2018 California Code
Business and Professions Code - BPC
DIVISION 2 - HEALING ARTS
CHAPTER 9 - Pharmacy
ARTICLE 7.5 - Sterile Drug Products
Section 4127.8.
(a) A pharmacy licensed pursuant to Section 4127.1 or 4127.2 that issues a recall notice regarding a sterile compounded drug shall, in addition to any other duties, contact the recipient pharmacy, prescriber, or patient of the recalled drug and the board as soon as possible within 12 hours of the recall notice if both of the following apply:
(1) Use of or exposure to the recalled drug may cause serious adverse health consequences or death.
(2) The recalled drug was dispensed, or is intended for use, in this state.
(b) A recall notice issued pursuant to subdivision (a) shall be made as follows:
(1) If the recalled drug was dispensed directly to the patient, the notice shall be made to the patient.
(2) If the recalled drug was dispensed directly to the prescriber, the notice shall be made to the prescriber, who shall ensure the patient is notified.
(3) If the recalled drug was dispensed directly to a pharmacy, the notice shall be made to the pharmacy, who shall notify the prescriber or patient, as appropriate. If the pharmacy notifies the prescriber, the prescriber shall ensure the patient is notified.
(Added by renumbering Section 4127.9 by Stats. 2017, Ch. 649, Sec. 3. (SB 510) Effective January 1, 2018.)
