There is actually a FDA "waiver" process known as a "Humanitarian Device Exemption" for medical devices. The FDA does allow compounding pharmacies [0] to produ

There is actually a FDA "waiver" process known as a "Humanitarian Device Exemption" for medical devices. The FDA does allow compounding pharmacies [0] to produce orphan drugs that are not otherwise available commercially. The big issue with using compounding pharmacies to produce orphan drugs is that these drugs can't be marketed for a specific use. The approval is as much about how the drug is marketed as the drug itself. The reason why the case of Daraprim [1] is so outrageous is that the drug is approved and in production, and the increase is profit for the "marketing" drug company. [0] https://en.wikipedia.org/wiki/Compounding#Regulation_in_the_United_States https://en.wikipedia.org/wiki/Compounding#Regulation_in_the_... [1] https://en.wikipedia.org/wiki/Pyrimethamine https://en.wikipedia.org/wiki/Pyrimethamine