BRequires pregnancy-safe categories to be applied and labeled for medications and supplements.
CRequires all over-the-counter (OTC) medications to be labeled with safety information for pregnancy and lactation.
DRemoved the FDA pregnancy categories applied to medications.
✓ Correct answer: D. Removed the FDA pregnancy categories applied to medications.The correct answer is B) Removed the FDA pregnancy categories applied to medications.<br/><br/> The 1979 system of pregnancy categories (A, B, C, D, X) was replaced with the PLLR. Pregnancy categories were too simple and were often misinterpreted. The PLLR provides the relevant drug information to allow for informed clinical decision-making.<br/><br/><strong>Choice A is incorrect. </strong>The PLLR does not apply to OTC medication labels. It only applies to prescription drugs and biological products, which are required to be labeled with pregnancy-risk categories.<br/><br/><strong>Choice C is incorrect. </strong>The PLLR replaced the old FDA pregnancy categories with pregnancy-risk categories and subsets of information required under each of the 3 categories: pregnancy (includes through delivery), lactation, and females/males of reproductive potential. The PLLR does not apply to labeling of supplements or OTC products, which is important for patients to understand.<br/><br/><strong>Choice D is incorrect. </strong>The pregnancy subsection established a pregnancy exposure registry that collects data on pregnant women and provides information on risks, clinical considerations, and data. The lactation subsection provides information on risks, clinical considerations, and data. The females and males of the reproductive potential subsection provide information on pregnancy testing, contraception, and infertility.
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