Okla. Admin. Code § 535:15-10-61

Current through Vol. 42, No. 7, December 16, 2024

Section 535:15-10-61 - Beyond use dating (BUD)

(a) BUDs shall be assigned to all compounded sterile preparations. The shorter of the chemical stability (established by the manufacturer, or listed in a current authoritative reference, or established by direct testing following USP standards or equivalent) and microbial limits of sterility (USP <797> standards) shall be used to determine the date. If a pharmacy does not have a program of sterility and endotoxin testing in place and additional documentation for longer dates, then the following BUDs are to be used for compounded sterile preparations as follows and as illustrated in the Appendix B Chart:

(1) If USP <797> Risk Level is "Immediate Use" BUD, and if kept

(A) at room temperature; use within 1 hour,

(B) refrigerated; use within 1 hour, or

(C) in freezer, N/A.

(2) If USP <797> Risk Level is "Low Risk" BUD, and if kept

(A) at room temperature, use within 48 hours,

(B) refrigerated, use within 14 days, or

(C) in freezer, use within 45 days.

(3) If USP <797> Risk Level is "Low Risk with 12 hour or less" BUD, and if kept

(A) at room temperature use within 12 hours or less

(B) refrigerated, use within 12 hours or less, or

(C) in freezer, N/A

(4) If USP <797> Risk Level is "Medium Risk" BUD, and if kept

(A) at room temperature, use within 30 hours,

(B) refrigerated, use within 9 days, or,

(C) in freezer, use within 45 days

(5) If USP <797> Risk Level is "High Risk" BUD, and if kept

(A) at room temperature, use within 24 hours

(B) refrigerated, use within 3 days, or

(C) in freezer, use within 45 days

(b) Reusable compounded preparations that are returned to a hospital pharmacy shall be placed in the refrigerator (unless contraindicated) with the original BUD on the label.

Okla. Admin. Code § 535:15-10-61

Added at 26 Ok Reg 2276, eff 7-1-09

Amended by Oklahoma Register, Volume 32, Issue 23, August 17, 2015, eff. 8/27/2015.