§ 4127.2. — 4127.2. (Repealed (in Sec. 6) and added by Stats. 2013, Ch. 565, Sec. 7.)

California § 4127.2.

• Jurisdiction: California
• Code BPC: Business and Professions Code - BPC
• Div. 2.: DIVISION 2. HEALING ARTS
• Ch. 9.: CHAPTER 9. Pharmacy
• Art. 7.5.: ARTICLE 7.5. Sterile Drug Products

Text

(a)
A nonresident pharmacy shall not compound sterile drug products for shipment into this state without a sterile compounding pharmacy license issued by the board pursuant to this section. The license shall be renewed annually and shall not be transferable.
(b)
A license to compound sterile drug products shall be issued only to a location that is licensed as a nonresident pharmacy and shall be issued only to the owner of the nonresident pharmacy licensed at that location.
(c)
A license to compound sterile drug products 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 pharmacy shall reimburse the board for all actual and necessary costs incurred by the board in conducting an inspection of the pharmacy at least once annually pursuant to subdivision (v) of Section 4400.
(d)
A license to compound sterile drug products shall not be issued or renewed until the board does all of the following:
(1)
Reviews a current copy of the nonresident pharmacy’s policies and procedures for sterile compounding.
(2)
Reviews the pharmacy’s completed self-assessment form required by Section 1735.2 of Title 16 of the California Code of Regulations.
(3)
Is
provided with copies of all inspection reports conducted of the nonresident pharmacy’s premises, and any reports from a private accrediting agency, conducted in the prior 12 months documenting the nonresident pharmacy’s operations.
(4)
Receives a list of all sterile drug products compounded by the pharmacy within the prior 12 months.
(e)
A pharmacy licensed pursuant to this section shall do all of the following:
(1)
Provide to the board a copy of any disciplinary or other action taken by its state of residence or another state within 10 days of the action.
(2)
Notify the board within 10 days of the suspension of any accreditation held by the pharmacy.
(3)
Provide to the board, within 12 hours, any recall notice issued by the pharmacy for sterile drug products it has compounded that have been shipped into, or dispensed in, California.
(4)
Advise the board of any complaint it receives from a provider, pharmacy, or patient in California.
(f)
Adverse effects reported or potentially attributable to a nonresident pharmacy’s sterile compounded drug product shall be reported to the board within 12 hours and immediately reported to the MedWatch program of the federal Food and Drug Administration.
(g)
On or before January 1, 2018, the board shall provide a report to the Legislature regarding the regulation of nonresident pharmacies. 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 pharmacies.
(2)
Whether fee revenue collected pursuant to subdivision (v) of Section 4400 and travel cost reimbursements collected pursuant to subdivision (c) of this section provide revenue in an amount sufficient to support the board’s activities related to the inspection and licensure of nonresident pharmacies.
(3)
The status of proposed
changes to federal law that are under serious consideration and that would govern compounding pharmacies, including legislation pending before the United States Congress, administrative rules, regulations, or orders under consideration by the federal Food and Drug Administration 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 pharmacies as a result of changes to federal law or any additional modifications necessary to protect the health and safety of the public.
(h)
The requirement for submitting a report imposed under subdivision (g) is inoperative on January 1, 2022, pursuant to Section 10231.5 of the Government Code.
(i)
This section shall become operative on July 1, 2014.

Legislative History

Repealed (in Sec. 6) and added by Stats. 2013, Ch. 565, Sec. 7. (SB 294) Effective January 1, 2014. Section operative July 1, 2014, by its own provisions.