Okla. Admin. Code § 535:15-10-50

Current through Vol. 42, No. 7, December 16, 2024

Section 535:15-10-50 - Purpose

(a) The objective of this chapter is to describe conditions and practices to prevent harm, including death, to patients that could result from (1) microbial contamination (non-sterility), (2) excessive bacterial endotoxins, (3) variability in the intended strength of correct ingredients that exceeds either monograph limits for official articles or 10% for nonofficial articles, (4) unintended chemical and physical contaminants, and (5) ingredients of inappropriate quality in compounded sterile preparations (CSPs). Contaminated CSPs are potentially most hazardous to patients when administered into body cavities, central nervous and vascular systems, eyes, and joints, and when used as baths for live organs and tissues. When CSPs contain excessive bacterial endotoxins they are potentially most hazardous to patients when administered into the central nervous system.

(b) To achieve the above five conditions and practices, this part 3 of subchapter 10 provides minimum practice and quality standards for CSPs of drugs and nutrients based on current scientific information and best sterile compounding practices. The use of technologies, techniques, materials, and procedures other than those described in this part 3 of subchapter 10 is not prohibited so long as they have been proven to be equivalent or superior with statistical significance to those described herein. The standards in this part 3 of subchapter 10 do not pertain to the clinical administration of CSPs to patients via application, implantation, infusion, inhalation, injection, insertion, instillation, and irrigation, which are the routes of administration. Four specific categories of CSPs are described in this chapter: low-risk level, medium-risk level, and high-risk level, and immediate use. For the purposes of this chapter, CSPs include, but are not limited to the following:

(1) Compounded biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals, including but not limited to the following dosage forms that must be sterile when they are administered to patients: aqueous bronchial and nasal inhalations, baths and soaks for live organs and tissues, injections (e.g., colloidal dispersions, emulsions, solutions, suspensions), irrigations for wounds and body cavities, ophthalmic drops and ointments, and tissue implants.

(2) Manufactured sterile products prepared according to the instructions in manufacturers' approved labeling. Product package inserts usually refer to aseptic technique, but do not usually describe environmental quality controls, storage, or BUD and times for radiopharmaceuticals.

(c) All personnel who prepare CSPs shall be responsible for understanding these fundamental practices and precautions, for developing and implementing appropriate procedures, and for continually evaluating these procedures and the quality of final CSPs to prevent harm.

Okla. Admin. Code § 535:15-10-50

Added at 26 Ok Reg 2276, eff 7-1-09

Amended by Oklahoma Register, Volume 32, Issue 23, August 17, 2015, eff. 8/27/2015.