The Operation Fund of the Pharmaceutical Plant of Controlled Drugs (hereinafter referred to as the “Fund”) is established for the purpose of handling the import, export, manufacture, quality control, sale, custody and research on the manufacturing methods of controlled drugs, and these Regulations are adopted according to Article 21 of the Budget Act.

The Fund is classified as the Special Fund, which is specified in Subparagraph 2 of Paragraph 1 of Article 4 of the Budget Act, with the budget compiled under a subordinate unit. The Ministry of Health and Welfare (hereinafter referred to as the “Ministry”) shall be the competent authority for the Fund, and the Food and Drug Administration of the Ministry is the regulatory agency.

The sources of the Fund are as follows:
1. The money appropriated by the government according to budgetary procedures.
2. The income from the sale of products and the provision of services by pharmaceutical plants.
3. The income from the interests of the Fund.
4. Other relevant income.

The Fund is used for the following purposes:
1. The expenditure on the production and sale of products and the provision of services by pharmaceutical plants.
2. The expenditure on the marketing, management, general affairs and research and development of products.
3. Other relevant expenditure.

The profitability and security of the custody and utilization of the Fund shall be emphasized, and the saving of the Fund shall be governed by the Government Treasury Act and other relevant laws and regulations.

The Fund may be used to purchase government bonds, treasury bills or other short-term instruments for the needs of business operations.

The compilation and execution of budget and the compilation of final account in relation to the Fund shall be governed by the Budget Act, Accounting Act, Financial Statement Act, Audit Act and other relevant laws and regulations.

An accounting system shall be adopted to handle the accounting matters of the Fund as required.

The surplus, if any, existing in the annual final account of the Fund shall be allocated as required.

The Fund shall be settled upon the closing of the Fund, and the remaining rights and interests of the Fund shall be reverted to the national treasury.

These Regulations shall take effect on January 1st, 2010.
The amendments to these Regulations shall take effect on the date of promulgation.