) or (3) of this
section or
(3) A building or area
located within a building, which building or area:
(i) Has walls or perimeter fences of
sufficient height and construction to provide security from burglary;
(ii) Has substantial doors which may be
securely locked during non-working hours by a multiple-position combination or
key lock;
(iii) Is equipped with an
alarm which, 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
or such other protection as the Indiana Board of Pharmacy or the Drug
Enforcement Administration may approve; and
(iv) In which all controlled substances are
segregated from all other merchandise and kept under constant surveillance
during normal business hours.
(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, non-employee maintenance
personnel, business guests, or visitors to be present in or pass through
controlled substances storage areas, the registrant shall provide for adequate
observation of the area by an employee specifically authorized in
writing.
(e) Compliance with the
requirements prescribed in Part 301, Section 301.72 of Title 21 of the Code of
Federal Regulations, effective April 1, 1973, shall be deemed in compliance
with this section.
