Controlled substances: research.

The document was reformatted from an authenticated chaptered legislative text (with page numbers like '90 Ch. 571' and formal layout) to a web-based bill text page that includes navigation elements such as 'skip to content', 'home', 'accessibility', 'FAQ', 'feedback', 'sitemap', and 'login'. The underlying statutory language is unchanged.

The Research Advisory Panel's mandatory review scope was broadened: the prior version required review of projects involving administration of Schedule I or II substances 'to human and animal research subjects,' while the enrolled version removes that limitation, covering any project requiring administration of those substances.

The requirement that the Attorney General collaborate with the chairperson of the Research Advisory Panel on the formulation of regulations relating to the panel was removed from the bill.

The description of expedited review criteria no longer specifically references an approval letter from an institutional review board or institutional animal care and use committee, suggesting the specific criterion was revised or replaced in the underlying text.

Section 11121.1(g) was renumbered from a (A)/(B) lettered structure to a simple (1)/(2) numbered structure, and the agency name in Section 11126(c)(9) was corrected from 'Council for Private Postsecondary and Vocational Bureau for Private Postsecondary Education' to 'Bureau for Private Postsecondary Education.'

A new Section 11482 is added to the Health and Safety Code, expanding the bill's reach beyond what was previously included (which only added Section 11480.3).

The criteria for expedited review of research projects now requires that the project have an approval letter from an institutional review board (IRB) or an institutional animal care and use committee (IACUC), in addition to federal approvals and independent peer review. This is a stricter gate for fast-track approval.

The panel chairperson's authority over expedited review subcommittees changed from 'assign' to 'deputize' 2 or more panel members, which may carry different legal implications regarding the delegated authority and accountability of those members.

A new requirement mandates that the Attorney General collaborate with the chairperson of the Research Advisory Panel on the formulation of any regulations relating to the panel, adding a layer of executive branch oversight to the rulemaking process.

Section 1 of the bill (which amended Government Code Section 11121.1) was removed from the body text, though the title still references amending that section. This appears to be a renumbering or consolidation change.

Expedited review criteria now include that the project has 'sought or received certain federal approvals' in addition to having an IRB or IACUC approval letter and proof of independent peer review. This broadens the pathway for expedited review by recognizing federal-level approvals as a qualifying factor.

The name 'Council for Private Postsecondary and Vocational Education' in Government Code Section 11126(c)(9) was updated to 'Council for Private Postsecondary and Vocational Bureau for Private Postsecondary Education,' reflecting an agency renaming.

Paragraphs (A) and (B) of Government Code Section 11121.1(g) were renumbered as paragraphs (1) and (2), a structural formatting change with no substantive policy effect.

Added a sunset provision (subparagraph (B)) to Government Code Section 11121.1(g) stating that the exemption of assigned panel members from the definition of 'state body' shall become inoperative on January 1, 2028. After that date, these members would again be subject to open meeting requirements.

Clarified the criteria for expedited review of research projects by removing the phrase 'have sought or received certain federal approvals' and instead requiring only that the project 'have an approval letter from an institutional review board or an institutional animal care and use committee.' This narrows the stated criteria to a specific document requirement.

Changed the verb from 'assign' to 'deputize' in describing the chairperson's authority to designate 2 or more panel members to review and approve a research project without a full panel vote.

New Section 1 amends Government Code Section 11126 (Bagley-Keene Open Meeting Act) to extend the Research Advisory Panel's authorization to hold closed sessions from January 1, 2027 to January 1, 2029, with required legislative findings.

Section 11213 is narrowed from covering all 'controlled substances' to specifically 'Schedule I and Schedule II controlled substances,' limiting the panel's review jurisdiction to those two schedules.

Cross-references in Sections 11213 and 11480 are updated to point to new Section 11480.1 instead of Section 11481 for the approval authority, reflecting the restructured review framework.

New Section 11480.1 requires the panel to review research projects involving administration of Schedule I or II controlled substances to human subjects in California, and mandates that the panel prioritize and expedite applications that include proof of independent peer review (NIH, DoD, Heffter Research Institute, NSF, or comparable group), FDA IND approval or documentation, IRB approval, and DEA registration.

New Section 11480.3 restricts the panel's ability to withdraw approval to only two circumstances (safety concerns for human subjects or diversion concerns) and requires written notice with a prescribed course of action and at least 10 days to cure before withdrawal takes effect.

New Section 11480.1 authorizes the panel chairperson to assign one or more individual panel members to conduct expedited review and approve eligible applications without a full panel vote, and permits asynchronous communication among panel members for this purpose.

Section 11480 adds a provision allowing the Attorney General to appoint an executive officer of the panel whose duties include coordinating with the chairperson to assign incoming applications to individual panel members with relevant core competencies.

The panel's authority to expedite review of qualifying research projects now expires on January 1, 2028, rather than being open-ended as in the prior version.

The authorization for the Research Advisory Panel to hold closed sessions under the Bagley-Keene Open Meeting Act was shortened from January 1, 2029 to January 1, 2028, aligning it with the expedited review sunset.

The panel chairperson can no longer assign a single member to review and approve a research project; at least 2 panel members must be assigned. This increases oversight for expedited approvals.

The standard for the panel to withdraw its approval of a research project was strengthened from 'specified circumstances' to 'specified circumstances for reasonable cause,' making it harder for the panel to revoke an existing approval.

Corrected 'Schedule I and or Schedule II' to 'Schedule I or Schedule II' in the digest, removing an ambiguous conjunction.

New Government Code Section 11121.1(g) exempts Research Advisory Panel members assigned by the chairperson to conduct expedited reviews (under Health and Safety Code Section 11480.1(e)) from the Bagley-Keene Open Meeting Act until January 1, 2028. This means these panel members are not considered 'state bodies' subject to open meeting requirements at all.

Removed the requirement that the panel must 'prioritize' research projects that meet expedited review criteria. The panel is now only authorized (not required) to expedite reviews of qualifying projects until January 1, 2028.

The standard for the panel to withdraw its approval of a research project was changed from 'only under specified circumstances for reasonable cause' to simply 'for reasonable cause,' broadening the panel's discretion to revoke approvals.

The inoperative date for the Research Advisory Panel's closed session exemption under Government Code Section 11126(c)(20)(B) was shortened from January 1, 2029 to January 1, 2028.

Removed the exemption that would have allowed studies registered with the DEA for therapeutic administration of psychedelics to treat specified disorders in military veterans at VA facilities to bypass Research Advisory Panel authorization or review.

Expanded the panel's review requirement from projects administering Schedule I and II controlled substances to human research subjects to projects 'to be conducted in this state' that administer such substances to both human and animal research subjects, adding a geographic limitation and extending coverage to animal studies.

Broadened the criteria for prioritizing and expediting review from projects that have sought or received certain federal approvals and proof of independent peer review to projects that satisfy 'certain criteria, including, among other things,' those same factors, suggesting additional qualifying criteria were added in the operative text.

Increased the minimum number of panel members the chairperson may assign to review and approve a research project without a full panel vote from one to two.

Extended the authorization for the Research Advisory Panel to hold closed sessions from January 1, 2027 to January 1, 2029, giving the panel two additional years of authority to discuss sensitive research project information in non-public meetings.