How to legally obtain FIASP in the USA

How can you purchase FIASP in the USA?

If you live in the US, FIASP has not yet been approved by the FDA, so it is not available for sale in a US pharmacy. It is, of course, illegal to import non-FDA-approved drugs in the US.

However, the FDA actually has a special “exception” (a tolerance, really) – they will, in general, not enforce their prohibition against someone who imports up to 3 months of a non-FDA-approved drug into the US if:

  • “The drug is for use for a serious condition for which effective treatment is not available in the United States” – FIASP can treat a patient who spikes quickly with other bolus insulins (true for all of us, really…)

  • “There is no commercialization or promotion of the drug to U.S. residents” – true for FIASP

  • “The drug is considered not to represent an unreasonable risk” – likely true for FIASP, since it was approved by Health Canada

  • “The individual importing the drug verifies in writing that it is for his or her own use, and provides contact information for the doctor providing treatment.”

So it seems that, if you can get a letter of medical necessity for it, this would appear to be enough to allow you to import for up to 3 months of FIASP supplies at a time from a Canadian Pharmacy into the US. A prescription is also probably good enough.

The exact FDA FAQ on the subject is here:

End of wiki ---------- comments start here

1 Like