Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 3 - Registration Information-Special Instructions › Section 3-33 - Additional security controls for nonpractitioners

Current through July 10, 2024
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.