Drug Shortage Access: New Rules for Pharmacies and Hospitals
This act aims to improve access to drugs in short supply by allowing pharmacies to compound them in limited quantities for hospitals and other clinical settings. These changes are intended to ensure patients receive urgently needed medications when standard supplies are unavailable, while introducing new labeling and adverse event reporting requirements.
Key points
Pharmacies can compound drugs in limited quantities for hospitals if the drug is on the shortage list and cannot be obtained otherwise.
New labeling requirements for compounded drugs include indicating urgent administration and lack of FDA approval.
Drug manufacturers must report not only manufacturing interruptions but also surges in demand to help prevent shortages.
Increased transparency regarding drug shortages aims to facilitate quicker responses to market deficiencies.
Status:
Introduced
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