(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.

Terms Used In California Business and Professions Code 4129.9

  • board: means any entity listed in Section 101, the entities referred to in Sections 1000 and 3600, the State Bar, the Department of Real Estate, and any other state agency that issues a license, certificate, or registration authorizing a person to engage in a business or profession. See California Business and Professions Code 31
  • State: means the State of California, unless applied to the different parts of the United States. See California Business and Professions Code 21
  • Subdivision: means a subdivision of the section in which that term occurs, unless some other section is expressly mentioned. See California Business and Professions Code 15

(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.

(Added by Stats. 2016, Ch. 484, Sec. 29. (SB 1193) Effective January 1, 2017.)

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