Ind. Admin. Code tit. 856, r. 1-30-8 – Physical requirements

Sec. 8. (a) A licensed pharmacy preparing sterile pharmaceuticals shall have a designated area for preparing compounded, sterile pharmaceuticals. The designated area shall be restricted to only those personnel authorized for the preparation of sterile pharmaceuticals. This area may be in a separate room or in a portion of a larger room. The area cannot be a warehouse or stockroom setting and must be free of dust and dirt.

(b) The designated preparation area shall be used only for the preparation of sterile pharmaceutical products and related functions.

(1) An environmental control device capable of maintaining at least an ISO Class 5 (Class 100) environment in the work space where critical objects are exposed and critical activities are performed. This device must be capable of maintaining ISO Class 5 (Class 100) conditions during normal activity. Examples of appropriate devices include the following:
1. (A) Laminar airflow hood.
2. (B) Zonal laminar flow of high efficiency particulate air (HEPA) filtered air.
3. (C) Barrier isolators.
(2) A sink with hot and cold running water that is convenient to the compounding area but outside the buffer area for the purpose of hand scrubs before compounding.
(3) Disposal containers for used needles, syringes, gowns, gloves, etc., and, if applicable, for hazardous waste from the preparation of chemotherapy agents and infectious wastes from patients.
(4) Environmental controls including biohazard cabinetry when hazardous drug products are prepared.
(5) A refrigerator with a thermometer.
(6) Infusion devices, if appropriate.
(7) Documentation to demonstrate adequate cleaning and sanitizing of the environment along with records of all necessary air sampling for particulates and microorganisms.
(8) Environmental control to maintain an ISO Class 8 (Class 100,000) conditions in the buffer area.

(d) The pharmacy shall maintain supplies adequate to maintain an environment suitable for the aseptic preparation of sterile products. All expired, recalled, or adulterated and misbranded drug substances must be removed from the restricted area. The licensed pharmacy preparing sterile pharmaceuticals shall include the following supplies:

(1) Disposable needles, syringes, and other supplies needed for aseptic admixture.
(2) Disinfectant cleaning tools and solutions.
(3) A hand washing agent with antibacterial action.
(4) Disposable towels or wipes.
(5) Filters and filtration equipment, if utilized.
(6) A hazardous drug spill kit shall be available in the facility if hazardous drugs are prepared.
(7) Disposable gowns and gloves.

(e) No one may have access to the pharmacy in the absence of the pharmacist, except as stated in 856 IAC 1-28.1-8.

(f) The pharmacy shall have sufficient current reference materials related to sterile products to meet the needs of pharmacy. A pharmacy preparing or proposing to prepare sterile pharmaceuticals shall have in its reference library:

(1) the Handbook on Injectable Drugs, published by the American Society of Hospital Pharmacists (ASHP), 4630 Montgomery Avenue, Bethesda, Maryland 20814;
(2) the King's Guide to Parenteral Admixtures, published by Pacemarq Inc., 11701 Borman Drive, St. Louis, Missouri 63146; or
(3) another board-approved printed or electronic database sufficient for determining mixing and administration guidelines and drug incompatibilities such as would be contained in the references listed in subdivision (1) or (2).

(g) If the pharmacy is handling or preparing hazardous drugs, the pharmacy shall have a current copy of Occupational Safety and Health Administration requirements for handling hazardous drugs as published by the Occupational Safety and Health Administration, Office of Occupational Medicine, Directorate of Technical Support, Occupational Safety and Health Administration, U.S. Department of Labor.

(Indiana Board of Pharmacy; 856 IAC 1-30-8; filed Jan 28, 1992, 5:00 p.m.: 15 IR 1018, 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.]; errata filed Mar 17, 1992, 10:20 a.m.: 15 IR 1394; readopted filed Nov 13, 2001, 3:55 p.m.: 25 IR 1330; filed Apr 6, 2005, 4:00 p.m.: 28 IR 2387; 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)