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



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Purpose:

This registration is required for businesses that resides 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).

"Drug" means any substance or preparation, except soaps, intended for external or internal use in the cure, mitigation, treatment, remedy or prevention of disease or ailment in man or any other animal, and any substance or preparation intended to affect the structure or function of the body of man or any other animal, not including food, but including medicinal or quasi-medicinal preparations.

"Cosmetics" and "toilet preparations" mean toilet articles and perfumes, toilet waters, face powders, creams, lotions, rouges, shaving creams, dentifrices, bath salts and all other similar preparations and substances, except soaps, designed and intended for application to the person for the purpose of cleansing, improving or changing in any way the appearance of the person, or of refreshing or preserving the person.

"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.

Required Documentation:

Complete the application below
Applications, Forms & Other:
    • 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.
Application Fee:
  • Initial/Renewal Application Fee
    • Manufacturers with 5 or fewer chemists and NO controlled substances - $285
      • Manufacturers with 5 or fewer chemists WITH controlled substances - $570
    • Manufacturers with 6-10 chemists and NO controlled substances - $375
      • Manufacturers with 6-10 chemists WITH controlled substances - $750
    • Manufacturers with 10 or more chemists and NO controlled substances - $940
      • Manufacturers with 10 or more chemists WITH controlled substances - $1880

Renewal Information:   

All Manufacturer of Drugs, Medical Devices/Cosmetics registrations expire annually on June 30th.  Renewal Information

 

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