Section 856 IAC 2-6-7 - Schedule II controlled substances; prescription required; exceptionsAuthority: IC 35-48-3-1
Affected: IC 35-48
Sec. 7.
(a) A pharmacist may dispense directly a controlled substance listed in schedule II, which is a prescription drug as determined under the federal Food, Drug, and Cosmetic Act, only pursuant to a prescription signed by the prescribing individual practitioner, except as provided in subsection (d).(b) An individual practitioner may administer or dispense directly a controlled substance listed in schedule II in the course of his or her professional practice without a prescription subject to section 6 of this rule.(c) An institutional practitioner may administer or dispense directly (but not prescribe) a controlled substance listed in schedule II only pursuant to a prescription signed by the prescribing individual practitioner or to an order for medication made by an individual practitioner that is dispensed for immediate administration to the ultimate user.(d) In the case of an emergency situation, as defined in subsection (e), a pharmacist may dispense a controlled substance listed in schedule II upon receiving oral authorization of a prescribing individual practitioner provided the following: (1) The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period. Dispensing beyond the emergency period must be pursuant to a written prescription signed by the prescribing individual practitioner.(2) The prescription shall be immediately reduced to writing by the pharmacist and shall contain all information required in section 4 of this rule, except for the signature of the prescribing individual practitioner.(3) If the prescribing individual practitioner is not known to the pharmacist, he or she must make a reasonable effort to determine that the oral authorization came from a registered individual practitioner, which may include a callback to the prescribing individual practitioner using his or her phone number as listed in the telephone directory and/or other good faith efforts to assure his or her identity.(4) Within seven (7) days after authorizing an emergency oral prescription, the prescribing individual practitioner shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist. In addition to conforming to the requirements of section 4 of this rule, the prescription shall have written on its face "Authorization for Emergency Dispensing" and the date of the oral order. The written prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail, it must be postmarked within the seven (7) day period. Upon receipt, the dispensing pharmacist shall attach this prescription to the oral emergency prescription that had earlier been reduced to writing. The pharmacist shall notify the Indiana board of pharmacy if the prescribing individual fails to deliver a written prescription to him or her, failure of the pharmacist to do so shall void the authority conferred by this subdivision to dispense without a written prescription of a prescribing individual practitioner.(e) For the purpose of authorizing an oral prescription of a controlled substance listed in schedule II of IC 35-48 as amended, "emergency situation" means those situations in which the prescribing practitioner determines the following: (1) Immediate administration of the controlled substance is necessary for proper treatment of the intended ultimate user.(2) No appropriate alternative treatment is available, including administration of a drug that is not a controlled substance under schedule II of IC 35-48 as amended.(3) It is not reasonably possible for the prescribing practitioner to provide a written prescription or electronically transmitted prescription to the person dispensing the substance, prior to the dispensing.Indiana Board of Pharmacy; Reg 28, Ch VI,Sec 6.11; filed Jul 9, 1974, 9:29 a.m.: Unpublished; filed May 26, 2000, 8:52 a.m.: 23 IR 2505; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; filed Jun 19, 2013, 10:06 a.m.: 20130717-IR-856120619FRA; readopted filed November 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFAReadopted filed 2/15/2024, 1:16 p.m.: 20240313-IR-856230795RFA