State Food and Drug Administration to further strengthen the management of clenbuterol

To further enhance the drug clenbuterol raw materials and aerosols, such as compound management, recently, the State Food and Drug Administration issued a notice on the matter made clear.

The circular stressed the need to standardize the production and strengthen the raw material drug production and use of management, the provincial food and drug supervision and administration departments shall report prepared by production or business plan required to review, strict control. Has been discontinued clenbuterol API manufacturer will be allowed to resume production. Do need to resume production, should be based on market demand, a contract of sale, to the provincial food and drug supervision and management department; the provincial food and drug supervision and management departments should carry out on-site inspection organization, upon inspection that the production of quality management system normal, and meet the appropriate security management requirements, before resuming production; the provincial food and drug supervision and management departments should promptly resume production of the State Food and Drug Administration for the record. 

To regulate the distribution channels to ensure the flow of drugs can be traced. Pharmaceutical production, sales enterprises shall establish customer profiles, verify and retain proof of qualification purchaser, legal power of attorney and procurement personnel identification documents, drug manufacturers sell clenbuterol API should also check the record of the required plan . Enterprises should designate a person responsible for sales and a database management, strict implementation of the library system for review and sales system, abnormal situation report to the local food and drug supervision and management departments.

Act to regulate clinics, strict prescription management. Food and drug supervision and management departments at all levels should earnestly fulfill relevant pharmaceutical production, the daily supervisory duties enterprises, strengthen supervision and inspection, to effectively implement the regulatory responsibility; health administrative departments at all levels should strengthen supervision and inspection of medical institutions and prescription management.