Chapter Phar 15

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.

Phar 15.12(11) (11) Total quantity compounded.

Phar 15.12(12) (12) Name of the person who prepared the preparation.

Phar 15.12(13) (13) Name of the person who performed the quality control procedures.

Phar 15.12(14) (14) Name of the person who approved the preparation.

Phar 15.12(15) (15) Date of preparation.

Phar 15.12(16) (16) Assigned control or prescription number.

Phar 15.12(17) (17) Assigned BUD.

Phar 15.12(18) (18) Copy of the label to dispense final product.

Phar 15.12(19) (19) Documentation of any adverse reactions or preparation problems reported by the patient or caregiver.

Phar 15.12 History History: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18.

Phar 15.13 Phar 15.13 Quality control.

Phar 15.13(1) (1) One or more pharmacists shall complete a verification of all the following before dispensing:

Phar 15.13(1)(a) (a) Written procedures were followed in the compounding process.

Phar 15.13(1)(b) (b) Preparation instructions were followed.

Phar 15.13(1)(c) (c) Finished preparation appears as expected.

Phar 15.13(1)(d) (d) Label includes all required elements.

Phar 15.13(1)(e) (e) Quality control procedures were completed.

Phar 15.13(1)(f) (f) Compounding records are complete.

Phar 15.13(2) (2) A pharmacist shall investigate any discrepancies found during any of verifications and take appropriate corrective action before dispensing.

Phar 15.13 History History: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18.

Phar 15.14 Phar 15.14 Training, Policies, and Procedures.

Phar 15.14(1) (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.

Phar 15.14(2) (2) Policies and procedures. The pharmacy and managing pharmacist shall establish written policies and procedures governing all of the following:

Phar 15.14(2)(a) (a) Personnel qualifications and training, responsibilities, and competencies.

Phar 15.14(2)(b) (b) Personal hygiene, garb, garbing, and personal protective gear.

Phar 15.14(2)(c) (c) Use and maintenance of compounding facilities and equipment, including applicable certifications.

Phar 15.14(2)(d) (d) Environmental monitoring.

Phar 15.14(2)(e) (e) Cleaning and disinfection of compounding area.

Phar 15.14(2)(f) (f) Component selection.

Phar 15.14(2)(g) (g) Sterilization and depyrogenation, if pharmacy does sterilization and depyrogenation.

Phar 15.14(2)(h) (h) Documentation requirements.

Phar 15.14(2)(i) (i) Establishing BUD.

Phar 15.14(2)(j) (j) Reporting of adverse drug events.

Phar 15.14(2)(k) (k) A risk management program, including documentation of incidents, adverse drug reactions and product contamination.

Phar 15.14(2)(L) (L) A quality assurance program.

Phar 15.14(2)(m) (m) Maintaining the integrity of any classified work areas.

Phar 15.14(2)(n) (n) Handling small and large spills of antineoplastic agents and other hazardous substances.

Phar 15.14(2)(o) (o) Notification to patients or practitioners of a preparation which is recalled when there is potential for patient harm.

Phar 15.14(3) (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.

Phar 15.14 History 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 Phar 15.15 Labeling. The label of a compounded preparation shall include all of the following:

Phar 15.15(1) (1) Labeling requirements in s. Phar 7.02 and 8.08.

Phar 15.15(2) (2) Storage conditions if other than controlled room temperature.

Phar 15.15(3) (3) BUD.

Phar 15.15(4) (4) Special handling instructions, when applicable.

Phar 15.15(5) (5) Indication that the preparation is compounded unless administered by health care personnel.

Phar 15.15 History History: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18.

Phar 15.16 Phar 15.16 Component Selection.

Phar 15.16(1) (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.

Phar 15.16(2) (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.

Phar 15.16(3) (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.

Phar 15.16(4) (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.

Phar 15.16 History History: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18.

Phar 15.17 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:

Phar 15.17(1) (1) The order shall include the name and address of the practitioner, drug, strength, quantity, and the purpose of the compounded preparation.

Phar 15.17(2) (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.”

Phar 15.17(3) (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.

Phar 15.17 History History: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18.

Subchapter II — Non-sterile Compounding

Phar 15.20 Phar 15.20 Component Selection.

Phar 15.20(1) (1) Components with an expiration date from the manufacturer or distributor may be used before the expiration date provided all of the following:

Phar 15.20(1)(a) (a) The component is stored in its original container under conditions to avoid decomposition.

Phar 15.20(1)(b) (b) There is minimal exposure of the remaining component each time component is withdrawn from the container.

Phar 15.20(2) (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.

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 15.20(3)(a) (a) Component name.

Phar 15.20(3)(b) (b) Original supplier.

Phar 15.20(3)(c) (c) Lot or control number.

Phar 15.20(3)(d) (d) Transfer date.

Phar 15.20(3)(e) (e) Expiration date.

Phar 15.20 History History: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18.

Phar 15.21 Phar 15.21 Assigning BUD.

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

Subchapter III — Sterile Compounding

Phar 15.30 Phar 15.30 Definitions. In this subchapter:

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.