Wisconsin Administrative Code
Pharmacy Examining Board
Chapter Phar 15 - Compounding Pharmaceuticals
Subchapter I - General
Section Phar 15.12 - Records of compounding
Current through August 26, 2024
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.
