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National Food and Drug Administration Office [2012] No. 260 

Published on September 04, 2012 
 

 Each province、Autonomous Region、Food and Drug Administration (Drug Supervision Administration)、Public Security Department (Bureau)、Department of Health (Bureau):

In recent years，Compound preparations containing ephedra -containing compound preparations of illegal criminals through various means，The problem of being used from normal medicinal channels to be used for drug making is repeatedly banned，Affects social stability and endangers public health，and cause adverse international impact。For this，Drug Supervision、Stake Sports BettingPublic stake online sports bettingSecurity、Health and other relevant departments have taken a variety of measures，Strengthen the supervision of ephedra -alkaline compound preparations，Prevent the loss of medicinal channels，Get a certain amount of results。But for a period of recent periods，Poison -making criminals adopt the way to buy multiple employers，Check the purchase of ephedrine -based compound preparations for some regional pharmaceutical retail companies，Drug loss caused to varying degrees，At the same time, a few pharmaceutical retail companies chase the benefits，Existing illegal sales behavior。So，It must be severely crackdown on this kind of behavior，Resolutely curb the spread of this illegal criminal behavior。The relevant matters are notified as follows:

1、The content of ephedrine drugs in the unit dosage of ephedrine is greater than 30mg (excluding 30 mg), a compound preparation of ephedrine，Prescription drug management that must be sold by prescription。Medical institutions should strictly open the prescription in accordance with the "Prescription Administrative Measures"。Drug retail companies must sell the above drugs with prescriptions prescribed by practicing physicians。
Each minimum packaging specifications of ephedra -alkaline compound preparations, ephedra alkaline drug content oral solid preparations must not exceed 720 mg，Oral liquid preparation must not exceed 800mg。
Related drug manufacturers should complete the label of the above drugs before February 28, 2013、Modification stake betting appof the stake online sports bettinginstructions and packaging，Undeads will not be sold after March 1, 2013。Drugs listed before February 28, 2013，Sale as the original sales method。

2、Pharmaceutical retail enterprises selling ephedra -alkaline compound preparations，The ID card of the buyer should be checked，and register its name and ID number。Except for the prescription drugs for sale，One sales must not exceed 2 minimum packaging。
Drug retail enterprises shall not open the shelf to sell ephedra base compound preparations，The counter should be set up by a special person managed、Special Registration，Registration content includes the name of the medicine、Specification、Sales quantity、Production Enterprise、Production batch number、The name of the buyer、ID number。
Drug retail companies have found more than normal medical needs，Large amount、Buy multiple compound preparations containing ephedra -alkaline compound preparations，Report to the local food and drug regulatory authorities and public security organs immediately。

3、Compound preparation manufacturers containing ephedra -alkaline compound preparations shall effectively strengthen sales management，Strict control of product sales channels，Ensure that the drugs produced in the flow of medicinal channels。
Anyone -containing compound preparation with a large amount of loss or a large amount of loss，The provincial food and drug regulatory authorities of the production enterprise where their production enterprise is located should reduce the approval of ephedrine and drugs related to their production enterprises，Stake Sports BettingMy stake betting appThe reduction of the reduction in principle is not less than 50%of the approval of the previous year。Provincial (district、City) Public security organs shall be in accordance with the State Food and Drug Administration and the Ministry of Public Security's "Guiding Opinions on the Approval of Purchase Approval of Ejly and Alkali Materials in the Production of Popularine Requesting Preparations" (Guo Food and Drug Administration [2009] 417 No.) Regulations，Continue to assist in the examination before approval。

4、Food and drug supervision departments at all levels must conscientiously implement the requirements of this notice，Strict supervision and inspection of ephedra base compound preparations，It is found that there is abnormal market sales，To remind timely，Resolutely correction; criticize criticism for violations of regulations，Disposal。Pharmaceutical production that contains ephedra -alkaline compound preparations that cause sales that violate the regulations、Business Enterprise，It should be in accordance with the "Drug Management Law"、"Special Provisions on Strengthening the Safety Supervision and Management of Food and other products such as food"，Give "Drug Production License"、Punishment of "Drug Operation License"。for suspected crime，Should be transferred to the public security organs in time。
This notice contains ephedra base compound preparations refer to the drug compound preparation of ephedrine substances containing the "Regulations stake betting appstake online sports bettingon the Management of Easy Poisonous Chemicals"。

National Food and Drug Administration
Ministry of Public Security of the People's Republic of China
Ministry of Health of the People's Republic of China
September 4, 2012