Section 856 IAC 2-4-1 - Records and inventoriesAuthority: IC 35-48-3-1
Affected: IC 35-48-3-7
Sec. 1.
(a) Every registrant shall keep records and maintain inventories in conformance with the record keeping and inventorying requirements of federal law and regulation.(b) For purposes of this article, "readily retrievable" means that certain records are kept by automatic data processing systems or other electronic or mechanized record keeping systems in such a manner that they can be separated out from all other records in a reasonable time and/or records are kept on which certain items are asterisked, red-lined, or in some manner visually identifiable apart from other items appearing on the records. Manufacturers, distributors, and research records or electronic data processing printouts shall be made available within five (5) working days after a request by the Indiana board of pharmacy for such records or information on controlled substances transactions.(c) Each registered pharmacy shall maintain, for a period of two (2) years, its prescriptions of controlled substances by maintaining any of the following:(1) Three (3) separate files as follows:(A) A file for schedule II drugs dispensed.(B) A file for schedules III, IV, and V drugs dispensed.(C) A file for prescriptions for all other drugs dispensed.(2) Two (2) separate files as follows: (A) A file for all noncontrolled drugs dispensed.(B) Another file for all controlled drugs dispensed in schedules II, III, IV, and V. If this method is used, the prescriptions in the file for schedules III, IV, and V must be stamped with the letter "C" in red ink, not less than one (1) inch high, in the lower right-hand corner.(3) Two (2) separate files as follows: (A) A file for schedule II drugs dispensed.(B) Another file for schedules III, IV, and V drugs, including all other noncontrolled drugs dispensed. If this method is used, the prescriptions in the file of schedules III, IV, and V drugs must be stamped with the letter "C" in red ink, not less than one (1) inch high, in the lower right-hand corner. However, if a pharmacy employs an automated data processing system or other electronic record keeping system for prescriptions that permits identification by prescription number and retrieval of original documents by prescriber's name, patient's name, drug dispensed, and date filled, then the requirement to mark the hard copy prescription with a red "C" under subdivisions (2) and (3) is waived.
(d) Electronically transmitted prescriptions must be maintained in accordance with applicable federal regulations.Indiana Board of Pharmacy; Reg 28, Ch IV, Sec 4.01; filed Jul 9, 1974, 9:29 a.m.: Unpublished; filed May 26, 2000, 8:52 a.m.: 23 IR 2504; 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