Okla. Admin. Code § 535:15-10-8.3

Current through Vol. 42, No. 4, November 1, 2024

Section 535:15-10-8.3 - Compounding record/ log/ formula worksheet

(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.

Okla. Admin. Code § 535:15-10-8.3

Adopted by Oklahoma Register, Volume 38, Issue 24, September 1, 2021, eff. 9/11/2021