(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 âCaution: federal law prohibits dispensing without prescription,â or âCaution: state law prohibits dispensing without prescription,â or âR x only.â 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 âR x onlyâ 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 âCaution: federal law restricts this device to sale by or on the order of a ____ ,â 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.
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