(a) Whenever the board has a reasonable belief, based on information obtained during an inspection or investigation by the board, that an outsourcing facility compounding sterile drug products or nonsterile drug products poses an immediate threat to the public health or safety, the executive officer of the board may issue an order to the outsourcing facility to immediately cease and desist compounding sterile drug products or nonsterile drug products. The cease and desist order shall remain in effect for no more than 30 days or the date of a hearing seeking an interim suspension order, whichever is earlier.

(b) Whenever the board issues a cease and desist order pursuant to subdivision (a), the board shall immediately issue a notice to the owner setting forth the acts or omissions with which the owner is charged, specifying the pertinent code section or sections and any regulations.

Terms Used In California Business and Professions Code 4129.4

  • 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

(c) The cease and desist order shall state that the owner, within 15 days of receipt of the notice, may request a hearing before the president of the board to contest the cease and desist order. Consideration of the owner’s contest of the cease and desist order shall comply with § 11425.10 of the Government Code. The hearing shall be held no later than five business days after the date the request of the owner is received by the board. The president shall render a written decision within five business days after the hearing. In the absence of the president of the board, the vice president of the board may conduct the hearing permitted by this subdivision. The owner or person in possession or control of the outsourcing facility may seek review of the decision pursuant to § 1094.5 of the Code of Civil Procedure.

(d) Failure to comply with a cease and desist order issued pursuant to this section shall be unprofessional conduct.

(Amended by Stats. 2021, Ch. 629, Sec. 21. (AB 1533) Effective January 1, 2022.)

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