Section 856 IAC 2-3-33 - Additional security controls for nonpractitionersAuthority: 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.Indiana Board of Pharmacy; Reg 28,Ch III,Sec 3.74; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed November 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFAReadopted filed 2/15/2024, 1:16 p.m.: 20240313-IR-856230795RFA