By Sarah Dahm
On July 23, 2021, the California Board of Pharmacy (Board) issued notice of its proposed rulemaking action to amend section 1709, Title 16 of the California Code of Regulations (CCR). This proposed rulemaking action follows SB 1193 (Hill)(Chapter 484, Statutes of 2016), which amended, among other things, Business and Professions Code section 4035 to add “trust” to the definition of “person,” and Business and Professions Code section 4201 to add requirements for the disclosure of information of any person with management or control over the license to the Board.
In the initial statement of reasons, the Board explained the amendments were meant to clarify and make specific the standards of pharmacy and ownership disclosure, as they relate to pharmacy ownership, management, and control, including through trusts. The Board noted that protection of the public is its highest priority in exercising its licensing, regulatory and disciplinary functions. Thus, the proposed changes ensure the Board is able to continue to track the beneficial ownership of a pharmacy or other regulated business entity, even when it is owned by a trust, and ensure that previously disciplined owners or other prohibited forms of ownership, for instance, prescriber-owned, are not occurring.
On October 26, 2016, the Board approved (p. 59) the proposed text for rulemaking. The proposed text of the regulation indicates that specifically, this proposal would change the term “permit” to “license,” would specify that a license shall not be transferred from one owner to another without written notification to the Board, and would specify the reporting time frame as required by Business and Professions Code section 4201. Additionally, this proposed rulemaking would identify the Board’s ability to issue a license to an entity controlled by a trust and specify the requirements for disclosure and notice to the Board, including identifying who must be identified (by role), when disclosure or notice is required, what information is required, and how notification is to be provided.
The 45-day public comment period was held July 23, 2021 to September 7, 2021. As of this writing, the comments are pending review by the Board.