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src=\"https:\/\/bioriusold.wpenginepowered.com\/wp-content\/uploads\/2020\/11\/constitution_usa.png\" sizes=\"(max-width: 1250px) 100vw, 1250px\" srcset=\"https:\/\/bioriusold.wpenginepowered.com\/wp-content\/uploads\/2020\/11\/constitution_usa.png 1250w, https:\/\/bioriusold.wpenginepowered.com\/wp-content\/uploads\/2020\/11\/constitution_usa-300x132.png 300w, https:\/\/bioriusold.wpenginepowered.com\/wp-content\/uploads\/2020\/11\/constitution_usa-1024x449.png 1024w, https:\/\/bioriusold.wpenginepowered.com\/wp-content\/uploads\/2020\/11\/constitution_usa-768x337.png 768w, https:\/\/bioriusold.wpenginepowered.com\/wp-content\/uploads\/2020\/11\/constitution_usa-24x11.png 24w, https:\/\/bioriusold.wpenginepowered.com\/wp-content\/uploads\/2020\/11\/constitution_usa-36x16.png 36w, https:\/\/bioriusold.wpenginepowered.com\/wp-content\/uploads\/2020\/11\/constitution_usa-48x21.png 48w\" alt=\"\" width=\"1250\" height=\"548\"><\/div>\n<\/figure>\n<\/div>\n<div class=\"wpb_text_column wpb_content_element \">\n<div class=\"wpb_wrapper\">\n<p>\u3057\u304b\u3057\u3001\u7c73\u56fd\u3067\u300c\u5316\u7ca7\u54c1\u300d\u3068\u547c\u3070\u308c\u3066\u3044\u308b\u3082\u306e\u306f\u3001EU\/\u82f1\u56fd\u3084\u4ed6\u306e\u307b\u3068\u3093\u3069\u306e\u56fd\u3005\u306b\u304a\u3051\u308b\u300c\u5316\u7ca7\u54c1\u300d\u306e\u5b9a\u7fa9\u3068\u5b8c\u5168\u306b\u4e00\u81f4\u3057\u3066\u3044\u308b\u308f\u3051\u3067\u306f\u306a\u3044\uff1a<\/p>\n<\/div>\n<\/div>\n<div class=\"wpb_text_column wpb_content_element \">\n<div class=\"wpb_wrapper\">\n<h3><strong>\u30ec\u30ae\u30e5\u30e9\u30fc\u5316\u7ca7\u54c1<\/strong><\/h3>\n<p><a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-laws-regulations\/it-cosmetic-drug-or-both-or-it-soap#Definecosmetic\">FDA\u306f\u3001\u5316\u7ca7\u54c1<\/a>\uff3bFD&amp;C\u6cd5\u7b2c201\u6761(i)\uff3d\u3092\u305d\u306e\u4f7f\u7528\u76ee\u7684\u306b\u3088\u3063\u3066<a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-laws-regulations\/it-cosmetic-drug-or-both-or-it-soap#Definecosmetic\">\u5b9a\u7fa9\u3057\u3066<\/a>\u304a\u308a\u3001<em>\u300c\u6e05\u6f54\u306b\u3057\u3001\u7f8e\u5316\u3057\u3001\u9b45\u529b\u3092\u5897\u9032\u3057\u3001\u307e\u305f\u306f\u5916\u89b3\u3092\u5909\u3048\u308b\u305f\u3081\u306b\u3001\u4eba\u4f53\u306b\u3053\u3059\u308a\u3064\u3051\u3001\u6ce8\u304e\u3001\u632f\u308a\u304b\u3051\u3001\u307e\u305f\u306f\u5674\u9727\u3057\u3001\u4eba\u4f53\u306b\u5c0e\u5165\u3057\u3001\u307e\u305f\u306f\u305d\u306e\u4ed6\u306e\u65b9\u6cd5\u3067\u9069\u7528\u3059\u308b\u3053\u3068\u3092\u610f\u56f3\u3057\u305f\u7269\u54c1<\/em>\u300d\u3068\u3057\u3066\u3044\u308b\u3002  <em>\u4f8b\uff1a\u76ae\u819a\u306e\u4fdd\u6e7f\u5264\u3001\u9999\u6c34\u3001\u53e3\u7d05\u3001\u30de\u30cb\u30ad\u30e5\u30a2\u3001\u30a2\u30a4\u30e1\u30a4\u30af\u3001\u9854\u7528\u5316\u7ca7\u54c1\u3001\u30af\u30ec\u30f3\u30b8\u30f3\u30b0\u30b7\u30e3\u30f3\u30d7\u30fc\u3001\u30d1\u30fc\u30de\u30cd\u30f3\u30c8\u30a6\u30a7\u30fc\u30d6\u3001\u30d8\u30a2\u30ab\u30e9\u30fc\u3001\u30c7\u30aa\u30c9\u30e9\u30f3\u30c8\u5264\u3001\u304a\u3088\u3073\u5316\u7ca7\u54c1\u306e\u6210\u5206\u3068\u3057\u3066\u4f7f\u7528\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u305f\u7269\u8cea\u3002<\/em><\/p>\n<\/div>\n<\/div>\n<div class=\"wpb_text_column wpb_content_element \">\n<div class=\"wpb_wrapper\">\n<h3><strong>\u5e02\u8ca9\u54c1<\/strong><\/h3>\n<p>\u4e00\u822c\u7528\u533b\u85ac\u54c1\u306f\u3001\u51e6\u65b9\u7b8b\u306a\u3057\u3067\u5165\u624b\u3067\u304d\u308b\u533b\u85ac\u54c1\u3067\u3042\u308b\u3002OTC\u533b\u85ac\u54c1\u306f\u3001<a href=\"https:\/\/www.fda.gov\/drugs\/types-applications\/drug-applications-over-counter-otc-drugs\">FDA<\/a>\uff08FD&amp;C\u6cd5201\u6761(g)(1)<a href=\"https:\/\/www.fda.gov\/drugs\/types-applications\/drug-applications-over-counter-otc-drugs\">\uff09\u306b\u3088\u308a<\/a> <em>\u300c\u533b\u7642\u5c02\u9580\u5bb6\u306b\u3088\u308b\u6cbb\u7642\u3092\u53d7\u3051\u308b\u3053\u3068\u306a\u304f\u3001\u4e00\u822c\u5927\u8846\u304c\u4f7f\u7528\u3067\u304d\u308b\u5b89\u5168\u304b\u3064\u6709\u52b9\u306a\u533b\u85ac\u54c1<\/em>\u300d\u3068<a href=\"https:\/\/www.fda.gov\/drugs\/types-applications\/drug-applications-over-counter-otc-drugs\">\u5b9a\u7fa9\u3055\u308c\u3066<\/a> <em>\u3044\u307e\u3059\u3002<\/em>BIORIUS\u3067\u306f\u3001\u65e2\u5b58\u306e\u30e2\u30ce\u30b0\u30e9\u30d5\u304c\u3042\u308bOTC\u533b\u85ac\u54c1\u3092\u30ab\u30d0\u30fc\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-laws-regulations\/it-cosmetic-drug-or-both-or-it-soap#Definecosmetic\">FDA\u306f\u30e2\u30ce\u30b0\u30e9\u30d5<\/a>\uff08\uff1d\u898f\u5247\uff09\u3092<a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-laws-regulations\/it-cosmetic-drug-or-both-or-it-soap#Definecosmetic\">\u516c\u8868\u3057\u3066<\/a>\u304a\u308a\u3001\u3069\u306e\u6210\u5206\u3092\u3069\u306e\u3088\u3046\u306a\u76ee\u7684\u3067\u4f7f\u7528\u3057\u3066\u3088\u3044\u304b\u306a\u3069\u306e\u8981\u4ef6\u3092\u660e\u8a18\u3057\u3066\u3044\u308b\u3002  <\/p>\n<\/div>\n<\/div>\n<div class=\"wpb_text_column wpb_content_element \">\n<div class=\"wpb_wrapper\">\n<h3><strong>\u77f3\u9e78<\/strong><\/h3>\n<p>\u306b\u3064\u3044\u3066  <a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-laws-regulations\/it-cosmetic-drug-or-both-or-it-soap#Define_soap\">FDA\u306f<\/a>2\u3064\u306e\u6761\u4ef6\u306b\u5f93\u3063\u3066<a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-laws-regulations\/it-cosmetic-drug-or-both-or-it-soap#Define_soap\">\u300c\u77f3\u9e78\u300d\u3092\u5b9a\u7fa9\u3057\u3066<\/a>\u3044\u308b\uff1a<\/p>\n<ul>\n<li>\u88fd\u54c1\u4e2d\u306e\u4e0d\u63ee\u767a\u6027\u7269\u8cea\u306e\u5927\u90e8\u5206\u306f\u8102\u80aa\u9178\u306e\u30a2\u30eb\u30ab\u30ea\u5869\u304b\u3089\u306a\u308a\u3001\u88fd\u54c1\u306e\u6d17\u5264\u7279\u6027\u306f\u3053\u308c\u3089\u306e\u30a2\u30eb\u30ab\u30ea\u8102\u80aa\u9178\u5316\u5408\u7269\u306b\u8d77\u56e0\u3059\u308b\u3002<\/li>\n<li>\u88fd\u54c1\u304c\u77f3\u9e78\u3068\u3057\u3066\u306e\u307f\u8868\u793a\u3001\u8ca9\u58f2\u3001\u8868\u793a\u3055\u308c\u3066\u3044\u308b\u5834\u5408<a href=\"https:\/\/www.ecfr.gov\/cgi-bin\/retrieveECFR?gp=&amp;SID=79073513f7ba6a05126c6da0aa85c460&amp;r=PART&amp;n=21y7.0.1.2.11#21:7.0.1.2.11.3.1.1\">[21 CFR 701.20<\/a>]\u3002<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<div 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