Fed Regist. 2012 May 11;77(92):27591-3.
The Food and Drug Administration (FDA) is delaying the compliance dates for the final rule for over-the-counter (OTC) sunscreen drug products that published in the Federal Register of June 17, 2011 (76 FR 35620). The final rule 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. The 2011 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. This final rule is part of FDA's ongoing review of OTC drug products.
美国食品药品监督管理局（FDA）正在推迟2011年6月17日在《联邦公报》（76 FR 35620）上发布的非处方（OTC）防晒药品最终规则的合规日期。该最终规则为某些含有特定活性成分且未经批准申请即上市的OTC防晒产品制定了标签和有效性测试要求。它还修改了目前尚无数据支持的标签声明，并取消了先前发布的对OTC防晒霜药品事实标签要求实施的延迟规定。2011年最终规则的合规日期之所以被推迟，是因为在2011年最终规则发布后收到的信息表明，要全面实施2011年最终规则对所有受影响产品的要求还需要额外6个月时间。本最终规则是FDA对OTC药品持续审查的一部分。
