(a) A drug or device that is subject to Section 111470 is misbranded if at any time prior to dispensing, its label fails to bear the statement “Caution: federal law prohibits dispensing without prescription,” or “Caution: state law prohibits dispensing without prescription,” or “R x only.” A drug or device to which Section 111470 does not apply is misbranded if at any time prior to dispensing its label bears the caution statement or “R x only” quoted in the preceding sentence.
(b) A device that is subject to Section 111470 is misbranded if, at any time prior to dispensing, its label fails to bear the statement “Caution: federal law restricts this device to sale by or on the order of a ____ ,” the blank to be filled in with the designation of the practitioner licensed to use or order use of the device. A device to which Section 111470 does not apply is misbranded if, at any time prior to dispensing, its label bears the caution statement quoted in the preceding sentence.