Prompt Approval of Safe Generic Drugs ActThis bill authorizes the Food and Drug Administration (FDA) to approve certain applications to market a generic drug despite the omission of certain safety information from the generic drug's labeling.Specifically, the FDA may not deem an abbreviated application for approval of a generic drug ineligible for approval solely because the drug's labeling omits safety information that is protected under another drug's patent or exclusivity protections. Similarly, a drug that is approved under this bill may not be considered mislabeled for lacking such safety information.Generally, an abbreviated application, for the purposes of this bill, is one that (1) uses required information from studies not conducted by the applicant; or (2) seeks approval of a drug that is, for drug approval purposes, a duplicate of an already-approved drug (i.e., a generic drug). Currently, the labeling for such a generic drug must generally be identical to that of the already-approved drug. This bill provides an exception to that requirement under the specified circumstances. For any drug approved under this bill, the FDA must require the drug's labeling to include any safety information that is necessary to assure safe use.
Prescription Freedom Act of 2023 This bill generally eliminates the authority of the Food and Drug Administration (FDA) to require that a drug be dispensed only with a prescription. However, the FDA may continue to require a prescription for any drug intended for terminating a pregnancy.
Healthy Technology Act of 2023 This bill establishes that artificial intelligence (AI) or machine learning technology may be eligible to prescribe drugs. Currently, certain drugs may be dispensed only upon a prescription provided by a practitioner licensed by law to administer the drug. Under this bill, an AI or machine learning technology may qualify as such a prescribing practitioner if the technology is (1) authorized by state law to prescribe the drug involved; and (2) approved, cleared, or authorized under certain federal provisions pertaining to medical devices and products.
Healthy Technology Act of 2025 This bill establishes that artificial intelligence (AI) or machine learning technology may be eligible to prescribe drugs.Currently, certain drugs may be dispensed only upon a prescription provided by a practitioner licensed by law to administer the drug. Under this bill, an AI or machine learning technology may qualify as such a prescribing practitioner if the technology is (1) authorized by state law to prescribe the drug involved; and (2) approved, cleared, or authorized under certain federal provisions pertaining to medical devices and products.
Prescription Freedom Act of 2025This bill generally eliminates the authority of the Food and Drug Administration (FDA) to require that a drug be dispensed only with a prescription. However, the FDA may continue to require a prescription for any drug intended for terminating a pregnancy.
Patient Access to Urgent-Use Pharmacy Compounding Act of 2023 This bill relaxes certain requirements for compounding drugs that are facing shortages. Drug compounding is the process of mixing or otherwise altering drugs to create a medication. Currently, the Food and Drug Administration (FDA) allows for drug compounding subject to certain requirements. Generally, a licensed pharmacist or physician not registered with the FDA may only compound drugs in limited quantities for prescriptions for a specific individual patient. On the other hand, an FDA-registered outsourcing facility may compound drugs in bulk for use in medical facilities but is subject to additional requirements. This bill allows a compounder not registered with the FDA to compound drugs in limited quantities for an urgent medical need not involving a specific patient if, among other requirements (1) the prescriber certifies that the prescriber is unable, despite reasonable attempts, to obtain certain related drugs with the same active ingredient and route of administration; (2) the compounded drug meets certain labeling requirements, including an indication that the compounded drug is provided only for urgent administration to a patient; and (3) the compounder requests and maintains certain records about patients receiving the compounded drug. Furthermore, a restriction against an unregistered compounder regularly compounding (or compounding inordinate amounts of) what is essentially a copy of a commercially available drug shall not apply if the drug is on a shortage list maintained by the FDA or the American Society of Hospital Pharmacists.
Nurse practitioners; authorize to dispense legend drugs to patients.
Nurse practitioners; authorize to dispense legend drugs to patients.
Prescription drugs; prohibit licensing boards from prohibiting practitioners from prescribing for off-label use.
Prohibiting certain health insurers from requiring cost-sharing for nonopioid prescription drugs or providing less favorable coverage for such drug than that for opioid or narcotic prescription drugs for the treatment of pain.