The FDA has been looking at this for a long time.            They have finally released the final rule for pregnancy              & lactation in the package inserts.  But there is            time as the rule will not take effect until June 30, 2015            for new drugs. For old (existing on the market) drugs it            will happen over time. 
The FDA published a final rule today            (12/3/2014) that sets standards on changes to pregnancy and            lactation labeling information for prescription drug and            biological products. The final                rule replaces the current product letter categories – A,                B, C, D and X – used to classify the risks of using                prescription drugs during pregnancy with            three detailed subsections that describe risks within the            real-world context of caring for pregnant women who may need            medication.
The rule            finalizes many of the provisions in the proposed rule that            the FDA issued in May 2008, and will be in effect as                of June 30, 2015. Once the final rule is in              effect, newly approved drug and biological product              applications will be required to use the new format              immediately, while the new labeling content and format            requirements for previously approved products            subject to the Physician Labeling Rule will be phased in              gradually. FDA press release: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm425317.htm              Final rule (Federal            Register): https://www.federalregister.gov/articles/2014/12/04/2014-28241/pregnancy-and-lactation-labeling-requirements-content-and-format-of-labeling-for-human-prescription 



Frank J. Nice, RPh, DPA, CPHP



 		 	   		  
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