Section 1735.4 - Labeling of Compounded Drug Preparations(a) Each compounded drug preparation shall be affixed with a container label prior to dispensing that contains at least: (1) Name of the compounding pharmacy and dispensing pharmacy (if different);(2) Name (brand or generic) and strength, volume, or weight of each active ingredient. For admixed IV solutions, the intravenous solution utilized shall be included;(3) Instructions for storage, handling, and administration. For admixed IV solutions, the rate of infusion shall be included;(4) The beyond use date for the drug preparation;(5) The date compounded; and(6) The lot number or pharmacy reference number.(b) Any compounded drug preparation dispensed to a patient or readied for dispensing to a patient shall also include on the label the information required under Business and Professions Code section 4076 and California Code of Regulations, title 16, section 1707.5.(c) Any compounded drug preparation dispensed to a patient or readied for dispensing to a patient shall also include, on the container label or on a receipt provided to the patient, a statement that the drug has been compounded by the pharmacy.(d) Prior to dispensing drug preparations compounded into unit-dose containers that are too small or otherwise impractical for full compliance with subdivisions (a), (b), and (c) shall be labeled with at least the name of the compounding pharmacy and dispensing pharmacy, if different, the name(s) of the active ingredient(s), strength, volume or weight of the preparation, pharmacy reference or lot number, and beyond use date, and shall not be subject to minimum font size requirements. Once dispensed, outer packaging must comply with 1735.4(a) - (c).(e) All hazardous agents shall bear a special label which states "Chemotherapy -- Dispose of Properly" or "Hazardous -- Dispose of Properly."Cal. Code Regs. Tit. 16, § 1735.4
1. New section filed 1-6-2010; operative 7-6-2010 (Register 2010, No. 2).
2. Amendment of section heading and section filed 9-13-2016; operative 1-1-2017 (Register 2016, No. 38). Note: Authority cited: Sections 4005 and 4127, Business and Professions Code. Reference: Sections 4005, 4036, 4037, 4051, 4052, 4076 and 4127, Business and Professions Code.
1. New section filed 1-6-2010; operative 7-6-2010 (Register 2010, No. 2).
2. Amendment of section heading and section filed 9-13-2016; operative 1/1/2017 (Register 2016, No. 38).