subject: Sfda Requirements Around The Strict Management Of Combined Oral Solution Containing Codeine-sfda, [print this page] Of the recent abuses in succession with codeine oral solution compound the problem, the State Food and Drug Administration (SFDA) spokeswoman Yan Jiangying on December 8, held a regular press conference that, SFDA recently under made "on the strengthening of combined oral solution containing codeine Control", on the production, wholesale, retail and Codeine oral solution propose a more stringent management measures.
First of all, to carry out combined oral solution containing codeine special inspection. Around the food and drug regulatory departments in their respective jurisdictions to organize a combined oral solution for the Codeine special inspection area containing codeine on the operation of combined oral solution, a comprehensive examination, focusing on inspection of the production, wholesale Enterprise compound with codeine oral solution sales flow, and drug retail sales business is strictly prescription codeine oral solution containing the situation.
Second, further standardize the compound with codeine oral solution business conduct. Required drug manufacturers to conduct a comprehensive clean-up on customer sales, moderate concentration of sales channels, select credit and better management of business enterprises in the pharmaceutical variety, shall not be qualified to no unit or individual sales with codeine oral solution compound; pharmaceutical production, wholesale business sales, we must strictly enforce the "Drug Administration Law," "Supervision and Administration of drug distribution" and other relevant provisions, the purchaser to verify proof of qualifications, identity procurement staff, etc., is correct only after sales, and tracking verification of drugs to the delivery; Drug retailers should strictly prescription sales combined oral solution containing codeine.
Again, to further increase the oral solution containing codeine compound production and operation of illegal activities in the crackdown on drug production, sale of enterprises according to the specified, must strictly abide by "Drug Administration Law" and "supervision of drug distribution Management Regulations "and other stipulations; on the drug wholesaler will compound with codeine oral solution sales to non-qualified units or individuals and drug retailers are not strictly prescription sales of abuse and lead to serious consequences, should be revoked," Drugs business license. "
Yan Jiangying, said at the press conference, the clinical oral solution compound containing codeine is mainly used for cough and effective, use wide, is a commonly used antitussive drugs. Normal use is safe and effective, but if high doses, which contains codeine phosphate and ephedrine superposition of two components, will produce hallucinogenic effects, are very vulnerable to abuse, damage to the human body, or even life-threatening. The late 90s of last century, parts of the country began with codeine oral solution compound abuse, abuse of youth-oriented crowd. Since the discovery of this issue, China has been closely monitoring the abuse of such drugs since 2000, several measures to strengthen the management of this class of drugs in 2005 to stipulate that the drugs must be strictly retail business with sales of prescription codeine oral solution compound.
It is reported that such products in China approved a total of 13 species listed, including 9 species of domestic and imported varieties 4. In the international arena, has not the class of drugs under special management.
