FDA revising drug label policy for pregnant women

A final rule from the FDA was recently announced pertaining to the way that medicine is labeled for expectant mothers. According to a release from the company, the new rule would simplify the existing method of classifying drugs based on how dangerous they could be to women in certain stages of pregnancy. It is scheduled to take effect by next June 30, meaning that all producers who would be affected need to have printing solutions in place by then to make compliant labels.

The newly submitted labeling requirements would create three categories instead of the five currently used: “Pregnancy,” “Lactation” and “Females and Males of Reproductive Potential,” The organization hopes that these categories will be more descriptive and help users better understand the risks for each individual step in a woman’s pregnancy.

In the announcement on this ruling, the FDA’s Dr. Sandra Kweder explained the rationale behind this system, and why they needed to be more detailed.

“The letter category system was overly simplistic and was misinterpreted as a grading system, which gave an over-simplified view of the product risk,” she said. “The new labeling rule provides for explanations, based on available information, about the potential benefits and risks for the mother, the fetus and the breastfeeding child.”

With a clear idea of what these labels need to accomplish, your company can focus on printing them in a way that saves you money and helps consumers stay informed. Industrial labeling systems will help you set up a regular production line that creates and sets up medicine labels ready for proper application. By establishing all of these settings beforehand, you will have a pre-set system perfect for printing new labels regularly and effectively.