Regulations Governing Management of Manufacturing Schedule 1 and 2 Controlled Drugs Commissioned to Pharmaceutical Firms Article 7
The commissioned pharmaceutical firm shall specify and implement the controlled drugs safety and protection plan, which shall also be submitted to the FDA for record.The foregoing plan shall cover the following aspects:1. Access control and camera surveillance system at the workplaces and storage locations.2. Process of transferring the controlled drugs.3. Waste disposal of the workplaces and storage locations, and the recycling process of the controlled drugs.4. 24-hour security guard services, who shall follow the work rules as below:(1) Confirm, register and conduct necessary inspection on any person accessing the workplaces and storage locations.(2) Immediately report any unusual event or alert at the workplaces and storage locations to the person designated by the commissioned pharmaceutical firm, and arrive at the scene to deal with the incident. Record the process and the result.5. Police-community collaboration covenant or security service agreement with the local police agency or a security service provider.6. Immediate reporting of any unusual access to the workplaces and storage locations, or any peril incident to the security office and the responsible person of the plant, and to the policy agency and the FDA as necessary.
中文原文 藥商受託製造第一級及第二級管制藥品管理辦法第7條
受託藥商應訂定管制藥品保全計畫，報食品藥物署備查，並落實執行。
前項保全計畫，應包括下列內容：
一、作業與儲存場所之進出管制及監視錄影措施。
二、管制藥品移轉程序。
三、管制藥品之作業與儲存場所之垃圾處理，及管制藥品回收作業程序。
四、置二十四小時駐廠警衛（保全）人員，並訂定工作守則，其內容如下：
（一）進出作業及儲存場所人員確認、登記與必要之檢查。
（二）作業及儲存場所有異常情事或警報發報時，應立即向受託藥商指定人員報告，並至現場處理；其過程及結果，應予記錄。
五、與轄區警察機關或保全業簽訂警民聯防支援協定或保全協議。
六、發現人員進出作業及儲存場所有異常，或發生危安事故時，立即通報警衛室及廠區負責人，必要時通報警察機關及食品藥物署。
前項保全計畫，應包括下列內容：
一、作業與儲存場所之進出管制及監視錄影措施。
二、管制藥品移轉程序。
三、管制藥品之作業與儲存場所之垃圾處理，及管制藥品回收作業程序。
四、置二十四小時駐廠警衛（保全）人員，並訂定工作守則，其內容如下：
（一）進出作業及儲存場所人員確認、登記與必要之檢查。
（二）作業及儲存場所有異常情事或警報發報時，應立即向受託藥商指定人員報告，並至現場處理；其過程及結果，應予記錄。
五、與轄區警察機關或保全業簽訂警民聯防支援協定或保全協議。
六、發現人員進出作業及儲存場所有異常，或發生危安事故時，立即通報警衛室及廠區負責人，必要時通報警察機關及食品藥物署。