第1條 本細則依管制藥品管理條例(以下簡稱本條例)第四十三條規定訂定之。
Article 1 These Enforcement Rules are issued in accordance with Article 43 of the Controlled Drugs Act(hereinafter “this Act”).
第2條 領有管制藥品登記證之機構或業者，其醫藥教育研究試驗人員依本條例第六條第二項規定申請使用管制藥品，應由該機構或業者備具申請書，檢附醫藥教育研究試驗人員身分證明文件影本及其相關研究試驗計畫資料，向行政院衛生署管制藥品管理局(以下簡稱管制藥品管理局)申請，經中央衛生主管機關核准後，始得為之。
Article 2 Institutions or business with registration licneses, whose medical or educational researchers are making application to dispense controlled drugs in accordance with Article 6 Paragraph 2 of this Act shall prepare said application, with a copy of documents proving identity of the researchers and relevant project materials, and submit same to the National Bureau of Controlled Drugs of the Department of Health Executive Yuan (hereinafter “the National Bureau of Controlled Drugs”).
Applicants shall not commence the project until permission is granted by the Central Health Administration.
第3條 醫師、牙醫師、獸醫師或獸醫佐依本條例第七條第一項規定申請核發管制藥品使用執照，應備具管制藥品使用執照費及下列文件，向管制藥品管理局辦理：
Article 3 Physicians, dentists, veterinarians or assistant veterinarians applying for controlled drugs prescription license in accordance with Article 7 Paragraph 1 of this Act shall submit the prescription license fee and the following documents to the National Bureau of Controlled Drugs:
管制藥品使用執照應登記使用者之姓名、出生年月日、專門職業證書字號及使用執照號碼等事項。
A prescription license shall bear items such as the licensee's name, birth date, the identification number of professional certificate, and the identification number of prescription license.
第4條 管制藥品使用執照登記事項變更時，應自事實發生之日起十五日內，檢附管制藥品使用執照變更登記申請書、前條第一項第二款、第三款之文件及原管制藥品使用執照正本，向管制藥品管理局辦理變更登記。
Article 4 In the event any of the information listed on a controlled drug prescription license becomes inaccurate or outdated the licensee shall present the application form of change of prescription license, documents of the preceding Article Paragraph 1 Subparagraph 2, 3 and prescription license to the National Bureau of Controlled Drugs indicating the change of within 15 days.
管制藥品使用執照遺失或損毀者，應備具前條第一項之文件，向管制藥品管理局申請補發或換發。
If a controlled drug prescription licenses is lost, damaged or destroyed, the licensee shall present the documents of the preceding Article Paragraph 1 to apply to the National Bureau of Controlled Drugs for a replacement.
嗣後發現已報失之使用執照，應即繳銷。
In the event the license is later recovered, the licensee shall immediately surrender it for cancellation.
領有管制藥品使用執照者死亡，由管制藥品管理局註銷其管制藥品使用執照。
When controlled drug prescription license holder dies, the National Bureau of Controlled Drugs may cancel the prescription license.
未依第一項規定辦理變更登記、專門職業證書或執業執照經撤銷、廢止或註銷者，管制藥品管理局得撤銷、廢止其管制藥品使用執照。
The licensee has not update the registration in accordance with Paragraph 1, the professional certificates, professional licenses are revoked, expired or cancelled, the National Bureau of Controlled Drugs may cancel the prescription license.
第5條 領有管制藥品登記證之機構，其所屬人員申領之管制藥品使用執照，應由該機構依本條例第十四條規定所置之管制藥品管理人列冊管理。
Article 5 The prescription licenses obtained by people employed by institutions with controlled drugs registration licenses shall be kept as a record by the controlled drugs manager established by institutions in accordance with Article 14 of this Act.
第7條 醫師、牙醫師、獸醫師或獸醫佐使用第一級至第三級管制藥品時，醫師、牙醫師應將使用執照號碼載明於管制藥品專用處方箋；
Article 7 When administering Schedule 1, 2 or 3 controlled drugs, physicians, dentists shall indicate their prescription license number on the special prescription form,.
獸醫師、獸醫佐應將使用執照號碼載明於診療紀錄。
Veterinarians and assistant veterinarians shall indicate their prescription license number on the relevant medical records.
第8條 本條例第十一條所稱含管制藥品成分屬醫師、藥師、藥劑生指示藥品，係指含有行政院依本條例第三條第二項規定所核定公告之各級管制藥品成分之製劑，且為醫師、藥師、藥劑生指示用藥者。
Article 8 The term “drugs, containing ingredients of controlled drugs, designated by physicians, pharmacists, and assistant pharmacists” as used in Article 11 of this Act shall mean drugs containing ingredients of controlled drugs that have been approved and publicly announced by the Executive Yuan in accordance with the provision of Article 3 Paragraph 2 of this Act, that also are designated drugs to physicians, pharmacists, and assistant pharmacists.
但所含管制藥品成分有下列情形之一者，不適用之：
However, if the ingredients of the controlled drugs fall into any to the following categories, this Article does not apply:
一行政院僅公告管制其原料藥。
1.The Executive Yuan has announced to the public that only the drugs in the form of raw materials are regulated.
二其濃度或劑量單位在中央衛生主管機關公告之限量以下。
2.The level of concentration or dosage falls under the limit announced by the Central Health Administration.
第9條 醫療機構依本條例第十二條規定申請使用第一級、第二級管制藥品，從事管制藥品成癮治療業務者，應檢附治療計畫、醫療設施及人力資料，向管制藥品管理局申請，並經中央衛生主管機關核准後，始得為之。
Article 9 Medical institutions applying to dispense Schedule 1 and Schedule 2 controlled drugs for the treatment of drug addiction in accordance with Article 12 of this Act shall provide materials concerning treatment projects, medical facilities and human resources to the National Bureau of Controlled Drugs along with the application, and permission must be given by the Central Health Administration before the institution begins administering.
第10條 本條例第十四條第二項所稱管制藥品管理人之資格，規定如下：
Article 10 The term “the qualification of controlled drugs managers” as used in Article 14 Paragraph 2 in this Act is defined as follows:
一醫療機構：所屬醫師、牙醫師或藥師。
1.Medical institutions: their physicians, dentists or pharmacists.
However, assistant pharmacists may purchase anddispense controlled drugs that do not contain narcotic drugs.
但購用之管制藥品不含麻醉藥品者，得為藥劑生。
1.Medical institutions: their physicians, dentists or pharmacists.
However, assistant pharmacists may purchase anddispense controlled drugs that do not contain narcotic drugs.
二藥局及西藥販賣業：所屬藥師。
2.Drug stores and human medicine sales: their pharmacists.
However, assistant pharmacists may purchase,dispense or sell controlled drugs that do not contain narcotic drugs.
但購用或販賣之管制藥品不含麻醉藥品者，得為藥劑生。
2.Drug stores and human medicine sales: their pharmacists.
However, assistant pharmacists may purchase,dispense or sell controlled drugs that do not contain narcotic drugs.
三醫藥教育研究試驗機構：所屬專任教師、編制內醫師、牙醫師、獸醫師、獸醫佐、藥師、研究人員或檢驗人員。
3.Medical and educational research laboratories: their full-time teachers, resident physicians, dentists, veterinarians,assistant veterinarians, pharmacists, researchers or technicians.
四獸醫診療機構及畜牧獸醫機構：所屬獸醫師或獸醫佐。
4.Veterinarian medical institutions and pasturage veterinarian institutions: their veterinarians or assistantveterinarians.