Importing non controlled pharmaceutical products to US from India for commerical sale

[Subhendu12449]

Hi,

I am setting up a business to import pharmaceutical products from India to US for sale via an online telemedicine service. We will have physicans on our team for patient evaluation and writing prescriptions as necessary.

I am not familiar with the rules and regulation. If these are non controlled medicines, what are the rules I need to follow to import from India?

Thanks
Subhendu

 

[GStough]

Have you researched the FDA's website for information? This would be a good place to start.

 

[Subhendu12449]

I did and there was a 90 page PDF that had details and read through it but it’s complicated. Was hoping someone could share the practical aspects

 

[Ed Panek]

If these are drugs intended to treat US Citizens there are probably FDA hurdles to navigate as well as I suspect US Pharmaceutical companies have lobbied to hinder you.

 

[EmiliaBedelia]

If you are not a US based entity, you need an importer/US agent. They would likely be the best source of info as they can advise you on your specific situation. You will need to ensure that the products you are importing are properly registered and approved for sale in the US, regardless of whether they are designated as "controlled" or not.

This site is a good summary of the basics.
Human Drugs Overview for Imported Products
I would highly recommend you take the time to understand the details of import requirements as this involves multiple federal entities (CBP, DEA, FDA) that you do not want negative attention from. You should also be aware of state regulations as (depending on your particular situation) you may need to register in the states you intend to sell in.