A bill to amend the Controlled Substances Act to define currently accepted medical use with severe restrictions, and for other purposes.
Impact
The proposed amendments are significant as they would alter the framework within which certain drugs are classified, potentially easing access for medical professionals to prescribe investigational drugs under strict guidelines. SB689 provides a more structured approach to the classification of substances, which may lead to greater emphasis on medical usage and safety protocols. By defining specific criteria for when a drug can be categorized as having medical use with restrictions, the bill is expected to affect medical practice, particularly in oncology and critical care domains, where novel therapies are often deployed under regulated access conditions.
Summary
SB689 is a legislative proposal aimed at amending the Controlled Substances Act with a focus on redefining what constitutes 'currently accepted medical use with severe restrictions' for certain drugs and substances. This bill introduces a specific definition that includes drugs designated as breakthrough therapies or authorized for expanded access treatment protocols. This change is intended to clarify the status and potential therapeutic uses of investigational drugs under stringent conditions, emphasizing patient access to treatments for serious or life-threatening conditions.
Contention
As with many legislative measures concerning controlled substances, SB689 may elicit debates over the balance between patient access to potentially life-saving treatments and the necessary regulatory oversight to ensure safety. Advocates argue that the bill is a progressive step toward more effective patient care, allowing broader access; however, critics may express concerns about the implications of reducing restrictions on substances that could pose risks to patients if not managed properly. The discourse surrounding SB689 reflects broader societal discussions on drug regulation and healthcare accessibility.
Halt All Lethal Trafficking of Fentanyl Act or the HALT Fentanyl Act This bill places fentanyl-related substances as a class into schedule I of the Controlled Substances Act. A schedule I controlled substance is a drug, substance, or chemical that has a high potential for abuse; has no currently accepted medical value; and is subject to regulatory controls and administrative, civil, and criminal penalties under the Controlled Substances Act. Additionally, the bill establishes a new, alternative registration process for schedule I research that is funded by the Department of Health and Human Services or the Department of Veterans Affairs or that is conducted under an investigative new drug exemption from the Food and Drug Administration. The bill also makes several other changes to registration requirements for conducting research with controlled substances, including permitting a single registration for related research sites in certain circumstances, waiving the requirement for a new inspection in certain situations, and allowing a registered researcher to perform certain manufacturing activities with small quantities of a substance without obtaining a manufacturing registration.
To amend the Controlled Substances Act to authorize pharmacies to deliver certain controlled substances to an administering practitioner in lieu of delivering such substances to the ultimate user, and for other purposes.
Halt All Lethal Trafficking of Fentanyl Act or the HALT Fentanyl Act This bill places fentanyl-related substances as a class into schedule I of the Controlled Substances Act. A schedule I controlled substance is a drug, substance, or chemical that has a high potential for abuse; has no currently accepted medical value; and is subject to regulatory controls and administrative, civil, and criminal penalties under the Controlled Substances Act. Additionally, the bill establishes a new, alternative registration process for schedule I research that is funded by the Department of Health and Human Services or the Department of Veterans Affairs or that is conducted under an investigative new drug exemption from the Food and Drug Administration. The bill also makes several other changes to registration requirements for conducting research with controlled substances, including permitting a single registration for related research sites in certain circumstances, waiving the requirement for a new inspection in certain situations, and allowing a registered researcher to perform certain manufacturing activities with small quantities of a substance without obtaining a manufacturing registration.