To ensure public safety, the U.S. Food and Drug Administration (FDA) regulates both prescription and over-the-counter medications. Just one way this agency accomplishes this is by setting strict pharmaceutical labeling requirements that companies must follow. Considering that labeling and packaging issues caused 33% of all medication errors in 2006, this is one area that matters immensely.
In order for your prescription or non-prescription medication to be approved for manufacture, sale, or distribution, it's essential that these guidelines are followed. And of course, there are different types of pharmaceutical labels that come with their own set of requirements. This includes labels used across various channels such as clinical trials, hospitals, retail pharmacies, and direct-to-consumer shipping. Regulated categories like healthcare, over-the-counter labeling, and clinical packaging each come with their own detailed requirements.
Inaccurate or incomplete labeling can lead to dosage errors, adverse reactions, or product recalls – impacting both patient safety and brand trust. From drug facts to usage instructions, the importance of pharmaceutical labeling is not just regulatory; it’s foundational to user understanding.
In today's post, we'll discuss a few of the main types of pharmaceutical labels to assist you on the road to FDA compliance.
The labels used for pharmaceutical product packaging are essential tools for communication, compliance, and product integrity. Whether you're a global pharmaceutical company or a contract manufacturer, understanding your label requirements is a critical step in meeting FDA labeling guidelines. Below is a breakdown of the most common label types and their distinct roles.
A professional patient package insert (sometimes known as a PPI) is an essential part of any pharmaceutical label design. It's the most basic and important way to express information about the drug in question to both patients and the individual(s) prescribing or recommending it.
These inserts typically include:
It's also key to note that all promotional branding and advertising must be consistent with the information relayed in the drug's PPI. Because this content is often too detailed for the primary label, it's commonly delivered through custom extended content labels or folded inserts, which are engineered for both legibility and regulatory durability.
The Patient Package Insert and FDA approved patient labeling is specifically geared towards the patient consuming the medication – not towards those who might prescribe it.
This type of labeling may sometimes be perforated or otherwise torn off as a leaflet to give to the patient to peruse. It is not the same thing as patient counseling information, but instructions in the patient counseling information may direct the patient to read the separate patient labeling information. This FDA approved patient labeling typically includes medication guides and instructions for use.
Whether or not a given medication must include a medication guide is determined by FDA regulations (usually, if they pose a significant health concern). But no matter what, this information must be legible and written in non-technical, easily understood language. The package insert must contain the foundation of information used in other components of the pharmaceutical packaging.
With growing FDA scrutiny and focus on accessibility, these materials must be durable, easy to read, and adaptable to various print formats like peel-back or booklet labels.
These types of pharmaceutical labels are found on the back of over-the-counter medications to help consumers understand how the drug is used and what factors to consider before using a given medication.
This labeling includes information pertaining to use and relevant warnings, including:
Keep in mind that vitamins or dietary supplements do not need a drug facts label; instead, they'll require a supplement facts label, as they are regulated as food products by the FDA.
At Premium Label & Packaging Solutions (PLPS), we help meet evolving standards by offering compliant packaging design that supports both user comprehension and label performance. For compact or space-limited packages, we offer pressure-sensitive labels that meet FDA layout standards and maintain durability on curved or flexible containers.
Learn more about our healthcare labeling solutions that support compliance across patient, provider, and regulatory audiences.
The area of pharmaceutical labeling can be extremely complex, particularly because different medications call for different types of pharmaceutical labels. What's necessary for an over-the-counter drug may be totally different for the type of packaging required for a prescription medication -- even if they're used to treat the same conditions. But no matter what types of labels you choose, you'll need to ensure that the information is expressed clearly and concisely to ensure all consumers can safely use your product.
That’s why it’s critical to go beyond simply applying ink to packaging. Labeling success isn’t just about printing – it’s about selecting the right materials, adhesives, and constructions that align with your product’s specific use case and regulatory needs. At PLPS, we take a consultative approach, helping clients account for variables like container shape, environmental exposure, and legibility requirements.
No matter if you're preparing for FDA review or launching a new pharmaceutical packaging line, our team will help you choose the format that meets both regulatory goals and your brand standards.
With decades of experience in prescription drug labeling and a focus on regulated industries, PLPS is the trusted partner of choice for pharmaceutical companies across the country. From concept to compliance, our team helps you navigate the complexities of label design, production, and fulfillment at scale.
Let’s build safer, smarter, and stronger packaging together. Contact us today to start your compliance-first labeling solution.
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