Regulations Governing Management of Manufacturing Schedule 1 and 2 Controlled Drugs Commissioned to Pharmaceutical Firms Article 6
The commissioned pharmaceutical firm and its staff carrying out the production, packaging, quality control, security and management of the controlled drugs shall comply with the following requirements:1. The commissioned pharmaceutical firm shall submit the name list of its staff, and the authorization of processes and accesses, as well as any changes thereto, to the FDA for record before commencing the work.2. Each individual participating in the process shall understand the schedule of the controlled drugs, read the safety datasheets, and understand the hazards of the drugs before commencing the work.3. Each individual shall implement the safety management procedures established by the commissioned pharmaceutical firm, avoid inhaling, or have the eyes, skin or clothes contact with the drugs.4. Each individual carrying out the production and packaging process shall wear a work jumpsuit with no pockets.5. Anyone who has direct skin contact with the controlled drugs shall immediately wash their skin and make a record under the direction of the supervisor.6. Each individual on the name list under Subparagraph 1 shall be subject to a urine test for drug abuse conducted by the FDA according to the Regulations of Urine Specimen Collection for Certain Persons at least once per year.
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6條
受託藥商或其管制藥品之生產、分包裝、品管、警衛（保全）及管理作業人員，應遵行下列規定：
一、受託藥商於作業前，將所有參與作業人員名冊與其作業及進出相關作業區之權限，送食品藥物署備查；其有異動時，亦同。
二、參與作業人員於作業前，瞭解管制藥品之管制等級，詳閱物質安全資料表，瞭解藥品之危險性。
三、參與作業人員依受託藥商建立之安全管理作業程序，確實執行，並避免藥品吸入口鼻或接觸眼睛、皮膚或衣服。
四、從事生產、分包裝之人員，穿著連身，且無口袋之作業服裝。
五、參與作業人員有皮膚直接接觸管制藥品時，立即清洗及記錄，並由監督製造人員督導。
六、第一款列冊人員，接受食品藥物署依特定人員尿液採驗辦法之規定，實施藥物濫用尿液篩檢，每年至少一次。
一、受託藥商於作業前，將所有參與作業人員名冊與其作業及進出相關作業區之權限，送食品藥物署備查；其有異動時，亦同。
二、參與作業人員於作業前，瞭解管制藥品之管制等級，詳閱物質安全資料表，瞭解藥品之危險性。
三、參與作業人員依受託藥商建立之安全管理作業程序，確實執行，並避免藥品吸入口鼻或接觸眼睛、皮膚或衣服。
四、從事生產、分包裝之人員，穿著連身，且無口袋之作業服裝。
五、參與作業人員有皮膚直接接觸管制藥品時，立即清洗及記錄，並由監督製造人員督導。
六、第一款列冊人員，接受食品藥物署依特定人員尿液採驗辦法之規定，實施藥物濫用尿液篩檢，每年至少一次。