California § 4129.9 - An outsourcing facility licensed pursuant to Section 4129.1 or 4129.2 that issues

§ 4129.9. An outsourcing facility licensed pursuant to Section 4129.1 or 4129.2 that issues

(a) An outsourcing facility licensed pursuant to Section 4129.1 or 4129.2 that issues a recall notice for a sterile drug or nonsterile drug compounded by the outsourcing facility, in addition to any other duties, shall contact the recipient pharmacy, prescriber, or patient of the recalled drug and the board as soon as possible within 24 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 prescriber, the notice shall be made to the prescriber and the prescriber shall ensure the patient is notified. (2) If the recalled drug was dispensed directly to a pharmacy, the notice shall be made to the pharmacy and that pharmacy shall notify the prescriber or patient, as appropriate. If the pharmacy notifies the prescriber, the prescriber shall ensure the patient is notified.