1. (a) A CSP label shall also include all of the following:

   1. (1) Route of intended administration;
   2. (2) For CSPs administered by infusion, the solution utilized;

   3. (3) Instructions for administration;

      1. (A) For CSPs administered by infusion, the rate of infusion, or range of rates of infusion as prescribed, or the duration for the entire CSP to be administered. A health care facility licensed pursuant to Health and Safety Code Section 1250 may reference the patient's chart in lieu of rate of infusion when a patient's condition requires a variable rate.
   4. (4) Name of compounding facility and dispensing facility (if different).
2. (b) The label for any CSP dispensed or ready to be dispensed to a patient shall also include the information required by Business and Professions Code section 4076 and section 1707.5. A CSP that is administered to an inpatient of a health care facility licensed pursuant to section 1250 of the Health and Safety Code, or to an inmate of an adult correctional facility or a juvenile detention facility shall be labeled with the patient's name, the directions for the use of the drug, and the date of issuance, but is otherwise exempt from these requirements.

In addition to the requirements in USP Chapter 797, the following requirements apply to sterile compounding.

Note: Authority cited: Sections 4005, 4126.8 and 4127, Business and Professions Code. Reference: Sections 4005, 4076, 4123, 4126.8 and 4127, Business and Professions Code.

History

1. New section filed 6-19-2025; operative 10-1-2025 (Register 2025, No. 25).