China News Service, March 26. According to the "China Pharmaceutical News" WeChat public account, the State Food and Drug Administration announced five typical cases of drug violations.
1. The case of Yingchunlai health products store operating drugs without a license in Burqin County.
In August 2023, the Market Supervision and Administration Bureau of Burqin County, Altay Region, Xinjiang Uygur Autonomous Region, and the local health authorities conducted an on-site inspection of the Yingchunlai health products store in Burqin County. After investigation, it was found that the store sold 35 kinds of medicines such as progesterone injections and blood flow tablets without obtaining a "Drug Business License", with a total value of 2,622 yuan. The above-mentioned behavior of the store violated the provisions of Article 51 of the Drug Administration Law of the People's Republic of China. In September 2023, Burqin County Market Supervision and Administration Bureau, in accordance with Article 115 of the "Drug Administration Law of the People's Republic of China" and Article 17 of the "Regulations on the Application of Administrative Penalty Discretion of the Xinjiang Uygur Autonomous Region Drug Administration" According to the provisions of Item (4) of Paragraph 1 and Article 1 of the "Discretionary Standards for Drug Administrative Penalties of the Xinjiang Uygur Autonomous Region Food and Drug Administration", the store shall be subject to an administrative penalty of confiscating drugs for operating without permission and a fine of 150,000 yuan.
2. The illegal purchase of drugs at the Century Clinic in Jiagedaqi District, Daxinganling Region.
In October 2023, the Market Supervision and Administration Bureau of Jiagedaqi District, Daxinganling Region, Heilongjiang Province conducted an on-site inspection of the Century Clinic in Jiagedaqi District based on clues reported by other departments. After investigation, the clinic illegally purchased drugs (including insulin that required low-temperature refrigeration) from companies that did not have drug business qualifications from 2021 to 2022, and did not refrigerate the drugs that needed to be refrigerated during transportation and storage. The value of the goods The amount is 94,600 yuan. The clinic's above-mentioned behavior violated Article 55 of the Drug Administration Law of the People's Republic of China. In December 2023, the Jiagedaqi District Market Supervision and Administration Bureau imposed an administrative penalty on the clinic of confiscating illegal gains of 94,600 yuan and fined 757,100 yuan in accordance with Article 129 of the Drug Administration Law of the People's Republic of China. .
3. The case of Longyan Changting County Maternal and Child Health Hospital preparing pharmaceuticals for medical institutions without a license.
In March 2023, the Changting County Market Supervision and Administration Bureau of Longyan, Fujian Province conducted supervision and inspection of Changting County Maternal and Child Health Hospital. After investigation, it was found that the hospital did not obtain the "Medical Institution Preparation License" and prepared and used 9 kinds of traditional Chinese medicine preparations such as "Exhaust Decoction" and "Liuhuang Decoction", with a value of 49,200 yuan. The above-mentioned behavior of the hospital violated the provisions of Article 74 of the Drug Administration Law of the People's Republic of China. In June 2023, Changting County Market Supervision and Administration Bureau, in accordance with Article 115 of the "Drug Administration Law of the People's Republic of China" and Article 13 of the "Implementation Rules for the Application of Administrative Penalty Discretion in Fujian Province Drug Supervision (Trial)" Item (1) stipulates that the hospital shall be subject to an administrative penalty of confiscating illegal gains of 45,200 yuan and a fine of 300,000 yuan.
4. Xuchun Pharmacy in Gaobeidian City did not establish true and complete purchase and sales records.
In September 2022, the Market Supervision and Administration Bureau of Gaobeidian City, Baoding City, Hebei Province conducted an on-site inspection of Xuchun Pharmacy in Gaobeidian City based on clues reported by other departments. After investigation, the pharmacy purchased and sold 9 kinds of medicines including paracetamol and tramadol tablets, totaling 1,343 boxes (bottles). However, it failed to record the purchase, acceptance and sales information as required, and was unable to provide true and complete purchase and sales records. It was found that Failure to report abnormal sales in time and stop sales resulted in the drugs involved flowing into illegal channels. The above-mentioned behavior of the pharmacy violated the provisions of Article 57 of the Drug Administration Law of the People's Republic of China. In August 2023, Baoding Municipal Administration for Market Regulation imposed an administrative penalty on the pharmacy by revoking its drug business license in accordance with Article 130 of the "Drug Administration Law of the People's Republic of China"; in accordance with the "List of Serious Violators and Untrustworthy Persons in Market Supervision and Administration" Article 2 of the Management Measures stipulates that the pharmacy will be included in the list of serious illegal and untrustworthy persons, which will be announced through the national enterprise credit information disclosure system.
5. Guigang Cihang Pharmacy Co., Ltd. provided false materials to defraud the drug business license.
In September 2023, the Guigang Municipal Market Supervision and Administration Bureau of Guangxi Zhuang Autonomous Region conducted an on-site inspection of Guangxi Guigang Cihang Pharmacy Co., Ltd. After investigation, it was found that the company's corporate leader and prescription reviewer Meng Mouren's resume, employment documents, resignation certificate and other application materials were inconsistent with the actual facts, and he defrauded the drug business license by providing false certificates and information. The above-mentioned behavior of the company violated the provisions of Article 123 of the Drug Administration Law of the People's Republic of China. In December 2023, the Guigang Municipal Administration for Market Regulation, in accordance with Article 123 of the Drug Administration Law of the People's Republic of China, ordered the company to revoke its drug business license, not accept its drug business license application for ten years, and fined the company 5 administrative penalty of 10,000 yuan.
Compliance Tips:
1. The "Drug Administration Law of the People's Republic of China" stipulates that those engaged in drug wholesale and retail activities must obtain approval from the relevant local drug regulatory department and obtain a drug business license. Without a drug business license, no drugs may be sold; a drug marketing license holder must Individuals, drug manufacturers, drug trading companies and medical institutions should purchase drugs from drug marketing authorization holders or enterprises with drug production and operation qualifications. Drug trading companies should strictly follow relevant laws and regulations to keep purchase, acceptance and sales records to prevent them from flowing into illegal channels.
2. Medical institution preparations are fixed prescription preparations prepared with approval based on clinical needs and for self-use in medical institutions. The "Drug Administration Law of the People's Republic of China" stipulates that the preparation of preparations by medical institutions must be approved by the local provincial drug regulatory department. Those who have not obtained a preparation license for medical institutions shall not prepare preparations.
3. Drug safety is directly related to the health and life safety of the people. The "Drug Administration Law of the People's Republic of China" clarifies that drug management takes people's health as the center, adheres to the principles of risk management, full-process control, and social co-governance. , establish a scientific and strict supervision and management system throughout the entire process of production, operation and use. Illegal acquisitions, unlicensed operations, unlicensed preparation and other behaviors have caused related products to escape from the drug regulatory system. While disrupting the order of the drug market, they also seriously affect drug quality and pose major risks to the safety and effectiveness of drug use by the public.
4. The State Food and Drug Administration reminds consumers to purchase medicines from regular and legal medical institutions, pharmacies, etc., and ask for and keep relevant certificates; when purchasing medicines, pay attention to the relevant labels on the outer packaging, such as production date, validity period, and approval number. If necessary, you can log on to the State Food and Drug Administration website to query drug registration-related information; after purchasing drugs, you must store the drugs according to the storage conditions indicated in the instructions, and take the drugs according to the doctor's instructions or usage and dosage.