The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
FDA Alternative to Certain Prescription Device Labeling Requirements
The guidance for industry addressess manufacturers, repackers, relabelers, and distributors of prescription devices which may wish to use the same symbol statement “Rx only” as an alternative to the prescription labeling requirements, under sec.801.109.