856 IAC 2-3-33 - Additional security controls for nonpractitioners
Authority: IC 35-48-3-1
Affected: IC 35-48-3-7
Sec. 33.
Other security controls for nonpractitioners:
(a) Before distributing a controlled
substance to any person who the registrant does not know to be registered to
possess the controlled substance the registrant shall make a good faith inquiry
either with the Indiana Board of Pharmacy or with the D.E.A. to determine that
the person is registered to possess the controlled substance.
(b) The registrant shall design and operate a
system to disclose to the registrant suspicious orders of controlled
substances. The registrant shall inform the Indiana Board of Pharmacy of
suspicious orders when discovered by the registrant. Suspicious orders include
orders of unusual size, orders deviating substantially from a normal pattern,
and orders of unusual frequency.
(c) The registrant shall notify in writing
the Indiana Board of Pharmacy of any theft or significant loss of any
controlled substances upon discovery of such theft or loss. Thefts must be
reported whether or not the controlled substances are subsequently recovered
and/or the responsible parties are identified and action taken against
them.
(d) The registrant shall not
distribute any controlled substance listed in Schedules II through V
[856 IAC 2-2-3 T
856 IAC 2-2-6] as a
complimentary sample to any potential or current customer (1) without the prior
written request of the customer, (2) to be used only for satisfying the
legitimate medical needs of patients of the customer, and (3) only in
reasonable quantities. Such request must contain the name, address and state
and federal registration number of the customer and the name and quantity of
the specific controlled substance desired. The request shall be preserved by
the registrant with other records of distribution of controlled substances. In
addition, the requirements of Part 3.5 [856 IAC 2-3-24 T
856 IAC 2-3-26] hereof
shall be complied with for any distribution of a controlled substance listed in
Schedule II [856 IAC 2-2-3] . For
purposes of this paragraph, the term "customer" includes a person to whom a
complimentary sample of a substance is given in order to encourage the
prescribing or recommending of the substance by the person.
(e) When shipping controlled substances, a
registrant is responsible for selecting common or contract carriers which
provide adequate security to guard against in-transit losses. When storing
controlled substances in a public warehouse, a registrant is responsible for
selecting a warehouseman which will provide adequate security to guard against
storage losses; wherever possible, the registrant shall store controlled
substances in a public warehouse which complies with the requirements set forth
in Section 3.72 [856 IAC 2-3-31] . In addition, the registrant shall
employ precautions (e.g., assuring that shipping containers do not indicate
that contents are controlled substances) to guard against storage or in-transit
losses.
(f) When distributing
controlled substances through agents (e.g., detailmen), a registrant is
responsible for providing and requiring adequate security to guard against
theft and diversion while the substances are being stored or handled by the
agent or agents.
Notes
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