I’m Ready for My So-Called “Vacation”

19 Jul

I’m happy to report that, despite an unusual 94 hour delay, I finally have on hand all the C1 Inhibitor I could possibly need for next week while my doctor is on vacation.

All non-FDA approved “medications” brought into the US must be accompanied by a “Certification of Compliance with FDA Personal Importation Policy” swearing I am an US citizen, were I reside, what potentially fatal disease I have, that the “medication” imported is the only treatment that provides relief, that it is not available for purchase within the US, that it has been available throughout the world for over a decade and has no safety issues, that I’m purchasing it for my own use and will not sell it, that I am not bringing in more than a 3 month supply, and the name and address of the prescribing physician.

When the refrigerated C1 Inhibitor is FedEx’d from Amsterdam, it goes to Memphis, TN, where it has to go through both Customs and FDA review.  The FDA has just instituted a random “FDA EXAM” and, yep, my shipment was randomly pulled for the EXAM.  The HAE Association has a FedEx Representative that takes care of getting our shipments through the two check points and everyone (including me) panicked when it first disappeared during the FDA review.

Every other time I have received C1 INH from overseas, neither the inner or outer boxes have been opened.  Only the packing slips have been opened and verified, so I expected that the FDA EXAM, taking 72 hours instead of a few minutes, would be to open the outer cardboard shipping box and the inner stryofoam packing box to see if there was really C1 INH inside.

Guess what?  No.  Neither box had been opened, but the coolant packing material was certainly nice and warm because it took seven days for them to deliver instead of three (by the time they finished their 72 hour EXAM, they’d missed the last flight out that day, which added another 24 hours)!  The only saving grace is that Lev Pharma is seeking a waiver in Europe to have the requirement to keep the unconstituted C1 INH powder refrigerated and they claim that, as long as you don’t “cook it,” it will be fine.  I’m still pissed at the FDA for the delay, though, if they didn’t do anything “value added” during the delay they caused [pout].

So wish me luck next week that the C1 INH didn’t get “cooked” in an overheated warehouse or FedEx delivery truck (it’s damn hot here in Florida) and that I don’t have any problems doing my own infusions.

I love you all who are keeping tabs on me and sending me healing love and prayers.

Faerie hugz back to all of you,


2 Responses to “I’m Ready for My So-Called “Vacation””

  1. Marvin the Martian July 20, 2008 at 4:11 PM #

    OMG OMG OMG you’re alive! I’m glad! And I’m glad your meds are alive too, despite their delay.

  2. Cheryl July 20, 2008 at 8:44 PM #

    Please let us know how it works out for you hun. Best of luck…..xoxo

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