§ 4078 Prescription Label Accuracy Rules

(a) (1) No person shall place a false or misleading label on a prescription. (2) No prescriber shall direct that a prescription be labeled with any information that is false or misleading. (b) Notwithstanding subdivision (a), a person may label a prescription, or a prescriber may direct that a prescription be labeled, with information about the drug that is false under either of the following circumstances: (1) If the labeling is a necessary part of a clinical or investigational drug program approved by the federal Food and Drug Administration or a legitimate investigational drug project involving a drug previously approved by the federal Food and Drug Administration. (2) If, in the medical judgment of the prescriber, the labeling is appropriate for the proper treatment of the patient. (c) The furnisher of a prescription labeled pursuant to subdivision (b) shall make, and retain for three years from the date of making, a record stating the manner in which the information on the prescription label varies from the actual drug in the container and documenting the order of the prescriber to so label the container. The prescriber shall make, and retain for at least three years, a record of his or her order to so label the container. (Amended by Stats. 1999, Ch. 655, Sec. 48. Effective January 1, 2000.)