Wisconsin Legislature: Phar 15.13(1)(c)

(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.

(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.

(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.

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

Phar 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:

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

(2) List of all APIs and added substances and their quantities.

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

(4) Equipment and supplies needed to prepare the preparation.

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

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

(7) Container or container-closure system used in dispensing.

(8) Packaging and storage requirements.

(9) Quality control procedures.

(10) Sterilization method when using non-sterile ingredients to make a sterile preparation.

(11) Total quantity compounded.

(12) Name of the person who prepared the preparation.

(13) Name of the person who performed the quality control procedures.

(14) Name of the person who approved the preparation.

(15) Date of preparation.

(16) Assigned control or prescription number.

(17) Assigned BUD.

(18) Copy of the label to dispense final product.

(19) Documentation of any adverse reactions or preparation problems reported by the patient or caregiver.

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

Phar 15.13 Quality control.

(1) One or more pharmacists shall complete a verification of all the following before dispensing:

(a) Written procedures were followed in the compounding process.

(b) Preparation instructions were followed.

(d) Label includes all required elements.

(e) Quality control procedures were completed.

(f) Compounding records are complete.

(2) A pharmacist shall investigate any discrepancies found during any of verifications and take appropriate corrective action before dispensing.

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

Phar 15.14 Training, Policies, and Procedures.

(1) Training. All personnel involved in the compounding, evaluation, packaging, and dispensing of compounded preparations shall be properly trained and competency is assessed for the type of compounding conducted. It is the responsibility of the managing pharmacist to ensure personnel training and competency assessments are completed and documented.

(2) Policies and procedures. The pharmacy and managing pharmacist shall establish written policies and procedures governing all of the following:

(a) Personnel qualifications and training, responsibilities, and competencies.

(b) Personal hygiene, garb, garbing, and personal protective gear.

(d) Environmental monitoring.

(e) Cleaning and disinfection of compounding area.

(f) Component selection.

(g) Sterilization and depyrogenation, if pharmacy does sterilization and depyrogenation.

(h) Documentation requirements.

(i) Establishing BUD.

(j) Reporting of adverse drug events.

(k) A risk management program, including documentation of incidents, adverse drug reactions and product contamination.

(L) A quality assurance program.

(m) Maintaining the integrity of any classified work areas.

(n) Handling small and large spills of antineoplastic agents and other hazardous substances.

(o) Notification to patients or practitioners of a preparation which is recalled when there is potential for patient harm.

(3) Review of policies and procedures. The policy and procedures shall be reviewed at least once every 36 months and shall be updated, on a continuous basis, to reflect current practice. Documentation of the review shall be made available to the board upon request.

History: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18; correction in (2) (o) made under s. 35.17, Stats., Register April 2018 No. 748.

Phar 15.15 Labeling. The label of a compounded preparation shall include all of the following:

(1) Labeling requirements in s. Phar 7.02 and 8.08.

(2) Storage conditions if other than controlled room temperature.

(3) BUD.

(4) Special handling instructions, when applicable.

(5) Indication that the preparation is compounded unless administered by health care personnel.

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

Phar 15.16 Component Selection.

(1) Active pharmaceutical ingredients or added substances used in compounding shall be manufactured by an FDA registered facility or accompanied by a certificate of analysis.

(2) APIs and added substances shall meet USP or NF monograph specifications when monographs are available. A pharmacist shall use professional judgement in selection of APIs if USP or NF grade is not available.

(3) All components shall be stored and handled consistent with the manufacturer’s labeling or USP or NF monographs and in a manner that prevents contamination and deterioration.

(4) A pharmacist compounding for human use may not use components that have been withdrawn or removed from the market for safety or efficacy reasons by the FDA. A pharmacist compounding for food producing animal use may not use components prohibited for use in food producing animals.

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

Phar 15.17 Non-patient specific compounding. Compounded preparations dispensed or distributed to a practitioner pursuant to a non-patient specific order to be administered by a practitioner or practitioner’s agent shall meet all of the following:

(1) The order shall include the name and address of the practitioner, drug, strength, quantity, and the purpose of the compounded preparation.

(2) The label shall include the practitioner’s name in place of the patient’s name and state “For Practitioner Administration Only — Not for Dispensing or Distribution.” If the sterility or integrity of the compounded preparation is not maintained after the initial opening of the container, the label shall state “Single-Dose Only.”

(3) The pharmacist shall record the name and address of the location the compounded preparation was dispensed or distributed, and the lot number and BUD of all preparations dispensed or distributed to the practitioner.

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

Subchapter II — Non-sterile Compounding

Phar 15.20 Component Selection.

(1) Components with an expiration date from the manufacturer or distributor may be used before the expiration date provided all of the following:

(a) The component is stored in its original container under conditions to avoid decomposition.

(b) There is minimal exposure of the remaining component each time component is withdrawn from the container.

(2) Components without an expiration date assigned by the manufacturer or supplier shall be labeled with the date of receipt and assigned a conservative expiration date, not to exceed three years after receipt, based upon the nature of the component and its degradation mechanism, the container in which it is packaged and the storage conditions.

(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:

(a) Component name.

(b) Original supplier.

(d) Transfer date.

(e) Expiration date.

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

Phar 15.21 Assigning BUD.

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

(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: