三其他認為有加強管理必要之藥品。
3.other drugs requiring regulation
第4條 管制藥品,由中央衛生主管機關專設管制藥品管理局管理之,其組織以法律定之。
Article 4 Controlled drugs shall be regulated by the National Bureau of Controlled Drugs established within the Central Health Administration, and whose organization shall be set forth by law.
管制藥品管理局必要時得設立分局。
The National Bureau of Controlled Drugs may establish branch bureaus as necessary.
為辦理第一級、第二級管制藥品之輸入、輸出、製造及販賣,管制藥品管理局應設立製藥工廠為之。
The National Bureau of Controlled Drugs shall establish pharmaceutical plant to handle the import, export, manufacture and selling of the Schedule 1 and 2 controlled drugs.
第5條 管制藥品之使用,除醫師、牙醫師、獸醫師、獸醫佐或醫藥教育研究試驗人員外,不得為之。
Article 5 Controlled drugs may not be administered by other than physicians, dentists, veterinarians, assistant veterinarians, or approved medical or educational researchers.
獸醫佐使用管制藥品,以符合獸醫師法第十六條第二項規定者為限。
Assistant veterinarians' use of controlled drugs is limited by Article 16 Paragraph 2 of the Veterinarian Law.
醫藥教育研究試驗人員非經中央衛生主管機關核准之正當教育研究試驗,不得使用管制藥品。
Medical or educational researchers may not use controlled drugs on research projects without the Central Health Administration's approval.
第7條 醫師、牙醫師、獸醫師或獸醫佐非領有管制藥品管理局核發使用執照,不得使用第一級至第三級管制藥品或開立管制藥品專用處方箋。
Article 7 Physicians, dentists, veterinarians, or assistant veterinarians may not administer Schedule 1, 2 or 3 controlled drugs or write special prescription form for controlled drugs without the prescription license issued by the National Bureau of Controlled Drugs.
前項使用執照之核發及管理,由中央衛生主管機關定之。
The National Central Health Administration shall regulate and the issuance of said prescription licenses in the preceding Paragraph.
獸醫師、獸醫佐使用管制藥品,其診療紀錄應記載飼主之姓名、住址、動物種類名稱、體重、診療日期、發病情形、診斷結果、治療情形、管制藥品品名、藥量及用法。
Veterinarians and assistant veterinarians administering controlled drugs shall record in the medical records: the names and addresses of the parties responsible for the animal(s), the species and weight of the animal(s), the treatment dates, symptoms, diagnosis, and the treatment plan.
In addition the names, dosage(s) and usage of the prescribed controlled drugs shall be recorded.
第一項管制藥品之範圍及其專用處方箋之格式、內容,由中央衛生主管機關訂定公告。
The specific scope of controlled drugs used in Paragraph 1 and the format and contents of the special prescription form shall be set forth and announced to the public by the Central Health Administration.
醫師、牙醫師調劑管制藥品,依藥事法第一百零二條之規定。
Physicians and dentists shall dispense controlled drugs according to the regulations set by Article 102 of the Act of Pharmaceutical Affairs.
第10條 醫師、牙醫師、藥師或藥劑生調劑第一級至第三級管制藥品,非依醫師、牙醫師開立之管制藥品專用處方箋,不得為之。
Article 10 Physicians, dentists, pharmacists, and assistant pharmacists may not dispense Schedule 1, 2 and 3 controlled drugs without utilizing the special prescription form for controlled drugs signed by a physician or dentist.
前項管制藥品,應由領受人憑身分證明簽名領受。
The controlled drugs administered per the above Paragraph shall only be received to persons upon a showing of that person's identity card and upon the person's signature.
第一級、第二級管制藥品專用處方箋,以調劑一次為限。
The special prescription for Schedule 1 and 2 controlled drugs shall not be refilled.
第11條 供應含管制藥品成分屬醫師、藥師、藥劑生指示藥品者,應將領受人之姓名、住址、所購品量、供應日期,詳實登錄簿冊。
Article 11 When supplying drugs, containing ingredients of controlled drugs, designate only by physicians, pharmacists and assistant pharmacists, the supplier shall maintain a detailed record of the names, addresses of the receivers, the amount received, the date of receipt.
Transfers recorded in medical records by medical institutions are exempt from this requirement.
但醫療機構已登載於病歷者,不在此限。
Article 11 When supplying drugs, containing ingredients of controlled drugs, designate only by physicians, pharmacists and assistant pharmacists, the supplier shall maintain a detailed record of the names, addresses of the receivers, the amount received, the date of receipt.
Transfers recorded in medical records by medical institutions are exempt from this requirement.
第12條 醫療機構未經中央衛生主管機關核准,不得使用第一級、第二級管制藥品,從事管制藥品成癮(以下簡稱藥癮)治療業務。
Article 12 Without the approval of the Central Health Administration, medical institutions may not use Schedule 1 and 2 controlled drugs for the treatment of addiction to controlled drugs (hereinafter “drug addiction”).
第13條 為醫藥及科學研究之目的,管制藥品管理局得使用經司法機關沒收之毒品。
Article 13 The National Bureau of Controlled Drugs may use the drugs confiscated by judiciary agencies for the purposes of medical and scientific research.
第14條 醫療機構、藥局、醫藥教育研究試驗機構、獸醫診療機構、畜牧獸醫機構、西藥製造業、動物用藥品製造業、西藥販賣業、動物用藥品販賣業使用或經營管制藥品,應置管制藥品管理人管理之。
Article 14 The position of “Controlled drugs managers” shall be established to manage the inventory of controlled drugs in each of the following types of institutions: medical institutions, drug stores, medical and educational research laboratories, veterinarian medical institutions, pasturage veterinarian institutions, human medicine manufactures, veterinary medicine manufactures, human medicine sales, veterinary medicine sales.
管制藥品管理人之資格,除醫療機構、藥局應指定醫師、牙醫師或藥師擔任外,其餘由中央衛生主管機關定之。
In addition to the physicians, dentists, or pharmacists appointed by medical institutions and pharmacies, the qualifications of other controlled drugs managers shall be prescribed by the Central Health Administration.
第15條 有下列情形之一者,不得充任管制藥品管理人;已充任者,解任之︰
Article 15 A person with any of the following conditions may not hold the position of controlled drugs managers; if in the course of their employment they become subject to such conditions they shall be removed as a controlled drugs manager.
一違反管制藥品相關法律,受刑之宣告,經執行完畢未滿三年者。
1.Convicted under a controlled drugs related laws and released from the confinement imposed for that convictionless than three years prior to their appointment as a controlled drugs manager.
二心神喪失、精神耗弱或藥癮者。
2.Insanity, other mental or physical debilitation, or addiction to drugs .