Phar 15.015 HistoryHistory: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18; CR 22-007: am. (11), (13), (17) Register July 2022 No. 799, eff. 8-1-22.

Phar 15.10Phar 15.10 Facilities. A pharmacist engaged in compounding shall ensure all of the following:

Phar 15.10(2)(2) Orderly placement of compounding equipment, materials, and components in order to minimize the potential for compounding errors.

Phar 15.10(3)(3) The compounding area is maintained in a clean and sanitary condition.

Phar 15.10(4)(4) The compounding area is easily accessible to all of the following:

Phar 15.10(5)(5) All compounding equipment, materials, and components shall be stored off the floor and in a manner to prevent contamination and permit inspection and cleaning of the compounding and storage areas.

Phar 15.10 HistoryHistory: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18.

Phar 15.11Phar 15.11 Equipment and Drug Preparation Containers.

Phar 15.11(1)(1) A pharmacy shall possess equipment and drug preparation containers or packaging appropriate to the type of compounding performed at the pharmacy.

Phar 15.11(2)(2) Equipment and drug preparation containers or packaging used in compounding shall be of appropriate design and capacity, and shall be suitably stored in a manner to facilitate use, cleaning, maintenance, and protect it from contamination.

Phar 15.11(3)(3) Equipment and drug preparation containers or packaging used in compounding drug products shall be of suitable composition and may not be reactive, additive, adsorptive, or absorptive so as to alter the stability of the compounded preparation.

Phar 15.11(4)(4) Equipment used in compounding shall be thoroughly cleaned and sanitized after each use, and when necessary, prior to use, according to written policies and procedures, in order to reduce bioburden and reduce the opportunity for cross-contamination.

Phar 15.11(5)(5) All equipment utilized in compounding preparations shall be inspected, maintained, calibrated, and validated at appropriate intervals, consistent with manufacturer’s recommendations, to ensure the accuracy and reliability of equipment performance. Records shall be kept indicating the equipment was inspected, maintained, calibrated, and validated.

Phar 15.11 HistoryHistory: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18.

Phar 15.12Phar 15.12 Records of compounding. The managing pharmacist shall ensure written or electronic compounding documentation to systematically trace, evaluate, and replicate the compounding steps throughout the process of a preparation. The compounding documentation shall be maintained for a period of 5 years after the date of the last refill. The compounding documentation shall include all of the following:

Phar 15.12(1)(1) Official or assigned name, strength, and dosage form of the preparation.

Phar 15.12(3)(3) Vendor or manufacturer, lot number and expiration date of each APIs and added substances.

Phar 15.12(5)(5) Mixing instructions pertinent to the replication of the preparation as compounded.

Phar 15.12(6)(6) Compatibility and stability information, including references or laboratory testing.