Enforcement Rules for the Controlled Drugs Act Article 24
When maintaining records in accordance with Article 28 Paragraph 1 of this Act, Human medicine or veterinary medicine manufacturers and sellers shall record the following items according to each individual drug and batch number:1. The name of drug, the ingredients and the 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 increase and decrease of stocks, the source of increase of stocks, the name, address, telephone number, controlled drugs registration license number of the institutions or sellers for decrease of stocks, and the following items:(1) If the increase of stocks derives from import or manufacturing, the number of the permit for importing or manufacturing shall be recorded.(2) If the increase of stocks derives from the seized lost controlled drugs, the number of the document for proving the seized lost controlled drugs shall be recorded.(3) If the decrease of stocks derives from exporting, destruction or loss, the number of the permit for exporting and of the documents for proving the destruction or loss shall be recorded.(4) If the decrease of stocks derives from manufacturing drugs, the names, batch number and the number of the permit for manufacturing of the manufactured drugs.3. The inventory amount.
中文原文 管制藥品管理條例施行細則第24條
西藥或動物用藥品製造業者及販賣業者依本條例第二十八條第一項規定登載簿冊時,應依各藥品品項及批號分別登載下列事項:
一、品名、管制藥品成分、含量、許可證字號、級別、批號、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、收入來源或支出對象機構、業者之名稱、地址、電話號碼與其管制藥品登記證字號及下列事項:
(一)收入原因為輸入或製造者,並應載明輸入或製造同意書編號。
(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)支出原因為輸出、銷燬或減損者,並應載明輸出同意書編號、銷燬或減損證明文號。
(四)支出原因為用於製造藥品者,並應載明生產製劑之品名、批號及製造同意書編號。
三、結存數量。
一、品名、管制藥品成分、含量、許可證字號、級別、批號、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、收入來源或支出對象機構、業者之名稱、地址、電話號碼與其管制藥品登記證字號及下列事項:
(一)收入原因為輸入或製造者,並應載明輸入或製造同意書編號。
(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)支出原因為輸出、銷燬或減損者,並應載明輸出同意書編號、銷燬或減損證明文號。
(四)支出原因為用於製造藥品者,並應載明生產製劑之品名、批號及製造同意書編號。
三、結存數量。