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A 11499

Relates to designated or rescheduled drugs

2025 Regular Session

Automatically aligns NY Schedule I-containing compounds with FDA/DEA federal rescheduling or designation, as of the federal action date.

REFERRED TO HEALTH
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Bill Summary · A 11499

Overview

  • Bill: A 11499 (2025-2026 Session, New York)
  • Jurisdiction: New York
  • Introduced by: Committee on Rules (at the request of Assembly Member Burke)
  • Status: Referred to Health (as of May 28, 2026)
  • Purpose: Amend the Public Health Law to address how compounds, mixtures, or preparations containing substances listed in Schedule I are reclassified or deemed scheduled when they are redesignated, rescheduled, or approved by federal agencies (FDA/DEA). Aligns state scheduling actions with federal designations and clarifies authorities and timelines.

Main purpose and intent

  • The bill aims to streamline and codify how New York state schedules controlled substances when a compound containing a Schedule I substance undergoes federal redesignation, rescheduling, or approval.
  • It seeks to ensure that state scheduling automatically reflects federal changes under certain conditions, reducing delays and avoiding gaps between federal and state classifications.

Key provisions and changes

  1. Schedule framework (public health law, section 3306)

    • Reiterates the five traditional schedules (I–V) of controlled substances, with substances identified by name or chemical designation as applicable.

  2. Authority to reclassify by the Commissioner (public health law, section 3307, subdivision 5)

    • The Commissioner may by regulation or emergency regulation reclassify any compound, mixture, or preparation containing a Schedule I substance when the same compound/mixture/pretreatment is redesignated or rescheduled at a level other than Schedule I under the federal CSA, or is exempted from federal control.
    • If the Commissioner acts under this provision and does not exempt the compound/mixture/preparation, the reclassification must be within the same numbered schedule or a higher numbered schedule than the federal designation.
    • This subdivision does not apply to compounds described in subdivision six (before amendment).

  3. New subdivision regarding automatic scheduling upon federal action (public health law, section 3307, subdivision 6 — renumbered as such)

    • If any compound, mixture, or preparation containing a Schedule I substance is approved by the FDA and is designated or rescheduled by the DEA to a schedule other than Schedule I under 21 U.S.C. § 812 and 21 C.F.R. Part 1308, that compound/mixture/preparation shall, as of the effective date of the federal designation/rescheduling, be deemed scheduled under NY Public Health Law section 3306 in the same federal schedule.
    • This occurs automatically, without the need for further action by the NY Commissioner.

  4. Effective date

    • The act takes effect immediately upon enactment.

Who/what would be affected

  • Substances and products containing Schedule I substances that undergo federal redesignation or rescheduling (via DEA designation or FDA approval processes).
  • State regulatory actions for compounds, mixtures, or preparations containing Schedule I substances, potentially accelerating alignment with federal schedules.
  • The NY Commissioner of Health, who would have authority to regulate reclassification under state law, and, in certain cases, the scheduling would occur automatically via federal action.

Procedural and timeline aspects

  • Once federal action occurs (FDA approval and DEA rescheduling/designation away from Schedule I), NY scheduling for the affected compound/mixture would automatically adopt the same federal schedule on the effective date.
  • In non-auto scenarios (subdivision 5 processes), the Commissioner can reclassify via regulation or emergency regulation, but must place the substance in the same or higher schedule unless exempted, and only within the constraints described (e.g., adherence to same or higher schedule if not exempt).

Potential impacts and considerations

  • Alignment: Reduces lag between federal scheduling actions and state scheduling, promoting consistency in enforcement and regulation.
  • Enforcement: Could affect law enforcement, healthcare compliance, prescription practices, research permissions, and penalties associated with Schedule I substances and derivatives.
  • Administrative: May require the Department of Health to monitor federal scheduling actions closely and implement automatic adjustments promptly.
  • Precision: Depends on the exact nature of FDA approvals and DEA scheduling actions to determine automatic NY scheduling outcomes.

Note: The bill adds automatic scheduling synchronization with federal actions for Schedule I-related compounds and provides a mechanism for the state to reclassify when federal changes occur, either automatically or through state regulation/emergency regulation.

Compiled from official sources — confirm details with the bill’s official record.

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