Ethical and Regulatory Implications of Sourcing Drug X During an FDA-Reported Shortage: 503A vs. 503B Compounding Facilities

Author(s):  Asbill Hayden R, Moore W Mark, Asbill Scott

Issue:  Mar/Apr 2026 - Volume 30, Number 2
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Abstract:  In the case of an FDA shortage of drug X, an injectable medication, the safer route to supply the drug to hospital systems would be through a 503B outsourcing facility. Unlike 503A pharmacies, 503B outsourcing facilities are permitted to compound medications in larger batches and are held to stricter FDA oversight. They must comply with current good manufacturing practices (cGMP), which help ensure the quality of medications intended for broader distribution during drug shortages in hospital systems.

Related Keywords: Drug shortages , FDA regulations

Related Categories: UNITED STATES PHARMACOPEIA CONVENTIONS, FDA

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