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.
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.
- Antidandruff shampoo
- Toothpaste containing fluoride
- Antiperspirant deodorant
- Cold and cough products
- 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.
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.
- Annual Service Fee
- Company Registration
- Product Listing
- U.S. Agent Service
User Fee is extra.