Section Phar 15.34 - Immediate-use compounded sterile preparations Immediate-use compounded sterile preparations are exempt from the requirements described for low-risk level, Category 1, and Category 2 compounding sterile preparations only when all the following criteria are met:
(1) The compounding process involves simple transfer of not more than three commercially manufactured sterile nonhazardous products or diagnostic radiopharmaceutical products from the manufacturers' original containers and not more than two entries into any one container or product of sterile infusion solution or administration container or device.(2) Unless required for the preparation, the compounding procedure is a continuous process not to exceed 1 hour.(3) During preparation, aseptic technique is followed and, if not immediately administered, the finished compound sterile preparation is under continuous supervision to minimize the potential for contact with nonsterile surfaces, introduction of particulate matter or biological fluids, mix-ups with other compound sterile preparations, and direct contact of outside surfaces.(4) Administration begins not later than 4 hours following the start of the preparation.(5) Unless immediately and completely administered by the person who prepared it or immediate and complete administration is witnessed by the preparer, the compounded sterile preparation shall bear a label listing patient identification information, the names and amounts of all ingredients, the name or initials of the person who prepared it, and the exact 4-hour BUD and time.(6) If administration of the compounded sterile preparation has not begun within 4 hours following the start of preparation, it shall be promptly, properly, and safely discarded.Wis. Admin. Code Pharmacy Examining Board Phar 15.34
Adopted by, CR 16-085: cr. Register April 2018 No. 748, eff. 11/1/2018Amended by, CR 22-007: r. and recr. Register July 2022 No. 799, eff. 8/1/2022.