Chapter Phar 15
COMPOUNDING PHARMACEUTICALS
Phar 15.01   Intent.
Phar 15.015   Definitions.
Subchapter I - General
Phar 15.10   Facilities.
Phar 15.11   Equipment and Drug Preparation Containers.
Phar 15.12   Records of compounding.
Phar 15.13   Quality control.
Phar 15.14   Training, Policies, and Procedures.
Phar 15.15   Labeling.
Phar 15.16   Component Selection.
Phar 15.17   Non-patient specific compounding.
Subchapter II - Non-sterile Compounding
Phar 15.20   Component Selection.
Phar 15.21   Assigning BUD.
Subchapter III - Sterile Compounding
Phar 15.30   Definitions.
Phar 15.31   Facility design and environmental controls.
Phar 15.32   Personnel hygiene, garbing and protective gear.
Phar 15.33   Cleaning and Disinfecting the Compounding Area and Supplies.
Phar 15.34   Urgent use compounded sterile preparations.
Phar 15.35   Sterilization methods.
Phar 15.36   Inspection, sterility testing and antimicrobial effectiveness.
Phar 15.37   Beyond Use Dating.
Phar 15.38   Training and evaluation.
Ch. Phar 15 Note Note: Chapter Phar 15 is shown as repealed and recreated by CR 16-085, effective November 1, 2018, Register April 2018 No. 748. Chapter Phar 15 in effect prior to November 1, 2018 is published in full following s. Phar 15.38.
Phar 15.01 Phar 15.01Intent. The intent of this chapter is to create a state regulatory standard that aligns with compounding standards found in the United States Pharmaceopeia (USP) general chapters lower than the number 1000.
Phar 15.01 History History: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18.
Phar 15.015 Phar 15.015Definitions. In this chapter:
Phar 15.015(1) (1) “Active pharmaceutical ingredient” or “API” means any substance or mixture of substances intended to be used in the compounding of a drug preparation and that, when used in the compounding of a drug preparation, becomes an active ingredient in the preparation intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans and animals or affecting the structure and function of the body.
Phar 15.015(2) (2) “Added substances” means ingredients that are necessary to compound a drug preparation that are not intended or expected to cause a pharmacologic response if administered alone in the amount or concentration contained in a single dose of the compounded preparation.
Phar 15.015(3) (3) “Adverse drug event” means an injury resulting from the use of a drug.
Phar 15.015(4) (4) “Beyond use date” or “BUD” means one of the following:
Phar 15.015(4)(a) (a) The date after which a non-sterile compounded preparation shall not be used.
Phar 15.015(4)(b) (b) The date and time after which a sterile compounded preparation shall not be used.
Phar 15.015(5) (5) “Certificate of analysis” means a report from the supplier of a component, container, or closure that accompanies the component, container, or closure and contains the specifications and results of all analyses and a description.
Phar 15.015(6) (6) “Chemical stability” means each active pharmaceutical ingredient retains its chemical integrity and labeled potency, within specified limits.
Phar 15.015(7) (7) “Classified area” means a space that maintains an air cleanliness classification based on the International Organization for Standardization (ISO).
Phar 15.015(8) (8) “Component” means any active pharmaceutical ingredient, or added substances used in the compounding of a drug preparation.
Phar 15.015(9) (9) “Compounding” means the preparation, mixing, assembling, altering, packaging, and labeling of a drug, drug delivery device, or a device in accordance with a prescription, or medication order. Compounding does not include repackaging. Compounding includes any of the following:
Phar 15.015(9)(a) (a) Preparation of drug dosage forms for both human and animal patients.
Phar 15.015(9)(b) (b) Preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns.
Phar 15.015(9)(c) (c) Reconstitution or manipulation of commercial products that may require the addition of one or more ingredients. Notwithstanding this paragraph, the reconstituting, mixing, or storage and beyond use dating that is performed for non-sterile preparations in accordance with the directions contained in approved labeling provided by the manufacturer is not compounding.
Phar 15.015(9)(d) (d) Preparation of drugs or devices for the purposes of, or as an incident to, research, teaching, or chemical analysis.
Phar 15.015(10) (10) “Container-closure system” means the sum of packaging components that together contain and protect a dosage form, including primary packaging components and secondary packaging components.
Phar 15.015(11) (11) “Controlled room temperature” means a temperature maintained thermostatically that encompasses the usual and customary working environment of 68 degrees to 77 degrees Fahrenheit.
Phar 15.015(12) (12) “FDA” means the United States food and drug administration.
Phar 15.015(13) (13) “Freezer” means a place in which a the temperature is maintained between -13 degrees and 14 degrees Fahrenheit.
Phar 15.015(14) (14) “Microbiological stability” means sterility or resistance to microbial growth is retained according to specified requirements and antimicrobial agents that are present retain effectiveness within specified limits.
Phar 15.015(15) (15) “NF” means the National Formulary.
Phar 15.015(16) (16) “Physical stability” means the original physical properties, including appearance, palatability, uniformity, dissolution, and suspendability, are retained.
Phar 15.015(17) (17) “Refrigerator” means a cold place in which the temperature is maintained between 36 degrees and 46 degrees Fahrenheit.
Phar 15.015(18) (18) “Stability” means the extent to which a compounded preparation retains, within specified limits and through its beyond use date, the same properties and characteristics that it possessed at the time of compounding.
Phar 15.015(19) (19) “Therapeutic stability” means the therapeutic effect remains unchanged.
Phar 15.015(20) (20) “Toxicological stability” means no significant increase in toxicity occurs.
Phar 15.015(21) (21) “USP” means the United States Pharmacopeia.
Phar 15.015 History History: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18.
Subchapter I - General
Phar 15.10 Phar 15.10Facilities. A pharmacist engaged in compounding shall ensure all of the following:
Phar 15.10(1) (1) An area designated for compounding.
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(4)(a) (a) Hot and cold running water, exclusive of the bathroom sink.
Phar 15.10(4)(b) (b) Soap or detergent.
Phar 15.10(4)(c) (c) Single-use towels.
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 History History: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18.
Phar 15.11 Phar 15.11Equipment 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 History History: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18.
Phar 15.12 Phar 15.12Records 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(2) (2) List of all APIs and added substances and their quantities.
Phar 15.12(3) (3) Vendor or manufacturer, lot number and expiration date of each APIs and added substances.
Phar 15.12(4) (4) Equipment and supplies needed to prepare the preparation.
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.
Phar 15.12(7) (7) Container or container-closure system used in dispensing.
Phar 15.12(8) (8) Packaging and storage requirements.
Phar 15.12(9) (9) Quality control procedures.
Phar 15.12(10) (10) Sterilization method when using non-sterile ingredients to make a sterile preparation.
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Published under s. 35.93, Stats. Updated on the first day of each month. Entire code is always current. The Register date on each page is the date the chapter was last published.