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Licensing A 503A pharmacy does Hold a state pharmacy license and answer to the state board A 503A pharmacy does not Hold FDA approval for any product it makes Prescription A 503A pharmacy does Require a valid prescription for a named patient A 503A pharmacy does not Sell to the public or ship without a prescription Ingredients A 503A pharmacy does Use pharmaceutical-grade raw material with a certificate of analysis A 503A pharmacy does not Submit each finished batch to the FDA for review Sterility A 503A pharmacy does Follow USP standards for sterile preparations (USP 797) A 503A pharmacy does not Guarantee the product was tested in clinical trials Inspection A 503A pharmacy does Get inspected by the state board and, at times, the FDA A 503A pharmacy does not Carry FDA sign-off on dose, indication, or labeling So "FDA-registered 503A pharmacy" is a real and meaningful phrase