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 I receive confirmation when I complete a License Maintenance submission?
11. How do I change the email address on the eLicense account if I do not have access to the email address associated with the account?
12. Will the State of Connecticut be sending me a certificate to show that I have registered?
13. Will the State of Connecticut provide a verification for out of state Manufacturers?
14. Does the registration as an out of state Manufacturer expire?

Question 1: I manufacture drugs, medical devices and/or cosmetics. What do I need to do to comply with the State of Connecticut?

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 or country in which you reside. Confirmation of your business registration with the Connecticut Secretary of the State is also required. Any questions can be email to DCP.DrugManufacturers@ct.gov. This application applies to all manufacturers including virtual manufacturers. It is the responsibility of the virtual manufacturers to obtain a manufacturer's license. The application will not be considered complete until this information is provided.

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Question 2: Is there a fee for registration for an Out of State Manufacturer?

Answer:   No.  There are no fees associated with registering as an Out of State Manufacturer at this time.

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Question 3:  What information do I need to provide to the State of Connecticut?

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 or country in which you reside. Confirmation of your business registration with the Connecticut Secretary of State is also required. All of the information must be submitted via our online application. Virtual manufacturers must also complete this application. It is the responsibility of the virtual manufacturer to see that their contract manufacturers obtain a manufacturer's license. The application will not be considered complete until this information is provided.

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Question 4:  Can I use information printed from the Food and Drug Administration (FDA) website to show that I have registered with the FDA?

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.

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Question 5:  Who should I contact if I have any questions about the Out of State Manufacturer information?

Answer:   You can email questions to DCP.DrugManufacturers@ct.gov or you can call (860) 713-6065 with any questions that you may have.

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Question 6:  Do I have to complete a Wholesaler of Drugs, Medical Devices, or Cosmetic registration?

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.

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Question 7:  I am a virtual manufacturer. Do I need to register as an Out of State Manufacturer?

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. It is the responsibility of the virtual manufacturer to see that their contract manufacturers obtain a manufacturer's license. The application will not be considered complete until this information is provided.

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Question 8:  My company has changed name, address, state, owner, etc. Is there a fee to make that change?

Answer:   No.

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Question 9:  Is there a form to fill out to complete the change of name, address, state, owner, etc.?

Answer:   No. Please sign in to the eLicense account associated with the license, under the Online Services, select License Maintenance. Please report any changes within 30 days. If you need assistance with the User ID & Password, please email  DCP.DrugManufacturers@ct.gov  and include the license number for which you are requesting the User ID & Password.

Question 10:  Will I receive confirmation when I complete a License Maintenance submission?

Answer:  Yes. When completed through your eLicense account, you will receive an email with confirmation we have receive it, shortly after your submission. if there are issues or questions with your submission we will contact you. Please note, the confirmation will be sent to the email address on file with the eLicense account. 

Questions 11: How do I change the email address on the eLicense account if I do not have access to the email address associated with the account?

Answer: You can email a request to DCP.DrugManufacturers@ct.gov  to request the email address be updated. please be sure to include the license number, and the email address with which you would like the account be updated. 

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Question 12:  Will the State of Connecticut be mailing me a certificate to show that I have registered?

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.

Questions 13: Will the State of Connecticut provide a verification for out of state Manufacturers?

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.

Questions 14: Does the registration as an out of state Manufacturer expire?

Answer: No.

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