856 IAC 1-29-3 - Hard copy of daily dispensing; verification and retention; back-up capability

Authority: IC 25-26-13-4

Affected: IC 25-26-13-25

Sec. 3.

(a) A pharmacy using an electronic data processing system must provide a separate hard copy printout of prescription or drug order and refill data for each day's dispensing or other board approved uniformly maintained readily retrievable system. This hard copy printout or other board approved system shall include the following:

(1) Prescription number.

(2) Date of dispensing.

(3) Patient name.

(4) Drug and strength (if applicable).

(5) Quantity dispensed.

(6) Prescriber identification.

(7) Pharmacist identification.

(8) Refill status.

(9) Controlled drug schedule identification.

(b) The dispensing pharmacist must verify that the data is correct to the best of his or her knowledge and date and sign the document or log book in the same manner as he or she would sign a check or legal document.

(c) This documentation shall be maintained for a period of two (2) years from the dispensing date. The daily hard copy printout may be replaced with a monthly printout or other permanent documentation containing the same information.

(d) Each system must have the capability of informational backup and such documentation must be stored in a secure location.

(e) If the electronic data processing system can capture an unalterable and legible digital image of the prescription or drug order, the digital image may be considered the original prescription record as follows:

(1) A prescription that is stored as a digital image must have any notes of clarification or alterations, or both, recorded as an electronic annotation on the digital image of the prescription.

(2) As used in this section, "digital image" means the electronic record produced through the process of imaging, whereby a hard copy prescription is scanned by a computer and converted from a human-readable format to a computer-readable, digital format that can be used in an electronic data processing system.

(3) As used in this section, "electronic annotation" means a means by which to mark up a digital image so as to allow notes or clarification, or both, to be added to the prescription record without altering the original digital image.

(f) The electronic data processing system must be capable of maintaining, printing, and providing, upon a request by the board or the board's compliance officers, all of the prescription information required by state law and regulations of the board within seventy-two (72) hours of the request.

Notes

856 IAC 1-29-3

Indiana Board of Pharmacy; 856 IAC 1-29-3; filed Aug 16, 1984, 3:55 p.m.: 7 IR 2544; readopted filed Nov 13, 2001, 3:55 p.m.: 25 IR 1330; 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-856130308RFA Readopted filed 2/15/2024, 1:16 p.m.: 20240313-IR-856230795RFA