Regulatory Open Forum

Our 3P distributor in Puerto Rico has requested copies of DEA Controlled Substances licenses for our manufacturing sites.  We've provided for our US sites, but PR thinks we also need to provide for our foreign contract manufacturing sites.  I did not think foreign sites required a DEA license – we have provided a license issued by MHRA but PR does not believe that is acceptable. Our foreign CMO has said they do not have a DEA license and we have not had any issues importing into the US the past 5 years.  Thinks makes me think they are not required to have a DEA license. I'm hoping someone can clarify whether foreign manufacturing sites require a DEA license in order to import a Controlled Substance into the US.  A reference would also be greatly appreciated.

Thank you

Tom

Chicago

Our 3P distributor in Puerto Rico has requested copies of DEA Controlled Substances licenses for our manufacturing sites.  We've provided for our US sites, but PR thinks we also need to provide for our foreign contract manufacturing sites.  I did not think foreign sites required a DEA license – we have provided a license issued by MHRA but PR does not believe that is acceptable. Our foreign CMO has said they do not have a DEA license and we have not had any issues importing into the US the past 5 years.  Thinks makes me think they are not required to have a DEA license. I'm hoping someone can clarify whether foreign manufacturing sites require a DEA license in order to import a Controlled Substance into the US.  A reference would also be greatly appreciated.

Thank you

Tom

Chicago

Thank you David.  I may not have been clear in my question. The foreign site I was referring to is in the UK. Our PR distributor is asking for a DEA License for the UK facility.  So my question is; would the UK site be required to have a DEA license? The UK facility does not currently have DEA license (only a MHRA license) and has been manufacturing our product for the US for over 5 years now. This makes me think foreign sites do not require DEA licensing, but I'm trying to find a reference to provide to PR that supports foreign this.

Tom