A drug is a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
Unlike a prescription drug, an over-the-counter (OTC) drug
▪ Does not require a doctor’s prescription.
▪ Can be purchased off-the-shelf in stores or online.
▪ Regulated by FDA through OTC Drug Monographs.
OTC drug monographs cover acceptable ingredients, doses, formulations, and labeling. Monographs are continually updated, with additional ingredients and labeling as needed.
Current OTC Monographs List
Anorectal Drug Products
Antacid Products
Antidiarrheal Drug Products
Antiemetic Drug Products
Anthelmintic Drug Products
Antiperspirant Drug Products
Cholecystokinetic Drug Products
Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products
Corn and Callus Remover Drug Products
Deodorant Drug Products
Drug Products Containing Certain Active Ingredients
Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis
Ingrown Toenail Relief Drug Products
Internal Analgesic, Antipyretic, and Antirheumatic Drug Products
Nighttime Sleep Aid Drug Products
Ophthalmic Drug Products
Oral Healthcare Drug Products
Orally Administered Menstrual Drug Products
Pediculicide Drug Products
Poison Treatment Drug Products
Sunscreen Drug Products
Skin Protectant Drug Products
Stimulant Drug Products
Topical Acne Drug Products
Topical Otic Drug Products
Wart Remover Drug Products
Products conforming to a monograph may be marketed without further FDA clearance.
There are more than 80 therapeutic categories of OTC drugs, ranging from acne drug products to weight control drug products.
- Sunscreen
- Antidandruff shampoo
- Toothpaste containing fluoride
- Antiperspirant deodorant
- Cold and cough products
- Laxative
- Skin protectant
- Vaginal contraceptive
- Weight control
- Hand sanitizers
Sales of hand sanitizer in the U.S. spiked by 1,400% due to the coronavirus (COVID-19).
Because there are over 300,000 marketed OTC drug products, FDA reviews the active ingredients and the labeling, instead of individual drug products.
Are considered illegal, among other acts:
▪ Introduction or delivery for introduction into interstate commerce of any drug that is adulterated or misbranded.
▪ Adulteration or misbranding of any drug in interstate commerce.
▪ Receipt in interstate commerce of any drug that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.
Any establishment engaged in the manufacture, repacking, relabeling, or salvaging of an OTC drug product for commercial distribution is required to register with the U.S. Food and Drug Administration.
Products that do not conform to an FDA Monograph require a New Drug Application (NDA).
Expect to pay these annual Service Fees, when seeking and requesting the assistance of ITB HOLDINGS LLC.
A foreign company or registrant must provide the name, address, and phone number of its 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.
LIMITED OFFER
$350.00
▪ Annual Service Fee.
▪ Company Registration.
▪ Product Listing.
▪ U.S. Agent Service.
User Fee is not included.
We expect you to provide:
- Full company name, complete physical address
- Company DUNS Number
- Product FDA compliant label, active and inactive ingredients.
The following fees are effective under the Over-The-Counter Monograph Drug User Fee Program (OMUFA).
User Fees are paid to the U.S. Treasury.
These new User Fees also apply to establishments manufacturing, processing hand sanitizers and alcohol wipes.
Monograph Drug Facility (MDF) Fee:
$26,153.
Contract Manufacturing Organization (CMO) Facility Fee:
$17,435.
These fees substantially increase yearly: 8 percent in comparison to the Fiscal Year (FY) 2022.
If a facility does not pay the annual facility fee within 20 calendar days of the due date, the FDA will place such company on a publicly available arrears list.
Furthermore, all OTC monograph drug products produced at that facility (or containing an ingredient manufactured at that facility) will be deemed misbranded under section 502(ff) of the FD&C Act.