Any drug or device sold by filling or refilling a written or oral prescription of a practitioner licensed to prescribe the drug or device shall be exempt from the labeling requirements of Sections 111335, 111340, 111350, 111355, 111360, 111365, 111375, 111380, 111385, 111395, 111415, and 111420, if the drug or device bears a label displaying all the following:
(a) Except where the prescriber orders otherwise, either the manufacturer’s trade name of the drug, or the generic name and the name of the manufacturer. Commonly used abbreviations may be used. Preparations containing two or more active ingredients may be identified by the manufacturer’s trade name or the commonly used name or the principal active ingredients.
(b) The directions for the use of the drug or device.
(c) The name of the patient(s).
(d) The name of the prescriber.
(e) The date of issue.
(f) The name, address of the furnisher, and prescription number or other means of identifying the prescription.
(g) The strength of the drug or drugs dispensed.
(h) The quantity of the drug or drugs dispensed.
(i) The expiration date of the effectiveness of the drug or device if the information is included on the original label of the manufacturer of the drug or device.
If a pharmacist dispenses a prescribed drug by means of a unit dose medication system, as defined by administrative regulation, for a patient in a skilled nursing, intermediate care or other health care facility, the requirements of this section will be satisfied if the unit dose medication system contains the aforementioned information or the information is otherwise readily available at the time of drug administration.
The exemption shall not apply to any drug or device dispensed in the course of the conduct of a business of dispensing drugs or devices pursuant to diagnosis by mail, or to a drug or device dispensed in violation of Section 111470.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
Last modified: October 25, 2018