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The fda allows the use of symbols in labeling for medical devices and biological products, including the symbol statement “rx only” or “℞ only” for prescription devices (iii) for purposes of paragraph (c) (1) (i) of this section: This final rule specifies the requirements and benefits of using symbols in labeling.
A medical prescription is a formal communication from healthcare professionals to a pharmacist, authorizing them to dispense a specific drug for a specific patient (ii) the use of symbols in device labeling which do not meet the requirements of paragraph (c) (1) (i) of this section renders a device misbranded under section 502 (c) of the act The symbol rx, often used for prescription, comes from the latin word recipe, meaning 'take'.
Rx only means that a medical device is only available with a prescription and should be used under a doctor's guidance
Learn more about the types of devices, prices, and legality of selling medical equipment in the us. I define rx only (with rectangle surrounding it) in the symbols glossary as follows The final rule also permits the use of the symbol statements “rx only” and “℞ only” for prescription devices Use of standalone symbols is optional and manufacturers can still choose to use the adjacent explanatory text.
(f) the symbol statement “rx only” or “℞ only” may be used as provided under § 801.109 (b) (1)
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