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).

USER FEES

The following 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).

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 ($24,178)
  • Contract Manufacturing Organization (CMO) Facility Fee ($16,119)

The facility fee was due no later than 5/10/2021, for fiscal year 2021, and 6/1/2022, for fiscal year 2022.

We expect you to provide:

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

OMUFA Facility Arrears List

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.

Prohibited Acts

Are considered illegal, among other acts:

  • Introduction or delivery for introduction into interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.
  • Adulteration or misbranding of any food, drug, device, tobacco product, or cosmetic in interstate commerce.
  • Receipt in interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.