Easier Access to Urgent-Use Compounded Medications
New rules aim to make it easier for hospitals and medical facilities to access urgently needed medications prepared individually by pharmacies when approved alternatives are unavailable. This means that in critical situations, patients can receive essential medications more quickly, improving treatment safety and effectiveness.
Key points
Compounded drugs can now be distributed in limited quantities to hospitals and clinics for urgent administration, even without an identified individual patient prescription at the time of compounding.
The prescribing practitioner must certify that reasonable attempts were made to obtain an FDA-approved drug or a drug from an outsourcing facility, but without success.
Packaging of compounded drugs must be marked to indicate urgent use and request patient identification records from the hospital or clinic.
Pharmacies are required to report adverse events associated with these compounded drugs to the FDA's MedWatch program.
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