Enforcement Rules for the Controlled Drugs Act Article 27
When reporting the records maintained of controlled drugs in accordance with Article 28 Paragraph 2 of this Act, medical institutions, drug stores, veterinarian medical institutions, pasturage veterinarian institutions, medical and educational research and testing laboratories shall follow the following regulations:1. Reporting Schedule 1, 2, 3 and 4 controlled drugs of the previous year to the local health administration and the FDA in January (institutions has no transaction record are included).2. When changing the institution of person in charge or controlled drugs manager in the content of controlled drugs registration license, the registrant shall report Schedule 1, 2, 3 and 4 controlled drugs to the local health administration and the FDA.3. The reporting mentioned in the 2 preceding Subparagraph shall bear the following items for each individual drug:(1) The name of the reporting institutions, controlled drugs registration license number, address, telephone number, the person in charge, controlled drugs manager of the reporting institutions, the reporting date and time period of the reported records with the official seal, the seal of the person in charge, the seal and signature of the controlled drug manager impressed.(2) The name of the drug, the ingredients and the contained amount of controlled drugs, drug permit license number, schedule, minimal unit and the name of the manufacturer.(3) The inventory amount of the previous time period.(4) The records of increase and decrease of stocks of the current time period shall be identical to the maintained records. However, if the increase of stocks is resulted from returning the drugs or the decrease of stocks is resulted from dispensing, administering, researching and testing, the institutions may record only the total amount of the increase and decrease of stocks of the reported time period.(5) The inventory amount of the current time period.The reporting mentioned in the preceding Paragraph may be done via electronic means. The format and specification of such means shall be announced to the public by the Central Health authority.
中文原文 管制藥品管理條例施行細則第27條
醫療機構、藥局、獸醫診療機構、畜牧獸醫機構及醫藥教育研究試驗機構依本條例第二十八條第二項規定申報管制藥品簿冊登載情形者，應依下列規定辦理：
一、每年一月向所在地衛生主管機關及食品藥物署辦理前一年管制藥品之申報；於該期間無任何管制藥品收入、支出或結存者，亦同。
二、申請管制藥品登記證之負責人或管制藥品管理人變更登記時，應向所在地衛生主管機關及食品藥物署辦理管制藥品之申報。
三、前二款之申報，應依各藥品品項分別載明下列事項：
（一）申報者之名稱、管制藥品登記證字號、地址、電話號碼、負責人、管制藥品管理人、申報日期及申報資料期間，並加蓋印信戳記、負責人印章及管制藥品管理人之簽章。
（二）品名、管制藥品成分、含量、許可證字號、級別、最小單位及製造廠名稱。
（三）上期結存數量。
（四）本期收入及支出資料，其內容並應與簿冊登載者相同。
但收入原因為退藥或支出原因為調劑、使用、研究、試驗者，得僅登載申報期間之收入及支出總數量。
（五）本期結存數量。
前項申報得以電子方式為之；其媒體形式及規格，由中央衛生主管機關公告之。
一、每年一月向所在地衛生主管機關及食品藥物署辦理前一年管制藥品之申報；於該期間無任何管制藥品收入、支出或結存者，亦同。
二、申請管制藥品登記證之負責人或管制藥品管理人變更登記時，應向所在地衛生主管機關及食品藥物署辦理管制藥品之申報。
三、前二款之申報，應依各藥品品項分別載明下列事項：
（一）申報者之名稱、管制藥品登記證字號、地址、電話號碼、負責人、管制藥品管理人、申報日期及申報資料期間，並加蓋印信戳記、負責人印章及管制藥品管理人之簽章。
（二）品名、管制藥品成分、含量、許可證字號、級別、最小單位及製造廠名稱。
（三）上期結存數量。
（四）本期收入及支出資料，其內容並應與簿冊登載者相同。
但收入原因為退藥或支出原因為調劑、使用、研究、試驗者，得僅登載申報期間之收入及支出總數量。
（五）本期結存數量。
前項申報得以電子方式為之；其媒體形式及規格，由中央衛生主管機關公告之。