Legal Issues for US Citizens

MedStore International is one of the increasing number of international online pharmacies found on the Internet. An FDA survey conducted in 2000 estimated there were at that time 300-400 Internet sites selling pharmaceuticals. More recent estimates suggest that the number of such sites has significantly increased. This growth in international online pharmacies is simply a response to consumer demand for the service they provide. Access to a discount prescription drugs!

Use of Discount Online Pharmacy in the U.S.

As the world shrinks through the power of the Internet, the high price of drugs in some countries has come under increased scrutiny. Americans pay more for prescription medicines than citizens of any other country on the planet, but the U.S. also boasts the highest Internet penetration of any country in the world. It not surprising therefore that Americans are using discount online pharmacy more than any other nation on earth in their effort to access a discount prescription drug. They are questioning why they must pay so much more for medicines when discount prescription drugs are so easily accessed through international online pharmacies.

A July 2000 report by Forrester Research predicted that online sales of prescription drugs would rise to $15 billion in the U.S. by 2004. It also forecast that Internet ordering of discount prescription drugs would grow from 1% to 9% of the U.S. pharmaceutical market over the next 3 years.

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U.S. Lawmakers Response to Discount Online Pharmacy

The U.S.A. is the most expensive pharmaceutical market in the world however there are 70 million of its citizens with little or no prescription drug coverage (including 34% of its more vulnerable seniors). Patient Assistance Services estimate there are fully 42 million Americans with absolutely no drug coverage. Yet perversely, because of the health delivery system in the U.S., the price that uninsured individuals or families have to pay for prescriptions is sometimes two and three times more than their insured neighbours?

Aware of the international differences in drug prices and under pressure to make lower priced drugs more readily available to their many needy constituents, Representatives in the Congress and in the Senate have tried to introduce laws that would allow U.S citizens to legally utilise international online pharmacies to purchase discount prescription drugs (see "Recent U.S. Legislative Initiatives Relating To Foreign Drug Imports" below). However on each occasion these proposals have failed to be passed into law because of regulators concerns about consumer safety, the quality of the products that might be imported, and the level of saving that might in fact be achieved after considering the administrative and compliance costs associated with the proposed changes.

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Because attempts at common sense law reform have so far been unsuccessful, many millions of dollars worth of discount prescription drugs purchased from discount online pharmacy are entering the country each year under the FDA's current Mail and Personal Use Import Policy. This policy was first introduced in1988 in response to concerns that certain potentially effective AIDS treatments were available in other countries and not in the U.S. While it was never intended to be a way for patients to bring discount prescription drugs into the country it has led to a dramatic increase in drug imports for personal use from international online pharmacies.

The policy lets patients bring a small amount (i.e. a 90 day supply) of non-FDA approved drugs into the country. Under the policy drugs cannot be imported commercially (i.e.for resale) and patients must affirm in writing that the drug is for personal use and provide the name and address of their physician.

However the FDA admits that because of the huge volume of imports now being sent to the U.S. by international online pharmacies, it is now beyond the ability of Customs and FDA staff to process them. They acknowledge that because of their limited resources it is extremely difficult to detain and refuse entry to mail imports for personal use as they are required to contact anyone importing these personal use shipments in a timely fashion, and give the addressee the opportunity to respond and provide reasons why the drug parcel should be allowed entry. If the addressee does not respond or gives an inadequate response, the parcel must then be returned to the exporter. The time, cost and storage facilities required to follow this procedure are simply not available to FDA officials.

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MedStore International is a discount online pharmacy service that specializes in sourcing and supplying brand name medicines. Customers are able to buy these medicines conveniently online, have them delivered confidentially to their door and make substantial savings!

All of the brand name products offered on the MedStore International site are medicines sourced from developed western countries with highly regarded drug regulatory systems. They are the same medicines found in all the major pharmaceutical markets around the world. The same multinational pharmaceutical companies, applying the same good manufacturing practices, manufacture them. The only difference is the price!

The medicines supplied through our online overseas pharmacies are either brand name medicines manufactured by international pharmaceutical companies who make these products worldwide or are generic products of the highest quality that comply with strict international manufacturing standards. Customers can therefore have confidence that the product they will receive will be of the highest quality.

In response to ongoing requests from regular customers, a select range of generic medicines have been added to the MedStore International site. MedStore International pharmacies source high quality generic products only from pharmaceutical manufacturers that comply with strict international regulatory standards. This means that MedStore International customers have the assurance of receiving products that meet internationally recognised quality standards.

To read more about generic medicines, please click here

To be taken to our catalogue to review products and prices simply click here

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October 1999
The International Prescription Drug Parity Act was introduced to the House to amend the Federal Food, Drug, and Cosmetic Act. This would have allowed American distributors and pharmacists to re-import prescription drugs into the United States as long as the drugs meet strict safety standards. Pharmacists and distributors would have been able to purchase drugs at lower prices and then pass the huge savings along to American consumers.

July 2000
"Amid growing public resentment of high prescription drug prices, the House voted overwhelmingly yesterday to prevent the government from discouraging the purchasing of drugs in Canada or other countries where the medicines are cheaper. The FDA sometimes sends warning letters to those caught doing it".

July 2001
"Under pressure from consumers to rein in sky-high prescription drug prices, the
House of Representatives voted on Wednesday to let Americans import less expensive medicines from Europe and elsewhere by mail order despite opposition from the Bush administration."

October 2001
Medication Equity and Drugs Savings Act II (MEDS II) is passed by Congress. This would have let pharmacists and drug wholesalers re-import FDA approved prescription drugs previously manufactured in the US. The Secretary of Health and Human Services opposed it on the basis that prescription drug safety could not be guaranteed and because any cost savings anticipated would disappear when the compliance costs of implementing this change (documentation, sampling, testing) were considered

July 2002
"The US House of Representatives voted to make it easier for individuals to import low cost prescription drugs from foreign countries for their own use, after rejecting a more sweeping proposal to allow bulk imports by drug wholesalers and pharmacies."

July 2002
"The Senate today approved a proposal that could make it easier for Americans to import prescription drugs from Canada, where drug prices are often lower than in the United States. But the Bush administration said it would not carry out the plan because it would endanger public health."

July 2003
“To…pass their bill providing prescription drug coverage under Medicare – House Republican leaders promised a separate vote on making drug importation legal. They expect the vote next week.”
“…in 2001 the United States imported $14.7 billion worth of brand-name medications from overseas plants. The bill would allow the purchase of reimported drugs as well as medications made in Europe or Canada.”

July 2003
“The U.S. house of representatives early Friday easily approved a bill to allow Americans to import drugs from 25 industrialized nations…where the same medicines often sell at a fraction of their U.S. prices”
http://www.publicbroadcasting.net/wbur/news.newsmain?action=article&ARTICLE_ID=526081

July 2003
“Drugs could be imported -- or reimported if, as is often the case, they were U.S.-manufactured -- from Canada, Australia, Israel, Japan, New Zealand, Switzerland, South Africa, and European Union countries.”
http://www.publicbroadcasting.net/wbur/news.newsmain?action=article&ARTICLE_ID=526081

June 2004
“AARP plans to mobilize its 36 million members, aged 50 and older, to overcome opposition by pharmaceutical companies to a bill to permit drug imports, lowering costs.”
“The Dorgan bill, introduced two months ago, would allow Americans to buy medicines from Canada within 90 days of its becoming law and from the European Union, Australia, New Zealand, Switzerland and Japan within a year.”

January 2006
The new Medicare system introduced in 2006 is seen by many as a 'Bad Deal for Seniors' "At least seniors and the disabled get a good prescription drug benefit, right? Wrong. About 30 percent of beneficiaries will receive substantial help, and that is great. The other 70 percent will receive very little – or actually pay more! First, there’s a large gap in coverage; the government provides no assistance for costs between $2,250 and $5,100. However, you must continue to pay the premium of about $35. This means a person with $5,100 in prescription costs will still pay about $4,020."
stabenow.senate.gov/rx

The countries MedStore International suppliers source their brand name medicines from are those countries identified in the articles above.

FDA's general position: The FDA, due to the current state of their regulations, has taken the position that virtually all shipments of prescription drugs imported from a pharmacy outside the U.S.A. by a U.S. consumer will violate the law.

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