Regulations Governing Management of Manufacturing Schedule 1 and 2 Controlled Drugs Commissioned to Pharmaceutical Firms Article 5
The facilities and equipment used by the commissioned pharmaceutical firm shall be dedicated to manufacturing the controlled drugs during the actual period of commissioned manufacturing. The active pharmaceutical ingredients, semi-finished products and finished products shall be kept at a designate storage location, or a fixed cabinet with double door lock.The walls, doors, and cabinets at the storage locations under the foregoing Paragraph shall be made of stainless steel unless otherwise permitted by the FDA under special circumstances.
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5條
受託藥商製造管制藥品，其設施及設備，於實際受託製造期間，應為專用；其原料藥、半製品及成品，應設置具雙重門鎖之專用儲存場所或固定式專櫃。
前項儲存場所之牆壁、門及專櫃本體，應為不鏽鋼材質。
但有特殊情況，經食品藥物署認可者，不在此限。
前項儲存場所之牆壁、門及專櫃本體，應為不鏽鋼材質。
但有特殊情況，經食品藥物署認可者，不在此限。