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What is OTC (Over the Counter) as defined by the US (FDA)?

OTC (Over the Counter) refers to drugs that are safe, effective, and used in the human body, that is, over-the-counter drugs that can be purchased without a doctor's prescription. OTC Drugs include sunscreens, BB creams, whitening or wrinkle improvement creams (if SPF is included), toothpaste, and quasi-drugs that can be purchased at pharmacies, such as trauma treatment ointments.

※ For active ingredients whose safety and effectiveness have not been verified, NDA approval must be obtained from the FDA before the product is sold, and pharmaceutical GMP standards must be followed.

• Over the Counter (OTC) Registration Requirements

In order to register a product as an OTC drug, it is first necessary to determine whether active ingredients are included through the FDA's Monograph.

If there is an active ingredient designated by the FDA, it is registered as an Approved drug

If there is no active ingredient designated by the FDA, it is registered as an Unapproved drug by determining whether it is possible

OTC Monograph is a kind of standard manufacturing standard that encompasses acceptable ingredients, dosage, formulation, labeling, and test-related matters as a standard standard for the marketing of non-prescription drugs that do not apply the New Drug Approval Procedure (NDA). FDA classifies over-the-counter drugs into about 80 categories through the Monograph and stipulates product Definition, Active ingredients, Doses, Formulation, Labeling, Testing, etc. for each product.
(※ Depending on the purpose of use, about 800 Active Ingredients are included in the Monograph, and the Monograph is updated according to the addition and revision of new ingredients or labeling regulations.)

• Advantages of OTC

In order to register OTC, the product must be composed of individual ingredients whose safety has been proven by the FDA, so it can be said that the safety of the ingredient itself has been proven.

• TC validity period

Validity Period: Specific validity period (OTC manufacturer registration is renewed every year)

• OTC registration process

Drug Facility Registration: Manufacturing facility registration _ FDA2656 (*Renewal of facility registration required every year)

OTC Drug Registration: Registration of drug product ingredients and composition _ FDA2657 & Form2658

Peer review with FDA reviewers

What is Drug Facility Registration required by the US (FDA)?

A related facility that manufactures, prepares, synthesizes, or processes OTC pharmaceuticals must register the facility within 5 days of business opening and renew the facility registration for that facility annually.

Information required for registration of manufacturing facilities: US Agent's name, address, contact information / Importer's business name, address, contact information in the US / Manufacturer's name, contact information, etc.

For registration of manufacturing facilities, a Data Universal Numbering System (D-U-NS®) number corresponding to overseas business registration must be obtained and submitted together before application.

• Drug Facility Registration

Pharmaceutical Manufacturers

Packer

Foreign manufacturer

•Drug Facility Registration Checklist

Prior to facility registration, a labeler code must be obtained for the use of NDC (National Drug Codes).

All companies engaged in manufacturing processes, such as manufacturing, preparation, packaging, and labeling, must register with the FDA.

Submission of form for registration of facilities

When changes occur after facility registration, submit a revised facility registration plan출

What is OTC Drug Registration as defined by the US (FDA)?

All manufacturers who intend to sell over-the-counter (OTC) drugs in the United States must provide all information required by FDA-related laws to register the ingredients and composition of their products through the SPL format.

Information necessary for product ingredient and composition registration: related manufacturer information and process, inactive ingredients, product-related information, OTC monograph number, packaging information, etc.

After inputting the necessary information for product registration through the SPL format, receive a CPIS registration number from the FDA and activate it

• For OTC Drug Registration

OTC drug manufacturer (Manufacturer)

Distributor

Foreign OTC drug manufacturer

• OTC Drug Registration Checklist

Submission of Form for OTC Drug Product Registration (FDA 2657)

For distributors, manufacturers must register their products on the register (FDA2658)

Submit amendments twice annually (June or December) using Form 2658 FDA

US (FDA) Latest Notice

Announcement of new regulations for quasi-drugs (OTC) products in 2018
http://consultingwithus.com/board/news/2558

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