BILL ANALYSIS C.S.H.B. 4813 By: Oliverson Public Health Committee Report (Substituted) BACKGROUND AND PURPOSE Under current law, Texas requires the commissioner of the Texas Department of State Health Services (DSHS) to annually establish schedules of controlled substances, mirroring federal schedules. The bill author has informed the committee that this annual process often results in delays, preventing timely access to treatments that are newly approved by the FDA and that, after FDA approval, substances currently classified as Schedule I must go through DEA rescheduling and state-level action before becoming accessible to patients. The bill author has further informed the committee that Texans suffering from mental health conditions such as treatment-resistant depression (TRD), major depressive disorder (MDD), and post-traumatic stress disorder (PTSD) need access to fast-acting, effective treatments and that the lengthy process of DEA rescheduling followed by the annual state action to align with the FDA reschedule creates unnecessary delays in access for Texas patients. C.S.H.B. 4813 seeks to address this issue to ensure that Texas law aligns promptly with federal decisions by requiring the commissioner to act as soon as practicable to make the same changes at the state level if a controlled substance is approved for medical use by the FDA, the substance is subsequently deleted as a controlled substance or reschedule and placed on a lower schedule under federal law, and notice of those facts is given to the commissioner. The bill preserves the right of the commissioner of DSHS to object to the designation of a substance as a controlled substance, the rescheduling of a substance, or the deletion of a substance. CRIMINAL JUSTICE IMPACT It is the committee's opinion that this bill does not expressly create a criminal offense, increase the punishment for an existing criminal offense or category of offenses, or change the eligibility of a person for community supervision, parole, or mandatory supervision. RULEMAKING AUTHORITY It is the committee's opinion that this bill does not expressly grant any additional rulemaking authority to a state officer, department, agency, or institution. ANALYSIS C.S.H.B. 4813 amends the Health and Safety Code to require the commissioner of state health services or their designee, if a controlled substance is approved for medical use by the FDA under the Federal Food, Drug, and Cosmetic Act and is subsequently deleted as a controlled substance or rescheduled and placed on a lower schedule under federal law and notice of those facts is given to the commissioner or designee, to similarly delete or reschedule the substance under the Texas Controlled Substances Act as soon as practicable. The bill accordingly makes changes in provisions relating to the establishment and modification of schedules under that act to account for this requirement. C.S.H.B. 4813 applies only to a controlled substance deleted as a controlled substance or rescheduled and placed on a lower schedule under federal law on or after the bill's effective date. EFFECTIVE DATE September 1, 2025. COMPARISON OF INTRODUCED AND SUBSTITUTE While C.S.H.B. 4813 may differ from the introduced in minor or nonsubstantive ways, the following summarizes the substantial differences between the introduced and committee substitute versions of the bill. Whereas the introduced required the commissioner of state health services or their designee to, as applicable and under the Texas Controlled Substances Act, delete or reschedule a controlled substance listed in Schedule I of that act approved by the FDA, the substitute requires the commissioner or their designee to do so for a controlled substance approved instead for medical use by the FDA.
BILL ANALYSIS
# BILL ANALYSIS
C.S.H.B. 4813
By: Oliverson
Public Health
Committee Report (Substituted)
C.S.H.B. 4813
By: Oliverson
Public Health
Committee Report (Substituted)
BACKGROUND AND PURPOSE Under current law, Texas requires the commissioner of the Texas Department of State Health Services (DSHS) to annually establish schedules of controlled substances, mirroring federal schedules. The bill author has informed the committee that this annual process often results in delays, preventing timely access to treatments that are newly approved by the FDA and that, after FDA approval, substances currently classified as Schedule I must go through DEA rescheduling and state-level action before becoming accessible to patients. The bill author has further informed the committee that Texans suffering from mental health conditions such as treatment-resistant depression (TRD), major depressive disorder (MDD), and post-traumatic stress disorder (PTSD) need access to fast-acting, effective treatments and that the lengthy process of DEA rescheduling followed by the annual state action to align with the FDA reschedule creates unnecessary delays in access for Texas patients. C.S.H.B. 4813 seeks to address this issue to ensure that Texas law aligns promptly with federal decisions by requiring the commissioner to act as soon as practicable to make the same changes at the state level if a controlled substance is approved for medical use by the FDA, the substance is subsequently deleted as a controlled substance or reschedule and placed on a lower schedule under federal law, and notice of those facts is given to the commissioner. The bill preserves the right of the commissioner of DSHS to object to the designation of a substance as a controlled substance, the rescheduling of a substance, or the deletion of a substance.
CRIMINAL JUSTICE IMPACT It is the committee's opinion that this bill does not expressly create a criminal offense, increase the punishment for an existing criminal offense or category of offenses, or change the eligibility of a person for community supervision, parole, or mandatory supervision.
RULEMAKING AUTHORITY It is the committee's opinion that this bill does not expressly grant any additional rulemaking authority to a state officer, department, agency, or institution.
ANALYSIS C.S.H.B. 4813 amends the Health and Safety Code to require the commissioner of state health services or their designee, if a controlled substance is approved for medical use by the FDA under the Federal Food, Drug, and Cosmetic Act and is subsequently deleted as a controlled substance or rescheduled and placed on a lower schedule under federal law and notice of those facts is given to the commissioner or designee, to similarly delete or reschedule the substance under the Texas Controlled Substances Act as soon as practicable. The bill accordingly makes changes in provisions relating to the establishment and modification of schedules under that act to account for this requirement. C.S.H.B. 4813 applies only to a controlled substance deleted as a controlled substance or rescheduled and placed on a lower schedule under federal law on or after the bill's effective date.
EFFECTIVE DATE September 1, 2025.
COMPARISON OF INTRODUCED AND SUBSTITUTE While C.S.H.B. 4813 may differ from the introduced in minor or nonsubstantive ways, the following summarizes the substantial differences between the introduced and committee substitute versions of the bill. Whereas the introduced required the commissioner of state health services or their designee to, as applicable and under the Texas Controlled Substances Act, delete or reschedule a controlled substance listed in Schedule I of that act approved by the FDA, the substitute requires the commissioner or their designee to do so for a controlled substance approved instead for medical use by the FDA.
BACKGROUND AND PURPOSE
Under current law, Texas requires the commissioner of the Texas Department of State Health Services (DSHS) to annually establish schedules of controlled substances, mirroring federal schedules. The bill author has informed the committee that this annual process often results in delays, preventing timely access to treatments that are newly approved by the FDA and that, after FDA approval, substances currently classified as Schedule I must go through DEA rescheduling and state-level action before becoming accessible to patients. The bill author has further informed the committee that Texans suffering from mental health conditions such as treatment-resistant depression (TRD), major depressive disorder (MDD), and post-traumatic stress disorder (PTSD) need access to fast-acting, effective treatments and that the lengthy process of DEA rescheduling followed by the annual state action to align with the FDA reschedule creates unnecessary delays in access for Texas patients. C.S.H.B. 4813 seeks to address this issue to ensure that Texas law aligns promptly with federal decisions by requiring the commissioner to act as soon as practicable to make the same changes at the state level if a controlled substance is approved for medical use by the FDA, the substance is subsequently deleted as a controlled substance or reschedule and placed on a lower schedule under federal law, and notice of those facts is given to the commissioner. The bill preserves the right of the commissioner of DSHS to object to the designation of a substance as a controlled substance, the rescheduling of a substance, or the deletion of a substance.
CRIMINAL JUSTICE IMPACT
It is the committee's opinion that this bill does not expressly create a criminal offense, increase the punishment for an existing criminal offense or category of offenses, or change the eligibility of a person for community supervision, parole, or mandatory supervision.
RULEMAKING AUTHORITY
It is the committee's opinion that this bill does not expressly grant any additional rulemaking authority to a state officer, department, agency, or institution.
ANALYSIS
C.S.H.B. 4813 amends the Health and Safety Code to require the commissioner of state health services or their designee, if a controlled substance is approved for medical use by the FDA under the Federal Food, Drug, and Cosmetic Act and is subsequently deleted as a controlled substance or rescheduled and placed on a lower schedule under federal law and notice of those facts is given to the commissioner or designee, to similarly delete or reschedule the substance under the Texas Controlled Substances Act as soon as practicable. The bill accordingly makes changes in provisions relating to the establishment and modification of schedules under that act to account for this requirement.
C.S.H.B. 4813 applies only to a controlled substance deleted as a controlled substance or rescheduled and placed on a lower schedule under federal law on or after the bill's effective date.
EFFECTIVE DATE
September 1, 2025.
COMPARISON OF INTRODUCED AND SUBSTITUTE
While C.S.H.B. 4813 may differ from the introduced in minor or nonsubstantive ways, the following summarizes the substantial differences between the introduced and committee substitute versions of the bill.
Whereas the introduced required the commissioner of state health services or their designee to, as applicable and under the Texas Controlled Substances Act, delete or reschedule a controlled substance listed in Schedule I of that act approved by the FDA, the substitute requires the commissioner or their designee to do so for a controlled substance approved instead for medical use by the FDA.