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If you start a business manufacturing, distributing, or retailing drugs, including prescription, controlled substances or over-the-counter; medical devices; or medicated cosmetics, your first duty is to get a drug, device and cosmetic registration approved by your state.

Because drugs and cosmetics can affect the skin and body in different ways, the industry is highly-regulated to ensure that the FDA knows exactly what is going into a given product. If you have your health license, you have nothing to worry about. But getting your business license is the tricky part.

Who Needs a Drug, Device and Cosmetic Registration?

There are so many types of businesses that need this health permit. Here are just a few:

  • Dental laboratories
  • Dental equipment sellers
  • Optical laboratories
  • Eyeglasses/contacts retailers
  • Prosthetics sellers
  • Dialysis equipment
  • Hearing aid manufacturers and repairs facilities

If your facility makes medical devices, you need this permit.

Additionally, if your business makes any kind of drug, including over-the-counter products like the following, you also need the drug, device and cosmetic registration:

  • Cough drops
  • Anti-perspirant deodorants
  • Diet aids
  • First aid kits
  • Fluoride toothpaste
  • Eye drops
  • Gauze and medicated bandages

If you aren’t sure if you need to register your product, check with your state’s business licenses, permits & tax agency.

Why You Need a Drug, Device and Cosmetic Registration

The FDA wants to protect consumers from faulty products. To that end, it wants you as the manufacturer to guarantee that you’re using nothing but quality ingredients and sanitary processes during production. You want your customers to feel confident that the products you sell are safe for them.

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