856 IAC 2-6-15 - Schedules III and IV controlled substances; label information; exceptions

Authority: IC 35-48-3-1

Affected: IC 35-48-3-9

Sec. 15.

Labeling of substances.

(a) The pharmacist filling a prescription for a controlled substance listed in Schedule III or IV [856 IAC 2-2-4 or 856 IAC 2-2-5] shall affix to the package a label showing the pharmacy name and address, the serial number and date of initial filling, the name of the patient, the name of the practitioner issuing the prescription, and directions for use and cautionary statement, "Federal Law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed", and other if any, contained in such prescription as required by law.

(b) The requirements of paragraph (a) of this section do not apply when a controlled substance listed in Schedule III or IV [856 IAC 2-2-4 or 856 IAC 2-2-5] is prescribed for administration to an ultimate user who is institutionalized: Provided, That:

(1) Not more than a 34-day supply or 100 dosage units, whichever is less, of the controlled substance listed in Schedule III or IV [856 IAC 2-2-4 or 856 IAC 2-2-5] is dispensed at one time;

(2) The controlled substance listed in schedule III or IV [856 IAC 2-2-4 or 856 IAC 2-2-5] is not in the possession of the ultimate user prior to administration;

(3) The institution maintains appropriate safeguards and records, the proper administration, control, dispensing, and storage of the controlled substance listed in Schedule III or IV [856 IAC 2-2-4 or 856 IAC 2-2-5] ; and

(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.

Notes

856 IAC 2-6-15

Indiana Board of Pharmacy; Reg 28,Ch VI,Sec 6.24; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed November 25, 2013, 9:24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-856130308RFA Readopted filed 2/15/2024, 1:16 p.m.: 20240313-IR-856230795RFA