(a) Every pharmacy shall document the drug compounding controls required in 535:15-10-8. Each pharmacy shall complete a compounding record/ log/ formula worksheet for each preparation which will include, but not be limited to, the following:
- (1) The assigned name of the preparation.
- (2) The name and actual measured quantity of each ingredient used.
- (3) The lot number, expiration date and manufacturer of each ingredient used.
- (4) The total quantity compounded.
- (5) The name/initials of the employee that compounded the preparation and the name/initials of the supervising pharmacist that approved the preparation.
- (6) The date the compound is prepared.
- (7) The lot/batch number assigned to the preparation.
- (8) The assigned beyond use date (BUD).
- (b) If an assigned BUD exceeds the allowable BUD according to 535:15-10-8.2, then you must include documentation of the source of the assigned BUD.
- (c) The assigned BUD cannot exceed the expiration date of any ingredient utilized to compound the preparation.
- (d) Compounding record/ log/ formula worksheet(s) shall be maintained in the pharmacy as required in 535:15-10-10.
Added at 38 Ok Reg 2440, eff 9-11-21