1. (a) For non-sterile compounding, the expiration date shall not exceed either of the following:

   1. (1) 180 days from the date the preparation is compounded.
   2. (2) The shortest expiration date of any ingredient in the non-sterile compounded drug preparation.

2. (b) For sterile compounding, the expiration date shall not exceed either of the following:

   1. (1) 30 days from the date the preparation is compounded.
   2. (2) The shortest expiration date or beyond use date of any ingredient in the sterile compounded drug preparation.
3. (c) For a compounded intravenous (IV) or subcutaneous (SQ) drug preparation that does not satisfy the definition of “immediate use,” the preparation shall expire up to 72 hours after the preparation is initially compounded.

Note: Authority cited: Section 4826.5, Business and Professions Code. Reference: Section 4826.5, Business and Professions Code.

History

1. New section filed 1-4-2022; operative 4-1-2022 (Register 2022, No. 1). (OAL review extended 60 calendar days pursuant to Executive Order N-40-20.)

2. New subsection (c) filed 1-12-2026; operative 4-1-2026 (Register 2026, No. 3).