Regulations Governing Management of Manufacturing Schedule 1 and 2 Controlled Drugs Commissioned to Pharmaceutical Firms Article 4
The commissioned pharmaceutical firm shall prepare its facilities, laboratories, and workplaces in the following manner:1. Facilities and laboratories: Strong, safe, equipped with anti-theft measures, the emergency reporting system is connected with the local policy agency or a security service provider.2. Workplaces for production and packaging: Strong, safe, a separate workspace equipped with enhanced protection devices unless otherwise permitted by the FDA under special circumstances.A separate workspace in Subparagraph 2 of the foregoing Paragraph is a space physically independent of others, and actually dedicated for manufacturing the controlled drugs during the manufacturing period.Any addition, modification, repair, change of purpose of the structures, partitions, and other hardware of the facilities, laboratories and workplaces under Paragraph 1 shall be subject to the prior consent of the FDA.
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4條
受託藥商之廠房、實驗室及作業場所，應符合下列條件：
一、廠房及實驗室：堅固、安全，設有防盜措施，且與轄區警察機關或保全業設有緊急通報連線系統。
二、生產及分包裝作業場所：堅固、安全，具加強防護設備之獨立作業場所。
但有特殊情況，經食品藥物署認可者，不在此限。
前項第二款獨立作業場所，指具實體區隔，且於製造期間，實際專用於製造管制藥品之場所。
第一項廠房、實驗室及作業場所之結構、隔間及其他硬體設施，有增建、改建、修繕或變更用途必要時，應經食品藥物署同意後，始得為之。
一、廠房及實驗室：堅固、安全，設有防盜措施，且與轄區警察機關或保全業設有緊急通報連線系統。
二、生產及分包裝作業場所：堅固、安全，具加強防護設備之獨立作業場所。
但有特殊情況，經食品藥物署認可者，不在此限。
前項第二款獨立作業場所，指具實體區隔，且於製造期間，實際專用於製造管制藥品之場所。
第一項廠房、實驗室及作業場所之結構、隔間及其他硬體設施，有增建、改建、修繕或變更用途必要時，應經食品藥物署同意後，始得為之。