The Maine personal importation law and how this could affect the future legal situation for users of online pharmacies in the United States
The motto of the State of Maine, “Dirigo”, or “I guide/lead” seems to be prophetic in the way the state might lead the whole country to change its drug importation law.
Several years ago, the idea of importing prescription drugs from other countries was heavily debated, but any actual attempts to legalize it were thwarted by the FDA because of the supposed risk of citizens ending up with counterfeit medicines.
Over the past year, however, against a backdrop of extortionate medicine costs, the State of Maine enacted a law that allowed its residents to legally obtain prescription drugs from internet pharmacies in the United Kingdom, Australia and Canada, the State’s close neighbor.
As feared by the pharmaceutical industry, this law in the State of Maine has set a precedent for something larger than itself. In December 13, 2013, a bill called Personal Drug Importation Fairness Act was proposed. The bill would allow American citizens “to buy prescription drugs from countries with a comparable safety standard the US or better, including Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, and countries in the European Union”. A purchase must be accompanied by a valid prescription for a supply not exceeding 90 days and must be dispensed by a licensed pharmacist. The prescription drug must have the same active ingredients, route of administration, and strength as an FDA-approved prescription drug.” (Personal Drug Importation Fairness Act)
Whether the bill passes or becomes a template for individual states to follow, will remain to be seen, but with the current high prices of prescription drugs and many dissatisfied citizens who pay the highest prices for drugs compared to any other country in the world, some kind of change is very likely to come.
Will the lower prices come with a risk of counterfeit drugs? Perhaps the state should create a list of reliable foreign pharmacies or some kind of authentication scheme? Please share your opinions on Pharmacy Reviewer: Maine to Allow Prescription-Drug Imports
What are the legal risks of using online pharmacies?
First of all, it should be said, that buying drugs that are NOT in the controlled substances list of the Drug Enforcement Administration ( Controlled Substances ) and from a valid online pharmacy is normally legal. The question of legality comes when controlled substances are put on the table.
As I have mentioned in my previous posts, the serious regulation of online pharmacies mainly started in 2009, when The Ryan Haight Online Pharmacy Consumer Protection Act was passed.
A quick reminder of what the act implies:
* The Ryan Haight Online Pharmacy Consumer Protection Act requires internet pharmacies to display information about the businesses, pharmacists and physicians associated with the website.
* The Act prohibits the sale of prescription drugs through online pharmacies when the website refers the customer to a doctor who then prescribes medication without seeing the patient. This effectively outlaws telemedicine where scheduled medicines are involved.
* Finally, the Act provides the states with a new enforcement authority that allows the attorney general to shut down any site which violates the law.
The above basically means that any online pharmacy which sells controlled drugs without requiring a prescription, without publishing verifiable contact information is a rogue pharmacy and buying medicine from them is considered illegal.
However, while it is illegal (and there is a risk of scam as well) to buy controlled substances without a prescription, it does not necessarily mean that the customer who got caught purchasing a controlled substance would have to face penalties (which in theory can be up to $250.000 and 5 years in prison).
The Food and Drugs Administration itself have stated that they allow certain shipments if they decide they are not harmful or meant for distribution:
“FDA personnel may use their discretion to allow entry of shipments of violative FDA regulated products when the quantity and purpose are clearly for personal use, and the product does not present an unreasonable risk to the user. Even though all products that appear to be in violation of statutes administered by FDA are subject to refusal, FDA personnel may use their discretion to examine the background, risk, and purpose of the product before making a final decision. Although FDA may use discretion to allow admission of certain violative items, this should not be interpreted as a license to individuals to bring in such shipments.”
That said, the risk of legal action taken against the buyer is still there. Buying really small orders would probably be on the safer side.
For more information about legality of buying medicines online, I would like to recommend this forum thread here: Pharmacy Reviewer Legality of Ordering From Online Pharmacies FAQ, inlcuding ordering from a no prescription required online pharmacy.
Upcoming changes in the legal status of tramadol and how this will affect online pharmacies
Unlike many other opioid analgesics, the popular painkiller tramadol is not scheduled as a controlled substance at the moment by the U.S. Drug Enforcement Administration. However, that looks set to change. Tramdaol might face reclassification this year, when it might be added to the list of schedule IV drugs, according to a DEA statement released in November 2013: http://www.deadiversion.usdoj.gov/fed_regs/rules/2013/fr1104.htm This might go into effect by June 2014. The DEA appears to be planning to follow the pattern set by several states where tramadol is currently controlled. Arkansas, Tennessee, Illinois, New Mexico, Ohio, West Virginia, Kentucky, Wyoming, Mississippi, North Dakota, Oklahoma, and the US military also classify Tramadol as a schedule IV controlled substance.
That means that Tramadol will no longer be widely available online at US-based sites like http://www.RxMegastore.com, or over the counter in the US and UK without a prescription. It might still be available online at international online pharmacies such as http://www.ehealthrx.com, but importing a controlled susbstance without a valid prescription would be illegal so buying tramadol in this way would be risky.
The trend to put tighter controls on Tramadol has been gathering pace for some years now in other countries and it appears to be reaching the tipping point in the USA (and the UK) right now where it will soon be much harder to get.
The change is definitely bad news for many genuine pain sufferers who cannot afford insurance, but need the medicine nevertheless. However, the only solution is ordering Tramadol in higher amounts while it is available.
Change in status of Tramadol is not being done just to upset people. In 2012, in the UK, in England and Wales alone, there were 175 deaths involving Tramadol, although not necessarily as the main cause. (see the link to the discussion on PR’s forum below.) Statistics show that the number of deaths involving Tramadol is on the rise. There are also many other reasons why Tramadol is not a medicine to be taken lightly – it is addictive with withdrawal symptoms possible, it also potentially affects digestion, like any opioid painkiller, and can induce drowsiness.
Genuine pain-sufferers who seriously need to continue using Tramadol might want to look into buying higher amounts of bulk Tramadol before it is too late. There have been shortages of Tramadol in 2013, too, so every day counts for those wanting to buy it.
There has been an interesting discussion on reclassification of Tramadol on the Pharmacy Reviewer forum:
Pharmacy Reviewer (UK – Tramadol faces reclassification after surge in deaths).
Why is it impossible to buy strong painkillers online these days?
For years now it has been increasingly difficult to buy strong painkillers online. The influence of the FDA and DEA on the web is only getting stronger, and means that, with the FDA’s increasingly aggressive stance in particular, previously available medicines are being reclassified as prescription only, for example even the relatively mild opioid painkiller tramadol.
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 is the key US legislation to enforce restrictive measures against online pharmacies.
The full read of the Ryan Haight Act can be read here:
Ryan Haight Online Pharmacy Consumer Protection Act of 2008
* Since 2009, The Ryan Haight Online Pharmacy Consumer Protection Act requires internet pharmacies to display information about the businesses, pharmacists and physicians associated with the website.
* The Act prohibits the sale of prescription drugs through online pharmacies when the website refers the customer to a doctor who then prescribes medication without seeing the patient. This effectively outlaws telemedicine where scheduled medicines are involved.
* Finally, the Act provides the states with a new enforcement authority that allows the attorney general to shut down any site which violates the law.
The effect of the Ryan Haight act today is that is nearly impossible to procure strong painkillers online, as they are all prescription only. A discussion on how was the situation with online pharmacies before the Act can be read on Pharmacy Reviewer forum here:
Pharmacy Reviewer (Buying drugs back in the day)
As of now, the only two options are 1) unreliable or even dangerous email dealers possibly linked to drug cartels in Mexico. 2) So-called “dark web” marketplaces such as the various successor marketplaces to the recently closed Silk Road on the Tor network. Ordering from sources like these could lead to money loss, or even arrest, so this path is not recommended.
The FDA and DEA have effectively achieved their objective of making it almost impossible to buy strong painkillers online and making the most viable route obtaining Rx through face-to-face contact with qualified medical personnel.