A. FDA is finalizing those changes that are based on proposals it made in earlier stages of rulemaking, including a 2007 proposed rule, on which it already received public comment. Those comments also helped to inform the Agency's thinking about additional aspects of sunscreen regulation, which in turn gave rise to the Proposed Rule and Advance Notice of Proposed Rulemaking (ANPR). The regulatory process requires FDA to give public notice and opportunity for comment before finalizing additional changes, which also gives the public and FDA an opportunity to further develop the record (data and information) on safety and effectiveness.
Over-the-counter medications can still carry a risk, even though they do not require a prescription. There is the possibility of side effects , drug interactions , or harm due to excessive doses . Consumers should read the “Drug Facts” label that is found on all OTC products. All patients should consult with their doctor, pharmacist or other health care provider if they have additional questions concerning OTC drug use. Pregnant women should speak with their doctor before taking any medication, vitamin, or herbal supplement, even if it's an OTC product.
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