Importing Over-The-Counter drug available overseas which is not available in US

[workplay]

I'm from Georgia, US.

I'm trying to buy an over-the-counter medication readily available in overseas but it is not approved or marketed in United States.

It's not anything remotely related to narcotics, it's a common medication for cough and congestion simply not available in US. The name of the medication is Ambroxol.

I've actually purchased online before but it's rather pricey due to it being only available overseas.

So, I plan on importing 1kg of the medication in powder form from Alibaba directly from a manufacturer. I've made small purchases before without a problem online but I'm wondering if I would have problem with the customs getting a 1kg of white powder which is not FDA approved over-the-counter medication for personal use.

Strictly speaking, the medication is not illegal to purchase or possess. It just lack FDA approval to be marketed in United States.

Any ideas?

 

[TheGeekess]

I'm from Georgia, US.

I'm trying to buy an over-the-counter medication readily available in overseas but it is not approved or marketed in United States.

It's not anything remotely related to narcotics, it's a common medication for cough and congestion simply not available in US. The name of the medication is Ambroxol.

I've actually purchased online before but it's rather pricey due to it being only available overseas.

So, I plan on importing 1kg of the medication in powder form from Alibaba directly from a manufacturer. I've made small purchases before without a problem online but I'm wondering if I would have problem with the customs getting a 1kg of white powder which is not FDA approved over-the-counter medication for personal use.

Strictly speaking, the medication is not illegal to purchase or possess. It just lack FDA approval to be marketed in United States.

Any ideas?

Find a product available in the USA that acts similarly. They're out there. Some are Rx, some are OTC.

 

[workplay]

Find a product available in the USA that acts similarly. They're out there. Some are Rx, some are OTC.

There isn't one. I'm a pharmacist.

I just like to know if I would run into any legal trouble if customs found 1kg of OTC medication not approved by FDA.

My guess is that it would be legal to obtain and possess oversea's OTC medication for personal use but I'm wary about customs since it's gonna be 1kg of powder.

 

[TheGeekess]

There isn't one. I'm a pharmacist.

I just like to know if I would run into any legal trouble if customs found 1kg of OTC medication not approved by FDA.

My guess is that it would be legal to obtain and possess oversea's OTC medication for personal use but I'm wary about customs since it's gonna be 1kg of powder.

For a pharmacist, you seem to lack the basic idea of how the FDA works. You'll end up with ICE, DEA and FDA agents on your doorstep.

 

[OHRoadwarrior]

Generally, the FDA will overlook small quantities of medication illegally imported for personal use. In your situation, the risk is higher due to your license to dispense. I would not try it. I do not think 1kg will be considered personal use.

 

[eerelations]

I don't believe OP is a pharmacist. I also don't believe OP has so many/such bad colds that he personally needs a whole kilo of foreign cold medicine to deal with said colds. I think OP wants to import a kilo of some white powder that's labelled "cold medicine" but really isn't cold medicine and wants to know from us if that'll pass inspection by US Customs.

 

[quincy]

There is no way a pharmacist in the U.S. is not aware of the laws on importing foreign medicines.

 

[Proserpina]

There is no way a pharmacist in the U.S. is not aware of the laws on importing foreign medicines.

And if OP does what s/he is suggesting, he'll won't be a pharmacist for much longer (if he is at all - which I doubt).

 

[workplay]

There is no way a pharmacist in the U.S. is not aware of the laws on importing foreign medicines.

The law we study is for commercial and business entities, not for personal use.

Plus, there are many areas of law that is in the grey area open for interpretation.

 

[TheGeekess]

The law we study is for commercial and business entities, not for personal use.

Plus, there are many areas of law that is in the grey area open for interpretation.

Once again, if you WERE a pharmacist, you would know that this product that is not approved by the FDA is not the only product in the world that IS available in the USA for treatment of what-ever your diagnosis happens to be. (COPD/Emphysema?)

 

[workplay]

Once again, if you WERE a pharmacist, you would know that this product that is not approved by the FDA is not the only product in the world that IS available in the USA for treatment of what-ever your diagnosis happens to be. (COPD/Emphysema?)

I knew this is not approved by FDA and that's the very reason why I started this thread.

This medication is for my dad who has mucous problem. Mucinex which is readily available in US as an expectorant; however, it's not too effective and carries kidney stone risks with prolonged use.

Ambroxol was going to be brought to US long time ago but it was suspected to cause mortality in pediatric population so it did not receive FDA approval.

I'm aware that importation of prescription medication amount is limited for personal use quantity, however I'm not sure how it would apply to Ambroxol since it is not a prescription drug and it's not FDA approved nor is it illegal to purchase or obtain it in US as long as it's not marketed for commercial purposes.

 

[quincy]

I knew this is not approved by FDA and that's the very reason why I started this thread.

This medication is for my dad who has mucous problem. Mucinex which is readily available in US as an expectorant; however, it's not too effective and carries kidney stone risks with prolonged use.

Ambroxol was going to be brought to US long time ago but it was suspected to cause mortality in pediatric population so it did not receive FDA approval.

I'm aware that importation of prescription medication amount is limited for personal use quantity, however I'm not sure how it would apply to Ambroxol since it is not a prescription drug and it's not FDA approved nor is it illegal to purchase or obtain it in US as long as it's not marketed for commercial purposes.

Why don't you contact authorities directly? Tell them you are a pharmacist and you wish to import Ambroxol for the personal use of your father and you are concerned about the risks of importing the quantity you wish to import?

You should not have a problem disclosing these facts to authorities if you have an honest purpose.

An FDA link with some information you might find interesting: http://www.fda.gov/ForIndustry/ImportProgram/ucm173751.htm and see 21 USC Section 331.

As a note: You might want to re-read the laws in Georgia that govern your pharmacist's license.

 

[workplay]

Why don't you contact authorities directly? Tell them you are a pharmacist and you wish to import Ambroxol for the personal use of your father and you are concerned about the risks of importing the quantity you wish to import?

You should not have a problem disclosing these facts to authorities if you have an honest purpose.

An FDA link with some information you might find interesting: http://www.fda.gov/ForIndustry/ImportProgram/ucm173751.htm and see 21 USC Section 331.

As a note: You might want to re-read the laws in Georgia that govern your pharmacist's license.

Thank you for the link. I will be contacting the US customs and FDA directly since this question falls into a grey area of importation vs. medication for personal use policies.

 

[quincy]

Thank you for the link. I will be contacting the US customs and FDA directly since this question falls into a grey area of importation vs. medication for personal use policies.

It is not really a "grey" area but one where, if certain steps are taken prior to importing the drug and certain criteria are met, a person could get approval to import X amount of an unapproved drug for personal use only (or, actually, it is not approval so much as FDA personnel can choose not to take action and the illegal drug will not be confiscated).

However, if you are really a pharmacist, any sort of approval may be hard to come by, especially if the Ambroxol is not for your own personal use but your father's, and if your dad's physician has not personally prescribed Ambroxol as an alternative drug for him to take. And your father will need a physician in the U.S. who will monitor his use of the drug.

Ambroxol is one of the drugs where even the importation of small quantities has been refused by Customs in the past - but it can depend on the country of origin and the manufacturer and various other factors may come into play.

If you read the link I provided, it says, "The importation of drugs that lack FDA approval, whether for personal use or otherwise, violates the [U.S. Federal Food, Drug, and Cosmetic] Act." Unapproved drugs are defined as (sort of circularly) "drugs that lack FDA approval. . .including foreign-made versions of U.S. approved drugs" that are not "manufactured in accordance with or pursuant to an FDA approval." (I think the FDA could use some help from Webster )

At any rate, I think you are smart to contact the FDA and US customs before attempting to import Ambroxol, certainly in the quantity you are looking at.

 

[single317dad]

The law we study is for commercial and business entities, not for personal use.

Plus, there are many areas of law that is in the grey area open for interpretation.

And who interprets those laws? Judges. Arguments on each side are made by attorneys. All that costs money, and happens after you're arrested.

Good luck.