We ordered Deflazacort for our son nearly a month ago from Masters in the UK and hadn't received it. Got a letter today from the US FDA at the Los Angeles Port of Entry saying the shipment is being detained and is "subject to refusal of admission into the US due to it being an unapproved new drug."

They give the following link as an explanation and a list of exceptions:

http://www.fda.gov/aboutfda/transparency/basics/ucm194904.htm

FDA, however, has a policy explaining that it typically does not object to personal imports of drugs that FDA has not approved under certain circumstances, including the following situation:

  • The drug is for use for a serious condition for which effective treatment is not available in the United States;
  • There is no commercialization or promotion of the drug to U.S. residents;
  • The drug is considered not to represent an unreasonable risk;
  • 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 or shows the product is for the continuation of treatment begun in a foreign country; and
  • Generally, not more than a 3-month supply of the drug is imported.

Seems like we meet most of the exceptions.

Anyone else had this happen yet? They give instructions on how to appeal, so I'll post back with the results.

Shawn

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Have not had any issues and we just received a shipment in April. I thought I also read in the recent edition of Quest Magazine (MDA) that they are trying to fast track deflazacort for approval in the US.  (I don't think I read that incorrectly, but will double check).

Was finally able to reach someone at the FDA and had to provide a letter from our neurologist stating the condition and why we needed the medicine. Also needed to send them the Rx before they would release it. Still haven't gotten it though.

Shawn

please can you tell me from where did you order the deflazacort??? as i m in Egypt and i need to get for my son urgently.

thanks 


Dear Sir,

We purchase Deflazacort from Masters Pharmaceuticals. The company is located in England.

Here is the website:  http://www.masters-uk.com/medicines/home.php

The international phone number is 011) 44.208.327.3169 / (011) 44.208.327.0900

My family and I have prayed that your son will receive this necessary drug as soon as possible. God speed as you continue to travel this journey. 

thank you so much sir

We ordered from Masters in UK for over 5 years and never once had a problem. Now we are in trial for Deflazacort through Marathon Pharmaceuticals. You can check the AccessDMD site and see if that trial is anywhere near you.


 Thanks Susan! We had looked into that program and brought it up to our neuromuscular doc (at Cincinnati Children's Hospital in Cincinnati, Ohio). She is not recommending it to her patients, for various reasons. From what my husband and I understand from PPMD and the MDA, Deflazacort is due to become FDA approved within the next year.

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