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BLOG: FDA’s Mandatory Pregnancy and Lactation Labeling Rule (PLLR) Implementation: Taking the Final ‘Baby’ Steps


WEBINAR:  Join us Thursday, May 14, 2020 at 11:00 am ET for our live webinar “FDA’s Pregnancy and Lactation Labeling Rule. Best practices to easily revise, submit and pass FDA validation of your label.  Here’s more information


When is it safe for a pregnant woman to continue taking her prescription medications? Which treatments are safe and effective for a breastfeeding mom? And with any prescription drug or biological treatment, what risks and considerations are relevant for patients who could become pregnant, or impregnate someone, while undergoing the therapy?

Labels for prescription drugs and biological products help healthcare providers and patients navigate the complexities of using treatments before, during and after pregnancy. For years, information in a label’s “Use in Specific Populations” section was organized into three subsections: “Pregnancy,” “Labor and Delivery” and “Nursing Mothers.”

As part of a broader effort to improve the content and formatting of drug labeling, in 2014 the U.S. Food and Drug Administration published new rules for how to present this information. The new Pregnancy and Lactation Labeling Rule (PLLR, or final rule, 79 FR 72064) requires that the content be organized as follows:

New Pregnancy and Lactation Labeling Rule (PLLR)
Mandatory FDA Compliance Deadline June 30, 2020

  • 1) Pregnancy, which now includes labor and delivery, offers sections on Risk Summary, Clinical Considerations and Data,
  • 2) Lactation, which covers nursing mothers, also offers Risk Summary, Clinical Considerations and Data sections and
  • 3) Females and Males of Reproductive Potential is a newly added category with sections addressing Pregnancy Testing, Contraception and Infertility.

The rule, which took effect on June 30, 2015, allows for phased implementation depending on when a prescription drug or biological product label was approved. Any new product label submitted on or after June 30, 2015 was required to follow PLLR. Older approved applications were split into three phases as follows:

  • Any labels approved between June 30, 2001 and June 29, 2007 had to make the update by June 30, 2018.
  • Any labels approved from June 30, 2007 to June 29, 2015, or that were pending on June 30, 2015, had to comply by June 30, 2019.
  • The final retrospective cohort—labels approved between June 30, 2002 and June 29, 2005—must be updated no later than June 30 of this year.

PLLR also removes the pregnancy letter categories (A, B, C, D and X) that had been used for decades. These categories had proven problematic due to the potential for oversimplification of risk when a drug with a specific category is given to a pregnant female. Additionally, the old system implied a “graded” level of risk and could imply, often incorrectly, that drugs within the same category had similar risks. The letter categories are being replaced by narrative information designed to provide greater clarity to clinicians as they apply the information in their practices.

With the final PLLR deadline fast approaching, companies can benefit from Reed Tech Drug Label Research and Structured Product Labeling Solutions. Reed Tech Navigator™ for Drug Labels makes it easy to access, research and compare the most up-to-date labels for more than 350,000 FDA-approved branded and generic drugs, providing valuable insights on how competitors are addressing PLLR. Our Structured Product Labeling Solutions provide expert help in submitting new or updated label content in SPL format—helping assure accuracy while alleviating overburdened internal resources.

The deadline for this mandatory compliance is June 30, 2020.  Please contact us at for more information and to discuss how our compliance experts, Drug Label Research and SPL Solutions can help you quickly and easily comply with the PLLR guidelines or other regulatory compliance initiatives you may have on your “to-do” list.


WEBINAR:  Join us Thursday, May 14, 2020 at 11:00 am ET for our live webinar “FDA’s Pregnancy and Lactation Labeling Rule. Best practices to easily revise, submit and pass FDA validation of your label.  Here’s more information


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