Over-the-counter (OTC) drugs are medicines that consumers can buy in pharmacies and stores without a prescription. In the United States they are regulated by the FDA, and manufacturers – including foreign ones – must meet clear requirements before and after placing them on the market.
1. The FDA’s responsibilities for OTC drugs
- Market entry: an OTC drug is either marketed under an OTC monograph (which sets acceptable active ingredients, doses, claims and labelling for a therapeutic category) or requires an approved New Drug Application (NDA). The FDA checks ingredients, claims, dosage form and labelling to ensure safety and effectiveness.
- Labelling: OTC labels must follow strict rules. The “Drug Facts” panel must clearly state the active ingredients, uses, directions, warnings (such as possible side effects, restrictions and interactions), storage conditions and inactive ingredients so that consumers can use the product correctly.
- Quality control: manufacturers must comply with current Good Manufacturing Practice (cGMP) from raw materials through production to packaging, and the FDA monitors compliance, including through inspections.
2. Documents typically needed
Company documents
- D-U-N-S number (with company name, business type, main activities, number of employees and contact details);
- business licence and company information in English;
- details of the U.S. agent – foreign establishments must appoint a U.S. agent for establishment registration who communicates with the FDA, including in urgent matters.
Product documents
- packaging and label artwork showing the overall design, Drug Facts panel, strength, active ingredients and content, uses, directions, warnings, storage conditions and inactive ingredients;
- instructions for use describing administration, indications, contraindications, adverse reactions, shelf life and storage;
- complete formulation listing all active and inactive ingredients and their proportions, which the FDA uses to assess conformity with the monograph and possible risks.
Other documents
- manufacturing licence and GMP certificates demonstrating that the company is qualified to produce medicines;
- company profile (history, technical capabilities, main products) to give the FDA an overview of the manufacturer.
Depending on the product, further documents may be needed; products outside a monograph require a full drug application including clinical data.
3. Two pathways: OTC monograph or NDA
Products that conform to an OTC monograph
- company preparations (registration data, U.S. agent);
- check of the product against the applicable monograph;
- establishment registration and drug listing (including the National Drug Code, NDC);
- GMP-compliant manufacturing and quality control.
Products that do not conform to a monograph
- non-clinical studies;
- clinical trials in phases;
- submission of an NDA with composition, manufacturing process, specifications, stability data and clinical study reports;
- FDA review, approval and pre-approval inspection.
| Aspect | Monograph product | Non-monograph product (NDA) |
|---|---|---|
| Pre-market approval | Not required – registration and listing | Full NDA including clinical data |
| Labelling review | Manufacturer ensures compliance; FDA checks post-market | FDA reviews labelling before approval |
| Typical timeframe | Around 3–6 months | Around 3–5 years |
| Cost level | Comparatively low (registration, listing, annual facility fees) | Very high, mainly due to clinical trials |
4. Practical questions
In practice, companies often need to clarify which pathway applies to their product (this can be checked against the monographs published by the FDA), whether a non-monograph product can be reformulated to meet a monograph, and how the electronic submission works. EVERBIZ can answer these questions for your specific product.
How EVERBIZ can help
EVERBIZ supports companies with FDA establishment registration, drug listing, U.S. agent services and label reviews for OTC products. Contact us to discuss your product.
This article is for general information only and does not constitute legal advice. The official FDA documents are authoritative.