FDA drug label review is a critical regulatory process that ensures drug labeling complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act). Accurate labeling is essential for patient safety, market access, and protecting your company from enforcement actions.
Our regulatory experts support you in the following areas:
- Identification of monograph
- Dosage Form and Strength
- Drug Facts panel requirements
- Marketing taglines and claims
- Overall Formatting and Presentation
At Liberty Management Group, our experts review your label, identify compliance gaps, and provide a revised, ready-to-use FDA-compliant version—accurately, efficiently, and cost-effectively.
Frequently Asked Questions (FAQs)
1. How are OTC drug labels reviewed?
OTC monograph drug labels must comply with the applicable OTC monographs and 21 CFR regulations.
2. Does the FDA approve drug labels?
FDA approves labeling as part of the NDA/ANDA process. For OTC drugs under an approved monograph, the FDA does not pre-approve the label prior to marketing; the manufacturer is responsible for compliance.
3. Can marketing claims be included on drug labels?
Yes, provided they are consistent with the monograph and do not misbrand the product.
4. What are the key elements required in an FDA drug label?
- Drug name (established name and pharmacological category)
- Dosage form and strength
- Indications and usage
- Directions for use and Warnings
- Inactive ingredients
- Proper Drug Facts formatting and layout
Example: Non-compliant vs. Corrected Label
5. Are foreign manufacturers subject to the same labeling requirements?
Yes. All drugs marketed in the U.S. must meet the same FDA labeling standards regardless of where they are manufactured.
6. Are there language requirements for drug labels?
Yes. Requirements vary depending on whether the label is in English only or is bilingual.
7. What happens if an OTC drug label is non-compliant?
Non-compliant products may be deemed misbranded, leading to FDA warning letters, import alerts, detentions, or recalls.
