Mohamad-Ali Salloum is a Pharmacist and science writer. He loves simplifying science to the general public and healthcare students through words and illustrations. When he's not working, you can usually find him in the gym, reading a book, or learning a new skill.
FDA pregnancy medication Labelling : Post 2015.
Mohamad Ali Salloum, PharmD • April 2, 2022
Share
Starting from 30 June 2015, the FDA implemented a new labelling rule for medications used during pregnancy and lactation.
As discussed in the previous article, the Categories published in 1979 (A, B, C, D, and X) were causing confusion for the patients and are increasing the risk to be misinterpreted by the health care professionals.
The new format is called the “Pregnancy and Lactation Labelling Rule” and is abbreviated as PLLR.
Using PLLR will remove some of the uncertainty that was caused by the previous five categories since it will contain a narrative information about the medication that will describe the potential risks of drug exposure based on available, evidence-based data. Ultimately, the new format will assist the health care professionals to assess the benefit versus risk when counseling pregnant women and nursing mothers who need the medication, and thus leading to enhanced protection of the mother and her baby.
After the PLLR was implemented, every pharmaceutical company that wants to register it’s new drug in the FDA, It should use the template provided by the FDA to include the required information in the leaflet.
Regarding the medications that were approved by FDA after 30 June 2001, The manufacturer was given from two to four years after 2015 to change the information on the leaflet as required.
Meanwhile, for the medications that were approved by the FDA before 30 June 2001, the format of the information was not required to be changed, however, It was mandated to remove the categorization that was assigned to this medication. The deadline for this action was 30 June 2018.
Concerning the OTC drugs, medications that can be given without a prescription, they were not affected by the new rule.
Not only the letter categorization was removed, the FDA also required the manufacturer to modify the sections in the leaflet.
The below picture will illustrate the modification on sections done between the 2 formats.
Briefly describing the change in the sections:
-The FDA decided to merge "Labor and Delivery" with the "Pregnancy" in section 8.1.
-Section 8.2 was named "Lactation".
-A new section was added, which is 8.3. and it described the information regarding the females and males of reproductive potential.
Speaking about this new section, it's very important to inform the physician about every drug that is being administered by the father or the mother of the baby. Also, if the couple were planning to have a baby, then they should discuss with the doctor about the drugs that being are being administered since a lot of drugs can remain in your body even after discontinuing it. (some medications can stay for weeks and even months in our bodies).
List of Services
ABOUT THE AUTHOR
Mohamad-Ali Salloum, PharmD
Share
Recent articles:
References: Harkin B, Webb TL, Chang BPI, Prestwich A, Conner M, Kellar I, et al. Does monitoring goal progress promote goal attainment? A meta-analysis of the experimental evidence. Psychol Bull . 2016;142(2):198–229. Available from: https://www.apa.org/pubs/journals/releases/bul-bul0000025.pdf Compernolle S, DeSmet A, Poppe L, Crombez G, De Bourdeaudhuij I, Cardon G, et al. Effectiveness of interventions using self-monitoring to reduce sedentary behavior in adults: a systematic review and meta-analysis. Int J Behav Nutr Phys Act . 2019;16(1):63. Available from: https://link.springer.com/article/10.1186/s12966-019-0824-3 Patel ML, Brooks TL, Bennett GG. Consistent self‑monitoring in a commercial app‑based intervention for weight loss: results from a randomized trial. J Behav Med . 2020;43:391–401. Available from: https://link.springer.com/article/10.1007/s10865-019-00091-8 Patel ML, Hopkins CM, Brooks TL, Bennett GG. Comparing self-monitoring strategies for weight loss in a smartphone app: randomized controlled trial. JMIR Mhealth Uhealth . 2019;7(2):e12209. Available from: https://mhealth.jmir.org/2019/2/e12209/ Lally P, Van Jaarsveld CHM, Potts HWW, Wardle J. How are habits formed: Modelling habit formation in the real world. Eur J Soc Psychol . 2010;40(6):998–1009. Available from: https://repositorio.ispa.pt/bitstream/10400.12/3364/1/IJSP_998-1009.pdf Singh B, Murphy A, Maher C, Smith AE. Time to form a habit: A systematic review and meta-analysis of health behaviour habit formation and its determinants. Healthcare (Basel) . 2024;12(23):2488. Available from: https://www.mdpi.com/2227-9032/12/23/2488 Gollwitzer PM, Sheeran P. Implementation intentions and goal achievement: A meta‑analysis of effects and processes. In: Advances in Experimental Social Psychology . 2006;38:69–119. Available from: https://www.researchgate.net/publication/37367696 Adriaanse MA, Gollwitzer PM, De Ridder DTD, De Wit JBF, Kroese FM. Breaking habits with implementation intentions: A test of underlying processes. Pers Soc Psychol Bull . 2011;37(4):502–13. Available from: https://dspace.library.uu.nl/bitstream/handle/1874/380229/0146167211399102.pdf Palmer CA, Bower JL, Cho KW, Clementi MA, Lau S, Oosterhoff B, et al. Sleep loss and emotion: A systematic review and meta-analysis of over 50 years of experimental research. Psychol Bull . 2023;149(11):2314–48. Available from: https://www.apa.org/pubs/journals/releases/bul-bul0000410.pdf Kong Y, Yu B, Guan G, Wang Y, He H. Effects of sleep deprivation on sports performance and perceived exertion in athletes and non-athletes: a systematic review and meta-analysis. Front Physiol . 2025;16:1544286. Available from: https://www.frontiersin.org/journals/physiology/articles/10.3389/fphys.2025.1544286/full Tadros M, Newby JM, Li S, Werner‑Seidler A. Psychological treatments to improve sleep quality in university students: systematic review and meta-analysis. PLoS One . 2025;20(2):e0317125. Available from: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0317125 Locke EA, Latham GP. Building a practically useful theory of goal setting and task motivation: A 35‑year odyssey. Am Psychol . 2002;57(9):705–17. Available from: https://med.stanford.edu/content/dam/sm/s-spire/documents/PD.locke-and-latham-retrospective_Paper.pdf
Reference: ACRP. “ICH E6(R2) to ICH E6(R3) Comparison.” (Jan 28, 2025) — terminology & essential records: PDF Clinical Trials Toolkit. “Summary of Key Changes in ICH E6(R3).” (Mar 25, 2025) — proportionality, QbD, safety reporting: Article PharmaEduCenter. “Key changes between ICH GCP E6 R3 and E6 R2.” (Aug 10, 2025) — structure & glossary: Blog CITI Program. “Navigating the Transition from ICH E6(R2) to ICH E6(R3).” (Mar 12, 2025) — consent & site practices: Blog IntuitionLabs. “ICH E6 (R3) Explained.” (Updated Jan 13, 2026) — rationale, data governance: Deep dive
Simplify your day with essentialism: set priorities, eliminate the non‑essential, time‑block deep work, and measure progress for stress‑free productivity.
A runner’s guide to VO₂ max: why plateaus happen and how to fix them with long intervals, tempo, hills, cross‑training and smart periodization.
Explore the science of cognitive dissonance and learn how attitude change occurs, why dissonance matters, and what recent brain studies reveal about decision-making and self-control.
Discover the science behind willpower and impulse control. Explore Dr. David Lewis’s “zombie brain” model, the ego depletion controversy, glucose myths, and evidence-based strategies like the 3-second pause, mindfulness, and environmental design to build lasting self-control.
Explore evidence-based insights into ACE inhibitors, calcium channel blockers, and ARBs for hypertension management.
Discover the latest scientific evidence (2022–2025) on Branched-Chain Amino Acids (BCAAs)—their role in muscle recovery, performance enhancement, and safety.
Explore the benefits of Combination therapy for patients with Hypertension.