Okla. Admin. Code § 535:15-10-8.2

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

Section 535:15-10-8.2 - Beyond-use dating

(a) Pharmacies engaging in compounding shall assign every compounded preparation an appropriate beyond-use date (BUD).

(b) BUD may be assigned based on criteria different from those applied to assigning expiration dates to manufactured drug products.

(c) BUD are to be assigned conservatively and should be based on the following State Board of Pharmacy regulations standards in (d) through (f) below.

(1) These standards may be exceeded when there is supporting scientific stability information that is directly applicable to the specific preparation (e.g., the same drug concentration range, pH, excipients, vehicle, water content, etc.)

(2) Information to be considered when assigning a BUD includes chemical, physical and microbiological stability; nature of the drug, its chemical degradation mechanism, the container in which it is packaged, expected storage conditions, and the intended duration of therapy.

(d) Non-aqueous Formulations. The BUD for non-aqueous formulations is not later than the time remaining until the earliest expiration date of any ingredient utilized or 6 months, whichever is earlier.

(e) Water-Containing Oral Formulations. The BUD for water-containing oral formulations is not later than 14 days when stored at controlled cold temperatures.

(f) Water-Containing Topical / Dermal and Mucosal Liquid and Semisolid formulations. The BUD for water-containing topical / Dermal and Mucosal Liquid and semisolid formulations is not later than 30 days.

(g) If water is not added to a topical compounded preparation itself then the compound could be considered anhydrous with a BUD of 6 months or the earliest expiration of products used, whichever is less.

Okla. Admin. Code § 535:15-10-8.2

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.

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

Amended by Oklahoma Register, Volume 40, Issue 22, August 1, 2023, eff. 9/1/2023