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.
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.
Is your company manufacturing, exporting, importing, distributing Hand Sanitizers, Wet Wipes, Fluoride Toothpaste, Antiperspirants, Dandruff Shampoos, Sunscreens?
More than 700 products sold over the counter today use ingredients or dosage strengths available only by prescription 30 years ago. As a result, American medicine cabinets contain a growing choice of nonprescription medicines to treat an expanding range of ailments.
Monographs define the safety, effectiveness, and labeling of all active ingredients. Click here for OTC ingredient list – alphabetical by monograph.
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.
Acne
Alcohol
Allergy
Analgesic, External
Analgesic, Internal
Anorectal
Antacid
Anthelmintic
Antibiotic, First Aid
Anticaries
Anticholinergic
Antidiarrheal
Antiemetic
Antiflatulent
Antifungal
Antihistamine
Antimalarial
Antimicrobial
Antiperspirant
Antipyretic
Antirheumatic
Antitussive
Aphrodisiac
Astringent
Benign Prostatic Hypertrophy
Boil Treatment
Bronchodilator
Camphorated Oil
Cholecystokinetic
Cold & Cough
Colloidal Silver
Callus Remover
Corn Remover
Dandruff
Daytime Sedative
Decongestant, Nasal
Dental Care
Deodorant
Diaper Rash
Digestive Aid
Drink Overindulgence
Exocrine Pancreatic Insufficiency
Expectorant
External Analgesic
Fever Blister
First Aid Antibiotic
Food Overindulgence
Hair Growth & Loss
Hormone
Hypophosphatemia
Hyperphosphatemia
Ingrown Toenail
Insect Bite & Sting
Insect Repellent
Internal Analgesic
Internal Deodorant
Laxative
Leg Muscle Cramps
Male Genital Desensitizers
Menstrual
Nailbiting
Nasal Decongestant
Nighttime Sleep Aid
Ophthalmic
Oral Health Care
Oral Wound Healing
Otic
Overindulgence, Food & Drink
Pancreatic Insufficiency
Pediatric
Pediculicide
Poison Oak/Ivy
Poison Treatment
Prostatic Hypertrophy
Psoriasis
Seborrheic Dermatitis
Sedative, Daytime
Skin Bleaching
Skin Protectant
Sleep Aid, Nighttime
Smoking Deterrent
Stimulant
Stomach Acidifier
Sunscreen
Sweet Spirits Of Nitre
Thumbsucking
Topical Analgesic
Vaginal Contraceptive
Vaginal Drug Products
Vitamins & Minerals
Wart Remover
Weight Control.
Establishment owners and operators (registrants) upon first engaging in the manufacture, preparation, propagation, compounding, or processing of OTC drugs, (including human drugs, veterinary drugs, and biological drug products) must register their establishments and submit listing information for all drugs in commercial distribution.
Registrants are also required to submit registration information for their establishments on or before December 31 of each year.
Failure to register is a prohibited act. An OTC drug is misbranded if it is manufactured in an establishment not duly registered.
A foreign company or registrant must provide the name, address, and phone number of the foreign registrant’s U.S. Agent, such as ITB HOLDINGS LLC.
The U.S. Food and Drug Administration will not confirm a registration, provide an FDA Establishment Identification (FEI) number, or provide confirmation of a registration renewal until ITB HOLDINGS LLC confirms it has agreed to serve as U.S. Agent.
The FDA recognizes the DUNS Number as an acceptable Unique Facility Identifier (UFI) for the purpose of registrations. The DUNS number is assigned and managed by Dun & Bradstreet (D&B) Inc. DUNS numbers can be obtained or confirmed by visiting D&B’s website.
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
FDA
FACILITY
REGISTRATION
$350.00
- Company Registration
- Product Listing
- U.S. Agent Service
FDA User Fee is not included.
FDA collects two types of user fees under Over-The-Counter Monograph Drug User Fee Program (OMUFA):
- Facility Fees
- OTC Monograph Order Request (OMOR) fees from certain manufacturers of OTC monograph drugs.
Monograph Drug Facility (MDF) Facility Fee: $26,153.
Contract Manufacturing Organization (CMO) Facility Fee: $17,435.
Manufacturers of hand sanitizers and alcohol wipes are no longer exempt.