{"id":19175,"date":"2026-01-02T13:56:55","date_gmt":"2026-01-02T05:56:55","guid":{"rendered":"https:\/\/greenoo.tw\/?p=19175"},"modified":"2026-01-02T13:58:33","modified_gmt":"2026-01-02T05:58:33","slug":"taiwan-seller-fda-otc-compliance-guide-drug-classification","status":"publish","type":"post","link":"https:\/\/greenoo.tw\/zh\/taiwan-seller-fda-otc-compliance-guide-drug-classification\/","title":{"rendered":"\u53f0\u7063\u8ce3\u5bb6\u8207\u5916\u8cbf\u5de5\u5ee0\u51fa\u53e3\u7f8e\u570b OTC \u5408\u898f\u5168\u6307\u5357\uff1a\u4f60\u7684\u7522\u54c1\u662f\u5426\u5df2\u88ab\u8996\u70ba\u85e5\u54c1\uff1f\uff082026\uff09"},"content":{"rendered":"<h2><img fetchpriority=\"high\" decoding=\"async\" class=\"alignnone size-full wp-image-19176\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/taiwan-seller-fda-otc-compliance-guide-drug-classification-2026.png\" alt=\"\u53f0\u7063\u8ce3\u5bb6\u51fa\u53e3\u7f8e\u570b OTC \u5408\u898f\u5168\u6307\u5357\u5c01\u9762\uff0c\u986f\u793a\u7522\u54c1\u662f\u5426\u88ab\u8996\u70ba\u85e5\u54c1\u7684\u5224\u5b9a\u7591\u554f\u8207 2026 \u6700\u65b0\u6a19\u6e96\" width=\"2560\" height=\"1352\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/taiwan-seller-fda-otc-compliance-guide-drug-classification-2026.png 2560w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/taiwan-seller-fda-otc-compliance-guide-drug-classification-2026-768x406.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/taiwan-seller-fda-otc-compliance-guide-drug-classification-2026-1536x811.png 1536w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/taiwan-seller-fda-otc-compliance-guide-drug-classification-2026-2048x1082.png 2048w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/taiwan-seller-fda-otc-compliance-guide-drug-classification-2026-18x10.png 18w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/><\/h2>\n<h2>\u4f60\u7684\u7522\u54c1\u5728\u7f8e\u570b\u6703\u88ab\u7576\u6210\u85e5\u54c1\u55ce\uff1f\u5148\u770b\u9019\u4e09\u500b\u95dc\u9375\u5224\u5b9a\u6a19\u6e96<\/h2>\n<p>\u662f\u7684\uff0c\u5373\u4f7f\u4f60\u5728\u53f0\u7063\u8ce3\u7684\u662f\u300c\u4fdd\u5065\u98df\u54c1\u300d\u6216\u300c\u65e5\u7528\u54c1\u300d\uff0c\u53ea\u8981\u7522\u54c1\u5ba3\u7a31\u5177\u6709\u6cbb\u7642\u3001\u9810\u9632\u75be\u75c5\u7684\u529f\u6548\uff0c\u5728\u7f8e\u570b\u5c31\u53ef\u80fd\u88ab FDA \u8996\u70ba OTC \u85e5\u54c1\u3002\u5224\u5b9a\u95dc\u9375\u5728\u65bc\u4e09\u5927\u8981\u7d20\uff1a<strong>\u7522\u54c1\u5ba3\u7a31\u5167\u5bb9\u3001\u6d3b\u6027\u6210\u5206\u3001\u6a19\u7c64\u683c\u5f0f<\/strong>\u3002\u4e00\u65e6\u88ab\u6b78\u985e\u70ba\u85e5\u54c1\uff0c\u5c31\u5fc5\u9808\u5b8c\u6210\u8a2d\u65bd\u8a3b\u518a\u3001\u85e5\u54c1\u5217\u8868\u7533\u5831\u3001\u7b26\u5408 cGMP \u88fd\u9020\u6a19\u6e96\uff0c\u5426\u5247\u5c07\u9762\u81e8\u7522\u54c1\u6263\u62bc\u3001\u7f70\u6b3e\u751a\u81f3\u5211\u4e8b\u8cac\u4efb\u3002\u8a31\u591a\u53f0\u7063\u8ce3\u5bb6\u8207\u5916\u8cbf\u5de5\u5ee0\u56e0\u4e0d\u4e86\u89e3 FDA \u7684\u5224\u5b9a\u908f\u8f2f\uff0c\u8aa4\u4ee5\u70ba\u7522\u54c1\u5728\u53f0\u7063\u5408\u6cd5\u5c31\u80fd\u76f4\u63a5\u51fa\u53e3\u7f8e\u570b\uff0c\u7d50\u679c\u5728\u6d77\u95dc\u88ab\u6263\u62bc\u6216\u6536\u5230 FDA \u8b66\u544a\u4fe1\u3002<\/p>\n<p>\u672c\u6587\u5c07\u5b8c\u6574\u89e3\u6790 FDA \u5982\u4f55\u5224\u5b9a\u7522\u54c1\u662f\u5426\u70ba OTC \u85e5\u54c1\uff0c\u5e6b\u52a9\u4f60\u5728\u51fa\u53e3\u524d\u505a\u597d\u6b63\u78ba\u5206\u985e\u8207\u5408\u898f\u6e96\u5099\u3002<\/p>\n<hr \/>\n<h2>\u70ba\u4f55\u53f0\u7063\u696d\u8005\u5bb9\u6613\u8aa4\u5224\u7522\u54c1\u5206\u985e\uff1f<\/h2>\n<p>\u53f0\u7063\u8207\u7f8e\u570b\u5c0d\u300c\u85e5\u54c1\u300d\u7684\u5b9a\u7fa9\u5dee\u7570\u6975\u5927\u3002\u5728\u53f0\u7063\uff0c\u8a31\u591a\u7522\u54c1\u88ab\u6b78\u985e\u70ba\u300c\u5065\u5eb7\u98df\u54c1\u300d\u6216\u300c\u7279\u5b9a\u7528\u9014\u5316\u599d\u54c1\u300d\uff0c\u4f46\u5728\u7f8e\u570b\uff0c<strong>FDA \u4ee5\u7522\u54c1\u5ba3\u7a31\u7684\u529f\u6548\u70ba\u4e3b\u8981\u5224\u5b9a\u4f9d\u64da\uff0c\u800c\u975e\u7522\u54c1\u985e\u5225\u540d\u7a31<\/strong>\u3002\u4f8b\u5982\uff0c\u4e00\u6b3e\u5ba3\u7a31\u300c\u7de9\u89e3\u95dc\u7bc0\u75bc\u75db\u300d\u7684\u8461\u8404\u7cd6\u80fa\u7522\u54c1\uff0c\u5728\u53f0\u7063\u53ef\u80fd\u662f\u5065\u5eb7\u98df\u54c1\uff0c\u4f46\u5728\u7f8e\u570b\u6703\u88ab\u8996\u70ba OTC \u85e5\u54c1\uff1b\u540c\u6a23\u5730,\u5ba3\u7a31\u300c\u6cbb\u7642\u9752\u6625\u75d8\u300d\u7684\u9762\u971c\uff0c\u5373\u4f7f\u5728\u53f0\u7063\u662f\u5316\u599d\u54c1\uff0c\u5728\u7f8e\u570b\u4e5f\u5c6c\u65bc OTC \u85e5\u54c1\u3002<\/p>\n<p>\u9019\u7a2e\u8a8d\u77e5\u843d\u5dee\u5c0e\u81f4\u8a31\u591a\u53f0\u7063\u696d\u8005\u5728\u4e0d\u77e5\u60c5\u7684\u60c5\u6cc1\u4e0b\u9055\u53cd FDA \u6cd5\u898f\u3002\u6839\u64da FDA \u57f7\u6cd5\u8a18\u9304\uff0c2023-2025 \u5e74\u9593\uff0c\u8d85\u904e 60% \u7684\u53f0\u7063\u51fa\u53e3\u7f8e\u570b\u7522\u54c1\u9055\u898f\u6848\u4ef6\u6d89\u53ca\u300c\u672a\u7d93\u6838\u51c6\u7684\u85e5\u54c1\u5ba3\u7a31\u300d\uff0c\u5176\u4e2d\u4ee5\u4fdd\u5065\u98df\u54c1\u3001\u5916\u7528\u8b77\u819a\u54c1\u3001\u53e3\u8154\u8b77\u7406\u7522\u54c1\u6700\u70ba\u5e38\u898b\u3002\u82e5\u4f60\u6b63\u5728\u6e96\u5099\u51fa\u53e3\u7f8e\u570b\u5e02\u5834\uff0c\u7406\u89e3 FDA \u7684\u7522\u54c1\u5206\u985e\u908f\u8f2f\u662f\u7b2c\u4e00\u6b65\uff0c\u4e5f\u662f\u6700\u95dc\u9375\u7684\u4e00\u6b65\u3002\u95dc\u65bc\u5b8c\u6574\u7684 OTC \u6cd5\u898f\u5236\u5ea6\u8207\u5e38\u898b\u9055\u898f\u60c5\u6cc1\uff0c\u53ef\u53c3\u8003\u6211\u5011\u7684\u6df1\u5ea6\u6307\u5357\uff1a<a href=\"https:\/\/greenoo.tw\/zh\/fda-otc-monograph-regulation-framework-compliance\/\" target=\"_blank\" rel=\"noopener\">FDA OTC \u6cd5\u898f\u5236\u5ea6\u8207 Monograph \u67b6\u69cb\u5b8c\u6574\u89e3\u6790<\/a>\u3002<\/p>\n<hr \/>\n<h2>FDA \u5224\u5b9a\u7522\u54c1\u662f\u5426\u70ba OTC \u85e5\u54c1\u7684\u4e09\u5927\u6838\u5fc3\u6a19\u6e96<\/h2>\n<h3>\u6a19\u6e96\u4e00\uff1a\u7522\u54c1\u5ba3\u7a31\u5167\u5bb9\uff08\u6700\u95dc\u9375\u7684\u5224\u5b9a\u4f9d\u64da\uff09<\/h3>\n<p>FDA \u4ee5\u300c\u7522\u54c1\u5ba3\u7a31\u7684\u529f\u6548\u300d\u4f5c\u70ba\u5224\u5b9a\u85e5\u54c1\u7684\u9996\u8981\u6a19\u6e96\uff0c\u800c\u975e\u7522\u54c1\u672c\u8eab\u7684\u6210\u5206\u6216\u5f62\u5f0f\u3002\u6839\u64da\u7f8e\u570b\u806f\u90a6\u6cd5\u898f 21 CFR 201.128\uff0c\u53ea\u8981\u7522\u54c1\u5ba3\u7a31\u5177\u6709\u4ee5\u4e0b\u529f\u80fd\uff0c\u5c31\u6703\u88ab\u8996\u70ba\u85e5\u54c1\uff1a<\/p>\n<ul>\n<li><strong>\u6cbb\u7642\u6216\u9810\u9632\u75be\u75c5<\/strong>\uff1a\u5982\u300c\u6cbb\u7642\u611f\u5192\u300d\u300c\u9810\u9632\u6d41\u611f\u300d\u300c\u7de9\u89e3\u9ad8\u8840\u58d3\u300d<\/li>\n<li><strong>\u5f71\u97ff\u8eab\u9ad4\u7d50\u69cb\u6216\u529f\u80fd<\/strong>\uff1a\u5982\u300c\u4fc3\u9032\u50b7\u53e3\u7652\u5408\u300d\u300c\u6e1b\u7de9\u95dc\u7bc0\u767c\u708e\u300d\u300c\u6539\u5584\u6d88\u5316\u4e0d\u826f\u300d<\/li>\n<li><strong>\u8a3a\u65b7\u75be\u75c5<\/strong>\uff1a\u5982\u300c\u6aa2\u6e2c\u8840\u7cd6\u300d\u300c\u6e2c\u91cf\u9ad4\u6eab\u300d\uff08\u4f46\u90e8\u5206\u5c6c\u65bc\u91ab\u7642\u5668\u6750\uff09<\/li>\n<\/ul>\n<p><strong>\u5be6\u52d9\u6848\u4f8b<\/strong>\uff1a\u4e00\u6b3e\u542b\u6709\u8591\u9ec3\u7684\u81a0\u56ca\u7522\u54c1\uff0c\u82e5\u6a19\u793a\u70ba\u300c\u589e\u5f37\u9ad4\u529b\u3001\u4fc3\u9032\u65b0\u9673\u4ee3\u8b1d\u300d\uff0c\u5728\u7f8e\u570b\u53ef\u6b78\u985e\u70ba\u4fdd\u5065\u98df\u54c1\uff08Dietary Supplement\uff09\uff1b\u4f46\u82e5\u5ba3\u7a31\u300c\u6e1b\u8f15\u95dc\u7bc0\u708e\u75c7\u72c0\u300d\u6216\u300c\u7de9\u89e3\u75bc\u75db\u300d\uff0c\u7acb\u5373\u88ab\u8996\u70ba OTC \u85e5\u54c1\uff0c\u9700\u7b26\u5408\u6240\u6709\u85e5\u54c1\u6cd5\u898f\u3002<\/p>\n<p>\u9700\u8981\u7279\u5225\u6ce8\u610f\u7684\u662f\uff0c\u5ba3\u7a31\u5167\u5bb9\u4e0d\u50c5\u9650\u65bc\u7522\u54c1\u6a19\u7c64\uff0c\u9084\u5305\u62ec<strong>\u7db2\u7ad9\u8aaa\u660e\u3001\u793e\u7fa4\u5a92\u9ad4\u8cbc\u6587\u3001Amazon \u7522\u54c1\u9801\u9762\u3001\u5ee3\u544a\u6587\u6848<\/strong>\u3002\u5373\u4f7f\u7522\u54c1\u6a19\u7c64\u7b26\u5408\u898f\u5b9a\uff0c\u4f46\u82e5\u5728 Facebook \u5ee3\u544a\u4e2d\u5ba3\u7a31\u300c\u6cbb\u7642\u6fd5\u75b9\u300d\uff0cFDA \u4ecd\u53ef\u8a8d\u5b9a\u70ba\u85e5\u54c1\u4e26\u57f7\u6cd5\u3002<\/p>\n<hr \/>\n<h3>\u6a19\u6e96\u4e8c\uff1a\u6d3b\u6027\u6210\u5206\u662f\u5426\u7b26\u5408 OTC Monograph \u6216\u7d93 FDA \u6838\u51c6<\/h3>\n<p>\u5373\u4f7f\u7522\u54c1\u6709\u85e5\u54c1\u5ba3\u7a31,\u9084\u9700\u6aa2\u8996\u6210\u5206\u662f\u5426\u5408\u6cd5\u3002FDA \u5c0d OTC \u85e5\u54c1\u7684\u6210\u5206\u7ba1\u5236\u6709\u5169\u7a2e\u9014\u5f91\uff1a<\/p>\n<div class=\"MarkdownTable_tableContainer__2k5Kh\" tabindex=\"0\" role=\"region\">\n<table>\n<thead>\n<tr>\n<th>\u5408\u898f\u9014\u5f91<\/th>\n<th>\u8aaa\u660e<\/th>\n<th>\u9069\u7528\u60c5\u5883<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td><strong>OTC Monograph<\/strong><\/td>\n<td>FDA \u5df2\u6838\u51c6\u7684\u7279\u5b9a\u6210\u5206\u8207\u5291\u91cf\u914d\u65b9\uff0c\u7121\u9700\u500b\u5225\u7533\u8acb<\/td>\n<td>\u5e38\u898b OTC \u7522\u54c1\uff08\u5982\u6b62\u75db\u85e5\u3001\u80c3\u85e5\u3001\u9632\u66ec\u54c1\uff09<\/td>\n<\/tr>\n<tr>\n<td><strong>NDA\/ANDA<\/strong><\/td>\n<td>\u65b0\u85e5\u7533\u8acb\u6216\u5b78\u540d\u85e5\u7533\u8acb\uff0c\u9700 FDA \u500b\u5225\u5be9\u6838\u6838\u51c6<\/td>\n<td>\u65b0\u6210\u5206\u6216\u4e0d\u5728 Monograph \u7bc4\u570d\u5167\u7684\u7522\u54c1<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<p><strong>\u95dc\u9375\u98a8\u96aa<\/strong>\uff1a\u82e5\u7522\u54c1\u5ba3\u7a31\u6cbb\u7642\u529f\u6548\uff0c\u4f46\u4f7f\u7528\u7684\u6210\u5206<strong>\u672a\u88ab FDA \u6838\u51c6\u6216\u4e0d\u5728 Monograph \u7bc4\u570d\u5167<\/strong>\uff0c\u5373\u70ba\u300c\u672a\u7d93\u6838\u51c6\u7684\u65b0\u85e5\u300d\uff08Unapproved New Drug\uff09\uff0cFDA \u53ef\u76f4\u63a5\u6263\u62bc\u7522\u54c1\u4e26\u5c0d\u8cac\u4efb\u65b9\u57f7\u6cd5\u3002\u4f8b\u5982\uff0c\u8a31\u591a\u53f0\u7063\u696d\u8005\u4f7f\u7528\u4e2d\u85e5\u6750\u6216\u8349\u672c\u8403\u53d6\u7269\u4e26\u5ba3\u7a31\u7642\u6548\uff0c\u9019\u4e9b\u6210\u5206\u7d55\u5927\u591a\u6578\u672a\u88ab FDA \u6838\u51c6\u4f5c\u70ba OTC \u85e5\u54c1\u4f7f\u7528\u3002<\/p>\n<p>2024 \u5e74 FDA CARES Act \u6539\u9769\u5f8c\uff0cOTC Monograph \u5236\u5ea6\u66f4\u52a0\u56b4\u683c\uff0c\u8a31\u591a\u904e\u53bb\u300c\u7070\u8272\u5730\u5e36\u300d\u7684\u6210\u5206\u73fe\u5df2\u660e\u78ba\u7981\u6b62\u3002\u82e5\u4f60\u7684\u7522\u54c1\u4f7f\u7528\u975e\u50b3\u7d71\u897f\u85e5\u6210\u5206\u4f46\u6709\u7642\u6548\u5ba3\u7a31\uff0c\u5efa\u8b70\u5728\u51fa\u53e3\u524d\u8aee\u8a62\u5c08\u696d\u9867\u554f\u78ba\u8a8d\u6210\u5206\u5408\u898f\u6027\u3002<\/p>\n<hr \/>\n<h3>\u5716 2\uff1aFDA OTC \u7522\u54c1\u5206\u985e\u5224\u5b9a\u6c7a\u7b56\u6a39<\/h3>\n<p><strong>\u5716\u7247\u7528\u9014\u8aaa\u660e<\/strong>\uff1a<br \/>\n\u6b64\u6c7a\u7b56\u6a39\u5c07\u300c\u7522\u54c1\u662f\u5426\u88ab\u8996\u70ba OTC \u85e5\u54c1\u300d\u7684\u5224\u5b9a\u908f\u8f2f\u8996\u89ba\u5316\uff0c\u5e6b\u52a9\u53f0\u7063\u8ce3\u5bb6\u8207\u5916\u8cbf\u5de5\u5ee0\u5feb\u901f\u81ea\u6211\u6aa2\u6e2c\u7522\u54c1\u5206\u985e\uff0c\u907f\u514d\u8aa4\u89f8\u6cd5\u898f\u7d05\u7dda\u3002<\/p>\n<p><img decoding=\"async\" class=\"alignnone size-full wp-image-19177\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-otc-product-classification-decision-tree-2026.png\" alt=\"FDA OTC \u7522\u54c1\u5206\u985e\u5224\u5b9a\u6c7a\u7b56\u6a39\uff0c\u986f\u793a\u5f9e\u5ba3\u7a31\u5167\u5bb9\u5230\u6700\u7d42\u5224\u5b9a\u70ba OTC \u85e5\u54c1\u6216\u4fdd\u5065\u98df\u54c1\u7684\u5b8c\u6574\u6d41\u7a0b\u8207\u95dc\u9375\u7bc0\u9ede\" width=\"1792\" height=\"2400\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-otc-product-classification-decision-tree-2026.png 1792w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-otc-product-classification-decision-tree-2026-768x1029.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-otc-product-classification-decision-tree-2026-1147x1536.png 1147w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-otc-product-classification-decision-tree-2026-1529x2048.png 1529w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-otc-product-classification-decision-tree-2026-9x12.png 9w\" sizes=\"(max-width: 1792px) 100vw, 1792px\" \/><\/p>\n<p>\u6a19\u6e96\u4e09\uff1a\u6a19\u7c64\u683c\u5f0f\u8207 Drug Facts \u9762\u677f<\/p>\n<div class=\"MarkdownCodeBlock_container__nRn2j\">\n<div class=\"MarkdownCodeBlock_codeBlock__rvLec force-dark\"><\/div>\n<\/div>\n<p><code><\/code><\/p>\n<p>OTC \u85e5\u54c1\u5fc5\u9808\u5728\u6a19\u7c64\u4e0a\u5305\u542b\u6a19\u6e96\u5316\u7684\u300cDrug Facts\u300d\u9762\u677f\uff0c\u9019\u662f FDA \u5f37\u5236\u8981\u6c42\u7684\u6a19\u7c64\u683c\u5f0f\uff0821 CFR 201.66\uff09\u3002Drug Facts \u9762\u677f\u5fc5\u9808\u5305\u542b\uff1a<\/p>\n<ul>\n<li><strong>Active Ingredient\uff08\u6d3b\u6027\u6210\u5206\uff09<\/strong>\uff1a\u5217\u51fa\u6240\u6709\u5177\u6709\u85e5\u6548\u7684\u6210\u5206\u53ca\u542b\u91cf<\/li>\n<li><strong>Purpose\uff08\u7528\u9014\uff09<\/strong>\uff1a\u8aaa\u660e\u7522\u54c1\u985e\u5225\uff08\u5982 Pain reliever\u3001Antacid\uff09<\/li>\n<li><strong>Uses\uff08\u9069\u61c9\u75c7\uff09<\/strong>\uff1a\u660e\u78ba\u5217\u51fa\u7522\u54c1\u53ef\u6cbb\u7642\u7684\u75c7\u72c0<\/li>\n<li><strong>Warnings\uff08\u8b66\u544a\u4e8b\u9805\uff09<\/strong>\uff1a\u5305\u542b\u904e\u654f\u8b66\u544a\u3001\u526f\u4f5c\u7528\u3001\u4f7f\u7528\u7981\u5fcc<\/li>\n<li><strong>Directions\uff08\u4f7f\u7528\u8aaa\u660e\uff09<\/strong>\uff1a\u8a73\u7d30\u7684\u5291\u91cf\u8207\u4f7f\u7528\u65b9\u5f0f<\/li>\n<li><strong>Inactive Ingredients\uff08\u975e\u6d3b\u6027\u6210\u5206\uff09<\/strong>\uff1a\u5217\u51fa\u6240\u6709\u8f14\u6599<\/li>\n<\/ul>\n<p>\u82e5\u7522\u54c1\u6a19\u7c64<strong>\u672a\u5305\u542b Drug Facts \u9762\u677f<\/strong>\uff0c\u4f46\u7522\u54c1\u672c\u8eab\u6709\u85e5\u54c1\u5ba3\u7a31\u6216\u4f7f\u7528\u53d7\u7ba1\u5236\u6210\u5206\uff0cFDA \u4ecd\u53ef\u5c07\u5176\u8996\u70ba\u300c\u672a\u6b63\u78ba\u6a19\u793a\u7684\u85e5\u54c1\u300d\uff08Misbranded Drug\uff09\u4e26\u57f7\u6cd5\u3002\u53cd\u4e4b\uff0c\u82e5\u7522\u54c1\u6a19\u7c64\u5305\u542b Drug Facts \u9762\u677f\uff0c\u4f46\u7522\u54c1\u5ba3\u7a31\u8207\u9762\u677f\u5167\u5bb9\u4e0d\u7b26\uff08\u5982\u6a19\u793a\u70ba\u6b62\u75db\u85e5\u4f46\u5ba3\u7a31\u6cbb\u7642\u7cd6\u5c3f\u75c5\uff09\uff0c\u540c\u6a23\u69cb\u6210\u9055\u898f\u3002<\/p>\n<p><strong>\u53f0\u7063\u696d\u8005\u5e38\u898b\u932f\u8aa4<\/strong>\uff1a\u76f4\u63a5\u4f7f\u7528\u53f0\u7063\u5065\u5eb7\u98df\u54c1\u6a19\u7c64\u683c\u5f0f\uff0c\u50c5\u7ffb\u8b6f\u6210\u82f1\u6587\u5f8c\u8cbc\u4e0a\u7522\u54c1\uff0c\u5b8c\u5168\u672a\u6309\u7167 FDA Drug Facts \u683c\u5f0f\u88fd\u4f5c\u3002\u9019\u7a2e\u60c5\u6cc1\u4e0b\uff0c\u5373\u4f7f\u7522\u54c1\u6210\u5206\u5408\u6cd5\uff0c\u4e5f\u6703\u56e0\u6a19\u7c64\u4e0d\u7b26\u800c\u88ab\u8996\u70ba\u9055\u898f\u3002<\/p>\n<hr \/>\n<h2>\u9700\u8981\u7279\u5225\u6ce8\u610f\u7684 4 \u500b\u9ad8\u98a8\u96aa\u60c5\u5883<\/h2>\n<h3>\u60c5\u5883\u4e00\uff1a\u7522\u54c1\u6a19\u7c64\u5408\u898f\u4f46\u7db2\u7ad9\u5ba3\u7a31\u9055\u898f<\/h3>\n<p>\u8a31\u591a\u53f0\u7063\u8ce3\u5bb6\u8a8d\u70ba\u53ea\u8981\u7522\u54c1\u6a19\u7c64\u7b26\u5408\u898f\u5b9a\u5373\u53ef\uff0c\u537b\u5ffd\u7565 Amazon \u7522\u54c1\u9801\u9762\u3001Facebook \u5ee3\u544a\u3001\u54c1\u724c\u5b98\u7db2\u7684\u5167\u5bb9\u4e5f\u53d7 FDA \u76e3\u7ba1\u3002\u82e5\u7522\u54c1\u6a19\u7c64\u672a\u5ba3\u7a31\u7642\u6548\uff0c\u4f46\u7db2\u7ad9\u4e0a\u5beb\u300c\u6cbb\u7642\u5931\u7720\u300d\u300c\u6539\u5584\u7cd6\u5c3f\u75c5\u300d\uff0cFDA \u4ecd\u53ef\u8a8d\u5b9a\u70ba\u85e5\u54c1\u4e26\u57f7\u6cd5\u3002<\/p>\n<blockquote><p>\u26a0\ufe0f <strong>\u6cd5\u5f8b\u98a8\u96aa<\/strong>\uff1aFDA \u8207 FTC\uff08\u806f\u90a6\u8cbf\u6613\u59d4\u54e1\u6703\uff09\u5171\u540c\u76e3\u7ba1\u7dda\u4e0a\u92b7\u552e\u5ba3\u7a31\uff0c\u9055\u898f\u8005\u53ef\u80fd\u540c\u6642\u6536\u5230\u5169\u500b\u55ae\u4f4d\u7684\u8b66\u544a\u4fe1\u6216\u7f70\u6b3e\u3002<\/p><\/blockquote>\n<h3>\u60c5\u5883\u4e8c\uff1aODM\/OEM \u4ee3\u5de5\u5ee0\u8cac\u4efb\u4e0d\u6e05<\/h3>\n<p>\u8a31\u591a\u53f0\u7063\u4ee3\u5de5\u5ee0\u70ba\u7f8e\u570b\u54c1\u724c\u5546\u751f\u7522 OTC \u7522\u54c1\uff0c\u537b\u672a\u660e\u78ba\u7d04\u5b9a\u8cac\u4efb\u6b78\u5c6c\u3002\u82e5\u54c1\u724c\u5546\u672a\u5728\u7f8e\u570b\u5b8c\u6210\u7522\u54c1\u8a3b\u518a\uff0cFDA \u8ffd\u67e5\u6642\u53ef\u80fd\u540c\u6642\u5c0d\u54c1\u724c\u5546\u8207\u4ee3\u5de5\u5ee0\u57f7\u6cd5\u3002\u95dc\u65bc\u8cac\u4efb\u6b78\u5c6c\u7684\u5b8c\u6574\u8aaa\u660e\uff0c\u8acb\u53c3\u8003\uff1a<a href=\"https:\/\/greenoo.tw\/zh\/fda-otc-responsibility-legal-risk-determination\/\" target=\"_blank\" rel=\"noopener\">FDA OTC \u7522\u54c1\u7684\u89d2\u8272\u3001\u8cac\u4efb\u6b78\u5c6c\u8207\u6cd5\u5f8b\u98a8\u96aa\u5224\u5b9a<\/a>\u3002<\/p>\n<h3>\u60c5\u5883\u4e09\uff1a\u6210\u5206\u5728\u53f0\u7063\u5408\u6cd5\u4f46\u5728\u7f8e\u570b\u672a\u6838\u51c6<\/h3>\n<p>\u8461\u8404\u7cd6\u80fa\u3001\u8edf\u9aa8\u7d20\u3001\u4e2d\u85e5\u6750\u8403\u53d6\u7269\u7b49\u6210\u5206\uff0c\u5728\u53f0\u7063\u53ef\u4f5c\u70ba\u5065\u5eb7\u98df\u54c1\u539f\u6599\uff0c\u4f46\u5728\u7f8e\u570b\u82e5\u5ba3\u7a31\u7642\u6548\uff0c\u9019\u4e9b\u6210\u5206\u5e7e\u4e4e\u90fd\u672a\u88ab FDA \u6838\u51c6\u70ba OTC \u85e5\u54c1\u6210\u5206\u3002\u82e5\u5f37\u884c\u51fa\u53e3\u4e26\u5ba3\u7a31\u7642\u6548\uff0c\u5373\u70ba\u300c\u672a\u7d93\u6838\u51c6\u7684\u65b0\u85e5\u300d\u3002<\/p>\n<h3>\u60c5\u5883\u56db\uff1a\u7522\u54c1\u5728\u53f0\u7063\u662f\u5316\u599d\u54c1\u4f46\u5728\u7f8e\u570b\u662f\u85e5\u54c1<\/h3>\n<p>\u8a31\u591a\u5916\u7528\u8b77\u819a\u54c1\u3001\u53e3\u8154\u8b77\u7406\u7522\u54c1\uff08\u5982\u5ba3\u7a31\u7f8e\u767d\u7259\u9f52\u3001\u6cbb\u7642\u7259\u9f66\u708e\u7684\u7259\u818f\uff09\u3001\u9632\u66ec\u54c1\uff08SPF \u6a19\u793a\u7684\u7522\u54c1\uff09\u5728\u7f8e\u570b\u90fd\u5c6c\u65bc OTC \u85e5\u54c1\uff0c\u800c\u975e\u5316\u599d\u54c1\u3002\u53f0\u7063\u5316\u599d\u54c1\u696d\u8005\u51fa\u53e3\u6642\u9700\u7279\u5225\u6ce8\u610f\u9019\u985e\u5dee\u7570\u3002<\/p>\n<hr \/>\n<h3>\u5716 3\uff1aFDA OTC \u5408\u898f\u7d05\u7dda\u6aa2\u6838\u8868<\/h3>\n<p><strong>\u5716\u7247\u7528\u9014\u8aaa\u660e<\/strong>\uff1a<br \/>\n\u6b64\u6aa2\u6838\u8868\u6574\u7406\u53f0\u7063\u8ce3\u5bb6\u8207\u5916\u8cbf\u5de5\u5ee0\u6700\u5e38\u8e29\u932f\u7684 OTC \u5408\u898f\u7d05\u7dda\uff0c\u5e6b\u52a9\u696d\u8005\u5728\u51fa\u53e3\u524d\u5feb\u901f\u81ea\u6211\u6aa2\u67e5\uff0c\u907f\u514d\u7522\u54c1\u88ab\u6263\u62bc\u6216\u6536\u5230 FDA \u8b66\u544a\u4fe1\u3002<\/p>\n<p><span style=\"background-color: rgba(0, 0, 0, 0); font-family: 'Courier 10 Pitch', Courier, monospace; font-size: 1em;\"><img decoding=\"async\" class=\"alignnone size-full wp-image-19178\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-otc-compliance-red-flags-checklist-taiwan-sellers-2026.png\" alt=\"FDA OTC \u5408\u898f\u7d05\u7dda\u6aa2\u6838\u8868\uff0c\u5217\u51fa\u53f0\u7063\u8ce3\u5bb6\u8207\u5916\u8cbf\u5de5\u5ee0\u6700\u5e38\u8e29\u932f\u7684 8 \u500b\u9055\u898f\u9677\u9631\uff0c\u5305\u542b\u8a3b\u518a\u3001\u6210\u5206\u3001\u6a19\u7c64\u7b49\u8981\u6c42\" width=\"1792\" height=\"2400\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-otc-compliance-red-flags-checklist-taiwan-sellers-2026.png 1792w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-otc-compliance-red-flags-checklist-taiwan-sellers-2026-768x1029.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-otc-compliance-red-flags-checklist-taiwan-sellers-2026-1147x1536.png 1147w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-otc-compliance-red-flags-checklist-taiwan-sellers-2026-1529x2048.png 1529w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-otc-compliance-red-flags-checklist-taiwan-sellers-2026-9x12.png 9w\" sizes=\"(max-width: 1792px) 100vw, 1792px\" \/><\/span><\/p>\n<p><code><\/code><\/p>\n<p>\u7e3d\u7d50\uff1a\u51fa\u53e3\u524d\u5fc5\u505a\u7684 5 \u9805\u6aa2\u67e5<\/p>\n<p>\u5728\u7522\u54c1\u51fa\u53e3\u7f8e\u570b\u524d\uff0c\u8acb\u52d9\u5fc5\u5b8c\u6210\u4ee5\u4e0b\u6aa2\u67e5\uff1a<\/p>\n<ul>\n<li><strong>\u5ba3\u7a31\u5167\u5bb9\u6aa2\u67e5<\/strong>\uff1a\u7522\u54c1\u6a19\u7c64\u3001\u7db2\u7ad9\u3001\u5ee3\u544a\u662f\u5426\u6709\u4efb\u4f55\u6cbb\u7642\u3001\u9810\u9632\u75be\u75c5\u7684\u5ba3\u7a31<\/li>\n<li><strong>\u6210\u5206\u5408\u898f\u6027\u78ba\u8a8d<\/strong>\uff1a\u6240\u6709\u6d3b\u6027\u6210\u5206\u662f\u5426\u7b26\u5408 OTC Monograph \u6216\u5df2\u7372 FDA \u6838\u51c6<\/li>\n<li><strong>\u6a19\u7c64\u683c\u5f0f\u6aa2\u67e5<\/strong>\uff1a\u82e5\u70ba OTC \u85e5\u54c1\uff0c\u662f\u5426\u5305\u542b\u5b8c\u6574\u4e14\u6b63\u78ba\u7684 Drug Facts \u9762\u677f<\/li>\n<li><strong>\u8cac\u4efb\u65b9\u78ba\u8a8d<\/strong>\uff1a\u54c1\u724c\u5546\u3001\u4ee3\u5de5\u5ee0\u3001\u9032\u53e3\u5546\u7684\u8cac\u4efb\u6b78\u5c6c\u662f\u5426\u660e\u78ba\u4e26\u6709\u5408\u7d04\u7d04\u5b9a<\/li>\n<li><strong>\u8a3b\u518a\u8207\u7533\u5831\u78ba\u8a8d<\/strong>\uff1a\u8a2d\u65bd\u8a3b\u518a\u3001Drug Listing\u3001\u7f8e\u570b\u4ee3\u7406\u4eba\u662f\u5426\u5df2\u5b8c\u6210\u4e14\u6709\u6548<\/li>\n<\/ul>\n<p>FDA OTC \u5408\u898f\u662f\u4e00\u500b\u8907\u96dc\u7684\u7cfb\u7d71\u5de5\u7a0b\uff0c\u6d89\u53ca\u7522\u54c1\u5206\u985e\u3001\u6210\u5206\u5be9\u67e5\u3001\u6a19\u7c64\u88fd\u4f5c\u3001\u8a2d\u65bd\u7ba1\u7406\u7b49\u591a\u500b\u74b0\u7bc0\u3002\u82e5\u5c0d FDA OTC \u85e5\u54c1\u5408\u898f\u4ecd\u6709\u7591\u554f\uff0c\u6b61\u8fce\u53c3\u8003 <a href=\"https:\/\/greenoo.tw\/zh\/\" target=\"_blank\" rel=\"noopener\">\u7da0\u5708\u5708\u5b98\u7db2<\/a> \u7684\u5c08\u696d\u9867\u554f\u670d\u52d9\uff0c\u6216\u95b1\u8b80\u6211\u5011\u7684\u76f8\u95dc\u6df1\u5ea6\u6307\u5357\u3002<\/p>","protected":false},"excerpt":{"rendered":"<p>\u4f60\u7684\u7522\u54c1\u5728\u7f8e\u570b\u6703\u88ab\u7576\u6210\u85e5\u54c1\u55ce\uff1f\u5148\u770b\u9019\u4e09\u500b\u95dc\u9375\u5224\u5b9a\u6a19\u6e96 \u662f\u7684\uff0c\u5373\u4f7f\u4f60\u5728\u53f0\u7063\u8ce3\u7684\u662f\u300c\u4fdd\u5065\u98df\u54c1\u300d\u6216\u300c\u65e5\u7528\u54c1\u300d\uff0c\u53ea\u8981\u7522 [&hellip;]<\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"footnotes":""},"categories":[1,45],"tags":[],"class_list":["post-19175","post","type-post","status-publish","format-standard","hentry","category-uncategorized","category-fda"],"_links":{"self":[{"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts\/19175"}],"collection":[{"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/comments?post=19175"}],"version-history":[{"count":1,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts\/19175\/revisions"}],"predecessor-version":[{"id":19179,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts\/19175\/revisions\/19179"}],"wp:attachment":[{"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/media?parent=19175"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/categories?post=19175"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/tags?post=19175"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}