Drug Shortage Compounding Patient Access Act of 2025
- Sponsor
- Rep. Harshbarger, Diana [R-TN-1]
- Committees
- Energy and Commerce Committee (primary)
- Last action
- Sep 11, 2025
Bottom line
The bill aims to enhance patient access to critical medications during drug shortages by providing greater flexibility for compounding pharmacies and improving early warning systems for supply chain disruptions.
What it actually does
This bill amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the ability of licensed pharmacists and physicians to compound drugs for urgent administration to patients during drug shortages. It clarifies the definition of what constitutes an "essentially a copy" drug product, broadens drug shortage reporting requirements for manufacturers to include surges in demand, and makes technical adjustments to regulations for outsourcing facilities.
Proponents argue
Supporters argue that this bill addresses critical gaps in patient access to essential medications, particularly in urgent clinical settings, by allowing compounding pharmacies to more readily supply drugs on the shortage list. They contend that improving reporting mechanisms for manufacturers will provide earlier warnings, enabling proactive measures to mitigate shortages and ultimately improve patient outcomes.
Opponents contend
Critics might raise concerns that expanding compounding flexibility, even for urgent use, could potentially introduce risks to patient safety if not accompanied by sufficiently robust oversight and quality control measures. Some may also argue that increased reporting burdens on manufacturers, especially for predicting 'surges in demand,' could be overly complex or lead to inaccurate data without clear guidelines.
The bill is relatively short and its core provisions are clearly articulated, making it accessible for an informed reader to evaluate its contents within a reasonable timeframe.
Section 2(a)
Expanding Compounding for Urgent Drug Shortage Needs
This provision creates an exception to the general rule that compounded drugs must be made for an identified individual patient based on a valid prescription. It allows licensed pharmacists or physicians to compound drugs in limited quantities for distribution to a licensed prescriber for urgent administration to a patient in a hospital or clinical setting. This is permitted only if the drug is on the FDA's drug shortage list, the prescriber certifies they could not obtain an outsourcing facility product, and specific labeling and adverse event reporting requirements are met.
Supporters argue
Supporters argue this provision is crucial for patient safety and access during critical drug shortages, providing healthcare providers with necessary flexibility to address urgent medical needs when other options are exhausted. It ensures that patients in acute situations are not left without essential medications.
Critics contend
Critics might express concerns that expanding compounding without individual prescriptions could potentially reduce oversight compared to traditional compounding, raising questions about consistent quality and safety standards for these urgently administered drugs. They may also point to the administrative burden of new reporting requirements.
Tradeoffs
The provision navigates the tension between ensuring rapid access to life-saving medications during emergencies and maintaining rigorous regulatory oversight to guarantee drug quality and patient safety. It balances flexibility for providers with new reporting and documentation requirements.
Section 2(b)
Clarifying 'Essentially a Copy' for Compounded Drugs
This section amends the definition of what is considered 'essentially a copy of a commercially available drug product.' It clarifies that this term does not include a drug compounded for an identified individual patient with a 'significant difference' as determined by the prescriber, nor does it include a drug on the shortage list that meets the urgent administration criteria outlined in subsection (a)(3). This prevents such compounded drugs from being subjected to the same strict FDA approval process as commercial products.
Section 3
Expanding Drug Shortage Reporting to Include Surges in Demand
This section amends Section 506C of the FFDCA to significantly broaden drug shortage reporting requirements. Manufacturers must now report not only discontinuances or interruptions in drug manufacturing but also any 'surge in demand' for a drug that they likely cannot meet. It also specifies earlier reporting timelines for these surges and updates the definition of 'drug shortage' to explicitly include periods where demand or projected demand exceeds supply, considering how the drug is prepared or dispensed.
Section 4
Adjustments to Outsourcing Facility Regulations
This section makes several changes to Section 503B of the FFDCA, which governs outsourcing facilities. It extends the look-back period for a drug appearing on the shortage list from 'at the time of' compounding to 'at any time during the 180-day period ending on the date of' compounding. It also removes a specific subclause (IX) related to bulk drug substances and mandates that the Secretary make publicly available annual updates on the evaluation of bulk drug substances for the list maintained under subsection (a)(2)(A)(i).
Section 5
Compounded Drug Labeling and Formulary Reference Updates
This section amends Section 503A of the FFDCA to mandate a specific labeling requirement for compounded drugs. Such drugs must now be labeled with the text: 'This medication has been compounded for dispensing to an individual patient and has not been approved by the Food and Drug Administration.' Additionally, it updates a reference in the Act to include 'National Formulary drug or dietary supplement monograph,' clarifying the scope of substances that can be used in compounding.
Requires the packaging of urgently administered compounded drugs to request that the hospital or clinical setting provide records identifying the patient(s) to whom the drugs were administered within 7 days of administration or discharge.
Section 2(a)(3)(D)(ii)
Why it matters:This is a standard legislative practice for detailed operational requirements, but its administrative impact could be significant.
Case for: Proponents would argue this is essential for patient safety and accountability, allowing compounding pharmacists to link specific compounded products to patient outcomes and facilitate adverse event reporting, thereby improving post-market surveillance.
Case against: Hospitals and clinical settings might argue this imposes a new, potentially burdensome administrative requirement for data collection and sharing, especially within a tight 7-day timeframe, which could divert resources from direct patient care.
Estimated impact: Creates a new administrative burden for hospitals and clinical settings, requiring new data sharing protocols and potentially IT system adjustments.
Amends Section 503B(a)(2)(A)(ii) for outsourcing facilities, changing the condition for compounding a drug on the shortage list from 'appears at the time of' compounding to 'appeared at any time during the 180-day period ending on the date of' compounding.
Section 4(1)
Why it matters:This is a common legislative technique for refining existing statutory language, often understood by specialists but easily missed by general readers.
Case for: Supporters would argue this provides crucial flexibility for outsourcing facilities to respond to drug shortages, as drugs may cycle on and off the shortage list or have lingering supply issues even after being removed. The 180-day look-back period ensures a broader window for addressing these needs.
Case against: Critics might argue that extending the look-back period could allow outsourcing facilities to compound drugs that are no longer in acute shortage, potentially leading to competition with commercial products once supply stabilizes, thereby undermining the market for FDA-approved drugs.
Estimated impact: Broadens the scope for outsourcing facilities to compound drugs that have recently experienced shortages, potentially increasing their role in addressing supply chain vulnerabilities.