Ind. Admin. Code tit. 856, r. 2-6-10 – Schedule II controlled substances; label information; exceptions

Sec. 10. (a) The pharmacist filling a written prescription, an electronically transmitted prescription, or an emergency oral prescription for a controlled substance listed in 856 IAC 2-2-3, Schedule II, shall affix to the package a label showing the following:

(1) The date of filling.
(2) The pharmacy name and address.
(3) The serial number of the prescription.
(4) The name of the patient.
(5) The name of the prescribing practitioner.
(6) Directions for use.
(7) The cautionary statement, "Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed".
(8) Any others if any, contained in the prescription or required by law.

(b) The requirements of subsection (a) do not apply when a controlled substance listed in 856 IAC 2-2-3, Schedule II, is prescribed for administration to an ultimate user who is institutionalized, provided the following:

(1) Not more than a seven (7) day supply of the controlled substance listed in 856 IAC 2-2-3, Schedule II, is dispensed at one (1) time.
(2) The controlled substance listed in 856 IAC 2-2-3, Schedule II, is not in the possession of the ultimate user prior to the administration.
(3) The institution maintains appropriate safeguards and records regarding the proper:
1. (A) administration;
2. (B) control;
3. (C) dispensing; and
4. (D) storage;
of the controlled substance listed in 856 IAC 2-2-3, Schedule II.
(4) The system employed by the pharmacist in filling a prescription is adequate to identify the supplier, the product, and the patient, and to set forth the directions for use and cautionary statements, if any, contained in the prescription or required by law.

(Indiana Board of Pharmacy; Reg 28,Ch VI,Sec 6.14; filed Jul 9, 1974, 9:29 a.m.: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; filed Jun 19, 2013, 10:06 a.m.: 20130717-IR- 856120619FRA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)