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Patient Access to Urgent-Use Pharmacy Compounding Act of 2023
1/26/2024, 8:15 AM
Summary of Bill HR 167
The bill seeks to streamline the process for healthcare providers to access compounded medications in urgent situations, such as when a patient has a severe allergy or other medical condition that requires immediate treatment. It would allow healthcare providers to obtain compounded medications from pharmacies without having to go through the usual lengthy approval process.
The bill also includes provisions to ensure the safety and quality of compounded medications, such as requiring pharmacies to comply with certain standards and regulations. This is important to protect patients from receiving substandard or unsafe medications. Overall, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2023 aims to improve patient access to necessary medications in urgent situations while also ensuring the safety and quality of those medications. It is an important piece of legislation that seeks to balance the needs of patients with the need for proper regulation in the healthcare industry.
Congressional Summary of HR 167
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.
