1. (a) In addition to the standards in USP Chapter 795 and section 353a of title 21, United States Code, a facility that limits its compounding as described in Section 1735.1(i) shall establish the following SOPs:

   1. (1) Provisions of accommodations as described in Personnel Preparation, Section 3.1 of USP Chapter 795.
   2. (2) Provisions for cleaning and sanitizing designated compounding area when in use.
   3. (3) Provisions to ensure documentation is available and maintained confirming that the quality of the medication is not impacted by adding the flavoring agent.
   4. (4) Provisions for maintaining the elements of the compounding record to ensure information is readily retrievable upon request.
   5. (5) Provisions to ensure the prescription label includes information that a flavoring agent was added.
   6. (6) Provisions to ensure documentation is available to support the establishment of a BUD.
   7. (7) Provisions for reporting to the Board the facility's receipt of a complaint of a potential quality problem involving the CNSP. At a minimum the provisions shall require notification to the Board within 96 hours of receipt of a complaint.
2. (b) A pharmacist may compound by combining a flavoring agent with a prescribed FDA approved drug in an oral liquid dosage form at the request of the patient or patient's agent without consultation with the prescriber or the prescriber's authorized agent. A pharmacist performing such compounding must document the compounding in the prescription or compounding record.

Note: Authority cited: Sections 4005 and 4126.8, Business and Professions Code. Reference: Sections 4005, 4081, 4105, 4126.8, 4301 and 4332, Business and Professions Code.

History

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