US FDA Regulations
Attention Brand Owners and Manufacturers / Contract Manufacturers of Over-The-Counter (OTC) Drugs:
Contact us today! Our experts are here to help you with your past due FDA registrations.
Be sure you know and understand the classification of your product. Did you know Salicylic Acid or an SPF or fluoride may classify your product as an Over-The-Counter (OTC) drug in the US? There are other ingredients that can change the product classification, so let us know and we will help you confirm where your product fits.
We work with a number of common Over-The-Counter (OTC) drugs, including:
- Sunscreens (sun protection factor / SPF)
- Acne products
- Toothpaste (fluoride product)
- Hand sanitizers
- Topical antiseptics
- Skin protectants
FDA registrations are required annually and can be quite confusing at times. We have been working with the FDA for over 20 years and know all of the “ins and outs” of these submissions. And, our rates are among the lowest for these services.
Facility registrations as well as Product Registrations were due December 31, 2020 for the 2021 year. If you miss a deadline, the product will be out of compliance/illegal. Incoming product will be held at US Customs causing daily storage fees or destruction. And worse, the company may be Red Listed causing FDA inspections with every shipment before release. So avoid the rush and call us today!
Here are answers to some of the questions you may have about FDA registrations:
Annual FDA Registrations are required for the following:
- Manufacturers (if you make fill, or package the product)
- you must register both your facility AND
- any OTC product intended for the US market
- If you are a
- Brand Owner (identified by name and address on the package – you must register each OTC product and each size
- Distributor (identified by name and address on the package) – you must register each OTC product and each size
- Labeler and/or provide OTC kit assembly – you must register each OTC product and each size
When should we start this registration?
- Annual facility registrations begin October through December for the following year
- Annual product registrations begin October through December for the following year
- If you are launching
- a US-made new OTC drug, it must be registered within 10 days of placing the product on the market
- Or you are importing an OTC drug, it must be fully registered before reaching US Customs to avoid detainment
How long does it take?
- Typical registration takes 1 to 2 weeks
- As December grows closer, it may take longer depending on work load and FDA response as needed.
What happens if the deadline is missed?
- FDA will identify the product registration as expired in their system and the product will be out of compliance/illegal
- Incoming product will be held at US Customs causing daily storage fees or destruction
- Company may be Red Listed causing FDA inspections before release