Enforcement Rules for the Controlled Drugs Act Article 25
When maintaining records in accordance with Article 28 Paragraph 1 of this Act, medical institutions, pharmacies, veterinarian medical institutions, pasturage veterinarian institutions, and medical and educational research laboratories shall record the following items for each individual drug:1. The name of the drug, the ingredient and contained amount of controlled drugs, drug permit license number, schedule, batch number, the minimal unit, and the name of the manufacturer.2. The records of increase and decrease of stocks, including the date, reason, amount of the revenue and expenditure, and the following items:(1) If the increase of stocks derives from purchasing or transferring, the drug batch number, the name and the controlled drugs registration license number of the providing institutions or businesses.(2) If the increase of stocks derives from the seized lost controlled drugs, the number of the documents for proving the seized lost controlled drugs shall be recorded.(3) If the decrease of stocks derives from destruction or loss, the number of the documents for proving such destruction or loss shall be recorded.(4) If the decrease of stocks derives from returning the goods or transferring, the name and controlled drugs registration license number of the institutions or businesses for such decrease of stocks shall be recorded.(5) If the decrease of stocks derives from dispensing or administering Schedule 1 to 3 controlled drugs, the name of the patient (or the number of medical record, and the name of the person responsible for the animal) and the quantity given out shall be recorded daily in details.(6) If the decrease of stocks derives from dispensing, administering Schedule 4 controlled drugs, the daily total dispensed amount shall be record in detail.(7) If the decrease of stocks derives from research or testing, the name, the number of document for approval of the research or testing projects and the names of the user shall be recorded.3. The inventory amount.
中文原文 管制藥品管理條例施行細則第25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一項規定登載簿冊時,應依各藥品品項分別登載下列事項:
一、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。
二、收入及支出資料,包括收入或支出之日期、原因、數量及下列事項:
(一)收入原因為購買或受讓者,並應登載藥品批號、來源之機構或業者名稱及其管制藥品登記證字號。
(二)收入原因為查獲減損之管制藥品者,並應載明減損管制藥品查獲證明文號。
(三)支出原因為銷燬或減損者,並應載明藥品銷燬或減損證明文號。
(四)支出原因為退貨或轉讓者,並應載明支出對象之機構或業者名稱及其管制藥品登記證字號。
(五)支出原因為調劑、使用第一級至第三級管制藥品者,並應逐日詳實登載病人姓名(或病歷號碼、飼主姓名)及其領用數量。
(六)支出原因為調劑、使用第四級管制藥品者,並應逐日詳實登載總使用量。
(七)支出原因為研究、試驗者,並應登載研究試驗計畫名稱與其核准文號及使用者姓名。
三、結存數量。
一、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。
二、收入及支出資料,包括收入或支出之日期、原因、數量及下列事項:
(一)收入原因為購買或受讓者,並應登載藥品批號、來源之機構或業者名稱及其管制藥品登記證字號。
(二)收入原因為查獲減損之管制藥品者,並應載明減損管制藥品查獲證明文號。
(三)支出原因為銷燬或減損者,並應載明藥品銷燬或減損證明文號。
(四)支出原因為退貨或轉讓者,並應載明支出對象之機構或業者名稱及其管制藥品登記證字號。
(五)支出原因為調劑、使用第一級至第三級管制藥品者,並應逐日詳實登載病人姓名(或病歷號碼、飼主姓名)及其領用數量。
(六)支出原因為調劑、使用第四級管制藥品者,並應逐日詳實登載總使用量。
(七)支出原因為研究、試驗者,並應登載研究試驗計畫名稱與其核准文號及使用者姓名。
三、結存數量。