Accurate and compliant drug labeling is one of the most critical requirements for marketing human and veterinary drugs in the United States. Under 21 CFR Part 201, the U.S. Food and Drug Administration (FDA) sets forth detailed labeling rules to ensure that healthcare providers and consumers have access to safe, reliable, and consistent product information.

Drug labels provide essential information such as dosage instructions, indications, contraindications, warnings, inactive ingredients, and proper usage. Any errors, omissions, or misleading claims can result in FDA enforcement actions, product recalls, or misbranding violations. For this reason, drug labeling compliance is a key focus area for all pharmaceutical manufacturers, repackers, relabelers, and distributors.

A major requirement of FDA compliance is Structured Product Labeling (SPL) formatting. This electronic standard ensures that drug labeling information is submitted in a consistent, machine-readable format through the FDA’s Electronic Submissions Gateway (ESG). FDA-approved SPL formatting is mandatory for both initial drug listings and ongoing updates.

Key aspects of 21 CFR 201 drug labeling compliance include:

• SPL formatting for structured submissions, ensuring compatibility with FDA databases.
• Label claims and warnings review, preventing misbranding and ensuring accuracy.
• Inactive ingredient verification against the FDA’s Inactive Ingredient Database (IID).
• Drug Facts and package insert compliance with FDA labeling standards.
• Monitoring regulatory updates to keep labels aligned with FDA changes.

At XPRO America, we help pharmaceutical companies, drug manufacturers, and distributors achieve full compliance with FDA drug labeling requirements. Our specialized services include:

• SPL formatting and electronic submissions through ESG.
• Comprehensive labeling review for claims, directions, and warnings.
• Inactive ingredient compliance checks using FDA databases.
• Ongoing compliance monitoring to meet evolving FDA regulations.
• Corrective support in case of FDA label deficiencies or enforcement actions.

With our expertise, companies can confidently market their drug products in the U.S. without facing delays or regulatory setbacks. XPRO America ensures your drug labeling meets FDA standards, protects patient safety, and supports seamless market entry.

XPRO America ensures FDA-compliant drug labeling with SPL formatting, claims review, and inactive ingredient checks to meet 21 CFR Part 201 requirements.