Notice of the general office of the General Administration of food and Drug Administration on Further Strengthening the purchase and sale of narcotic drugs and oral administration of tramadol 2017-05-18

The food and Drug Administration of all provinces, autonomous regions and municipalities directly under the central government:
To further curb the abuse of narcotic drugs and tramadol oral compound and prevent the loss of medical channels, the General Administration has decided to further strengthen the administration of oral and oral tramadol containing compounds. The relevant requirements are hereby notified as follows:
1. In the retail chain of drugs, all the narcotic drugs and tramadol oral preparations listed in the annex to this notice shall be included in the scope of drugs that must be sold by prescription, and no doctor's prescription shall be strictly prohibited.
Two, annexes containing narcotic drugs and oral tramadol compound preparation and requirements shall be in accordance with the State Food and Drug Administration Office of "notice on further strengthening with compound codeine oral solution, Compound Liquorice Tablets and Compound Diphenoxylate Tablets sales management" (food and Drug Administration Office of drug supervision 2013 No. 33) management regulations, will not be allowed sales through the internet.
Three, pharmaceutical production and wholesale enterprises should raise awareness of the abuse of narcotic drugs and tramadol oral compound preparations, and effectively enhance their awareness of prevention. We must strictly implement the drug electronic supervision codes, yards and out of storage, "see the code will sweep" operation, to ensure the correct nuclear note verification, and timely processing of system warning information. To strengthen the sales of the downstream enterprise management, electronic monitoring and warning information receiving enterprise core information is incorrect note must immediately suspend delivery, carries on the investigation, found that sales quantity and flow abnormal situation should be reported to the local food and drug regulatory authorities in a timely manner.
Four, the local food and drug supervision departments shall strengthen the supervision and control over the production and purchase and sale of these drugs, and strictly implement the provisions of this notice and relevant documents. To strengthen supervision and inspection, in addition to strengthening the inspection of the supply and marketing qualification, bill management, no cash transactions, electronic supervision, sales management and other key aspects, but also should pay attention to the use of electronic drug supervision information on suspected illegal channels, sales to the problem must be traced in the end. To strengthen the pharmaceutical retail business prescription sales of the drug supervision and inspection, comparison verification number and retained prescription drug sales quantity, for non implementation of prescription sales business, in addition shall be punished in accordance with relevant regulations, it shall cancel its qualification of prescription drug management. Direct the drug into illegal channels of the enterprise in violation of the relevant provisions, to revoke the "drug production license" or "drug license", alleged to constitute a crime, shall be transferred to the public security organs shall be investigated for criminal responsibility.