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Frequently Asked Questions for Wholesalers of Drugs, Medical Devices and/or Cosmetics Within the State of Connecticut

  1. When is a registration required for a Wholesaler of Drugs, Medical Devices and/or Cosmetics?
  2. My wholesaler/distributor business is not located in Connecticut, but I plan on shipping drugs, medical devices and/or cosmetics into Connecticut. Am I required to register as a Wholesaler of Drugs, Medical Devices and/or Cosmetics?
  3. Do I need to register each location where I do business as a Wholesaler of Drugs, Medical Devices and/or Cosmetics within the State of Connecticut?
  4. What do I need to do in order to be a wholesaler of controlled substances in the State of Connecticut?
  5. Will I need to be inspected prior to obtaining a Wholesaler of Drugs, Medical Devices and/or Cosmetics registration?
  6. Is there any reporting requirement for the State of Connecticut regarding what products have been wholesaled and to whom they have been sold?
  7. What are the record keeping requirements for a Wholesaler of Drugs, Medical Devices and/or Cosmetics registration?
  8. What registration do I need if I distribute liquid oxygen or concentrators?
  9. What registration do I need if I distribute durable medical equipment (DME) and/or diabetic testing supplies to consumers within the State of Connecticut based on a medical order or prescription?
  10. How long does it take to obtain a registration for a Wholesaler of Drugs, Medical Devices and/or Cosmetics?
  11. What do I need to do if I want to change the address on my Wholesaler of Drugs, Medical Devices and/or Cosmetics registration?
  12. What should I do if I want change the types of products that I distribute in the State of Connecticut?
  13. Is there a fee to change the types of products that I distribute in the State of Connecticut?
  14. What should I do if I have a change of ownership for my Wholesaler of Drugs, Medical Devices and/or Cosmetics registration?
  15. Is there a fee for a submitting change of ownership documentation?
  16. What should I do if there is a change in the organizational structure for my Wholesaler of Drugs, Medical Devices and/or Cosmetics registration?
  17. Is there a fee for submitting a change in the organization structure for my Wholesaler of Drugs, Medical Devices and/or Cosmetics registration?
  18. What should I do if there is a change in principal officers of my company and I have a Wholesaler of Drugs, Medical Devices and/or Cosmetics registration?
  19. How often should I expect to be inspected as Wholesaler of Drugs, Medical Devices and/or cosmetics?
  20. What should I do if another state is requesting a copy of my most recent inspection?
  21. Do I need to register as a Wholesaler of Drugs, Medical Devices and/or Cosmetics with the State of Connecticut if I am a broker or facilitate the distribution of Drugs, Medical Devices or Cosmetics by drop shipment?
  22. How do I renew my Wholesaler of Drugs, Medical Devices and/or Cosmetics registration?

Question 1: When is a registration required for a Wholesaler of Drugs, Medical Devices and/or Cosmetics?

Answer: This registration is required for businesses that supply controlled substances, legend drugs, over-the-counter drugs, medical devices (legend or non-legend), or cosmetics to other wholesalers, manufacturers, prescribing practitioners, hospitals, pharmacies, grocery stores, gas stations, convenience stores, etc. There are instances where companies that accept a prescription for legend and non-legend products are required to obtain this registration please see questions below.

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Question 2: My wholesaler/distributor business is not located in Connecticut, but I plan on shipping drugs, medical devices and/or cosmetics into Connecticut. Am I required to register as a Wholesaler of Drugs, Medical Devices and/or Cosmetics?

Answer: Yes, whether you are located within Connecticut or in another state, if your business plans on shipping drugs, medical devices and/or cosmetics within or into the State of Connecticut, you are required to be properly registered with a Wholesaler of Drugs, Medical Devices and/or Cosmetics registration. Please see the Frequently Asked Questions for Out of State Wholesalers of Drugs, Medical Devices and/or Cosmetics.  If you distribute over-the-counter medications (not requiring a prescription) directly to consumers you would need a Non-Legend Drug Permit.

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Question 3: Do I need to register each location where I do business as a Wholesaler of Drugs, Medical Devices and/or Cosmetics within the State of Connecticut?

Answer: Effective June 2013 All Locations Which Store for Distribution Drugs, Medical Devices and/or Cosmetics within and outside the State of Connecticut Must Be Separately Registered.  Please complete a separate application for each location.

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Question 4: What do I need to do in order to be a wholesaler of controlled substances in the State of Connecticut?

Answer: In order to be a Wholesaler of Drugs, Medical Devices and/or Cosmetics you need to accurately complete the application on our website and submit it with the appropriate fee. Your location(s) are subject to an inspection prior to being approved to distribute drugs, medical devices and or cosmetics from your location(s).  The application can be found here http://www.ct.gov/dcp/cwp/view.asp?a=1620&q=512124.  

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Question 5: Will I need to be inspected prior to obtaining a Wholesaler of Drugs, Medical Devices and/or Cosmetics registration?

Answer: Yes. The location(s) that you register will be subject to inspection prior to being approved to distribute drugs, medical devices and/or cosmetics.

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Question 6: Is there any reporting requirement for the State of Connecticut regarding what products have been wholesaled and to whom they have been sold?

Answer: Not at this time however records need to be made available for inspection/review at reasonable times in a reasonable manner.

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Question 7: What are the record keeping requirements for a Wholesaler of Drugs, Medical Devices and/or Cosmetics registration?

Answer: A Wholesaler of Drugs, Medical Devices and/or Cosmetics is required to maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of drugs, medical devices and/or cosmetics.

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Question 8: What registration do I need if I distribute liquid oxygen or concentrators?

Answer: In the State of Connecticut, Oxygen is considered a prescription drug and therefore a company that distributes oxygen to patients, health care facilities, hospitals, pharmacies, etc., would be required to maintain a Wholesaler of Drugs, Medical Devices, and/or Cosmetics registration. (Note: If you trans fill oxygen from one storage tank to another you would also be required to maintain a Manufacturer of Drugs, Medical Devices, and/or Cosmetics registration.)

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Question 9: What registration do I need if I distribute durable medical equipment (DME) and/or diabetic testing supplies to consumers within the State of Connecticut based on a medical order or prescription?

Answer: The State of Connecticut requires a Wholesaler of Drugs, Medical Devices and/or Cosmetics for distribution of durable medical equipment (DME) when the facility accepts a prescription or order of a practitioner.

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Question 10: How long does it take to obtain a registration for a Wholesaler of Drugs, Medical Devices and/or Cosmetics?

Answer: In general, the process takes approximately thirty (30) days but much of that depends on the condition of your facility. Once you have sent in your application, you can track it on our website www.elicense.ct.gov. It is important to make sure that you provide a contact phone number that is accurate so that the Drug Control Agent assigned your inspection can contact you to schedule the inspection.  If you have any questions about the inspection they should be emailed to DCP.DrugWholesalers@ct.gov.  

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Question 11: What do I need to do if I want to change the address on my Wholesaler of Drugs, Medical Devices and/or Cosmetics registration?

Answer: You are required to notify the Department of Consumer Protection, Drug Control Division within 30 days regarding a change of address. To change the address of your Wholesaler of Drugs, Medical Devices and/or Cosmetics registration you should send an email to DCP.DrugWholesalers@ct.gov and include your registration number and explain that you would like to change locations in the email. You should also provide the old address, new address and a contact phone number so that a Drug Control Agent can contact you regarding inspection of your new location. You can also call 860-713-6065 to request the change of address however email is the preferred method of communication. Please keep in mind that you cannot store product at the new location until an inspection has been completed and the address on your license has been changed.  

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Question 12: What should I do if I want change the types of products that I distribute in the State of Connecticut?

Answer: You are required to notify the Department of Consumer Protection, Drug Control Division within 30 days regarding a change in the types of products distributed. Send an email to DCP.DrugWholesalers@ct.gov detailing the change and please include your license number in the email only if you are making changes that do not include controlled substances. If you are adding controlled substances, your facility will be required to have an inspection prior to the changes being approved and there is an additional fee.  Please send a letter detailing the changes that you would like to make, your registration number, address, a contact name and phone number, and an approximate timeline for when you intend to be ready for an inspection.  The additional fee can be calculated by taking the difference of the non-controlled substance fee and the controlled substance fee. (Please note that if you intend to add controlled substances you will also be required to contact the Drug Enforcement Administration (DEA) as well.)

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Question 13: Is there a fee to change the types of products that I distribute in the State of Connecticut?

Answer: Yes, if you are adding controlled substances to the list of products that you wholesale. For all other products, there is currently no fee associated.

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Question 14: What should I do if I have a change of ownership for my Wholesaler of Drugs, Medical Devices and/or Cosmetics registration?

Answer: You are required to notify the Department of Consumer Protection, Drug Control Division within 30 days of a change of ownership. An inspection is required for any change of ownership of a Wholesaler of Drugs, Medical Devices and/or Cosmetics registration.

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Question 15: Is there a fee for a submitting change of ownership documentation?

Answer: Not at this time.

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Question 16: What should I do if there is a change in the organizational structure for my Wholesaler of Drugs, Medical Devices and/or Cosmetics registration?

Answer: You are required to notify the Department of Consumer Protection, Drug Control Division within 30 days of a change in organizational structure. Submit an email to DCP.DrugWholesalers@ct.gov detailing the change and the effective date. In the email please be sure to include your license number and a new list of officers of the company if applicable.

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Question 17: Is there a fee for submitting a change in the organization structure for my Wholesaler of Drugs, Medical Devices and/or Cosmetics registration?

Answer: Not at his time.

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Question 18: What should I do if there is a change in principal officers of my company and I have a Wholesaler of Drugs, Medical Devices and/or Cosmetics registration?

Answer: Send an email to DCP.DrugWholesalers@ct.gov with the information detailing the changes within 30 days of the change.

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Question 19: How often should I expect to be inspected as Wholesaler of Drugs, Medical Devices and/or cosmetics?

Answer: There is no specific inspection schedule for a Wholesaler of Drugs, Medical Devices, and/or Cosmetics in the State of Connecticut. However, Connecticut law requires that Inventories, records and facilities shall be made available for inspection during normal business hours. Inventories and records must be maintained for a period of 3 years following disposition of the drugs.  

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Question 20: What should I do if another state is requesting a copy of my most recent inspection?

Answer: Contact the Department of Consumer Protection, Drug Control Division via email at DCP.DrugWholesalers@ct.gov and request a copy of your most recent inspection. Please be sure to provide your registration number in the email to help us expedite our response to you. If the State is requesting a more current inspection, please contact our office at the same email address above and request an inspection.

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Question 21: Do I need to register as a Wholesaler of Drugs, Medical Devices and/or Cosmetics with the State of Connecticut if I am a broker or facilitate the distribution of Drugs, Medical Devices or Cosmetics by drop shipment?

Answer: Yes you would need to register as a Wholesaler of Drugs, Medical Devices, and/or Cosmetics.

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Question 22: How do I renew my Wholesaler of Drugs, Medical Devices and/or Cosmetics registration?

Answer: Approximately 30-45 days prior to the expiration, you will be mailed a renewal document. The document will provide you with instructions, a user name and password to renew online or you can mail in the document with the appropriate fee.

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