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doi: 10.2337/dc20-2080 166 GriffinSJLeaverJKIrvingGJ

If a pregnant woman is taking these drugs and doesnt realize the risks, and it does bear out the drugs cause human fetal harm, he said, we could end up in an awful mess pregnancies ending in miscarriage or neonates born with birth defects. What animal studies have found While seven in 10 people in the US take a prescription drug during pregnancy, only 10 percent of medicines recently approved by the FDA reach the market after theyve been studied during human pregnancy, according to an analysis published in JAMA , because of safety and ethical concerns

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While compounding is still permitted for individualized patient needs if a drug is formulated differently, such as removing an allergen or altering the dosage form, mass-producing exact replicas of branded injections is no longer an open option (Burr & Forman LLP, 2025)

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