Section 856 IAC 1-30-18 - Quality assuranceAuthority: IC 25-26-13-4
Affected: IC 25-26-13-18
Sec. 18.
(a) The designated qualifying pharmacist shall conduct a documented, ongoing quality assurance program that monitors personnel performance, equipment, and facilities. Samples of finished products shall be examined, or other continuous monitoring methods shall be used to assure that the pharmacy is capable of consistently preparing sterile pharmaceuticals meeting specifications in accordance with good compounding practices and the current USP/NF Chapter on sterile preparation. Quality assurance procedures shall include the following: (1) Recall procedures for compounded sterile pharmaceuticals.(2) Storage and dating for compounded sterile pharmaceuticals.(3) Sterile procedures, including the following: (A) Monitoring the temperature of the refrigerator.(C) Report of laminar flow hood certification.(4) Written documentation of periodic hood cleaning.(b) All biological safety cabinets and Class 100 environments shall be certified by an independent contractor or facility specialist as meeting Federal Standard 209B or National Sanitation Foundation Standard 49, as referenced in section 2 of this rule, for operational efficiency. Such certification shall be performed every six (6) months. Records documenting certification, which, at a minimum, includes laminar air flow velocity and particle count, shall be maintained for a period of not less than two (2) years.(c) Prefilters for the clean air source shall be replaced or cleaned as applicable on a regular basis and the replacement or cleaning date documented.(d) A vertical flow Class II biological safety cabinet may be used to compound any sterile pharmaceutical product; however, the cabinet must be thoroughly cleaned between each use for hazardous and nonhazardous drug compounding.(e) If manufacturing of parenteral solutions is performed utilizing nonsterile chemicals, extensive end product testing, as referenced in Remington's Pharmaceutical Sciences, published by Mack Publishing Company, Easton, Pennsylvania 18042, or other Federal Drug Administration approved testing methods, must be documented prior to the release of the product from quarantine. This process must include appropriate tests for particulate matter, microbial contamination, and testing for pyrogens. This does not preclude the extemporaneous compounding of certain sterile pharmaceuticals.(f) There shall be:(1) written justification of the chosen expiration dates for compounded parenteral products documented in the policy and procedure manual; and(2) documentation of quality assurance audits at planned intervals, including infection control and sterile technique audits.Indiana Board of Pharmacy; 856 IAC 1-30-18; filed Jan 28, 1992, 5:00 p.m.: 15 IR 1021, 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 2389; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed November 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFAReadopted filed 2/15/2024, 1:16 p.m.: 20240313-IR-856230795RFA