FDA Delays Compliance for OTC Sunscreen Drug Products Rule by 6 Months
Compliance dates for the FDA’s final rule for over-the-counter sunscreen drug products is now delayed by six months, i.e. until December 17, 2013 (from June 17, 2013), for products with annual sales of less than $25,000 and December 17, 2012 (from June 18, 2012), for all other products subject to the rule, the Food and Drug Administration announced.
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FDA said its final rule, published in the Federal Register on June 17, 2011, establishes labeling and effectiveness testing for certain OTC sunscreen products containing specified active ingredients and marketed without approved applications. It also amends labeling claims that are not currently supported by data and lifts the previously-published delay of implementation of the Drug Facts labeling requirements for OTC sunscreens.
According to the FDA, The final rule’s compliance dates are being delayed because information received after publication of the 2011 final rule indicates that full implementation of the 2011 final rule’s requirements for all affected products will require an additional 6 months.