FDA releases updated guidance on pharmaceutical labeling

The U.S. Food and Drug Administration (FDA) released updated guidance, titled “Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products”, earlier this week in order to increase the clarity of labels for consumers. 

Pharmaceutical labeling requirements remain among the strictest and most heavily overseen by the FDA, as it is important to consumer safety that the labels contain the necessary information. The FDA requires that pharmaceutical labels contain a list of ingredients, warnings and instructions, and that the text be clearly visible regardless of the environment or conditions the container may encounter.

The latest updates from the FDA focused on labeling the risks of drugs, and what descriptions are sufficient to adequately warn users of potential harm. The changes, while small, have significant impact for manufacturers.

“Clinical pharmacology information collected throughout a drug product’s life can contribute to the product’s labeling,” the FDA released in a statement. “Specifically, we consider what clinical pharmacology information can be directly translated to patient care management.”

One of the proposed changes requires pharmaceuticals to show whether the drug’s efficacy is affected by race, ethnicity, sex or age. Regulators say that these concerns will now be listed under the “specific populations” part of the label. 

Errors in pharmaceutical labeling can have significant and costly consequences for manufacturers. Because of this fact, it is best practice for those in the industry to sever ties with third-party printers and invest in their own in-house label printing solutions. Not only is this strategy more cost-efficient, it can also allow organizations to quickly react to changes in regulation, such as the FDA’s most recent guidance.