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A Primer on Pharmaceutical Label Types and Requirements

August 30, 2018

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. 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.

Pharmaceutical Labeling Types Include:

Professional Labeling or Professional Package Inserts

A professional 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.

It includes the official description of the drug itself, what it's used for, who should take this medication, possible adverse side effects, specific instructions for certain demographics (e.g., pregnant women, children, etc.), and general safety information.

It's also key to note that all promotional branding and advertising must be consistent with the information relayed in the drug's PPI.

FDA Approved Patient Labeling and Medication Guides

Sometimes known as the Patient Package Insert, the 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.

Drug Facts 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 active ingredients, symptoms that it can help to treat, possible side effects, conditions in which a consumer should refrain from taking the drug or cease their use of it, inactive ingredients, specific directions, and other information. 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.

Pharmaceutical Labeling Resources

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. For more information on pharmaceutical labeling, please contact us today.

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