ITB HOLDINGS LLC | 390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | United States
OTC DRUGS

Over-the-Counter (OTC) Drugs

Prescription Drugs or Over-the-Counter (OTC) Drugs?

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 MONOGRAPHS

OTC drug monographs cover acceptable ingredients, doses, formulations, and labeling. Monographs are continually updated, with additional ingredients and labeling as needed.

Products conforming to a monograph may be marketed without further FDA clearance.

POPULAR OTC DRUG PRODUCTS

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.

OTC DRUG ESTABLISHMENT REGISTRATION

Any establishment engaged in the manufacture, repacking, relabeling, or salvaging of an OTC drug product for commercial distribution is required to register with FDA.

Products that do not conform to an FDA Monograph require a New Drug Application (NDA).

We expect you to provide

  • Full company name, complete physical address
  • Company DUNS Number
  • Product FDA compliant label, active and inactive ingredients.

At this time, MDF Facility Fees ($24,178), or CMO Facility Fees ($16,119), are required. These fees are effective for the period from October 1, 2021, through September 30, 2022 under the Over-The-Counter Monograph Drug User Fee Program (OMUFA).

These new User Fees also apply to establishments manufacturing, processing hand sanitizers and alcohol wipes.

OVER-THE-COUNTER (OTC) DRUGS
FDA ESTABLISHMENT REGISTRATION

LIMITED OFFER

$350.00

  • Annual Service Fee
  • Company Registration
  • Product Listing
  • U.S. Agent Service

User Fee is extra.