Article 3
The term “controlled drugs” as used in this Act refers to the following types of drugs:
1. addictive narcotic drugs
2. psychotropic drugs
3. other drugs requiring regulation
The controlled drugs mentioned above, shall be classified into four schedules by their potential for habitual use, dependence, abuse, and danger to the society. Said controlled drugs may only be used for medical and scientific purposes. The schedules and items of the controlled drugs shall be reviewed and announced to the public by the Executive Yuan after consideration by the Controlled Drugs Review Committee established by the central competent health authority and published in the Government Gazette.

Article 4
The pharmaceutical plant of the Food and Drug Administration shall handle the import, export, manufacture and selling of the Schedule 1 and 2 controlled drugs.
The pharmaceutical plant referred to in the preceding Paragraph may be established as a company. The establishment of the said company shall be stipulated by law separately.

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 controlled drugs prescription license for the use of controlled drugs issued by the Food and Drug Administration.
Any changes in the registered items of the controlled drugs prescription license mentioned in the preceding Paragraph shall be reported to the Food and Drug Administration for the record of the changes within 15 days after the day of the changes made.
If the controlled drugs prescription license was lost or damaged, a new one could be obtained by submitting an application to the Food and Drug Administration.
Regulations governing the issuance, alteration of registration, re-issuance, replacement, and management of the controlled drugs prescription license shall be prescribed by the central competent health authority.

Article 8
Physicians and dentists administering Schedule 1, 2 or 3 controlled drugs shall utilize approved special prescription form.
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.
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 competent health authority and published in the Government Gazette.

Article 13
The Food and Drug Administration may use the drugs confiscated by judiciary agencies for the purposes of medical and scientific research.

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.
1. Convicted under the controlled drugs related laws and released from the confinement imposed for that conviction less than three years prior to their appointment as a controlled drugs manager.
2. Persons who are subjects to the commencement of guardianship or assistantship and have not yet revoked those orders or addiction to drugs.

Article 16
The import, export, manufacture, selling or purchasing of controlled drugs shall follow the following procedures and guidelines:
1. The pharmaceutical plant listed in Article 4 Paragraph 1 may handle the export, import, manufacture and sales of Schedule 1 and 2 controlled drugs.
2. Human medicine manufactures or veterinary medicine manufactures may handle the buying and export of the raw materials of controlled drugs, and the export, manufacture or sales of Schedule 3 and 4 controlled drugs.
3. Human medicine companies or veterinary medicine companies may handle the import, export or transfer of Schedule 3 and 4 controlled drugs.
4. Medical institutions, drug stores, veterinarian institutions, pasturage veterinarian institutions and research laboratories may purchase controlled drugs.
The institutions and companies mentioned in the preceding Paragraph shall apply to the Food and Drug Administration for registration and obtain controlled drugs registration license.
Upon a change of circumstances regarding the registration mentioned in the preceding Paragraph, the registrants shall notify the Food and Drug Administration regarding the changes within 15 days.
Controlled drugs registration licenses shall not be lent to other people nor shall the ownership be transferred.
Regulations governing the issuance, alteration of registration, re-issuance, replacement, revocation, annulment and management of the controlled drugs registration license shall be prescribed by the central competent health authority.

Article 17
The Food and Drug Administration shall make an estimate of the amount of Schedule 1 and 2 controlled drugs that will be needed each year. That estimate shall be submitted to the Executive Yuan for ratification through the central competent health authority.

Article 18
The Food and Drug Administration shall report the monthly increase and decrease of stocks, and the current inventory amount of Schedule 1 and 2 controlled drugs to the central competent health authority, which shall make an annual public announcement and publish it in the Government Gazette.

Article 19
Pharmaceutical plant listed in Article 4 Paragraph 1 shall apply to the Food and Drug Administration for a permit to import or export of Schedule 1 and 2 controlled drugs.
The import and export ports of entry and exit as used in the preceding Paragraph shall be approved by the central competent health authority.

Article 20
Besides obtaining the drug permit license as prescribed in Article 39 of the Act of Pharmaceutical Affairs, the import, export and manufacturing of Schedule 3 and 4 controlled drugs shall apply to the Food and Drug Administration for a permit on a batch by batch basis. However, if the actions are permitted by the central competent health authority because of special demand, they shall be exempted.

Article 22
The Food and Drug Administration may allocate and limit the amount of Schedule 1 and 2 controlled drugs sold, and the regulations governing such sales shall be prescribed by the central competent health authority.

Article 23
A permit shall be applied for and issued from the Food and Drug Administration prior to domestically transporting Schedule 1 and 2 controlled drugs. However, a transporter handling the destruction of the above mentioned drugs with the local competent health authority’s certificate shall be exempted.

Article 27
Upon the loss of controlled drugs, the responsible manager shall immediately report the loss to the local competent health authority for inspection, and submit relevant documents from the local competent health authority to the Food and Drug Administration within 7 days. When all or part of the lost controlled drugs is seized, the same procedures shall be followed.
If the loss of controlled drugs referred to in the preceding Paragraph, includes loss due to mislaying, theft and other criminal cases, the reporting party shall enclose the documents of the report of the loss to the local police agencies.

Article 28
A person who has obtained a controlled drugs registration license shall maintain records at their business department. Said records shall include the daily increase and decrease of stocks, destruction, loss and inventory of controlled drugs.
The records mentioned in the proceeding Paragraph shall follow the regulations of the central competent health authority concerning both methods and timeliness. Periodical reports shall be made to the local competent health authority and the Food and Drug Administration.

Article 29
A person who has obtained a controlled drugs registration license shall follow the following procedures in the event of having their practice license, drug company permission license, registration license or other authorizing documents revoked, cancelled or suspended:
1. Report the increase and decrease of stocks, destruction loss and inventory to the local competent health authority and the Food and Drug Administration within 15 days of the start of the revocation, cancellation or suspension.
2. Books, receipts and special prescription forms for controlled drugs shall be kept by the original persons in charge.
3. The inventory of controlled drugs of a person whose license is revoked, canceled, shall be transferred to other registrants within 60 days of the reporting date prescribed in Subparagraph 1. A report shall then be made to the local competent health authority and the Food and Drug Administration for their inspection. In the alternative, a report shall be made to the local competent health authority, and after the controlled drugs are destroyed with the presence of the local competent health authority, a report shall be made to the Food and Drug Administration for inspection.
4. Registrants who are suspended shall handle the inventory in accordance with the preceding Paragraph or retained by themselves.

Article 30
Upon an application to permanent or temporary suspend their business related to controlled drugs, a registrant shall follow these procedures:
1. Report the increase and decrease of stocks, destruction, loss and inventory to the local competent health authority and the Food and Drug Administration.
2. A registrant applying to permanently suspend business shall transfer the inventory of controlled drugs to other registrants, and report to the local competent health authority for that agency’s inspection, or in the alternative destroy the inventory of controlled drugs and file a report of such action with the local competent health authority for their inspection prior to the suspension of the business.
3. A registrant applying for temporary suspension shall handle the inventory according to the preceding Subparagraph or retain the stock of controlled drugs in their safekeeping.
Upon permission for permanent or temporary suspension of business or upon the acceptance of the application referred to in Subparagraph 1 of the preceding Paragraph, the local competent health authority shall submit to the Food and Drug Administration a report and notification as soon as possible.

Article 33
The competent health authorities and the Food and Drug Administration may inspect and oversee the import, export, manufacture, selling, purchasing, administering, dispensing, and management of controlled drugs. Upon a showing of proper documentation the inspectors may sampling for testing. Said samples shall be limited to the amount of controlled drug needed for examination.

Article 37
A person, who violates Article 5, Article 9, or the import, export, manufacture and sales of Schedule 1 and 2 controlled drugs by pharmaceutical plant that are not authorized in Article 4 Paragraph 1, may be fined 150,000 to 750,000 NT dollars in addition to other punishments allowed under the Statue for Narcotics Hazard Control.

Article 42-1
Fees may be charged for applying for prescription license for the use of controlled drugs and controlled drugs registration license issued by the Food and Drug Administration in accordance with Article 7 and Article 16 Paragraph 2, and the fee shall be prescribed by the central competent health authority.