Okla. Admin. Code § 535:15-10-67

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

Section 535:15-10-67 - Compounding of sterile allergen extracts

(a) Allergen extracts as CSPs are single-dose and multiple-dose intradermal or subcutaneous injectionsthat are prepared by specially trained physicians and pharmacy personnel under their direct supervision. Allergen extracts as CSPs are not subject to the personnel, environmental, and storage requirements for all CSP Microbial Contamination Risk Levelsin this chapter only when all of the following criteria are met:

(1) The compounding process involves simple transfer via sterile needles and syringes of commercial sterile allergen products and appropriate sterile added substances (e.g., glycerin, phenol in sodium chloride injection).

(2) All allergen extracts as CSPs shall contain appropriate substances in effective concentrations to prevent the growth of microorganisms. Non-preserved allergen extracts shall comply with the appropriate CSP risk level requirements in the chapter.

(3) Before beginning compounding activities, personnel perform a thorough hand cleansing procedure by removing debris from under fingernails using a nail cleaner under running warm water followed by vigorous hand and arm washing to the elbows for at least 30 seconds with either non-antimicrobial or antimicrobial soap and water.

(4) Compounding personnel don hair covers, facial hair covers, gowns, and face masks.

(5) Compounding personnel perform antiseptic hand cleansing with an alcohol based surgical hand scrub with persistent activity.

(6) Compounding personnel don powder-free sterile gloves that are compatible with sterile 70% isopropyl alcohol (IPA) before beginning compounding manipulations.

(7) Compounding personnel disinfect their gloves intermittently with sterile 70% IPA when preparing multiple allergen extracts as CSPs.

(8) Ampul necks and vial stoppers on packages of manufactured sterile ingredients are disinfected by careful wiping with sterile 70% IPA swabs to ensure that the critical sites are wet for at least 10 seconds and allowed to dry before they are used to compound allergen extracts as CSPs.

(9) The aseptic compounding manipulations minimize direct contact contamination (e.g., from glove fingertips, blood, nasal and oral secretions, shed skin and cosmetics, other non-sterile materials) of critical sites (e.g., needles, opened ampuls, vial stoppers).

(10) The label of each multiple-dose vial (MDV) of allergen extracts as CSPs lists the name of one specific patient and a BUD and storage temperature range that is assigned based on manufacturers' recommendations or peer-reviewed publications.

(11) Single-dose allergen extracts as CSPs shall not be stored for subsequent additional use.

(b) Personnel who compound allergen extracts as CSPs must be aware of greater potential risk of microbial and foreign material contamination when allergen extracts as CSPs are compounded in compliance with the foregoing criteria instead of the more rigorous standards in this chapter for CSP Microbial Contamination Risk Levels.Although contaminated allergen extracts as CSPs can pose health risks to patients when they are injected intradermally or subcutaneously,these risks are substantially greater if the extract is inadvertently injected intravenously.

Okla. Admin. Code § 535:15-10-67

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.