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The final rule specifies the requirements and conditions for using symbols in labeling. So, we do not intend to object if a firm uses a combination of the two prescription statements in its labeling. (1) the symbol statement rx only or ℞ only or the statement caution

Federal law restricts this device to sale by or on the order of a ___, the blank to be filled with the word physician, dentist, veterinarian, or with the descriptive designation of any other practitioner licensed by the law of the state in. The symbol statement rx only conveys essentially the same message as the standard regulatory text The final rule also specifies that the use of symbols, accompanied by adjacent explanatory text continues to be permitted

Fda is also revising its prescription device labeling regulations to allow the use of the symbol statement rx only or ℞ only in the labeling for prescription devices.

Prescription device labeling would be allowed to state rx only in place of the currently required legend Federal law restricts this device to sale by or on the order of a [type of licensed practitioner], under guidance currently being drafted, agency staffers say The change, which the fda modernization act allowed for drugs, was advocated for devices in a march 1 citizen petition filed. Some medical devices include a label that reads rx only to indicate that they are only available with a prescription

This label indicates that the item is a prescription item, and that it should only be used under the guidance of a qualified healthcare provider Prescription devices must have a prescription in order to be used properly and be monitored, and the fda oversees them to. While not included in this final rule, the fda will also be revising its prescription device labeling regulations to allow the use of the symbol statement rx only or ℞ only on prescription device labels. Learn how to use symbols in device labeling, including the symbol statement rx only or ℞ only for prescription devices

Find out the requirements and standards for symbols, symbols glossary, and label prominence.

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