Regulations Governing Management of Manufacturing Schedule 1 and 2 Controlled Drugs Commissioned to Pharmaceutical Firms Article 13
The FDA may conduct unscheduled inspections on the commissioned pharmaceutical firm pursuant to these Regulations. The commissioned pharmaceutical firm shall not circumvent, interfere with or reject such inspections.The FDA may invite the representatives of relevant agencies, experts or scholars to join the inspections in the foregoing Paragraph.
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13條
食品藥物署得就本辦法規定事項，對受託藥商進行不定期查核，受託藥商不得規避、妨礙或拒絕。
前項查核，食品藥物署得邀請相關機關代表或專家學者參加。
前項查核，食品藥物署得邀請相關機關代表或專家學者參加。