Frequently Asked Questions for Out Of State Manufacturers
1. I manufacture drugs, medical devices and/or cosmetics what do I need to do to comply with the State of Connecticut?
2. Is there a fee for registration for an Out of State Manufacturer?
3. What information do I need to provide to the State of Connecticut?
4. Can I use information printed from the Food and Drug Administration (FDA) website to show that I have registered with the FDA?
5. Who should I contact if I have any questions about the Out of State Manufacturer information?
6. Do I have to complete a Wholesaler of Drugs, Medical Devices, or Cosmetic registration?
7. I am a virtual manufacturer. Do I need to register as an Out of State Manufacturer?
8. My company has changed name, address, state, owner, etc is there a fee to make that change?
9. Is there a form to fill out to complete the change of name, address, state, owner, etc?
10. Will the State of Connecticut be sending me a certificate to show that I have registered?
11. Will the State of Connecticut provide a verification for out of state Manufacturers?
12. Does the registration as an out of state Manufacturer expire?
Answer: In order to provide the information that we require, you need to complete our online application. The application requires you to provide the State of Connecticut with a copy of your Food and Drug Administration (FDA) registration and a copy of the registration that you have in the state in which you reside. Any questions can be email to DCP.DrugManufacturers@ct.gov. This application applies to all manufacturers including virtual manufacturers.
Answer: No. There are no fees associated with registering as an Out of State Manufacturer at this time.
Answer: You need to provide the State of Connecticut with a copy of your Food and Drug Administration (FDA) registration and a copy of the registration that you have in the state in which you reside. All of the information must be submitted via our online application. Virtual manufacturer must also complete this application.
Answer: Yes. We understand that the FDA is no longer sending certificates of registration, and we will accept a copy of the information from the FDA website.
Answer: You can email questions to DCP.DrugManufacturers@ct.gov or you can call (860) 713-6065 with any questions that you may have.
Answer: Maybe. If your company distributes products that are exclusively manufactured or repackaged by you or made for you by a contract manufacturer (sent out with your company name on the label) then you would be considered a manufacturer, and a Wholesaler of Drugs, Medical Devices or Cosmetics would not be required. On the other hand, if you distribute another company’s product in any capacity, that does not have your company’s name on it, then you would also be required to register as a wholesaler.
Answer: Yes. You need to register as an Out of State Manufacturer as would the company that is manufacturing the product for you (if they have not done so already). We understand that you may not have a registration with the Food and Drug Administration, please make a note of that when sending in the information.
Answer: No. Please email a formal request of the changes to DCP.DrugManufacturers@ct.gov with both the old information and the new information.
Answer: No. The Department does not currently mail paper licenses. Licenses are sent via email to the primary contact email on file and can be printed on a color printer. Additionally, you can see a copy of the information you have submitted in our online licensing system at www.elicense.ct.gov.
Answer: No. This is an informational filing only. Proof that the company has met the requirements can be found on our website at www.elicense.ct.gov.