Regulatory Guidelines for Labeling in Pharma

Pharmaceutical labeling is a critical element of healthcare products and services that are strictly regulated by health authorities. This includes the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe. The FDA oversees the safety and efficacy of pharmaceutical drugs, biopharmaceuticals, and other healthcare products. As a result, pharmaceutical labeling is a complex and meticulous process, with even minor errors resulting in significant consequences.

In fact, over 22% of detentions in the US occur due to labeling mistakes. Adhering to the FDA’s strict code is essential for manufacturers, big or small, to get their products approved. The FDA’s guidance includes formatting requirements, critical information to highlight, and more.

To navigate this complex process, companies can utilize regulatory tools such as proofreading and text verification software to ensure compliance, reducing the amount of time required for proofreading while increasing accuracy and speed to market. This guide will explore the regulatory guidelines for labeling in pharma and how companies can ensure their products are compliant while getting to market faster.

An Overview of Labeling in Pharma

Labeling is a critical component that provides crucial information to healthcare professionals and patients about the product, including its intended use, dosage, and potential side effects.

The FDA defines labeling as “all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article.” The FDA requires labeling for prescription drugs, over-the-counter (OTC) drugs, biological products, and biosimilars. The labeling requirements for each product type may differ, but they all serve the same purpose: providing accurate and complete product information.

Labeling can take many forms, including the product label, package insert, and prescribing information. Labeling plays a significant role in ensuring patient safety. After all, it’s the primary means through which patients receive information about their medication, including its risks and benefits. Accurate labeling is essential to help patients make informed decisions about their treatment options.

Alongside providing information about the product, labeling also plays a crucial role in marketing. The label is often the first point of contact that patients and healthcare professionals have with the product. An effective label can communicate the benefits of the product, its indications, and its unique features.

Products that Require Pharmaceutical Labeling

Pharmaceutical labeling helps healthcare professionals, patients, and caregivers to understand critical information about a medication and its safe use. The following products require pharmaceutical labeling:

Prescription Drugs

Prescription drugs are medications that are regulated by the FDA and are only available with a prescription from a licensed healthcare provider. These drugs need a label that provides essential information such as indications and usage, dosage and administration, contraindications, warnings, precautions, adverse reactions, and drug interactions. The label must also include the manufacturer’s name, the drug’s name, strength, and the route of administration.

Over-the-counter (OTC) Drugs

Over-the-counter drugs are medications that can be purchased without a prescription from a licensed healthcare provider. These drugs are also regulated by the FDA and require labeling, including the drug’s active ingredients, uses, warnings, directions, and other important information. OTC labeling needs to be more detailed than prescription labeling because these drugs are considered safe for self-medication by the general public.

Biologics

Biologics are biological products that are derived from living organisms or their products, such as vaccines, blood and blood products, gene therapy, and cellular therapy. These products are regulated by the FDA and require labeling that provides essential information about the product, its indications and usage, dosing and administration, warnings, precautions, adverse reactions, and other important information.

Medical Devices

Medical devices are products that are used to diagnose, treat, or prevent medical conditions. These products are regulated by the FDA and require labeling or e-labeling that provides essential information about the product, including its intended use, warnings, precautions, contraindications, and instructions for use.

Combination Products

Combination products combine two or more types of regulated products, such as a drug-device combination or a biologic-device combination. These products are regulated by the FDA and require labeling that provides essential information about the product, its indications and usage, dosing and administration, warnings, precautions, adverse reactions, and other important information.

All regulated pharmaceutical products require labeling that provides essential information about the product, its intended use, and its safe use. Failure to comply with FDA labeling requirements can result in serious consequences for manufacturers and can jeopardize patient safety.

What Information is Necessary on a Pharmaceutical Label?

In 2016, the FDA finalized a new rule that requires prescription drug manufacturers to include a summary of the most important information about the drug’s use in the labeling, called the Highlights of Prescribing Information (HPI). The HPI is intended to make it easier for healthcare providers to find important information about the drug’s safe use quickly.

In 2020, the FDA made significant changes to labeling over-the-counter (OTC) drugs. The FDA released a final rule requiring OTC drug manufacturers to include a standardized “Drug Facts” label on their products. This label includes important information such as active ingredients, uses, warnings, directions, and more in a user-friendly format.

Additionally, on March 27th of that year, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law. This act added section 505G to the Federal Food, Drug and Cosmetic (FD&C) Act, which reforms and modernizes the framework for regulating OTC monograph drugs. These changes aim to provide consumers with clear and concise information about the OTC drugs they use.

Importance of Complying with FDA Labeling Requirements

Compliance with FDA labeling requirements is critical for manufacturers to ensure patient safety and avoid regulatory action. Failure to comply with labeling requirements can result in serious consequences, including product recalls, warnings, and fines.

Additionally, non-compliance with labeling requirements can expose manufacturers to liability in lawsuits from patients who have suffered harm due to inadequate or inaccurate labeling.

TVT: Your Labeling Solution

In regulated industries, the accuracy and reliability of pharmaceutical labeling are of paramount importance. Here at Schlafender Hase, we have developed an innovative solution to simplify and streamline the process of pharmaceutical labeling with the Text Verification Tool (TVT).

With modules that verify text, spelling, artwork, and barcodes, TVT provides a comprehensive solution that ensures the accuracy of pharmaceutical labeling, making it the tool trusted by global leaders in regulated industries.  

Compliance with FDA labeling requirements is critical to ensure patient safety and avoid regulatory action. By using TVT, manufacturers in the pharmaceutical industry can be confident that their labeling is accurate and compliant, mitigating the risk of recalls, warnings, and fines. The TVT solution also provides the added benefit of generating an audit trail report, ensuring compliance across your organization.