In pharmaceutical manufacturing, a label is elevated from a branding material to a critical component of product safety for company and consumer alike. One mislabeled batch can trigger recalls, regulatory action, and significant financial exposure—not to mention health risks. For quality assurance teams, working with FDA labeling requirements means building out systems to protect both your operation and the patients who depend on your products.

As a GMP-certified label converter with four decades of experience serving regulated industries, Systems Graphics has seen how the smallest production details can have the biggest compliance impact. Here’s what you need to know before your approved designs move to print.

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Know Before You Go to Print

1. Understanding FDA Labeling Authority

Relevant FDA labeling requirements vary significantly depending on your product category, and understanding these distinctions is crucial for both regulatory compliance and production planning. Each category carries specific requirements for content, placement, font sizes, and approval processes.

Critical Regulatory Frameworks:

  • Prescription drugs under 21 CFR 201 –  Prescription drug labels have to include detailed prescribing information, contraindications, and adverse reactions. 
  • Over-the-counter medications under 21 CFR 330 – OTC products require Drug Facts panels with specific formatting requirements. 
  • Dietary supplements under 21 CFR 101 – Dietary supplements need Supplement Facts panels that differ from both drug and food labeling standards. 

The complexity multiplies when you consider that many pharmaceutical companies produce multiple product categories within the same facility. This means your labeling system must be equipped to accommodate different regulatory frameworks, approval workflows, and production requirements—all while maintaining strict version control and traceability.

2. Claims, Disclaimers, & Substantiation

One of the most scrutinized aspects of pharmaceutical labeling is the accuracy and substantiation of claims. The FDA distinguishes between structure/function claims, disease claims, and health claims—each with different requirements for evidence and disclosure.

For dietary supplements, any structure/function claims will need the standard disclaimer: 

This statement has not been evaluated by the Food and Drug Administration.
This product is not intended to diagnose, treat, cure, or prevent any disease.

This disclaimer must appear prominently and in the same font size as the claim itself.

Drug products face even more stringent requirements. Every claim must be supported by substantial evidence, typically from controlled clinical trials. The prescribing information must accurately reflect the approved indication, and any off-label marketing through labeling is strictly prohibited.

Production Impact: Claims substantiation affects more than just regulatory approval—it impacts label version control, change management, and inspection readiness. Any modification to claims typically requires regulatory review and approval before production.

3. Supplement Facts Panels & Formatting

FDA labeling requirements for dietary supplements differ significantly from both drug and food labeling standards. The Supplement Facts panel must include serving size, servings per container, and a complete list of dietary ingredients with amounts per serving.

The formatting requirements are precise: specific font sizes based on label size, required headings, proper indentation for ingredient hierarchies, and specific units of measurement. Vitamins and minerals must be listed with both the amount per serving and the percent Daily Value (%DV) when established.

Proprietary blends present a unique situation—while you can list a proprietary blend with a total weight, you’re not required to list individual ingredient amounts within the blend. Even still, all ingredients must still be listed in descending order by weight.

4. Serialization & Track-and-Trace Requirements

The Drug Supply Chain Security Act (DSCSA) requires serialization of prescription drug packages at the unit level. Each package must have a unique product identifier that includes the product’s standardized numerical identifier (SNI), lot number, expiration date, and a unique serial number.

This serialization must be both human-readable and machine-readable, which can typically be accomplished through 2D Data Matrix barcodes. The serialization information must be printed directly on the label or packaging, and the quality of the barcode must meet GS1 standards for reliable scanning throughout the supply chain.

GMP Considerations: Serialization impacts label inventory management, production workflow, and quality control processes. Each serialized label is unique and must be handled, stored, and applied with appropriate controls to prevent mix-ups or counterfeiting. This is an area in which your chosen label converter will have significant impact.

5. Preparing for FDA Inspections

Your labeling program will be a key focus during FDA inspections, and preparation requires both documentation and operational readiness. Inspectors will examine your labeling controls, change management processes, and evidence that your actual labels match your approved labeling. Some areas of frequent inspection focus include:

  • Label storage and handling procedures
  • Version control systems and change management documentation
  • Training documentation and personnel qualifications
  • Final label verification before product release
  • Traceability systems and batch record integration

When under inspection, you’ll need to be able to demonstrate that your labeling process prevents mix-ups, maintains accuracy, and supports traceability. Your labeling partner’s GMP compliance becomes an extension of your own quality system during these evaluations.

Working With a GMP-Certified Labeling Partner

Pharmaceutical companies play a key role in following the FDA labeling requirements and recommendations outlined here. Consistent attention to precision and reliability throughout each stage of labeling production helps support regulatory approval and product safety. 

While a well-designed label is important, meeting FDA standards also depends on maintaining quality during printing and application. By adhering to these best practices—and working with GMP-certified partners such as Systems Graphics—companies can strengthen their compliance processes. 

Our support includes:

  • Serialization-ready printing systems with integrated quality control
  • Secure handling and storage of pharmaceutical labeling materials
  • Version control systems that integrate with your change management processes
  • Quality documentation that supports FDA inspection readiness
  • Materials expertise for pharmaceutical packaging environments

We work with pharmaceutical manufacturers to ensure that approved labeling translates into fully compliant, premium-quality printed materials. Through GMP-certified printing processes, integrated quality systems, and hard-earned experience in label production for diverse industries, our labels are precise, expertly crafted, and compliant.

Contact Systems Graphics today to discuss how our GMP-certified printing processes and pharmaceutical expertise can help support your FDA-compliant labeling.