2021 California Code
Business and Professions Code - BPC
DIVISION 2 - HEALING ARTS
CHAPTER 9 - Pharmacy
ARTICLE 7.7 - Outsourcing Facilities
Section 4129.4.
(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.
(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 Section 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 Section 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.)
