856 Ind. Admin. Code 1-30-17

Current through September 4, 2024

Section 856 IAC 1-30-17 - Hazardous drugs

Authority: IC 25-26-13-4

Affected: IC 25-26-13-18

Sec. 17.

In addition to the minimum requirements for a pharmacy established by rules of the board, the following requirements are necessary to ensure the protection of the personnel involved in those licensed pharmacies that prepare hazardous drugs:

(1) All hazardous drugs shall be compounded in a Class II, biological safety cabinet. If this cabinet is not dedicated solely to the compounding of hazardous drugs, policies and procedures must be in place for the cleaning and decontaminating this biological safety cabinet.

(2) Protective apparel shall be worn by personnel compounding hazardous drugs. This shall include disposable gloves and gowns with tight cuffs.

(3) Appropriate safety and containment techniques for compounding hazardous drugs shall be used in conjunction with the aseptic techniques required for preparing sterile products.

(4) Procedures for disposal of hazardous waste shall be specified within the policy and procedure manual as required by section 7 of this rule and comply with all applicable local, state, and federal requirements.

(5) Written procedures for handling both major and minor spills of hazardous agents must be developed and included in the policy and procedure manual.

(6) Prepared doses of hazardous drugs shall be dispensed and labeled with proper precautions inside and outside and shipped in a manner designed to minimize the risk of accidental rupture of the primary container.

856 IAC 1-30-17

Indiana Board of Pharmacy; 856 IAC 1-30-17; 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 Nov 13, 2001, 3:55 p.m.: 25 IR 1330; filed Apr 6, 2005, 4:00 p.m.: 28 IR 2389; 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