Special examination of codeine containing compound oral solution started nationwide

Fujian Provincial Bureau issued a notice to carry out special inspection on the production and operation of codeine containing compound oral solution in Fujian Province It is required that pharmaceutical manufacturers that produce codeine containing compound oral solution shall comprehensively clean up the sales customers, appropriately concentrate the sales channels, select pharmaceutical trading enterprises with good reputation and management to operate the product, and shall not sell codeine containing compound oral solution to unqualified units or individuals; pharmaceutical production and trading enterprises must strictly implement the pharmaceutical management law when selling the product 》, measures for the supervision and administration of drug circulation and other relevant regulations, verify the qualification certification materials of the buyer and the identity certification of the purchasing personnel, and then sell the drugs without any error, and track the arrival of the drugs; drug retail enterprises shall strictly sell the compound oral solution containing codeine by prescription Hainan Province launched "lightning action" on August 6, the special action of "lightning action" in Hainan Province, that is, rectifying the sale of codeine containing compound oral solution without prescription, began The operation ended on September 30 and lasted for two months and was carried out in three phases *The second stage is the supervision stage of the Provincial Bureau, and the third stage is the consolidation and summary stage The special action will reduce the business scope of "compound oral solution containing codeine" if it is found that it does not rely on prescription sales, counterfeiting prescription sales, issuing sales certificate, incomplete purchase and sales records, excessive sales and other illegal sales If it is found again, a fine of less than 1000 yuan will be imposed If the circumstances are serious, the drug business license will be revoked according to law If the case constitutes a crime, it shall be transferred to the judicial organ for criminal responsibility Shenzhen Municipal Bureau of Guangdong Province has taken four special measures to strengthen the management of addictive drugs: first, to strengthen the management of production sources Drug manufacturers are required to comprehensively clean up sales customers, appropriately concentrate sales channels, and implement the "three record" system for agent enterprises, varieties and monthly production and sales The second is to strengthen the management of wholesale allocation The wholesale enterprises and varieties filing system shall be implemented, and the enterprises without filing shall not deal in addictive drugs; the monthly filing system shall be implemented for the flow direction of drugs; it is required to implement the system of one ticket for wholesale (tax ticket with goods), and shall not be engaged in the allocation of related varieties among the drug wholesale enterprises in this city; the drug wholesale enterprises shall not sell more than 20 oral solutions containing codeine compound to the drugstores Bottle, and then according to the number of addictive drugs in the prescription provided by the drugstore, sell the same amount of the drug The third is to strengthen the management of retail terminals A prescription based sales restriction system shall be implemented Each sales volume shall not exceed the daily dosage of the drug 3 No compound oral solution containing codeine shall be sold to minors The management system of special person, special account and special counter shall be implemented Pharmaceutical technicians shall not sell addictive drugs without being on duty Fourth, we will especially strengthen the management of the reduction of the scope of permits In case of any violation of the above provisions, the drug manufacturer shall suspend the preliminary examination of its purchase application for narcotic drug APIs; the drug wholesale enterprise shall report to the provincial food and drug administration to reduce (cancel) its business scope of "compound oral solution containing codeine"; the drug retail enterprise shall withdraw its drug business license and reduce (cancel) "compound oral solution containing codeine" At the same time, if the circumstances are serious, the drug business license shall be revoked, the GMP and GSP certificates shall be withdrawn, and the relevant information shall be made public to the public If a crime is constituted, it shall be transferred to the judicial organ for criminal responsibility Xiamen Municipal Bureau of Fujian Province has taken a number of measures to try out the reporting system for the sale of drugs containing codeine First, the wholesale and chain enterprises are required to report the sales flow of cough drugs containing codeine phosphate to the Municipal Bureau every quarter, including the name of the drugstore and clinic at the sales terminal, the quantity and batch number of drugs, etc Second, strictly follow the relevant regulations to sell to legally qualified drug distributors and medical institutions In the process of sales, any abnormal purchase of drugstores and clinics should be reported in time Three is to require retail enterprises to sell such drugs according to the prescribed dosage according to the prescription issued by the practitioner, and actively issue the sales certificate, which shall be kept for future reference, and shall not be sold to minors; enterprises shall regularly educate employees on policies and regulations to ensure the sales according to the regulations Fourth, we will focus on the sale of the drug by prescription, and the drug retail enterprises that illegally sell prescription drugs will be dealt with seriously according to law once verified.