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    Home > Medical News > Medical World News > One bottle of OTC pharmacy fined 100,000!

    One bottle of OTC pharmacy fined 100,000!

    • Last Update: 2021-07-15
    • Source: Internet
    • Author: User
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    Medical Network
    reported on March 19 that
    counterfeit and inferior drugs were identified.
    Prior to this, in 15 typical cases notified by the State Administration of Markets, a pharmacy was fined 100,000 yuan for selling expired drugs
    .
    You know, a bottle of Huo Dan pills, the pharmacy's profit is only 0.
    1 yuan
    .
    If due to a mistake, other losses and costs are not included, only the fine needs to be sold 1 million bottles to make up
    .
    However, it is not uncommon for pharmacies to be fined 100,000 yuan for expired drugs in the past year
    .
    A pharmacy in Chengdu sold expired Chinese herbal medicine pieces, the value of which was 77.
    61 yuan, sold 10 grams, the illegal gain was 4.
    5 yuan, and was fined 100,000 yuan; a pharmacy in Xiacheng District, Hangzhou City, Zhejiang Province was ordered by the District Market Bureau for selling two boxes of expired medicines A fine of 100,000 was issued, and the total value of the two boxes of medicines was less than 100 yuan.
    .
    .
    Since medicines that have expired are punished according to the standard of inferior medicines, according to the new version of the "Drug Administration Law" the 100th Article 17 stipulates that those who produce or sell inferior medicines shall be confiscated of illegally produced and sold medicines and illegal income, and shall also be fined ten times to twenty times the value of the illegally produced and sold medicines (pharmaceuticals sold illegally).
    If the value is less than 10,000 yuan, it will be calculated as 10,000 yuan)
    .
    In other words, the above pharmacies are fined 100,000 yuan for selling expired drugs, which is the minimum penalty.
    If the value of the goods is large (more than 10,000 yuan) or a higher multiple is imposed, the fine is far more than 100,000 yuan
    .
    In this context, in order to strictly regulate administrative law enforcement, on March 17, the Shaanxi Provincial Food and Drug Administration announced the "Guiding Opinions on the Identification of Counterfeit and Inferior Drugs and Other Related Issues (Draft for Solicitation of Comments)" (hereinafter referred to as the "Opinions") Announcement for comments
    .

    These conditions are counterfeit drugs
    As for how to evaluate counterfeit drugs, the "Opinions" clarify that, based on the conclusions of drug quality inspections, the situations that should generally be recognized as counterfeit drugs are as follows: The ingredients contained in the drug do not conform to the ingredients prescribed by the national drug standards, including but not limited to: 1.
    Drug quality inspection conclusions identified in item or items displayed content determination, not detected under standard national drug ingredient or Found zero or a divalent inactive; 2.
    the medicinal drugs outside, Chinese Herbal medicine, quality inspection findings identify content items or The test items show that other drug ingredients, medicinal flavors, extracts, chemical substances or other substances that do not meet the requirements for medicinal use (excluding excipients ) other than those specified in the national drug standards have been detected
    .
    Using non-drugs to pretend to be drugs or other drugs to pretend to be such drugs, including but not limited to: 1.
    The quality inspection conclusions of Chinese medicinal materials and Chinese medicinal pieces show that the sample does not meet the basis of the national drug standard or other drug standards.
    , Or the traits or inspection items show that other medicinal flavors and other impurities are detected that exceed 40% of the source specified in the drug standard (excluding 40%)
    .
    2.
    It is shown in the identification items or content determination items of the quality inspection conclusions of traditional Chinese medicine formula granules that the ingredients specified by the provincial drug standards are not detected or the actual measured value is zero
    .

      Deteriorating drugs, including but not limited to:
    1.
    The inspection items of the quality inspection conclusion of injections and sterile preparations show that the sterility inspection conclusion does not meet the requirements of the national drug standards; 2.
    The color, gas, and taste are significantly changed (including mildew) , Does not meet the national drug standards or other drug standards; 3.
    The inspection items of the drug quality inspection conclusion show that the endogenous toxin substance does not meet the national drug standards or other drug standards;   these conditions are inferior drugs

    As for how to evaluate inferior drugs, the "Opinions" clarify that based on the conclusions of drug quality inspections, the situations in which inferior drugs should generally be identified are: The content of the drug ingredients does not meet the national drug standards, including but not limited to: 1.
    The identification items of the drug quality inspection conclusions or The content determination item shows that the content and potency of the drug ingredients do not meet the national drug standards; 2.
    The identification item or content determination item of the quality inspection conclusion of the Chinese patent medicine shows that the dosage or content of the prescription drug flavor, extract and other ingredients is not Comply with the provisions of the national drug standards; 3.
    The identification items or content determination items of the quality inspection conclusions of Chinese medicinal materials and traditional Chinese medicine decoction pieces show that other medicinal flavors or impurities other than those specified in the national drug standards are detected, but do not exceed 40% of the source specified in the standard ( 40%); 4.
    The total ash content and acid-insoluble ash content of Chinese medicinal materials and Chinese herbal medicine decoction pieces do not meet the requirements of the national drug standards
    .

      Contaminated drugs, including but not limited to:
    1.
    The inspection items of the drug quality inspection conclusions show that heavy metals and harmful elements, mycotoxins, microbial limits, prohibited pesticide residues, and other toxic ingredients other than endogenous toxins exceed the national drug standards Or other drug standards stipulate the limit; 2.
    The inspection items of other drug quality inspection conclusions other than injections and sterile preparations show that the hygiene inspection results do not meet the national drug standards or other drug standards; 3.
    Chinese medicine decoction pieces are moth-eaten Of
    .
    The identification items or content determination items of the quality inspection conclusions of traditional Chinese medicine decoction pieces show that other medicinal flavors or impurities other than those specified in the provincial TCM decoction pieces processing regulations have been detected, but not exceeding 40% (including 40%) of the sources specified in the provincial TCM decoction pieces processing regulations.
    ; Or if the total ash content and acid-insoluble ash content of traditional Chinese medicine decoction pieces are not in compliance with the provincial regulations on the processing specifications of Chinese medicine decoction pieces, the inspection items show that the total ash content and acid-insoluble ash content do not comply with the drug standards
    .
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