本站大部份資料在 2016 年後就未更新，若資料內無明確標示資料時間，請預設該資料為過時資料並斟酌使用，謝謝
| column | value |
|---|---|
| 類別 | 藥政管理類,成藥及固有成方製劑管理辦法 |
| 法規性質 | 法規命令 |
| 法規名稱 | 成藥及固有成方製劑管理辦法 |
| 條文內容 | <p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">一</span> <span style="font-family: 新細明體,serif;">章</span> <span style="font-family: 新細明體,serif;">總則</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本辦法依藥事法第八條規定訂定之。</span> </p><p><span style="font-family: 新細明體,serif;">成藥及固有成方製劑之管理，除藥事法另有規定者外，依本辦法之規定。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本辦法所稱成藥係指原料藥經加工調製，不用其原名稱，其摻入之麻醉藥藥品、毒劇藥品，不超過中央衛生主管機關所規定之限量，作用緩和、無積蓄性、耐久儲存、使用簡便，不待醫師指示即可供治療疾病之用者。</span> </p><p><span style="font-family: 新細明體,serif;">成藥分甲、乙兩類，其範圍及審核標準如基準表（附件一、二）。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">成藥中摻用麻醉藥品，除嗎啡含量應在千分之二以下，可卡因應在千分之一以下外，其他麻醉藥品摻用量由中央衛生主管機關比照上述標準視其劑量核定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">成藥中摻用毒劇藥品，如為中華藥典所載者，不得超過常用量三分之一，其未為中華藥典所載者，由中央衛生主管機關核定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本辦法所稱固有成方係指我國固有醫藥習慣使用，具有療效之中藥處方，並經中央衛生主管機關選定公佈者而言。依固有成方調製</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">劑</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">成之丸散、膏、丹稱為固有成方製劑。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">成藥及以批發或供人出售之固有成方製劑，應由藥品製造業者製造。中藥販賣業者得依固有成方所載之原名稱、成分、製法、效能、用法及用量，調製</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">劑</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">固有成方製劑但以於其營業處所自行零售為限。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">二</span> <span style="font-family: 新細明體,serif;">章</span> <span style="font-family: 新細明體,serif;">審核及許可</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 7 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">藥品製造業者調製成藥或固有成方製劑，應依藥事法第三十九條、第四十三條、第四十六條至第四十八條、第五十六條及第五十七條之規定辦理。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 8 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">成藥依成藥基準表審核之，但含藥酒類依其有關規定辦理。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 9 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">中藥販賣業者調製</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">劑</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">固有成方製劑，應列具名稱、成分、製法、效能、用法及用量，連同有關資料證件，向該管直轄市、縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生主管機關提出申請，經核准登記發給登記證後，始得製售。</span> </p><p><span style="font-family: 新細明體,serif;">前項經核准發給登記證案件，直轄市、縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生主管機關應按月列冊報請中央衛生主管機關備查。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 10 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">中藥販賣業者調製</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">劑</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">固有成方製劑，應於其管理藥品之中醫師監督下為之。但不含毒劇藥品者，可由確具中藥基本知識及鑑別能力人員自行調製</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">劑</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 11 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">固有成方製劑不得摻入防腐劑、色素、人工甘味劑、化學溶劑及其他有害添加物。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 12 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">成藥之標籤、仿單或包裝應標明甲類成藥或乙類成藥。固有成方製劑應標明名稱及固有成方字樣。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">三</span> <span style="font-family: 新細明體,serif;">章</span> <span style="font-family: 新細明體,serif;">販賣之管理</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 13 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">藥品製造業者除含藥酒類不得以留置方式供銷家庭用戶外，得將自製之成藥或固有成方製劑，以留置方式直接供銷家庭用戶。但以供銷民眾購用藥品較為不便之偏僻地區為限。</span> </p><p><span style="font-family: 新細明體,serif;">家庭留置成藥或固有成方製劑之地區，應由直轄市、縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生主管機關每年查核一次，逐步縮減留置地區範圍。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 14 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">藥品製造業者將自製成藥或固有成方製劑留置於家庭用戶者，應依左列各款之規定：</span> </p><p><span style="font-family: 新細明體,serif;">一、申請供銷家庭留置成藥或固有成方製劑，應事先檢具藥品名清單</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">格式如附件三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">二份，申請直轄市、縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生主管機關，轉報中央衛生主管機關核定。</span> </p><p><span style="font-family: 新細明體,serif;">二、供銷留置成藥或固有成方製劑之日起十五日內開具左列事項，向直轄市、縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生主管機關報備：</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">藥品製造業者之名稱、地址及負責人姓名。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">銷售地區</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">列明直轄市、縣市、鄉鎮市區或村里名稱</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">及留置成藥或固有成方製劑服務員名冊</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">格式如附件四</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">一份。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">留置藥品清單一份。</span> </p><p><span style="font-family: 新細明體,serif;">三、留置之成藥或固有成方製劑應裝置在「家庭藥品留置袋」或「箱」內，其袋</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">箱</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">應採堅固耐用材料製成，並應載明藥品製造業者</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">藥商</span><span style="font-family: calibri;"> ) </span><span style="font-family: 新細明體,serif;">名稱、地址與留置藥品之品名、許可字號、效能、價格、數量及注意事項等</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">格式如附件五</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">。但所刊載文字圖畫，不得有藥事法第六十八條所列各款情事。</span> </p><p><span style="font-family: 新細明體,serif;">四、應發給留置成藥或固有成方製劑服務人員服務證</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">格式如附件六</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">，並指定其服務員勤予巡檢留置之藥品，每次間隔不得逾三個月。</span> </p><p><span style="font-family: 新細明體,serif;">附件三</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">藥品製造廠商名稱</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">家庭留置成藥固有成方製劑品名清單</span> </p><p><span style="font-family: 新細明體,serif;">┌────┬───────┬───┬────┬────┬───┐</span> </p><p><span style="font-family: 新細明體,serif;">│許可字號│藥</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">品</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">名</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">稱│劑</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">型│包括容量│核准效能│備</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">考│</span> </p><p><span style="font-family: 新細明體,serif;">├────┼───────┼───┼────┼────┼───┤</span> </p><p><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">字│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">│第</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">號│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">├────┼───────┼───┼────┼────┼───┤</span> </p><p><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">字│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">│第</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">號│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">├────┼───────┼───┼────┼────┼───┤</span> </p><p><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">字│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">│第</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">號│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">├────┼───────┼───┼────┼────┼───┤</span> </p><p><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">字│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">│第</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">號│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">├────┼───────┼───┼────┼────┼───┤</span> </p><p><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">字│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">│第</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">號│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">├────┼───────┼───┼────┼────┼───┤</span> </p><p><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">字│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">│第</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">號│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">├────┼───────┼───┼────┼────┼───┤</span> </p><p><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">字│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">│第</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">號│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">└────┴───────┴───┴────┴────┴───┘</span> </p><p><span style="font-family: 新細明體,serif;">註：</span> </p><p><span style="font-family: 新細明體,serif;">一、申請直轄市、縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生主管機關轉報中央主管機關核定及向直轄</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">市、縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生主管機關報備之清單均依此格式。</span> </p><p><span style="font-family: 新細明體,serif;">二、向縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市、局</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生主管機關報備之品名清單，須在備考欄註明核定</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">機關名稱及文號。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">備</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">註：附件三之註一請參閱行政院公報第</span><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">卷</span><span style="font-family: calibri;"> 10 </span><span style="font-family: 新細明體,serif;">期</span><span style="font-family: calibri;"> 21 </span><span style="font-family: 新細明體,serif;">頁</span><span style="font-family: calibri;">)</span></p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">備</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">註：附件三～六請參閱中華民國現行法規彙編</span><span style="font-family: calibri;"> (83</span><span style="font-family: 新細明體,serif;">年</span><span style="font-family: calibri;">5</span><span style="font-family: 新細明體,serif;">月版</span><span style="font-family: calibri;">) (</span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">三○</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 20905</span><span style="font-family: 新細明體,serif;">～</span><span style="font-family: calibri;">20909 </span><span style="font-family: 新細明體,serif;">頁</span><span style="font-family: calibri;">)</span></p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 15 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">家庭留置成藥或固有成方製劑之服務員，於推銷或執行工作時，應配帶服務證，指導用戶將藥品留置袋</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">箱</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">置於不被日晒、雨淋、受潮及不易為兒童獲取之處所。如發現袋</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">箱</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">內藥品有變質、沉澱、損壞或其他不良狀況時，應即收回或換入新品。並不得將任何成藥或固有成方製劑拆封或改裝及沿途或設攤販賣。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 16 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">乙類成藥得由百貨店、雜貨店及餐旅服務商兼營零售之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 17 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">兼營零售乙類成藥者應依左列各款之規定：</span> </p><p><span style="font-family: 新細明體,serif;">一、對內服及外用成藥，應各別專設櫥櫃陳列，妥善貯藏。但含藥酒類不在此限。</span> </p><p><span style="font-family: 新細明體,serif;">二、商號或招牌不得使用藥商名稱或易被誤認為藥商之字樣。</span> </p><p><span style="font-family: 新細明體,serif;">三、不得設置藥品推銷員及本辦法所稱之服務員。</span> </p><p><span style="font-family: 新細明體,serif;">四、不得將成藥拆除包裝零售。</span> </p><p><span style="font-family: 新細明體,serif;">五、不得買賣來源不明之成藥。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">四</span> <span style="font-family: 新細明體,serif;">章</span> <span style="font-family: 新細明體,serif;">檢查及取締</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 18 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">直轄市、縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生主管機關對於成藥及固有成方製劑之檢查或抽驗，除依藥事法有關規定辦理外，並得派員檢查或抽驗留置於家庭用戶之成藥、固有成方製劑及其裝置用袋</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">箱</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 19 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">違反本辦法之規定或涉及偽藥、劣藥、禁藥者，依藥事法有關規定處理。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">五</span> <span style="font-family: 新細明體,serif;">章</span> <span style="font-family: 新細明體,serif;">附則</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 20 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本辦法自發布日施行。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span></p> |
| 發佈日期 | 2013-12-04 |
| 附件檔案 | https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6052&type=0 |