Before you export any Over-the-Counter (OTC) drug product to the United States, register your company with the U.S. Food and Drug Administration, to avoid the detention of your shipment.
Is your company manufacturing, exporting, importing, distributing Hand Sanitizers, Wet Wipes, Fluoride Toothpaste, Antiperspirants, Dandruff Shampoos, Sunscreens?
ITB HOLDINGS LLC provides the following services to domestic and foreign companies that are manufacturers, exporters, importers, or distributors:
■ OTC Drug Establishment Registration
■ Drug Product Listing
■ New Drug Application (NDA)
■ Label Review
■ Label Design
Hand sanitizers and Sunscreens are some of more than 300,000 Over-the-Counter (OTC) drug products that are marketed in the U.S. without the need for FDA pre-approval.
OTC drug products are available to consumers without a doctor’s prescription.
Monographs define the safety, effectiveness, and labeling of all active ingredients.
A New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) is required when a product does not conform to a final monograph.
There are more than 80 therapeutic categories of OTC drugs, ranging from acne drug products to weight control drug products.
Antibiotic, First Aid
Benign Prostatic Hypertrophy
Cold & Cough
Exocrine Pancreatic Insufficiency
First Aid Antibiotic
Hair Growth & Loss
Insect Bite & Sting
Leg Muscle Cramps
Male Genital Desensitizers
Nighttime Sleep Aid
Oral Health Care
Oral Wound Healing
Overindulgence, Food & Drink
Sleep Aid, Nighttime
Sweet Spirits Of Nitre
Vaginal Drug Products
Vitamins & Minerals
OTC Monographs are not subject to user fee, yet. That could change, soon.
(Over-the-Counter Monograph Drug User Fee Act – OMUFA).
FDA plans to publish a Federal Register Notice (FRN) to establish fees with respect to OTC monograph drug facilities and OMORs for FY 2021 (Fiscal Year 2021 – October 1, 2020 to September 30, 2021).
FDA will collect two types of user fees under OMUFA: Facility Fees and OTC Monograph Order Request (OMOR) fees from certain manufacturers of OTC monograph drugs.
All Drug Establishments must renew their registration between October 1 and December 31, 2020.