OTC Drug(Over the Counter Drug)

Over the Counter (OTC) refers to a safe and effective drug used in the human body that can be purchased without a doctor's prescription, that is, a general drug.
Over the counter drug, OTC Drug, monographed drug, OTC moonograph drug, non-prescription drug, and over-the-counter drug are all called the same thing.
General medicines in about 80 categories, including sunscreen, BB cream, whitening or wrinkle-improving cream (including SPF), toothpaste, and trauma treatment ointment, generally fall into the category of OTC Drug.

※ In particular, in the case of Korean ‘functional cosmetics’, in the United States, they may be classified as OTC drugs rather than cosmetics, so it is necessary to review the classification of the product.

Requirements for Over the Counter (OTC) registration

In order to register a product as an OTC drug, you must check whether active ingredients are included through the FDA's monograph, and the registration method varies depending on whether they are included.

• If the active ingredient specified by the FDA is not included in the monograph:
  A New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) is required. To prove safety and effectiveness, you must secure evidence and conduct clinical trials, and you must pay significant fees to submit and maintain an NDA.
• If the FDA-designated active ingredient is included in the monograph:
  Although the product formulation is not specified in the Monograph/Final Order format, the individual active ingredients are identified and are deemed to have met GRASE by the FDA. Therefore, no prior marketing approval is required.

All registered facilities must register with the FDA any over-the-counter (OTC) drugs they produce for commercial distribution.
OTC Drug products must be registered within 5 days of placing them on the market. When clearing customs, the customs office checks whether the OTC drug product is registered.
Product registration must be renewed every year between October 1 and December 31.

(※ OTC Monograph is a standard manufacturing standard for the marketing of non-prescription drugs that does not apply the New Drug Approval Procedure (NDA) and includes acceptable ingredients, dosage, dosage form, labeling information, and testing-related matters.
Approximately 800 Active Ingredients are included in Monograph depending on the purpose of use. Through the Monograph, the FDA classifies over-the-counter drugs into approximately 80 categories and regulates product definition, active ingredients, doses, formulation, labeling, testing, etc. for each product.)

Drug Facility Registration

Any establishment that manufactures or engages in the repackaging, relabeling, or recall of OTC drugs or pharmaceutical active ingredients for use in the United States must register with the FDA.

• You must register your facility within 5 days of commercially distributing your product in the United States. Products must be registered with the FDA before being imported into the United States, and the FDA verifies registration status upon import.
• Manufacturing facilities outside the United States must designate a U.S. Agent in the United States.
• Facility registration must be renewed every year between October 1 and December 31.

If there are changes to the existing importer's information or a new importer is added to the register, the registration must be updated prior to shipment.
If a facility goes out of business or is no longer involved in manufacturing a drug, you must report this to the FDA.
Establishments that manufacture OTC monograph drug products (MDFs) are required to pay fees for the OMUFA program. The scope also includes contract manufacturers (CMOs), who will only be charged two-thirds of the fee. The fee is set differently each year, and the facility fee must be paid by June 1 of the fiscal year in which the fee is due.

Cosmetics MoCRA Act

On December 29, 2022, the “Consolidated Appropriations Act of 2023” signed by U.S. President Biden included the “MoCRA – Modernization of Cosmetics Regulation Act of 2022”. This MoCRA law completely renewed U.S. cosmetic regulations.
The law establishes new standards for cosmetic facility registration, product registration, mandatory labeling, Good Manufacturing Practices (GMP), and adverse event reporting and recording.

(※ In accordance with the MoCRA, the FDA declared the termination of the VCRP Program (Voluntary Cosmetic Registration Program) on March 27, 2023, and VCRP product registration has been suspended. A new system has been opened for registration of facilities and products under MoCRA. Since existing VCRP data is not transferred to the MoCRA system, all cosmetics that were previously registered with VCRP must also be re-registered in accordance with these MoCRA regulations.)

Mandatory registration of cosmetic products

According to MoCRA regulations, registration of cosmetic products is mandatory in the future.
The Responsible Person (RP) must register all cosmetics sold in the United States.

• All cosmetics sold in the United States before MoCRA’s enactment date (2022/12/29) must complete product registration by July 1, 2024.
• If a product is marketed in the United States for the first time after the MoCRA enactment date (December 29, 2022), cosmetic product registration is required within approximately 120 days after marketing.
• Product registration must be renewed every year.

(※ Responsible Person – RP: This refers to the entity indicated on the label of the cosmetic product as a cosmetics manufacturer, packaging company, or distributor. The person in charge is responsible for cosmetic product listings, side effects, safety verification, labeling, and disclosure and recording of allergenic fragrances.)

Mandatory registration of cosmetic facilities

All cosmetics manufacturers and processors located in the United States and abroad must register. Manufacturing facilities outside the United States must designate a U.S. Agent in the United States.

• Existing facilities must complete facility registration by July 1, 2024.
• New establishments must register their establishment within 60 days from the date of first manufacture.
• Mandatory renewal every two years.
• Any changes must be submitted within 60 days.

Cosmetic OTC Drug and MoCRA Registration Procedure

ICMC Service Scope

• Review of cosmetics (MoCRA) registration vs. over-the-counter drug (OTC drug) registration
• Review of active ingredients and monograph of product for OTC drug registration
• Perform the role of US Agent in the United States, which requires mandatory designation when registering a manufacturing facility
• Perform facility or product registration duties
• Labeling review
• Registration renewal notification service
• Guide to enacted and revised regulations