FDA Enforcement Policy -- OTC Sunscreen Drug Products Marketed Without an Approved Application
标准简介
Enforcement Policy -- OTC Sunscreen Drug Products Marketed Without an Approved Application[附网盘链接]是FDA发布的FDA标准，适用于美国。标准截图
![Enforcement Policy -- OTC Sunscreen Drug Products Marketed Without an Approved Application[附网盘链接]](/img/20210914103738pa7br.jpg)
标准文档说明
标准文档类型为Enforcement Policy -- OTC Sunscreen Drug Products Marketed Without an Approved Application[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Enforcement Policy — OTC Sunscreen Drug Products
Marketed Without an Approved Application
1
Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. I. INTRODUCTION This guidance describes FDA’s enforcement approach with respect to over-the-counter (OTC) sunscreen products marketed without approved applications during the period before a final sunscreen monograph becomes effective. It is intended for manufacturers who market OTC 2
sunscreen drug products without an approved application. OTC sunscreens are not yet the subject of an effective final monograph, and we continue to evaluate information relevant to defining conditions under which such products are generally recognized as safe and effective (GRASE) and not misbranded. However, OTC sunscreens marketed without approved applications and containing specified active ingredients (see section II., Background) are subject to labeling and testing requirements located at 21 CFR 201.327. Several other ongoing and planned rulemaking proceedings will also address these products. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. 1 This guidance has been prepared by the Division of Nonprescription Drug Products in the Center for Drug Evaluation and Research at the Food and Drug Administration. 2
See section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355). Approved applications under section 505 include both new drug applications and abbreviated new drug applications. Some OTC sunscreen products are currently marketed under approved applications. This guidance does not address those products. 1
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