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.
The legislation represents a significant shift in how compounded medications are managed, particularly during shortages. By allowing licensed compounding pharmacists to create limited quantities of certain medications without individual prescriptions, the bill aims to improve healthcare providers' ability to respond quickly to urgent patient needs. This could positively impact patient outcomes in medical settings where time-sensitive treatment is critical. Additionally, it could alleviate the burden on hospitals during periods when certain medications are in short supply.
House Bill 167, known as the Patient Access to Urgent-Use Pharmacy Compounding Act of 2023, aims to amend existing regulations under the Federal Food, Drug, and Cosmetic Act to enhance patient access to compounded medications during times of drug shortages. The bill notably relaxes certain compounding requirements, enabling pharmacists and physicians to compound medications for urgent medical needs without a specific prescription for an individual patient, provided specific conditions are met. This change seeks to address situations where approved drugs may be unavailable due to shortages, thereby expediting patient care in hospitals and clinical settings.
Despite the intended benefits, the bill also raises concerns among stakeholders about potential safety and regulatory issues. Critics argue that loosening the restrictions on compounding could lead to increased risks of medication errors or substandard drugs being produced, given that oversight mechanisms may be diminished. Furthermore, the specific requirements for documenting urgent needs and maintaining records introduce a layer of complexity that may be met with resistance from some healthcare providers. The balance between improving access and ensuring patient safety remains at the forefront of ongoing discussions regarding the bill.