Hardship Program
Regulatory framework for patient access to unregistered medicines.
Overview
Manufacturer program for patients without alternatives.
When Hardship Program applies
Hardship Program is typically used when a patient's treating physician has determined that an FDA-approved or internationally-approved drug is clinically appropriate, but that drug is not registered, not reimbursed, or not available in the patient's country of residence. The pathway provides a legal means to obtain the medicine under physician supervision.
Typical requirements
- Prescription from a licensed physician in the destination country.
- Clinical justification documenting why the requested drug is appropriate for the specific patient.
- Regulatory or institutional approval (requirements vary by country and pathway).
- Chain-of-custody documentation for the drug supply (DSCSA-compliant in the US).
- Patient consent for cross-border import.
How {Reserve Meds} supports Hardship Program
We help the treating physician prepare the clinical justification, navigate destination-country regulatory filings, source the drug through DSCSA-compliant US wholesaler channels, and ship cold-chain where required. We do not replace the physician; we coordinate the supply side so the physician can focus on patient care.
Risks and considerations
Patients and physicians should understand that pathway requirements vary by country, that approvals can take days to weeks, that drug pricing is not typically reimbursed under national insurance, and that manufacturer allocation or shortage can affect supply. We will be transparent about these factors upfront.