Phar 15.20(3)(3) Components transferred to another container which shall provide integrity that is minimally equivalent to the original container and shall be identified with all of the following:

Phar 15.21(1)(1) The BUD shall not be later than the expiration date on the container of any component.

Phar 15.21(2)(2) Only in the absence of stability information that is applicable to a specific drug product and preparation, the maximum BUD for a non-sterile compounded drug preparation that is packaged in a tight, light-resistant container is as follows:

Phar 15.21(2)(a)(a) For nonaqueous formulations stored at controlled room temperature, the BUD shall not be later than the time remaining until the earliest expiration date of any active pharmaceutical ingredient or 6 months, whichever is earlier.

Phar 15.21(2)(b)(b) For water-containing oral formulations, the BUD shall not be later than 14 days when stored in a refrigerator.

Phar 15.21(2)(c)(c) For water-containing semisolid mucosal liquid, topical, or dermal formulations, stored at controlled room temperature, the BUD shall not be later than 30 days.

Phar 15.21(3)(3) Assignment of BUD shall include an assessment of the need for antimicrobial agents or storage in a refrigerator to protect against bacteria, yeast, and mold contamination introduced during or after the compounding process.

Phar 15.30(1)(1) “Ante area” means an ISO Class 8 or better area where personnel hand hygiene and garbing procedures, staging of components, order entry, labeling and other high particulate generating activities are performed. The ante-area is the transition area between the unclassified area of the facility and the buffer area.

Phar 15.30(2)(2) “Buffer area” means an ISO Class 7 or ISO Class 8 if using an isolator or cleaner area where the primary engineering control that generates and maintains an ISO Class 5 environment is physically located.

Phar 15.30(3)(3) “Category 1” means a compounded sterile preparation compounded with a primary engineering control in a segregated compounding area.

Phar 15.30(4)(4) “Category 2” means a compounded sterile preparation compounded with a primary engineering control in a classified area.

Phar 15.30(5)(5) “Clean” means to physically remove debris, dirt, dust, and other impurities from surfaces or objects using a cleaning agent with a detergent.

Phar 15.30(6)(6) “Compounded sterile preparation” means a compounded final preparation intended to be sterile through the BUD.

Phar 15.30(7)(7) “Compounded stock solution” means a compounded solution to be used in the preparation of multiple units of a finished compounded sterile preparation.

Phar 15.30(8)(8) “Critical site” means a location that includes any component or fluid pathway surfaces or openings that are exposed and at risk of direct contact with air, moisture, or touch contamination.

Phar 15.30(9)(9) “Disinfect” means the killing of microorganisms when used according to the disinfectant’s label.

Phar 15.30(10)(10) “HEPA” means high-efficiency particulate air.

Phar 15.30(10m)(10m) “High-risk level compounded sterile preparations” means preparations compounded from non-sterile ingredients or from ingredients that are incorporated using non-sterile equipment before terminal sterilization, or from commercially manufactured sterile products that lack effective antimicrobial preservatives and whose preparation, transfer, sterilization, and packaging is performed in air quality worse than ISO class 5 for more than one hour. High-risk level compounded sterile preparations include water containing preparations that are stored for more than six hours before terminal sterilization.

Phar 15.30(11)(11) “ISO Class 5” means conditions in which the air particle count is no greater than a total of 3,520 particles of 0.5 micrometers and larger per cubic meter of air that is supplied by HEPA or HEPA-filtered air.