Article 7.7 - Outsourcing Facilities

California Business and Professions Code — §§ 4129-4129.9

Sections (8)

Amended by Stats. 2021, Ch. 629, Sec. 20. (AB 1533) Effective January 1, 2022.

(a)A facility registered as an outsourcing facility with the federal Food and Drug Administration (FDA) shall be concurrently licensed with the board as an outsourcing facility if it compounds sterile medication or nonsterile medication for nonpatient-specific distribution within or into California.

(b)A facility premises licensed with the board as a sterile compounding pharmacy shall not be concurrently licensed with the board as an outsourcing facility at the same location.

(c)The board may adopt regulations in accordance with the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code) to establish policies, guidelines,

and procedures to implement this article.

(d)The board shall review any formal requirements or guidance documents developed by the FDA regarding outsourcing facilities within 90 days after their release in order to determine whether revisions are necessary for any regulations promulgated by the board.

(e)An outsourcing facility licensed by the board dispensing patient-specific compounded preparations pursuant to a prescription for an individual patient shall not be required to be licensed as a pharmacy, but shall otherwise comply with the same requirements of a pharmacy.

§ 4129.1

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

(a)An outsourcing facility that is licensed with the federal Food and Drug Administration (FDA) and with an address in this state shall also be licensed by the board as an outsourcing facility before doing business within this state. The license shall be renewed annually and is not transferable.

(b)An outsourcing facility shall compound all sterile products and nonsterile products in compliance with regulations issued by the board and with federal current good manufacturing practices applicable to outsourcing facilities.

(c)An outsourcing facility license shall not be issued or renewed until the location is inspected by the board and

found in compliance with this article and regulations adopted by the board.

(d)An outsourcing facility license shall not be issued or renewed until the board does all of the following:

(1)Prior to inspection, reviews a current copy of the outsourcing facility’s policies and procedures for sterile compounding and nonsterile compounding.

(2)Is provided with copies of all federal and state regulatory agency inspection reports, as well as accreditation reports, and certification reports of facilities or equipment of the outsourcing facility’s premises conducted in the prior 12 months.

(3)Prior to inspection, receives a list of all sterile drugs and nonsterile drugs compounded by the outsourcing facility as reported to the FDA in the last 12 months.

(e)An outsourcing facility licensed pursuant to this section shall provide the board with all of the following:

(1)A copy of any disciplinary or other action taken by another state or the FDA within 10 days of the action.

(2)Notice within 24 hours of any recall notice issued by the outsourcing facility.

(3)A copy of any clinically related complaint it receives involving an outsourcing facility’s compounded products from or involving any provider, pharmacy, or patient in California within 72 hours of receipt.

(4)Notice within 24 hours after learning of adverse effects reported or potentially attributable to the outsourcing facility’s products.

§ 4129.2

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

(a)An outsourcing facility that is licensed with the federal Food and Drug Administration (FDA) as an outsourcing facility and has an address outside of this state but in the United States of America is a nonresident outsourcing facility. A nonresident outsourcing facility shall not compound sterile drug products or nonsterile drug products for distribution or use into this state without an outsourcing license issued by the board pursuant to this section. The license shall be renewed annually and shall not be transferable.

(b)A nonresident outsourcing facility shall compound all sterile products and nonsterile products to be distributed or used in this state in compliance with regulations of the

board and with federal current good manufacturing practices applicable to outsourcing facilities.

(c)A license for a nonresident outsourcing facility shall not be issued or renewed until the location is inspected by the board and found in compliance with this article and any regulations adopted by the board. The nonresident outsourcing facility shall reimburse the board for all actual and necessary costs incurred by the board in conducting an inspection of the nonresident outsourcing facility at least once annually pursuant to subdivision (x) of Section 4400.

(d)A license for a nonresident outsourcing facility shall not be issued or renewed until the board:

(1)Prior to inspection, reviews a current copy of the nonresident outsourcing facility’s policies and procedures for sterile compounding and nonsterile

compounding.

(2)(A) Is provided with copies of all federal and state regulatory agency inspection reports, as well as accreditation reports, and certification reports of facilities or equipment of the nonresident outsourcing facility’s premises conducted in the prior 12 months.

(B)For purposes of this paragraph, “state” refers to the state in which the nonresident outsourcing facility resides.

(3)Prior to inspection, receives a list of all sterile drug products and nonsterile drug products compounded by the pharmacy as reported to the FDA within the prior 12 months.

(e)A nonresident outsourcing facility licensed pursuant to this section shall provide the board with all of the following:

(1)A copy of any disciplinary or other action taken by another state or the FDA within 10 days of the action.

(2)Notice within 24 hours of any recall notice issued by the nonresident outsourcing facility.

(3)A copy of any complaint it receives involving an outsourcing facility’s compounded products from or involving any provider, pharmacy, or patient in California within 72 hours of receipt.

(4)Notice within 24 hours after learning of adverse effects reported or potentially attributable to a nonresident outsourcing facility’s products.

§ 4129.3

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

(a)On or before January 1, 2018, the board shall provide a report to the Legislature regarding the regulation of nonresident outsourcing facilities. The report shall be submitted to the Legislature in the manner required pursuant to Section 9795 of the Government Code. At a minimum, the report shall address all of the following:

(1)A detailed description of board activities related to the inspection and licensure of nonresident outsourcing facilities.

(2)Whether fee revenue collected pursuant to subdivision (x) of Section 4400 and travel cost reimbursements collected pursuant to subdivision (c) of Section 4129.2 provide revenue in an

amount sufficient to support the board’s activities related to the inspection and licensure of nonresident outsourcing facilities.

(3)The status of proposed changes to federal law that are under serious consideration and that would govern outsourcing facilities and compounding pharmacies, including, but not limited to, legislation pending before Congress, administrative rules, regulations or orders under consideration by the FDA or other appropriate federal agency, and cases pending before the courts.

(4)If applicable, recommended modifications to the board’s statutory duties related to nonresident outsourcing facilities as a result of changes to federal law or any additional modifications necessary to protect the health and safety of the public.

(b)The requirement for submitting a report imposed under subdivision

(a)is inoperative on January 1, 2022, pursuant to Section 10231.5 of the Government Code.

§ 4129.4

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

(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.

§ 4129.5

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

Notwithstanding any other law, a violation of this article, or regulation adopted pursuant thereto, may subject the person or entity that committed the violation to a fine of up to five thousand dollars ($5,000) per occurrence pursuant to a citation issued by the board.

§ 4129.8

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

The board, at its discretion, may issue a temporary license to an outsourcing facility upon the conditions and for any periods of time as the board determines to be in the public interest. A temporary license fee shall be required as specified in subdivision (w) of Section 4400. When needed to protect public safety, a temporary license may be issued for a period not to exceed 180 days, and may be issued subject to terms and conditions the board deems necessary. If the board determines a temporary license was issued by mistake or denies the application for a permanent license, the temporary license shall terminate upon the earlier of personal service of the notice of termination upon the licenseholder or service by certified mail with return receipt requested at the licenseholder’s

address of record with the board. The temporary licenseholder shall not be deemed to have a vested property right or interest in the license for purposes of retaining a temporary license or for purposes of any disciplinary or license denial proceeding before the board.

§ 4129.9

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

(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.