Iowa Admin. Code r. 657-10.13 - Security requirements
All registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substances. In order to determine whether a registrant has provided effective controls against diversion, the board shall use the security requirements set forth in these rules as standards for the physical security controls and operating procedures necessary to prevent diversion.
(1)
Physical security. Physical security controls shall be
commensurate with the schedules and quantity of controlled substances in the
possession of the registrant in normal business operation. A registrant shall
periodically review and adjust security measures based on rescheduling of
substances or changes in the quantity of substances in the possession of the
registrant.
a. Controlled substances listed in
Schedule I shall be stored in a securely locked, substantially constructed
cabinet or safe.
b. Controlled
substances listed in Schedules II through V may be stored in a securely locked,
substantially constructed cabinet or safe. However, pharmacies and hospitals
may disperse these substances throughout the stock of noncontrolled substances
in a manner so as to obstruct the theft or diversion of the controlled
substances.
c. Controlled
substances collected via an authorized collection program for the purpose of
disposal shall be stored pursuant to federal regulations, which can be found at
http ://deadiversion.usdoj .gov/drug disposal/.
(2)
Factors in evaluating physical
security systems. In evaluating the overall security system of a
registrant or applicant necessary to maintain effective controls against theft
or diversion of controlled substances, the board may consider any of the
following factors it deems relevant to the need for strict compliance with the
requirements of this rule:
a. The type of
activity conducted.
b. The type,
form, and quantity of controlled substances handled.
c. The location of the premises and the
relationship such location bears to security needs.
d. The type of building construction
comprising the facility and the general characteristics of the building or
buildings.
e. The type of vault,
safe, and secure enclosures available.
f. The type of closures on vaults, safes, and
secure enclosures.
g. The adequacy
of key control systems or combination lock control systems.
h. The adequacy of electronic detection and
alarm systems, if any.
i. The
adequacy of supervision over employees having access to controlled substances,
to storage areas, or to manufacturing areas.
j. The extent of unsupervised public access
to the facility, including the presence and characteristics of perimeter
fencing, if any.
k. The procedures
for handling business guests, visitors, maintenance personnel, and nonemployee
service personnel.
l. The
availability of local police protection or of the registrant's or applicant's
security personnel.
m. The adequacy
of the registrant's or applicant's system for monitoring the receipt,
manufacture, distribution, and disposition of controlled substances.
(3)
Manufacturing and
compounding storage areas. Raw materials, bulk materials awaiting
further processing, and finished products which are controlled substances
listed in any schedule shall be stored pursuant to federal laws and
regulations.
Notes
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