TOPIC: US Importation .. Legal or Not ? How to Proceed.

Here is the best, most definitive article I have found so far on the subject.

Short version ... it's technically illegal, but if you're bringing it into the country for your own use they are almost never going to stop you.

From WebMD (runs four short pages, no publication date posted)
www.webmd.com/healthy-aging/features/let...-of-drug-import-laws


The Letter (and Spirit) of Drug Import Laws
It's illegal (nudge, nudge) to buy prescriptions drugs (wink, wink) from other countries.

By Neil Osterweil
WebMD Feature

Let's make this very clear. It's absolutely, unequivocally, without question illegal to reimport into the U.S. prescription drugs that have been exported to other countries, or to bring in substances that are banned under U.S. law, for any reason, except when you've got a prescription and the FDA or customs agents say it's OK, or decide to look the other way.

Get it? Neither do we.

The old adage that "those who love the law and sausages should never watch either one being made" certainly applies to drug policy. But neither the FDA nor the U.S. Department of Homeland Security are necessarily to blame for the confusion.

Burdened by skyrocketing health care costs, consumers, employers, and insurers are looking for ways to save, and one of the most obvious targets is drug costs. Because Canada and most other industrialized nations impose price restrictions and limit what pharmacies can charge for drugs, the cost of a brand-name medication sold in Toronto can be as much as 55% less than what the identical drug is sold for just across Lake Ontario in Rochester, N.Y.

While the practice of reimporting drugs from Canada, Mexico, or other countries is still technically illegal (with the possible exceptions noted below), it is increasingly becoming a custom more honored in the breach than in the observance. The U.S. House of Representatives has passed three versions of bills that would allow consumers to import legal drugs for personal use. A similar measure, known as the Dorgan-Snowe Drug Importation bill, is currently before the Senate.

In the meantime, the mission of the FDA, as always, is to promote and protect the health of Americans. The mission of the U.S. Customs service is to enforce Federal laws and regulations as they pertain to imported substances such as drugs. And here's where the law gets kind of squishy.

Current law says that if Granny decides she can get her heart medications more cheaply in Alberta than in Alabama, she could be busted for either bringing it over the border or having it delivered to her. Does that mean that dear Granny is likely to do a stretch in solitary? Hardly, experts say, because nobody wants to be seen putting the cuffs on elderly pensioners. Also, they'd have to arrest the governments of the states of Wisconsin, Minnesota, Illinois, Vermont, as well as many city governments and private employers who have turned north for lower-cost prescription drugs.

Don't Ask, Don't Tell

When it comes to the importation of drugs from foreign countries, the FDA acts a bit like Captain Renault in Casablanca who tells Rick that "I am shocked, shocked to find that gambling is going on in here!" as he gambles in Rick's club.

Here's how the FDA puts it in a consumer advisory on its web site:

"Don't purchase from foreign web sites at this time because generally it will be illegal to import the drugs bought from these sites, the risks are greater, and there is very little the U.S. government can do if you get ripped off."

And there's the rub: the words "generally" and "at this time." Under current law, stated in an FDA "guidance" paper titled "Coverage of Personal Importations," the importation or interstate shipment of unapproved new drugs is prohibited. The definition of "unapproved" includes "foreign-made versions of U.S. approved drugs that have not received FDA approval to demonstrate they meet the federal requirements for safety and effectiveness. It is the importer's obligation to demonstrate to the FDA that any drugs offered for importation have been approved by FDA."

Under those rules, it appears to be illegal to import into the U.S. the cholesterol-lowering drug Lipitor purchased in Canada, even though the drug is made in Ireland for shipment to both the U.S. and Canada. To make things even more confusing, the FDA guidance cites "circumstances in which FDA may consider exercising enforcement discretion and refrain from taking legal action against illegally imported drugs."

These extenuating circumstances include importing an unapproved drug for a serious condition for which there may be no effective treatment available in the U.S. But the drug can't be marketed to U.S. citizens by distributors of the drug in question, the product can't be considered to "represent an unreasonable risk," and the patient doing the importing has to be ready to affirm in writing that the drug is for his/her own use. The patient also has to be willing to furnish contact details for a physician in the U.S., or provide "evidence that the product is for the continuation of a treatment begun in a foreign country."

To hedge its bets, the FDA cautions that "even if all of the factors noted in the guidance are present, the drugs remain illegal and the FDA may decide that such drugs should be refused entry or seized. The guidance represents the FDA's current thinking regarding the issues of personal importation and is intended only to provide operating guidance for FDA personnel. The guidance does not create any legally enforceable rights for the public; nor does it operate to bind the FDA or the public."

As for the consequences, FDA associate commissioner for planning and policy William Hubbard told the Wall Street Journal in March 2003 that "any party participating in" an import plan in which a health insurer or claims processor helps arrange a purchase in Canada "does so at its own legal risk." The article also quotes Hubbard as saying that "our highest enforcement priority would not be actions against consumers."

"The agency doesn't go after individuals, per se," says Tom McGinnis, PharmD, director of pharmacy affairs for the FDA. "The agency has tended to focus its priorities on people making money from this illegal activity."

McGinnis tells WebMD that the personal importation policy "has been in existence for a long time, probably since the '50s, and that if you read it carefully, only deals with things that are not available in the U.S." McGinnis says that the policy was intended to allow patients with serious, life-threatening conditions who have exhausted all available alternatives in the U.S. to try, under the guidance of their physicians, alternative therapies approved for the condition in other countries.

Anything to Declare?

U.S. Customs, for its part, warns travelers not to assume that medications approved abroad are also legal in the U.S., or that the labeled uses for which a drug is approved elsewhere hold true in the United States. The Customs service also cautions that:

Some medications available only by prescription in the U.S. may be sold over the counter in foreign countries. They could be dangerous to use without medical supervision.
Some drugs that appear to be made in the U.S. may be counterfeits.
It may be a violation of federal or state law to be in possession of some drugs without a prescription from a U.S. physician.
All imported medications must be properly declared to U.S. Customs.

The Customs service warns that "when the type of drug, the quantity, or the combination of various drugs arouse suspicions, U.S. Customs inspectors will ordinarily contact the nearest FDA or DEA [Drug Enforcement Administration] office for advice and will then make a final determination about whether to release or detain the article."

And if all of the above makes perfect sense to you, we'd like to know what you've been taking -- we'd like some, too.

Attention U.S. Visitors!
6/07/16 current update:
There is great information in this topic about accessing reliable, affordable HCV treatment. Things are changing rapidly in a good way. Feel free to contact me at This email address is being protected from spambots. You need JavaScript enabled to view it. for the latest information.
Mike



I ordered my 12 week supply of sof & led from Rachel at Mesochem in mid October. I wired the money, $1916.00, to the company bank on Monday. It was delivered to my door on Friday at 7:30 am. I know of one other person I advised who had the same success. It would be nice to hear about other success or non success stories about getting these life saving APIs into the U.S. It might help those who can't get approval from insurance to make the decision to take matters into their own hands here in the States. I know of many people whose insurance would only approve an 8 week course of Harvoni, but want the added assurance of achieving SVR that comes with the 12 week tx. A $700 investment could give them that peace of mind.
Mike

I carried mine in. MesoChem (Edit: Unknown Chinese APIs of) Sof and Dac already encapsulated and with proper bottles with pharmacy labels and Dr.Freeman's prescription on them. No one at customs asked about any medicine and I didn't say anything at all about it.

I had all the necessary paperwork if it came down to that, but there's not even a line to write in or a box to check that has any questions about pharmaceuticals. The only potentially relevant question on the form is about the value of goods brought into the country.

Last time I was in the office in Hobart, Dr. James told me there were two more Americans on their way.

As far as I know, up until these new trials they were not shipping out of Australia. The little bit I'm aware of the people shipping into the US is what I've read in Greg's blog, and so far I have heard of no failures, though there was some hinting of people ordering from online pharmacies that got scammed. I don't remember the details.

I suspect there are hundreds, maybe thousands of people doing this all on their own and simply not talking about it. But if we weren't talking they wouldn't know how to do it.

I had planned to go to India to get my generic harvoni originally, but then the release date kept being delayed. Five days in India, airfare and expenses, including medical, was going to cost around $7000.00.
During my wait for generic harvoni in India, I ran across Greg and, a couple of days later, Dr. Freeman and fixhepc. That was my "ahaaa" moment. If there was a company that sold pure sofosbuvir and ledipasvir to individuals for a reasonable price, then my awful illness's days were numbered. I would go to the mountain if the mountain wouldn't come to me. So simple after being so hard for so very long. A few exchanged emails, wired some money, bought some digital mg scales and a capsule funnel. Four days later, take your first dose.
Those people at Customs and the FDA are Americans. I firmly believe they are not out to prevent people from getting the life-saving medications they need into the country-right now.
Enough money in the right campaign fund might change that.
Get well folks!
You can do this.

Mike
Day 21: Mesochem sof & led

I understand how Americans might be wondering if the post is a risk I don't get
the worry about customs. Here's why.

Firstly, the postal issue is mainly about fake and illegal drugs, it was never set up to
go after people buying legal drugs with prescriptions.

Secondly, as I have said in prior posts, I lived in the States for a good 20 years in that time
I flew in and out at least one every two months too Europe.

Never once.........in Fact never have I being asked about prescription drugs it was not a subject that came up,
I have asked friends who also travel into the States a lot, they say the same.

What customs guy knows enough to decide you can't take prescription drugs in? None is who.

I just came through US customs yesterday with my prescriptions from Dr. Freeman and filled and in labeled packaging from the pharmacy. Like Khilde said, they didn't ask me about it and I didn't say anything about it. I had them in the bag with other various and numerous medicines I brought from the US just to add a confusion factor. I had all my documentation and a conversation ready to go if I needed it, but it was simply a non event. Sofosbuvir and Daclatasvir for my 2b genotype, popped first ones down the hatch the first day, on my 8th day now and feel fine.

Hey Sir,
I had mine shipped to the US directly from Rachel. I am testing them on myself. My 4 week test is Wednesday. I wonder how many Mesochem batches they have tested down under?
Mike

Thank you very much for posting this article. My friend can't afford the meds so I told her I would pay for them but she's refusing to get them because she doesn't want to "break the law". This article is just what I need to convince her.

Hello Price,
Here is how I did it:

1. Email Rachel at: This email address is being protected from spambots. You need JavaScript enabled to view it.
2. Tell her you are a researcher with a university in your home state
3. Put the university name on the line below your name and above your home address
4. Wire the money to the Mesochem bank account Rachel will furnish
6. Be at home 5 days later to sign for your package
7. Make sure to put the US international code in front of your area code
8. Order AWS digital mg scales from ebay-$20
9. Order "00" profunnel from www.torpac.com
10. Kill those little buggers!

Mike

Thank you Mike, I just have to convince my friend its okay.

I told her if she's not around I would have to take care of her website and the first thing I would do is change it to hot pink.
I'm hoping that will help change her mind.

PP

Hi PP,
Show her this:


This brings me to the next topic, flying to Australia for generic Hepatitis medicines.
Australia is now unique in the 'developed' world because there are three compound chemists now compounding Chinese Hep C APIs into consumable doses. The catch with this is that these pharmacies can only supply the medication to people who have an Australian prescription. The patient does not have to be an Australian citizen or resident but they must have an Australian doctor's prescription.
As a result of this a lot of people from countries where their government obstructs access to generic meds being sent by courier, like Canada and the USA, are now flying to Australia to get see an Australian doctor and then buy their Hep C meds and fly home with them, a totally legal thing to do.
The process is quite simple.
I can supply you with a list of doctors who will prescribe Hep C meds for you and you can make an appointment with one of these doctors, fly to Australia with your most recent test results, see the doctor, get the prescription buy the meds begin treatment (swallow a tablet) and fly home where your own doctor can monitor your treatment.
Ideally you should also bring a letter from your doctor explaining your situation. Even a prescription if you can get one. This makes it all the easier for the Australian doctor.

If you are short of time this process should take less than one week. If you have spare time then stay a couple of weeks and enjoy the natural beauty of Australia.
If you are really pressed for time then you can speed this process up to a 3 night stay by doing it this way:
1. Make an online appointment with GP2U, an Australian online medical consultancy.
2. Meet the doctor online, with reports etc and explain the situation.
3. Get the prescription sent to you by email. (total cost AUD$100)
4. Send an email explaining your situation and attach a scan of the prescription to Sydney Compounding Chemist This email address is being protected from spambots. You need JavaScript enabled to view it.
5. Pay for the meds before you leave your country so they are made up and waiting for you when you arrive.
6. Fly to Australia.
7. Get the meds delivered to where you are staying.
8. Start treatment
9. Fly home.

If you need any more information of this option then just email me at This email address is being protected from spambots. You need JavaScript enabled to view it.

SVR 12 is within easy reach. Get yourself healthy and well... LIVE LIFE

Mike

Hi All,
I was just notified of another success story by a friend I helped guide through the direct importation process.
It is working. We need to find a testing method other than the two legged variety that is affordable,
Mike

Great stuff Mike - you're becoming a one-man ambassador for generics lol


But yeah if you can find an affordable testing method, that should bring the more tentative into the process. Awesome work

For those importing to the US, whether by mail or on their person, as noted by others it helps to have documentation (officials and bureaucrats love cya "documentation").

Prior to getting my meds, I read everything I could on the vague FDA/sustoms mishmash and I came across references to the FDA "Orange Book". I read somewhere that customs officials sometimes consult the Orange Book when they are trying to figure out if a medicine is OK to come in. I looked it up, and the Orange Book lists the generic versions of Daclatasvir and Sofosbuvir, so I printed those out and had them with my medication in case I had to have those conversations.

A link to the Orange book is here: www.accessdata.fda.gov/scripts/cder/ob/
IF you read down a little, theres a search box for the "active ingredient" you want to look up.
If for example, you type in daclatasvir, it brings you to this, a handly little synopsis about generic daklinza: www.accessdata.fda.gov/scripts/cder/ob/docs/tempai.cfm

Here's the one for sofosbuvir: www.accessdata.fda.gov/scripts/cder/ob/docs/tempai.cfm

It might be overkill, but you never know, it might be the extra piece of paper that gets your meds through, I figure it can't hurt to have it traveling with your medication documentation.

Good luck to all on their imports. (Damn, 11 days into medicine and I'm wide awake after onlyl 3 1/2 hours of sleep, there is a definite sleep deprivation side effect going on for me at this point).

Hey 2,
That is some really good info and advice! What I am seeing, is a lot of people really afraid to self-import due to the Customs issue. I know that was MY scariest moment, but nobody, at least that I am personally aware of, has had a shipment detained from Rachel. I figure there are a whole lot of prople reading what we are writing and following our suggestions that never post a thing. Hopefully, they are quietly getting well.
That is a big reason I post. Those people are approaching the process exactly like I did-eyes and ears open, mouth tightly shut. The old "If you don't say anything, nobody will ever know" principle. Maybe some of them have had their package detained and, later, released. Or, its hard to even write this, destroyed.
I really don't think that is happening.
Mike