Section 4127.8 - Additional requirements for recall of sterile compounded drug(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.Ca. Bus. and Prof'l. Code § 4127.8
Renumbered from Ca. Bus. and Prof'l. Code § 4127.9 and amended by Stats 2017 ch 649 (SB 510),s 3, eff. 1/1/2018.Amended by Stats 2016 ch 484 (SB 1193),s 27, eff. 1/1/2017.Added by Stats 2013 ch 302 (AB 1045),s 1, eff. 1/1/2014.