Manufacturer of Drugs, Medical Devices, or Cosmetics in the State of Connecticut

Those who are looking to obtain a Hemp Manufacturing License may visit our hemp information page located here. 

Purpose:

This registration is required for businesses that reside within the State of Connecticut and produces, prepares, cultivates, grows, propagates, compounds, converts or processes, directly or indirectly, by extraction from substances of natural origin or by means of chemical synthesis or by a combination of extraction and chemical synthesis, or who packages, repackages, labels or relabels a container under such manufacturer’s own or any other trademark or label any drug, device or cosmetic for the purpose of selling such items. The words “drugs”, “devices” and “cosmetics” shall have the meaning ascribed to them in section 21a-92 (21a-70).

"Device" means instruments, apparatuses and contrivances, including their components, parts and accessories, intended (A) for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or other animals, or (B) to affect the structure or any function of the body of humans or other animals, but does not mean contact lenses.

Prerequisites:

Prior to obtaining this registration you will be subject to an inspection by the Department of Consumer Protection, Drug Control Division. Once you have submitted your application, the Drug Control Agent assigned to your facility will contact you to schedule the inspection. Sample inspection forms can be found here (not all forms have been created yet, please check back for updated information).

Required Documentation:

•  
  • Food and Drug Administration (FDA) registration may be required for Manufacturers of Drugs, Medical Devices and/or Cosmetics. Information pertaining to FDA registration can be found at www.fda.gov. 
  • Drug Enforcement Administration (DEA) registration may be required for Manufacturers of Drugs that include controlled substances. The application can be found here: www.deadiversion.usdoj.gov.
  • Do not complete this application if you do not have a physical location within the State of Connecticut.
  • Verify a license/track your application        

• Initial/Renewal Application Fee (non-refundable)

  	Without Controlled Substances	With Controlled Substances
  5 or fewer chemists	$285	$570
  6-10 chemists	$375	$750
  Greater than 10 chemists	$940	$1880

Renewal Information:   

• DCP.DrugManufacturers@ct.gov