Provisions on penalties for expired drugs 2022

Expired drugs are identified as inferior drugs, and the punishment standard is:

1, the production and sale of inferior drugs, the illegal production and sale of drugs and illegal income, and impose a fine of more than ten times and less than twenty times the value of illegal production and sale of drugs;

2, illegal production, wholesale drug value is less than one hundred thousand yuan, calculated by one hundred thousand yuan, illegal retail drug value is less than ten thousand yuan, calculated by ten thousand yuan;

3, if the circumstances are serious, shall be ordered to suspend production and business for rectification, until the revocation of drug approval documents, drug production license, drug business license or medical institution preparation license.

The minimum fine for expired drugs is a fine of more than one time and less than three times the value of illegally produced and sold drugs. Those who constitute the crime of producing and selling inferior drugs, and those who produce and sell inferior drugs and cause serious harm to human health, shall be sentenced to fixed-term imprisonment of not less than three years but not more than ten years, and shall also be fined not less than 50% but not more than two times the sales amount.

Drugs are out of date, and we can't just look at the expiration date. Although some drugs are still in the expiration date, they may have expired. For example, if refrigerated products are not refrigerated and sealed products are not sealed, it will easily lead to deterioration and failure of drugs, including mildew in syrup, moth-eaten honey pills, vitamin oxidation, antibiotic degradation, protein degeneration and so on.

There are also some special drugs whose expiration date is closely related to the opening date:

(1) Eye Drops: It is recommended to be regarded as expired drugs after being opened for more than 1 month, because the opened eye drops are easily contaminated by tears and microorganisms in the air during use and storage, and it is recommended to use them up within 1 month after opening;

(2) Bottled oral liquid: After opening, the storage time is generally about 2 months under the specified storage conditions;

Sub-package drugs: it is recommended to use up scattered drugs within 1 month;

Insulin: put it in the refrigerator before opening, and keep it at room temperature for no more than 1 month;

(3) Nitroglycerin: The effective period is only half a year after taking it. After prolonged use, the drug effect decreases, and it cannot play its role in relieving angina pectoris.

legal ground

Article 98 of the Drug Administration Law of People's Republic of China (PRC) prohibits the production (including preparation, the same below), sale and use of counterfeit and inferior drugs.

In any of the following circumstances, it is a counterfeit drug:

(1) The ingredients contained in the drug are inconsistent with those stipulated in the national drug standards;

(2) passing off non-drugs as drugs or passing off other drugs as drugs;

(3) Deteriorated drugs;

(4) The indications or functional indications of drugs are beyond the prescribed scope.

Under any of the following circumstances, it is inferior medicine:

(a) the content of pharmaceutical ingredients does not meet the national drug standards;

(2) Contaminated drugs;

(3) Drugs whose expiry date has not been marked or changed;

(4) Drugs whose product batch number is not marked or changed;

(5) expired drugs;

(6) Drugs with preservatives and auxiliary materials added without authorization;

(seven) other drugs that do not meet the drug standards.

Prohibit the production and import of drugs without obtaining the drug approval certificate; It is forbidden to use raw materials, packaging materials and containers that have not been examined and approved in accordance with regulations to produce drugs.

Article 140 of the Criminal Code of People's Republic of China (PRC).

Producers and sellers who adulterate their products, pass fake products off as genuine products, and pass unqualified products off as qualified products, with a sales amount of more than 50,000 yuan but less than 200,000 yuan, shall be sentenced to fixed-term imprisonment of not more than two years or criminal detention, and shall also, or shall only, be fined not less than 50% but not more than two times the sales amount; If the sales amount is more than 200,000 yuan but less than 500,000 yuan, he shall be sentenced to fixed-term imprisonment of not less than two years but not more than seven years, and shall also be fined not less than 50% but not more than two times the sales amount; If the sales amount is more than 500,000 yuan but less than 2 million yuan, he shall be sentenced to fixed-term imprisonment of more than seven years, and shall also be fined more than 50% but less than two times the sales amount; If the sales amount is more than 2 million yuan, he shall be sentenced to fixed-term imprisonment of 15 years or life imprisonment, and shall also be fined more than 50% but less than 2 times the sales amount or his property shall be confiscated.