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We Which statements in the Pregnancy and Lactation Labeling Final Rule (PLLR) are true? Select all that apply. The PLLR uses three narrative sections and multiple subsections Prescription drugs submitted for U.S. Food and Drug Administration (FDA) approval after June 30, 2015, have to use the PLLR format. Medications approved before June 29, 2001, are not subject to the PLLR rule but had to remove the letter category by June 29, 2018. Prescription drugs approved by the FDA on or after June 30, 2001, are already in PLLR format. Over-the-counter (OTC) drugs are subject to PLLR pregnancy labeling.

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