FDA OTC Over the Counter
About
Over the Counter (OTC) drugs are safe and proven drugs that can be purchased without a doctor's prescription.
Drugs that are generally available at pharmacies, such as sunscreen, BB cream, whitening or wrinkle improvement cream (if SPF is included), dandruff and hair loss prevention shampoo, acne cosmetics, hand sanitizer, toothpaste, trauma treatment ointment, quasi-drugs, etc. which involves 80 categories of drugs, are categorized as over-the-counter drugs.
Necessity and Expected Outcomes of the Certification
- Essential for entering the US market.
- Establishment of product safety and reliability through FDA certification.
- New business opportunities
Certification Process
- Takes about 2 weeks to 1 month per product
- During customs clearance, customs checks whether OTC products are registered or not, so all procedures must be completed before starting sales in the United States.
Certification Requirements
Drug Facility Registration
- A facility that manufactures, prepares, synthesizes, or processes an OTC drug must register within 5 days of market launch, and the registration for the facility must be renewed every year.
- Subject of facility registration
- Pharmaceutical manufacturers
- Packaging businesses
- Overseas pharmaceutical manufacturers
- Items to check before facility registration
- Prior to registration, a labeler code must be obtained for use of the National Drug Codes (NDCs).
- Submission of forms for registration of facility
- If changes are made after registration, supplementary materials must be submitted
OTC Drug Registration
- All manufacturers that sell over-the-counter drugs in the United States must register the ingredients and composition of their products by providing all information required by FDA regulations.
- Subjects of registration of over-the-counter drugs
- OTC drug manufacturers
- Distributors
- Overseas OTC drug manufacturers
- General drugs checklist
- Forms related to OTC drug product registration must be submitted (FDA 2657)
- Manufacturers must register their products for distributors (FDA2658)
- A revision using the form FDA 2658 must be submitted twice a year
GSC is doing our best to support customers' global corporate activities by getting the latest information and expertise through the US FDA U.S Agent that can respond in real time.
