FDA drug labeling requirements are among the most complex in regulatory compliance, from Drug Facts panels on OTC products to full Prescribing Information for prescription drugs. We review your labels before submission to catch issues before they become enforcement actions.
OTC Drug Facts Panel Review
OTC drug labels must include a Drug Facts panel with specific format, order, and content requirements under 21 CFR Part 201.66.
- Active ingredient & purpose statements
- Uses, warnings & directions review
- Inactive ingredient list review
- Type size & format compliance
Prescription Drug Labeling Review
We review prescription drug labels and package inserts (Prescribing Information) for compliance with FDA content and format requirements under 21 CFR Part 201.
- Full prescribing information review
- Boxed warning compliance
- Highlights section review
- Medication guide assessment
Homeopathic Drug Labeling
Homeopathic drug products have specific FDA labeling requirements. Since FDA withdrew its longstanding compliance policy in 2019, the agency applies a risk-based enforcement approach under its revised guidance. We review homeopathic product labels for compliance with current FDA requirements and guidance.
- Homeopathic ingredient listing
- Indication statement compliance
- Drug Facts panel (if OTC)
- FDA guidance alignment
Multi-Language & Import Labels
Imported drug products must meet all FDA labeling requirements in English. We review and advise on multi-language label compliance for import.
- English-language label requirement
- Import label compliance review
- Country-specific requirements
- Bilingual label assessment
Start Your Drug Label Review Now:
A non-compliant label can trigger an FDA warning letter or import refusal. Let us review it before you submit.
Drug Label Review FAQs
OTC drug labels must include a Drug Facts panel meeting the format, order, and content requirements in 21 CFR Part 201.66, covering active ingredients, uses, warnings, and directions.
Prescription drug labels and package inserts must meet the content and format requirements of 21 CFR Part 201, including a Highlights section, full prescribing information, and any required boxed warnings.
No. The FDA withdrew its prior compliance policy in 2019 and now applies a risk-based enforcement approach to homeopathic drugs under revised guidance, meaning these products face increased scrutiny, not exemption.
FDA requires labeling content in English at minimum. Labeling solely in another language, such as Spanish for the Puerto Rico market, is permitted only under specific conditions and must include an accurate English translation on file.