Frequently Asked Questions for Wholesalers Outside the State of Connecticut
- When is a registration required for a Wholesaler of Drugs, Medical Devices and/or Cosmetics?
- When I distribute product into the State of Connecticut from multiple facilities, do I need to register each location as a Wholesaler of Drugs, Medical Devices and/or Cosmetics?
- What do I need to do in order to be a wholesaler of controlled substances in the State of Connecticut?
- Will I need to be inspected prior to obtaining a Wholesaler of Drugs, Medical Devices and/or Cosmetics registration?
- Is there any reporting requirement for the State of Connecticut regarding what products have been wholesaled and to whom they have been sold?
- What are the record keeping requirements for a Wholesaler of Drugs, Medical Devices and/or Cosmetics registration?
- What registration do I need if I distribute liquid oxygen or concentrators into the State of Connecticut?
- 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?
- How long does it take to obtain a registration for a Wholesaler of Drugs, Medical Devices and/or Cosmetics?
- What do I need to do if I want to change the address on my Wholesaler of Drugs, Medical Devices and/or Cosmetics registration?
- What should I do if I want to change the types of products that I distribute in the State of Connecticut on my Wholesaler of Drugs, Medical Devices, and/or Cosmetics Registration?
- Is there a fee to change the types of products that I distribute in the State of Connecticut?
- What should I do if I have a change of ownership for my Wholesaler of Drugs, Medical Devices and/or Cosmetics registration?
- Is there a fee for a submitting change of ownership documentation?
- What should I do if there is a change in the organizational structure for my Wholesaler of Drugs, Medical Devices and/or Cosmetics registration?
- Is there a fee for submitting a change in the organizational structure for my Wholesaler of Drugs, Medical Devices and/or Cosmetics registration?
- 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?
- 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?
- When does my Wholesaler of Drugs, Medical Devices, and/or Cosmetics registration expire?
- How do I renew my Wholesaler of Drugs, Medical Devices and/or Cosmetics registration?
- If I am a manufacturer of Drugs, Medical Devices, and/or Cosmetics, do I need to register as 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 (Oxygen see Question 7 and for durable medical equipment (DME)/diabetic testing supplies see Question 8). This registration is also required for reverse distributors.
Answer: 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.
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 (found on the application). Along with your application, please provide a copy of your home state license and your Drug Enforcement Administration (DEA) registration if you distribute controlled substances. Applications that do not have all of the information requested may be delayed in their processing.
Answer: Not by the State of Connecticut. Please provide a copy of your home state license and your Drug Enforcement Administration (DEA) registration if you distribute controlled substances.
Answer: Not at this time however records need to be made available for inspection/review at reasonable times in a reasonable manner.
Answer: A Wholesaler of Drugs, Medical Devices and/or Cosmetics would be required to maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of drugs, medical devices and/or cosmetics.
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., in the State of Connecticut 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 an Out of State Manufacturer of Drugs, Medical Devices, and/or Cosmetics registration.)
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. NOTE: Pharmacies that distribute Drugs, Medical Devices, and/or Cosmetics into the State of Connecticut must register as a Non-Resident Pharmacy.
Answer: In general, the process takes approximately thirty (30) days but much of that depends on our ability to contact an individual from your company who can answer our questions and how completely you have filled out your application. 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 a representative from Drug Control can contact you to complete the application process. (NOTE: If the facility phone number is different from the contact number of the individual who can answer questions please provide that information separate from the application paperwork to assist the Drug Control representative with contacting the appropriate individual.)
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 if there are any further questions. You can also call 860-713-6065 to request the change of address however email is the preferred method of communication. Please also provide a copy of your home state license which reflects the new address and a copy of the Drug Enforcement Agency (DEA) registration which reflects the new address if applicable (This information can be scanned and attached to the email). It is permissible to send the email to inform the Drug Control Division prior receiving all of the paperwork from the appropriate State and Federal Agencies, however your address will not be changed until the appropriate State and Federal documentation has been submitted. There is no fee for this change.
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. If you are adding controlled substances, you will be subject to an additional fee and should also submit a copy of your home state registration which reflects that you have permission to distribute controlled substances and your Drug Enforcement Administration (DEA) registration. All additional fees are only accepted via check at this time, therefore you would be required to send a letter with the fee difference and what you would like to add to your registration. Please be sure to include your registration number on any written or emailed communication.
Answer: Yes, if you are adding controlled substances to the list of products that you currently wholesale you will need to pay the difference for adding controlled substances. For all other products, there is currently no fee associated.
Question 13: 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. Please send 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. You do not need to submit a new application.
Question 14: Is there a fee for a submitting change of ownership documentation?
Answer: Not at this time.
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.
Answer: Not at this time.
Answer: 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.
Question 18: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 by completing the application with the appropriate fee.
Question 19:When does my registration as a Wholesaler of Drugs, Medical Devices and/or Cosmetics expire?
Answer: The Wholesaler of Drugs, Medical Devices and/or Cosmetics registration expires annually on June 30th. Approximately 30-45 days prior to the expiration of your registration you will receive a renewal document in the mail.
Question 20: 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.
Answer: A manufacturer of Drugs, Medical Devices and/or Cosmetics would ONLY be required to register as a Wholesaler of Drugs, Medical Devices and/or Cosmetics if they distribute products that were not manufactured by them or specifically for them by another manufacturer.