1. (a) The label for any compounded HD preparation dispensed to a patient or readied for dispensing to a patient shall also include on the label the information required by Business and Professions Code section 4076 and section 1707.5. A compounded HD preparation 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.
2. (b) All compounded antineoplastic HDs shall be transported from the facility in an impervious plastic container and labeled as Hazardous Drugs on the outside of the container, unless the label is visible through the outer container.
3. (c) When furnishing a compounded antineoplastic HD for administration within a health care facility licensed pursuant to Health and Safety Code section 1250, the HD shall be placed in a plastic container and labeled as a hazardous drug on the outside of the container or with a label that is visible through the outer container.

In addition to the standards in USP Chapter 800, the following requirements apply to a facility where compounding of HDs is performed.

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

History

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