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LegitScript Standard #4: Pharmacy Location

Next up in our discussion of LegitScript standards is a seemingly simple, but very important standard.

Standard 4: Pharmacy location. The pharmacy must be domiciled in the United States.

What does it mean?

It may seem self-explanatory, but we’ve actually had a lot of inquiries about this being one of the standards we use to identify safe online pharmacies. LegitScript requires that an online pharmacy’s dispensing pharmacy be physically located within the United States in order to make our “approved” list. This requirement is based on the fact that it is currently against the law to ship prescription drugs into the United States from another country.

Wait, what about the 90-day rule? It’s okay to order from an Internet pharmacy outside of the US, as long as it’s a 90-day supply or less, right?

No. This is one of the fictions that Internet pharmacies outside of the US perpetrate. There is nothing in US federal law that makes this legal.

What does exist is an FDA policy that, in very specific circumstances not involving Internet pharmacies, allows an FDA or Customs agent the discretion to let the drugs through the border. That discretion exists only if all of these conditions are met:

# The drug is for a condition that there is no approved treatment for available in the United States.
# The drug isn’t being advertised to persons residing in the United States.
# The drug doesn’t present an “unreasonable risk.”
# The patient states, in writing, that it is for the patient’s own limited use (usually a 90-day supply or less), and provides the name and address of a doctor licensed in the US that will supervise the patient’s use of the drug (or, if the patient was first prescribed the drug in another country, and is simply continuing treatment).

Many Internet pharmacies have taken this FDA policy and misrepresented it as authorizing a “90-day supply” of prescription drugs from outside of the country. Additionally, Congress limited funds for the FDA to conduct some enforcement activities under this law, but that is different from saying that the import of these drugs is legal.

Does this even apply to Canadian Internet pharmacies?

Yes. Even Canada. This is not to say that drugs from Canada are necessarily inferior to drugs that come from the US: indeed, if you walked into a Canadian pharmacy in person, you would often receive the very same drug you would receive from a US pharmacy. The problem is, many online pharmacies claim to be Canadian when, really, the drugs are being manufactured and shipped from locations across the globe, usually third world countries. (This is unfortunately true for many Canadian Internet pharmacies licensed in Canada selling prescription drugs to US residents.) Since these “Canadian” Internet pharmacies, even if licensed in Canada, are located outside of the United States, the FDA has little or no jurisdiction to ensure that the drugs are genuine and safe, and actually come from the US or from safe sources in Canada. And that’s why it’s not legal.

So Canadian and other foreign pharmacies will never receive LegitScript approval?
As long as the practice is illegal and unregulated, No. However, LegitScript has consistently said that if Congress authorizes the import of prescription drugs from outside of the country, and if the FDA develops a system to ensure the safety and legitimacy of those drugs, we will open up our certification program to include pharmacies that adhere to those laws and safety standards.

The Bottom Line: If an online pharmacy is willing to cut corners with the law to make an extra buck, what makes you think they wouldn’t be willing to cut corners with your safety?

US pharmacies and pharmaceutical manufacturers are held to high standards established by the FDA to protect consumers. When you order from a legitimate, US-based pharmacy, you can be sure the medications you will be putting in your body, for your health, meet these standards. Ordering from pharmacies that intentionally ignore US regulations is a risk that we at LegitScript don’t think is worth taking.