Introduction

Since you arrived at the “Reclaim your seized meds” section of the Prescription Justice site, it is likely that you have received a notification from the U.S. Food and Drug Administration (FDA) that your prescription drug order was intercepted (detained or refused) by the FDA or U.S. Customs and Border Patrol.

A new federal law gives the FDA authority to destroy your personally imported medication, but not without notifying you first, and providing you with appropriate due process and opportunity to obtain your prescription drug order.

This section of our site provides you with guidance for responding to the FDA notification, and includes sample letters you may use.

We cannot guarantee that your response will result in a favorable decision to release your medication to you. Then again, the FDA has been known to release detained meds after reasonable correspondence. We encourage and urge you to exercise your rights.

Guidance & Instructions

It is a presentation of evidence to the FDA for arguing that they should release medication that you ordered for personal use, which they detained and are potentially threatening to destroy. It can be presented orally, telephonically, via fax or email, or through the FDA’s electronic system, ITACS. The ITACS system is commonly used by commercial importers, not by people who ordered medications for personal use. We recommend that you first use email to communicate with the FDA and then follow up by telephone

Simply by holding up your medication order, the FDA has not officially taken them away — but it’s planning to unless you argue with them. In its notification, the FDA is telling you that they have intercepted your medication order and will give you some reasons why. They will give you approximately 20 days to argue with them. Until the FDA makes a final decision, you are still the owner of your prescription drug order.

Don’t be fooled by words. The FDA’s notification will likely inform you that your medication “appears” to be misbranded, unapproved, or even adulterated or counterfeit, as their reasons for detaining your prescription order. If ordered from a licensed pharmacy, a drug that is deemed by the FDA as merely appearing to be “misbranded” or “unapproved” is likely to be a genuine, safe and effective medication.

Generally, U.S. law restricts drug importation to medications that are manufactured and labeled in accordance with FDA regulations. There is a strong chance that your imported medication was made in an establishment registered with the FDA but that the drug was not intended by the manufacturer for U.S. distribution. It’s unlikely, however, that it’s labeled exactly as it would be at your local pharmacy.

Many medications imported for personal use may not have been manufactured in a plant that is registered with the FDA. That does not mean that they are not genuine, safe and effective. Many medications sold in pharmacies throughout the world, including Canada, are not made in FDA registered establishments – yet, they are functionally the equivalent of “FDA approved” drugs – even if technically they are not approved by the FDA.

No. It is your RIGHT to do so! Furthermore, we have received expert legal advice and have been informed that no one has ever been prosecuted for importing medication for their own use. Even FDA personnel have attested to this.

If you received a letter from the FDA informing you that they have detained your prescription drug order then they already know you have ordered the medication. It is likely that they have informed you of your rights regarding submitting testimony. Exercise those rights!

If the FDA writes: “The drug appears to be unapproved or misbranded” then you can respond to the extent you know your responses are true:

A. “You assert that the medication I ordered appears to be an unapproved drug as the reason to postpone or deny its importation. Please consider why that is not a legitimate or fair reason. An ‘unapproved’ drug is one that was not manufactured in an FDA registered establishment. I believe that this drug was made in an establishment registered with the FDA.” [Provide any evidence you have to support that statement].

B. “You assert that the medication I ordered appears to be misbranded as the reason to postpone or deny its importation. Please consider why that is not a legitimate or fair reason. A ‘misbranded’ drug is one that does not have adequate directions for use. Since this drug was dispensed to me pursuant to a valid prescription by a licensed practitioner in the U.S., the drug is exempted by FDA regulation from the “adequate directions for use” requirement. [21 U.S. Code §353 (b) (2), CFR 201.100]. Furthermore, I have the benefit of the FDA’s guidelines for adequate directions for use and the drug warnings pertaining to this medication. As evidence, please see the attached label, which is the official FDA-approved U.S. label. I have the requisite information I need to use this medication safely.”

i. Print out and include in your submission the U.S. label for the medication that you have ordered.

ii. Go to this webpage: http://dailymed.nlm.nih.gov/dailymed/index.cfm.

iii. Type in the name of your drug.

iv. Click on the first result.

v. Click on “drug label.”

vi. Print out the first two pages and include them as part of your submission or submit the Web link if you are emailing your testimony.

C. If you know that it was NOT made in an establishment registered with the FDA then you could write: “I believe this drug was made in an establishment registered with the FDA’s counterpart in [NAME THE COUNTRY: CANADA, AUSTRALIA, INDIA, NEW ZEALAND, TURKEY, UK, ETC.] and that it was manufactured under Good Manufacturing Practices such as those that the FDA requires.

Reimported medications are ones manufactured in the United States and then exported to other countries for sale in foreign pharmacies. These drugs are sold by the U.S. manufacturer to foreign wholesalers at prices usually dramatically lower than the U.S. manufacturers charge domestic wholesalers. The FDA may refer to these drugs as “American Goods Returned.” Under most circumstances, these drugs are not permitted for import except by the company that made them. If the FDA alleges that your imported drug was originally made in the USA and therefore subject to refusal because you are not the company that manufactured the drug, we recommend arguing by using the following language:

“You assert that the medication I ordered appears to be reimported as the reason to postpone or deny its importation. [21 U.S. Code § 381 (d)]. Please consider why that is not a legitimate or fair reason.

A ‘reimported’ drug is one that was manufactured in the United States, made under the jurisdiction of the FDA and in compliance with U.S. law. These drugs are clearly approved, safe, and effective, according to the FDA. Also, the manufacturer is clearly registered with the FDA and has listed the U.S. identical version of this drug. Congress never intended Section 801 (d) to apply to individuals buying American-made medications from a foreign pharmacy for their own use. As you know, I am only able to afford this imported medication dispensed by a foreign pharmacy (at much lower prices).”

“The Congressional record on the legislation giving rise to Section 801 (d) focused solely on preventing the re-importation of medication for commercial resale in the United States. I’ve ordered this medication for myself, as evidenced by the quantity and my prescription, and will not distribute it to any other person for any reason.”

You can conclude your testimony by noting the most important points and making a personal appeal for compassion.

Here’s an example:

“The medication I ordered was manufactured in an FDA-registered establishment. Since I have a prescription and a copy of the U.S. label, I have proven that I’m under the care of a licensed practitioner and I know how to use the medication. Moreover, I have ordered the medication from a licensed pharmacy in Canada. Pursuant to the evidence and reasons given above, I believe my testimony overcomes the FDA’s justifications for refusing my medication order and ask that you release it to me. If you don’t then my health may be jeopardized because I can’t afford it locally. Please be compassionate. Imagine if I was a member of your family and could not afford my medication. Depriving me of this medication would go against your stated mission to protect public health.

You can contact me at [YOUR PHONE NUMBER] or reply by email.

Sincerely,

[YOUR NAME]…………………………………………………………………………

You should submit the testimony to the FDA compliance officer who sent it to you, but you may have to take your argument up the chain of command.

The letter you have received will contain an FDA reference number. It may have an official Customs entry number, or it may be an unofficial reference number created by the FDA to get your product into their import compliance system. The letter will also have the FDA compliance officer’s name, address, telephone number, email address and/or fax number. Submit and address your testimony to that person and send it by email. Make clear reference to the Customs entry number or other FDA reference numbers, so the compliance officer can find your shipment in the FDA system. You can copy PJAG if you wish at testimony@pjag.com.

After sending the email, you should call the compliance officer to ensure that he or she has received your testimony. They may say that they have received it and are reviewing it. Make a note of the date that you called and what the officer said in the conversation. We recommend asking for a response by email.

If the compliance officer tells you that your testimony is unsuccessful, DON’T GIVE UP. You should be persistent, but also polite and respectful. You should not accept the compliance officer’s “no.” Ask to be transferred to, and for the name, email, and phone number of, the compliance officer’s supervisor so that you can appeal the compliance officer’s decision. If you get the supervisor on the phone, make your case verbally and/or ask that you be able to email the testimony. If you only obtain the supervisor’s name from the compliance officer then you can go to the following website and locate the supervisor’s direct telephone number and email address and contact that person directly: http://directory.psc.gov/employee.htm.

a) Use the “Begins With” option for last name and first name.

b) Select “FDA” for agency.

c) Type “500” in the box for number of names to return.

You will receive a list of names of FDA employees, alphabetical by last name. Each name is a link to a contact page showing the employee’s name, title, address, telephone, fax and email address.

Email the testimony you initially sent to the compliance officer to the supervisor.

If your medications are released to you then you know you have been successful. If the FDA informs you that your testimony did not succeed then you will not be getting your prescription order. Please let us know what your results were because it will help strengthen our ability to help others.

IF YOUR MEDICATION IS NOT RELEASED THEN CONTACT YOUR HEALTHCARE PROVIDER IMMEDIATELY. YOUR HEALTHCARE PROVIDER MAY BE ABLE TO ASSIST YOU WITH AN ALTERNATIVE MEDICATION AT A LOCAL PHARMACY OR YOU CAN TRY ORDERING FROM ANOTHER FOREIGN PHARMACY IF THAT IS YOUR ONLY OPTION.

IF THE FDA NOTIFIES YOU THAT YOUR MEDICATION ORDER APPEARS TO BE COUNTERFEIT OR ADULTERATED THEN WE RECOMMEND YOU INQUIRE WITH THEM ON WHAT BASIS THEY HAVE MADE THAT DETERMINATION. IF THEY HAVE PROTECTED YOU FROM A COUNTERFEIT OR ADULTERATED MEDICATION THEN YOU SHOULD THANK THE FDA.

Sample Letter – Word Doc.
Sample Letter:
Misbranded and/or Unapproved Meds

If you received a notice concerning Misbranded and/or Unapproved meds, click on the button below, to download a sample response letter.

Sample Letter:
Reimported Meds

If you received a notice concerning Reimported meds, click on the button below, to download a sample response letter.

Sample Letter – Web Form
WEB FORM WORK IN PROGRESS

For now please use the Sample Documents to create your letter to submit testimony to the FDA.