856 Ind. Admin. Code 1-30-14

Current through October 31, 2024
Section 856 IAC 1-30-14 - Records and reports

Authority: IC 25-26-13-4

Affected: IC 25-26-13-15; IC 25-26-13-18

Sec. 14.

(a) The qualifying pharmacist shall be responsible for such records and reports as required to ensure the patient's health, safety, and welfare. Such records shall be readily available and maintained for two (2) years from the date of issuance of the prescription or drug order and be subject to inspection by the Indiana board of pharmacy or its designated inspector. These records shall include the following:
(1) Patient profile or medication record system.
(2) Policy and procedure manual.
(3) Training manuals.
(4) Policies and procedures for disposal of hazardous waste, when applicable.
(b) Information regarding individual patients shall be maintained in a manner to assure confidentiality of the patient's record. Release of this information shall be in accordance with IC 25-26-13-15.
(c) If appropriate, the qualifying pharmacist must document the patient's training and competency in managing this type of therapy provided by the pharmacist to the patient in the home environment. A pharmacist must be involved in the patient training process in any area that related to drug:
(1) compounding;
(2) labeling;
(3) administration;
(4) storage;
(5) stability;
(6) compatibility; or
(7) disposal.

The pharmacist shall be responsible for seeing that the patient's competency in the areas in subdivisions (1) through (7) is reassessed at appropriate intervals.

856 IAC 1-30-14

Indiana Board of Pharmacy; 856 IAC 1-30-14; filed Jan 28, 1992, 5:00 p.m.: 15 IR 1020, eff Jan 1, 1992 [IC 4-22-2-36 suspends the effectiveness of a rule document for thirty (30) days after filing with the secretary of state. LSA Document #91-6 was filed Jan 28, 1992.]; readopted filed Dec 2, 2001, 12:35 p.m.: 25 IR 1338; filed Apr 6, 2005, 4:00 p.m.: 28 IR 2388; 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