Drug Shortage Compounding Patient Access Act of 2025
Summary
The Drug Shortage Compounding Patient Access Act of 2025 aims to amend the Federal Food, Drug, and Cosmetic Act to improve patient access to compounded medications during drug shortages and urgent medical needs. It addresses compounding pharmacy regulations, drug shortage reporting, and outsourcing facility operations. The bill seeks to ensure that patients can receive necessary medications when commercially available options are limited or unavailable.
Expected Effects
This act will likely expand the role of compounding pharmacies in providing medications during shortages. It will also require manufacturers to provide earlier and more comprehensive notifications of potential drug shortages or surges in demand. These changes could lead to more consistent access to needed medications for patients, but also introduce new regulatory requirements for pharmacies and manufacturers.
Potential Benefits
- Improved access to medications during drug shortages.
- Greater flexibility for compounding pharmacies to address urgent patient needs.
- Enhanced reporting requirements for manufacturers to predict and mitigate shortages.
- Clearer definitions and labeling requirements for compounded drugs.
- Public availability of evaluations of bulk drug substances.
Most Benefited Areas:
Potential Disadvantages
- Potential for increased regulatory burden on compounding pharmacies.
- Risk of adverse events associated with compounded drugs if not properly monitored.
- Possible increased costs associated with reporting and compliance.
- May not fully address the underlying causes of drug shortages.
- Could create confusion if labeling is not consistently applied.
Constitutional Alignment
The bill aligns with the Constitution's general welfare clause (Preamble) by aiming to improve public health through better access to medications. Congress's authority to regulate interstate commerce (Article I, Section 8) provides the basis for regulating drug manufacturing, compounding, and distribution. The bill does not appear to infringe on any specific individual rights or freedoms outlined in the Bill of Rights.
Impact Assessment: Things You Care About ⓘ
This action has been evaluated across 19 key areas that matter to you. Scores range from 1 (highly disadvantageous) to 5 (highly beneficial).