{"id":19180,"date":"2026-01-02T14:38:11","date_gmt":"2026-01-02T06:38:11","guid":{"rendered":"https:\/\/greenoo.tw\/?p=19180"},"modified":"2026-01-02T14:38:11","modified_gmt":"2026-01-02T06:38:11","slug":"fda-otc-monograph-regulation-framework-compliance","status":"publish","type":"post","link":"https:\/\/greenoo.tw\/zh\/fda-otc-monograph-regulation-framework-compliance\/","title":{"rendered":"FDA OTC \u6cd5\u898f\u5236\u5ea6\u8207 Monograph \u67b6\u69cb\u5b8c\u6574\u89e3\u6790\uff1a\u6d77\u5916\u696d\u8005\u6700\u5e38\u8e29\u932f\u7684\u5408\u898f\u7d05\u7dda\uff082026\uff09"},"content":{"rendered":"

\"FDA<\/h2>\n

FDA OTC Monograph \u662f\u4ec0\u9ebc\uff1f\u70ba\u4f55\u6d77\u5916\u696d\u8005\u5fc5\u9808\u4e86\u89e3\uff1f<\/h2>\n

FDA OTC Monograph\uff08\u975e\u8655\u65b9\u85e5\u5c08\u8ad6\uff09\u662f\u4e00\u5957\u91dd\u5c0d\u7279\u5b9a\u985e\u5225 OTC \u7522\u54c1\u5236\u5b9a\u7684\u300c\u914d\u65b9\u8207\u6a19\u7c64\u6a19\u6e96\u300d\uff0c\u7b26\u5408 Monograph \u898f\u5b9a\u7684\u7522\u54c1\u53ef\u76f4\u63a5\u4e0a\u5e02\uff0c\u7121\u9700\u500b\u5225\u6838\u51c6\u3002<\/strong> \u7136\u800c\uff0c\u591a\u6578\u53f0\u7063\u88fd\u85e5\u5ee0\u3001\u4fdd\u5065\u54c1\u5ee0\u8207\u5916\u8cbf\u5de5\u5ee0\u56e0\u4e0d\u719f\u6089\u6b64\u5236\u5ea6\uff0c\u5e38\u5728\u6210\u5206\u5291\u91cf\u3001\u6a19\u7c64\u683c\u5f0f\u3001\u88fd\u9020\u5408\u898f\u4e0a\u8e29\u932f\u7d05\u7dda\uff0c\u5c0e\u81f4\u7522\u54c1\u88ab FDA \u8996\u70ba\u300c\u672a\u6838\u51c6\u65b0\u85e5\u300d\u800c\u906d\u6263\u62bc\u6216\u7981\u552e\u3002<\/p>\n

\u6839\u64da 2020 \u5e74 CARES Act \u6539\u9769\uff0cOTC Monograph \u5236\u5ea6\u5df2\u5f9e\u300c\u6700\u7d42\u5c08\u8ad6\uff08Final Monograph\uff09\u300d\u8f49\u70ba\u300c\u884c\u653f\u547d\u4ee4\uff08Administrative Order\uff09\u300d\u6a21\u5f0f\uff0c\u6240\u6709\u696d\u8005\u5fc5\u9808\u5728 2026 \u5e74\u524d\u5b8c\u6210\u7522\u54c1\u8a3b\u518a\u8207\u5408\u898f\u8abf\u6574\u3002\u82e5\u60a8\u7684\u7522\u54c1\u5ba3\u7a31\u6cbb\u7642\u3001\u9810\u9632\u75be\u75c5\u529f\u6548\uff08\u5982\u6b62\u75db\u3001\u9000\u71d2\u3001\u6b62\u7662\u3001\u9632\u66ec\uff09\uff0c\u5c31\u5c6c\u65bc OTC \u85e5\u54c1\u7bc4\u7587\uff0c\u5fc5\u9808\u7b26\u5408 Monograph \u898f\u5b9a\u6216\u53d6\u5f97 FDA \u6838\u51c6\uff0c\u5426\u5247\u5c07\u9762\u81e8\u6cd5\u5f8b\u98a8\u96aa\u3002<\/strong><\/p>\n

\u95dc\u65bc\u7522\u54c1\u662f\u5426\u88ab\u8996\u70ba OTC \u85e5\u54c1\u7684\u5b8c\u6574\u5224\u5b9a\u6a19\u6e96\uff0c\u8acb\u53c3\u8003\u6211\u5011\u7684\u6838\u5fc3\u6307\u5357\uff1a\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<\/a><\/p>\n

\n

OTC Monograph \u5236\u5ea6\u7684\u6838\u5fc3\u67b6\u69cb<\/h2>\n

Monograph \u7684\u4e09\u5927\u6838\u5fc3\u8981\u7d20<\/h3>\n

FDA OTC Monograph \u5236\u5ea6\u898f\u7bc4\u4e09\u500b\u95dc\u9375\u9762\u5411\uff1a<\/p>\n

    \n
  1. \u6d3b\u6027\u6210\u5206\u8207\u5291\u91cf\uff08Active Ingredients & Dosage\uff09<\/strong>\uff1a\u660e\u78ba\u5217\u51fa\u53ef\u4f7f\u7528\u7684\u6210\u5206\u53ca\u5176\u5b89\u5168\u5291\u91cf\u7bc4\u570d\uff08\u5982\uff1aIbuprofen \u6b62\u75db\u4e0d\u5f97\u8d85\u904e 200mg\/\u5291\uff09<\/li>\n
  2. \u6a19\u7c64\u8981\u6c42\uff08Labeling Requirements\uff09<\/strong>\uff1a\u5305\u542b Drug Facts \u9762\u677f\u683c\u5f0f\u3001\u8b66\u8a9e\u3001\u4f7f\u7528\u8aaa\u660e\u7b49\u5f37\u5236\u5167\u5bb9<\/li>\n
  3. \u88fd\u9020\u6a19\u6e96\uff08Manufacturing Standards\uff09<\/strong>\uff1a\u5fc5\u9808\u7b26\u5408 cGMP\uff08\u73fe\u884c\u512a\u826f\u88fd\u9020\u898f\u7bc4\uff09\u4e26\u5b8c\u6210\u8a2d\u65bd\u8a3b\u518a<\/li>\n<\/ol>\n

    \u4efb\u4e00\u8981\u7d20\u4e0d\u7b26\u5408\uff0c\u7522\u54c1\u5373\u88ab\u8996\u70ba\u300c\u672a\u6838\u51c6\u65b0\u85e5\u300d\uff0c\u4e0d\u5f97\u5728\u7f8e\u570b\u92b7\u552e\u3002<\/strong><\/p>\n

    CARES Act \u6539\u9769\uff1a\u5f9e Final Monograph \u5230 Administrative Order<\/h3>\n
    \n\n\n\n\n\n\n\n\n
    \u9805\u76ee<\/th>\n\u820a\u5236\uff08Final Monograph\uff09<\/th>\n\u65b0\u5236\uff08Administrative Order\uff0c2020\u8d77\uff09<\/th>\n<\/tr>\n<\/thead>\n
    \u6cd5\u5f8b\u6548\u529b<\/td>\n21 CFR \u6cd5\u898f\u689d\u6587<\/td>\nFDA \u884c\u653f\u547d\u4ee4\uff08\u5177\u6cd5\u5f8b\u7d04\u675f\u529b\uff09<\/td>\n<\/tr>\n
    \u66f4\u65b0\u901f\u5ea6<\/td>\n\u9700\u6578\u5e74\u4fee\u8a02\u6d41\u7a0b<\/td>\n\u53ef\u5feb\u901f\u8abf\u6574\uff0818\u500b\u6708\u5167\uff09<\/td>\n<\/tr>\n
    \u696d\u8005\u7fa9\u52d9<\/td>\n\u81ea\u884c\u7b26\u5408\u5373\u53ef<\/td>\n\u5fc5\u9808\u5b8c\u6210 OTC \u8a3b\u518a\u7533\u5831<\/strong><\/td>\n<\/tr>\n
    \u5408\u898f\u671f\u9650<\/td>\n\u7121\u660e\u78ba\u671f\u9650<\/td>\n2026\u5e74\u70ba\u591a\u6578\u7522\u54c1\u7684\u5408\u898f\u622a\u6b62\u65e5<\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n

    \u26a0\ufe0f \u91cd\u8981\u63d0\u9192<\/strong>\uff1a\u5373\u4f7f\u60a8\u7684\u7522\u54c1\u914d\u65b9\u7b26\u5408\u820a\u7248 Final Monograph\uff0c\u82e5\u672a\u5728 2026 \u5e74\u524d\u5b8c\u6210\u65b0\u5236\u8a3b\u518a\uff0c\u4ecd\u53ef\u80fd\u88ab\u8996\u70ba\u9055\u898f\u3002<\/p>\n

    \n

    \u5716 2\uff1aFDA OTC Monograph \u7522\u54c1\u985e\u5225\u8207\u5e38\u898b\u7d05\u7dda<\/h3>\n

    \u6b64\u5716\u6574\u7406\u4e3b\u8981 Monograph \u985e\u5225\u8207\u5404\u985e\u5225\u6700\u5e38\u898b\u7684\u5408\u898f\u932f\u8aa4\uff0c\u5e6b\u52a9\u6d77\u5916\u696d\u8005\u5feb\u901f\u8b58\u5225\u81ea\u8eab\u7522\u54c1\u9069\u7528\u7684 Monograph \u53ca\u6f5b\u5728\u98a8\u96aa\u9ede\u3002<\/p>\n

    \"FDA<\/p>\n

    \n
    \n
    <\/div>\n<\/div>\n<\/div>\n

    \u6d77\u5916\u696d\u8005\u6700\u5e38\u8e29\u932f\u7684 8 \u5927\u5408\u898f\u7d05\u7dda<\/h3>\n

    \u7d05\u7dda 1\uff1a\u4f7f\u7528\u672a\u7d93\u6838\u51c6\u7684\u6d3b\u6027\u6210\u5206\u6216\u8d85\u51fa\u5291\u91cf\u7bc4\u570d<\/h3>\n

    \u8a31\u591a\u53f0\u7063\u696d\u8005\u8aa4\u4ee5\u70ba\u300c\u5929\u7136\u6210\u5206\u300d\u6216\u300c\u4f4e\u5291\u91cf\u300d\u5c31\u4e0d\u53d7\u7ba1\u5236\uff0c\u4f46\u53ea\u8981\u5ba3\u7a31\u85e5\u6548\uff08\u5982\u300c\u8212\u7de9\u75bc\u75db\u300d\u300c\u9810\u9632\u611f\u5192\u300d\uff09\uff0c\u5c31\u5fc5\u9808\u4f7f\u7528 Monograph \u6838\u51c6\u7684\u6210\u5206\u8207\u5291\u91cf\u3002<\/p>\n

    \u5e38\u898b\u932f\u8aa4<\/strong>\uff1a<\/p>\n