059-17 Wyo. Code R. §§ 17-12 - Establishing Beyond Use Dates

(a) Low-risk level CSPs are prepared under the following conditions:

(i) The CSPs are compounded with aseptic manipulations entirely within ISO Class 5 or better air quality using only sterile ingredients, products, components, and devices;

(ii) Compounding only involved transferring, measuring and mixing manipulations using not more than three (3) commercially manufactured packages of sterile products, and no more than two (2) entries into any sterile container, product, or administration container/device;

(iii) Manipulations are limited to aseptically opening ampules, penetrating disinfected stoppers on vials with sterile needles and syringes, and transferring sterile liquids in sterile syringes to sterile administration devices, package containers of other sterile products, and containers for storage and dispensing; and

(iv) In the absence of passing a sterility test, the storage periods shall not exceed forty-eight (48) hours at controlled room temperature (20-25°C/68-77°F), fourteen (14) days at a cold temperature (2-8°C/36-46°F), and forty-five (45) days in a solid frozen state (-25 to -10°C/-13 to 14°F).

(b) Medium-risk level CSPs are prepared aseptically under low-risk level conditions and one or more of the following conditions exists:

(i) Multiple individual or small doses od sterile products are combined or pooled to prepare a CSP that will be administered either to multiple patients or to one patient on multiple occasions;

(ii) The compounding process includes complex aseptic manipulations other than a single-volume transfer;

(iii) The compounding process requires unusually long duration; and

(iv) In the absence of passing a sterility test, the storage periods shall not exceed thirty (30) hours at controlled room temperature, nine (9) days at cold temperature and forty-five (45) days in a solid, frozen state.

(c) High-risk level CSPs are prepared under the following conditions:

(i) Nonsterile ingredients, including manufactured products not intended for sterile routes of administration, are incorporated, or a nonsterile device is employed before terminal sterilization;

(ii) Any of the following are exposed to air quality worse than ISO Class 5 for more than one (1) hour:

(A) Sterile contents of commercially manufactured products;

(B) CSPs that lack effective antimicrobial preservatives; and

(C) Sterile surfaces of devices and containers for the preparation, transfer, sterilization, and packaging of CSPs.

(iii) Pharmacy compounding staff are improperly garbed and gloved;

(iv) Nonsterile water-containing preparations are stored for more than six (6) hours before being sterilized; and

(v) In the absence of passing a sterility test, storage periods shall not exceed twenty-four (24) hours at controlled room temperature, three (3) days at a cold temperature, and forty-five (45) days in solid, frozen state.

(d) Pharmacy staff shall meet the following requirements for high-risk level compounding:

(i) Batches of twenty-five (25) or more CSPs shall undergo sterility testing;

(ii) All nonsterile measuring, mixing, and purifying devices shall be sensed thoroughly with sterile, pyrogen-free water, and then thoroughly drained or dried immediately before use;

(iii) All high-risk level CSPs subjected to terminal sterilization shall be prefiltered by passing through a filter with nominal port size no larger than 1.2 microns preceding or during filling into their final containers, to remove particulate matter; and

(iv) Sterilization by filtration shall be performed with a sterile 0.2 or 0.22 micron nominal pore size filter, entirely within an ISO Class 5 or superior air quality environment.

(e) A sterile compounding pharmacy with a cleanroom suite may compound low, medium, or high-risk level CSPs.

(f) A sterile compounding pharmacy with a SCA may compound low-risk level CSPs and shall not assign a BUD greater than twelve (12) hours at controlled room temperature, or twenty-four (24) hours at refrigerated temperature.

(g) CSPs that have undergone extended sterility and stability testing may be assigned a BUD greater than outlined in this Chapter. CSPs that are assembled according to the manufacturer's instructions may be assigned a BUD in accordance with the manufacturer's recommendations.

Notes

059-17 Wyo. Code R. §§ 17-12

Adopted, Eff. 5/13/2021.