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A 503B outsourcing facility is a sterile-compounding business registered with the FDA that can make larger batches, including office stock without patient prescriptions.
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Section 503B was added to federal law in 2013 after a deadly outbreak tied to contaminated compounded injections.
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A 503B label signals stronger manufacturing standards, not FDA approval of the medicine inside.
A 503B outsourcing facility is a sterile-compounding business registered with the FDA that can make larger batches, including office stock without patient
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