California CodesBusiness and Professions Code - BPCDivision 2 — Healing ArtsChapter 9 — PharmacyArticle 7.7 — Outsourcing FacilitiesSection 4129.3
(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.
Notes
Requires the board, by January 1, 2018, to report to the Legislature on nonresident outsourcing-facility regulation, including inspection and licensing activities, revenue sufficiency, significant proposed federal changes, and any recommended statutory modifications needed for public protection. The report must follow the specified submission method, and the reporting requirement becomes inoperative January 1, 2022.
Use as reference
Lexinter.net | California Code, Business and Professions Code - BPC § 4129.3 | https://laws.lexinter.net/codes/california/business-and-professions-code/division-2/chapter-9/article-7-7/section-4129-3