确保化妆品符合美国食品药品监督管理局(FDA)的监管标准是非常重要的,以确保产品的安全性、合规性和市场合法性。以下是一些方法来确保你的化妆品符合FDA的监管标准: 了解FDA法规: 首先,了解适用于化妆品的FDA法规、指南和要求,包括《化妆品标签指南》(Cosmetic Labeling Guide)等。这些文件将指导你产品标签、成分、宣传...
FDA化妆品良好生产规范指南(中文)[一].pdf,美国食品和药品管理局 Cosmetic Good Manufacturing Practice Guidelines 化妆品良好生产规范指南 联邦食品、药品和化妆品法案 (The Federal Food, Drug and Cosmetic Act, 以下简称FDC 法案)禁止在州际直接贸易的化妆品是掺杂
Manual (RPM) (监管程序手册(RPM)是FDA人员的参考手册,为FDA人员提供了在处理国内和进口监管和执法事务中使用的内部程序信息、Federal Food, Drug, and Cosmetic Act (FD&C Act)(联邦食品、药品和化妆品法(FD&C法))、FDA Compliance Policy Guides (CPG) (FDA合规政策指南(CPG))及 Regulatory Procedures Manual ...
Cosmetics should be labeled according to the Cosmetic Labeling Manual. Cosmetic companies can’t have it both ways. They can’t tell the FDA that their product isn’t a drug but then tell consumers that their product acts like a drug. For example, claims that cosmetics can reduce cellulite,...
Franz, Neil
美国FDA现行的良好制造规范(GoodManufacturingPractices,GMP)在质量体系(QualitySystem,QS)规章中提出,发布在联邦食品、药品和化妆品法(Food,DrugandCosmetic,FD&C)第520节中。GMP要求任何国内或国外的制…
(4)FDCA第609节:化妆品标签和香精过敏原披露(Cosmetic Labeling and FragranceAllergen Transparency) MoCRA颁布之前,产品标签只需要标注“Fragrance”即可,未强制标注香精过敏原相关信息。但新增的第609节,在FDA化妆品标签当前要求的基础上,设定了三种方式:
04/16/2018 Page 3 of 31 PROGRAM 7348.809A An additional regulation has been promulgated at 21 CFR 201.129, which provides an exemption from section 502(f)(1) (adequate directions for use) of the Federal Food, Drug, and Cosmetic Act if the packaging, labels, and labeling of the research ...
美国FDA 指导原则 根据联邦食品、药品和化妆品法行业指南第503B条,实质上是经批准的药品的复制品的复合药物产品 英文原版.pdf,Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosme
Manual (RPM) (监管程序手册(RPM)是FDA人员的参考手册,为FDA人员提供了在处理国内和进口监管和执法事务中使用的内部程序信息、Federal Food, Drug, and Cosmetic Act (FD&C Act)(联邦食品、药品和化妆品法(FD&C法))、FDA Compliance Policy Guides (CPG) (FDA合规政策指南(CPG))及...