Non-public use: almost no worries. Public use:
worries.
Nurtec ODT is about the letter "D" in "The FDA". The K.K. story is pretty common and usually scrutinized by Health Authorities (not only by "F" or "D" function) in all countries I have been working as an HCP. Kindly note that the FDA regulates the approval of (medical) products, not the practice. So, HCPs are primarily responsible for determining appropriate off-label uses in individual situations. However, off-label use is an increasing concern, and the FDA is still working on a draft SIUU. It's interesting to see that the FDA is working on this in the US. While in many other countries, the same stories are usually with other health agencies eq. to (US) NIH or HRSA.
