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.
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 competent health authority.
When buying controlled drugs, which do not include narcotic drugs, medical institutions and drug stories may appoint assistant pharmacists as controlled drugs managers.

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.

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. The commissioned pharmaceutical firms listed in Article 4 Paragraph 1 may manufacture the Schedule 1 and 2 controlled drugs.
3. 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.
4. Human medicine companies or veterinary medicine companies may handle the import, export or transfer of Schedule 3 and 4 controlled drugs.
5. 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 FDA 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 FDA 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.

The FDA 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 central competent health authority for ratification.

The FDA 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.

Pharmaceutical plant listed in Article 4 Paragraph 1 shall apply to the FDA 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.

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 FDA 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.

When selling controlled drugs, the names of purchasers and their institutions, organizations, the person in charge, the registration numbers, purchased amount, and dates shall be recorded in detailed records and shall be kept together with the receipt containing the purchasers’ signature.

The FDA 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.

A permit shall be applied for and issued from the FDA 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.

Controlled Drugs shall be under the safekeeping of the business department. Schedule 1, 2 and 3 controlled drugs shall be kept and locked in special storage cabinets.

The labels of controlled drugs shall bear the schedule, written warnings in Chinese and alert signs or colors. Said labeling in the case of narcotic drugs shall bear the sign of narcotic drugs in Chinese.
The signs of the schedule of the controlled drugs and narcotic drugs mentioned in the preceding Paragraph shall be prescribed by the central competent health authority.