Use and Control of Controlled Drugs

The divisions of License Management, and Inspection and Control, and the Pharmaceutical Factory of the Bureau, are in charge of the control of legal controlled drugs. Controlled drugs are managed from the importation, exportation, manufacturing, and sales by industries at the upper stream down to the procurement and the adequacy of use of the user institutions at the lower stream. Advance review and approval of permit license and inspection afterward are two pillars of a tight control system from the upper stream down to the lower stream. Controlled drugs can only flow and use within the system, thus to prevent them from being abused.

The license system for controlled drugs includes:
1. to control at the upper stream, the import, export and manufacturing of controlled drugs by batch through permit license and letter of consent to ensure their legal flow;
2. to affirm and control institutions and dealers of controlled drugs through registration of controlled drugs, and also to trace their flow;
3. to regulate through controlled drug use permit license the use behavior of professionals, and thus to protect the safe use of drugs of patients.

In addition, to upgrade the efficiency of management, and in coordination with the information technology and electronic-government policy, the Bureau has set up a Controlled Drug Information System to timely and effectively understand the status of institutions concerned and dealers, and also to allow the public to apply online for various licenses, to simplify flow of operations, and thus to improve efficiency in issuing licenses.

For inspection and control, to control the flow of drugs, dealers and institutions must, by regulations, maintain books at their business sites to register balances of controlled drugs. They must report regularly to the Bureau and the local health bureaus.

The Bureau has also set up an Internet System for Reporting the Flow of Controlled Drugs for institutions and dealers to report online. The System is quick and convenient. The information so reported can be verified automatically by computers to check the flow of the drugs.

Cases suspected of problems by computer verification or dealers failing to make reports will be field-inspected by the Bureau in collaboration with local health bureaus. Violations of regulations will be punished according to law. Through this way, the institutions and dealers are alerted to be more cautious to the use and management of controlled drugs.