Authority: IC 25-26-13-4

Affected: IC 25-26-13-18

Sec. 9. (a) Each pharmacist, pharmacist intern, pharmacist extern, and pharmacy technician engaged in preparing sterile pharmaceuticals must be trained in the specialized functions of preparing and dispensing compounded, sterile pharmaceuticals, including the principles of aseptic technique and quality assurance. Documentation of such training or experience shall be made available for inspection by the board or its representatives.

(b) The qualifying pharmacist shall be responsible for the following:

1. (1) Purchasing, storage, compounding, repackaging, dispensing, and distribution of all sterile pharmaceuticals.

2. (2) Development and continuing review of all:

   1. (A) policies and procedures;
   2. (B) training manuals; and
   3. (C) quality assurance programs.

(c) The qualifying pharmacist shall:

1. (1) assure the environmental control of all products shipped, as controllable by the pharmacist to the extent such aspect of shipping is controllable by the pharmacist; and
2. (2) be responsible for adherence to all current USP Standards related to sterile compounding, personnel cleansing and gowning; or
3. (3) reject or cause to be rejected any such shipment or drugs as prepared in violation of applicable USP Standards.

(Indiana Board of Pharmacy; 856 IAC 1-30-9; filed Jan 28, 1992, 5:00 p.m.: 15 IR 1019, 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 1337; 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 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)