Drug Shortage Compounding Patient Access Act of 2025

Increased Access to Urgent Medications: The bill allows for the compounding and distribution of drug products in limited quantities to licensed prescribers for urgent administration in hospital or clinical settings, provided the drug was on a shortage list within the last 60 days (Section 2(a)(3)).

Improved Shortage Information: The bill expands the definition of drug shortages to include "surges in demand," which may help better identify when a manufacturer cannot meet demand without a shortfall or delay (Section 3).

Enhanced Transparency for Bulk Substances: The Secretary will now be required to make annual updates publicly available regarding the evaluation of bulk drug substances (Section 4).

Clearer Labeling for Individual Patients: The bill updates labeling requirements to specify that a medication was compounded for an individual patient and has not been approved by the FDA (Section 5).

Increased Documentation Burdens for Medical Staff: Licensed pharmacists or physicians must ensure that records identifying patients who received compounded drugs are provided back to them within 7 days of administration or discharge (Section 2(a)(3)(D)).

Mandatory Adverse Event Reporting: Licensed pharmacists or physicians are required to report adverse events associated with compounded drug products to the MedWatch Adverse Event Reporting program as soon as possible, but no later than 15 days after becoming aware of them (Section 2(a)(3)(F)).