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c. Within 45 days when the preparation is stored in a freezer.
2. No sterility testing performed or sterility testing not passed, and prepared with only sterile starting components, one of the following:
a. Within 4 days when the preparation is stored at controlled room temperature.
b. Within 10 days when the preparation is stored in a refrigerator.
c. Within 45 days when the preparation is stored in a freezer.
3. Sterility testing performed and passed, one of the following:
a. Within 30 days when the preparation is stored at controlled room temperature.
b. Within 45 days when the preparation is stored in a refrigerator.
c. Within 60 days when the preparation is stored in a freezer.
(d) For Category 2 compounded sterile preparations, terminally sterilized by a validated procedure, one of the following:
1. No sterility testing performed or sterility testing not passed, one of the following:
a. Within 14 days when the preparation is stored at controlled room temperature.
b. Within 28 days when the preparation is stored in a refrigerator.
c. Within 45 days when the preparation is stored in a freezer.
2. Sterility testing performed and passed, one of the following:
a. Within 45 days when the preparation is stored at controlled room temperature.
b. Within 60 days when the preparation is stored in a refrigerator.
c. Within 90 days when the preparation is stored in a freezer.
(2)The BUD established in sub. (1) may not be exceeded or extended for compounded sterile preparations without verifiable supporting valid scientific sterility and stability information that is directly applicable to the specific preparation or compound.
(3)For compounded sterile preparations which have been assigned a BUD based upon storage in a freezer, the integrity of the container-closure system with the specific compounded sterile preparation in it shall have been demonstrated for 45 days at frozen storage. The container-closure integrity test may be conducted only once on each formulation in the specific container closure-system in which it will be stored or dispensed.
(4)When a preservative is added, the compounded sterile formulation shall pass antimicrobial effectiveness testing that shall include inoculation of standardized microorganisms, incubation serial sampling, and calculation of the changes in colony forming unit concentrations in terms of log reduction. The results of antimicrobial effectiveness testing shall be obtained before any of the compounded sterile preparation is dispensed. Preservatives shall not be used as a substitute for good compounding practices.
(5)For low-risk level compounded sterile preparations, in the absence of passing a sterility test:
(a) Within 48 hours when the preparation is stored at controlled room temperature.
(b) Within 14 days when the preparation is stored in a refrigerator.
(c) Within 45 days when the preparation is stored in a freezer.
(d) For products prepared in an airflow workbench not located in a buffer area, administration shall begin within 12 hours or less of preparation.
(6)For medium-risk level compounded sterile preparations, in the absence of passing a sterility test:
(a) Within 30 hours when the preparation is stored at controlled room temperature.
(b) Within 9 days when the preparation is stored in a refrigerator.
(c) Within 45 days when the preparation is stored in a freezer.
(7)For high-risk level compounded sterile preparations, in the absence of passing a sterility test:
(a) Within 24 hours when the preparation is stored at controlled room temperature.
(b) Within 3 days when the preparation is stored in a refrigerator.
(c) Within 45 days when the preparation is stored in a freezer.
History: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18; CR 22-007: am. (1) (intro.), (c) (intro.), 1. (intro.), a., b., 2. (intro.), a., b., 3., r. (1) (c) 4., 5., am. (1) (d) 1. (intro.), 2., r. (1) (d) 3., 4., cr. (5) to (7) Register July 2022 No. 799, eff. 8-1-22; correction in (6) (b), (7) (b) made under s. 35.17, Stats. July 2022 No. 799.
Phar 15.38Training and evaluation.
(1)General. The managing pharmacist, pharmacists, pharmacy technicians, pharmacy interns and pharmacy externs compounding sterile preparations shall successfully complete didactic or practical training. The didactic or practical training shall be done before any compounding personnel initially prepares compounded sterile preparations and annually thereafter and shall include all of the following:
(a) Hand hygiene and garbing.
(b) Cleaning and disinfection.
(c) Measuring and mixing.
(d) Aseptic manipulation.
(e) Cleanroom behavior.
(f) Sterilization and depyrogenation.
(g) Use of equipment.
(h) Documentation.
(i) Use of primary engineering controls.
(2)Evaluation. Compounding personnel shall successfully complete an initial and annual evaluation which includes all of the following:
(a) Visual observation of hand hygiene and garbing.
(b) Visual observation of aseptic technique.
(c) Gloved fingertip and thumb sampling.
(d) Media-fill tests.
(3)Gloved fingertip. Successfully gloved and thumb sampling is measured by samplings resulting in zero colony-forming units no fewer than three times. Sampling shall be performed on sterile gloves inside of an ISO Class 5 primary engineering control. Gloved fingertip and thumb sampling in a RABS or an isolator shall be taken from the sterile gloves placed over the gauntlet gloves. When gloved fingertip sample results exceed action levels defined by the pharmacy, a review of hand hygiene and garbing procedures, glove and surface disinfection procedures and work practices shall be performed and documented.
(5)Records. The pharmacy shall maintain written policies and procedures for the initial and ongoing training and evaluation of persons involved in compounding sterile preparations. Documentation of all training, assessments, gloved fingertip tests and media-fill simulations shall be maintained by the pharmacy for 5 years and made available to the Board upon request.
History: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18.
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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.