In the past, clinical considerations around reproductive health have been labeled thus: pregnancy (8.1), labor and delivery (8.2), nursing mothers (8.3). Following a revision by the Food and Drug Administration (FDA), two of those categories will merge and a third will be added, starting June 30, 2015.
The new categories will be represented like this:
- 8.1 Pregnancy. This umbrella will now include pregnancy-related considerations as well as labor and delivery for expectant mothers. “The first section of the new labeling structure includes information pertaining to pregnancy, including dosing that could be different if a woman were not pregnant; risks to the developing fetus; and information about whether there is a registry that collects data on how pregnant women are affected when using the medication,” writes Loren Bonner of the American Pharmacists Association.
- 8.2 Lactation. Replacing the old “nursing mothers” category, this takes into account warnings for women who are currently breastfeeding.
- 8.3 Females and Males of Reproductive Potential. This new categorization provides for considerations that people of both genders make about pharmaceutical use as it relates to their reproductive ability.
For pharmaceutical providers, reflecting these changes in 2015 will help focus the industry less on the adverse effects of medicines on pregnant women, but on a range of medical considerations that can result from use of a particular drug. Staying abreast of FDA regulations and updating labels with the aid of an industrial label printer will ensure that patients and pharmacists are aware of risks and indications for prescriptions.
Top-of-the-line printing technology allows companies to adapt to changing standards without missing a beat. The advantage of custom label printing is that it saves time and money, instead of spending resources paying third parties.