Pharmacies selling expired medicines have violated Article 49 of the Chinese People's Republic of China Drug Administration Law.
Referring to Article 49 of the Drug Administration Law of the People's Republic of China*** and the People's Republic of China, it is prohibited to produce or sell inferior drugs. Pharmaceutical ingredients whose contents do not comply with the national drug standards are inferior drugs. Drugs with one of the following circumstances are treated as inferior drugs:
(a) failure to indicate the expiration date or change the expiration date;
(b) failure to indicate or change the production batch number;
(c) exceeding the expiration date;
(d) unauthorized packaging materials and containers in direct contact with the drugs;
(e) unauthorized additions of coloring agents, preservatives, spices, flavoring agents and excipients;
(vi) other non-compliance with the provisions of the drug standard.
Expanded Information
Referring to Article 74 of the "Chinese People's Republic of China*** and the State Drug Administration Law", those who produce or sell substandard medicines shall confiscate the illegally produced or sold medicines and the illegal income, and shall be sentenced to pay a fine of not less than double and not more than triple of the amount of the value of the illegally produced or sold medicines; and if the circumstances are serious, the production shall be suspended, or the operation shall be suspended or the operation shall be consolidated or the approval certificate of the medicine shall be revoked, or the approval certificate of the medicines shall be suspended. Revocation of drug approval documents, revocation of the "Drug Manufacturing License", "Drug Business License" or "Medical Institutions Preparation License"; constitutes a crime, shall be investigated for criminal responsibility.
Referring to Article 75 of the Drug Administration Law of the People's Republic of China*** and the State of China, enterprises or other units engaged in the production and sale of counterfeit drugs and the production and sale of substandard drugs under serious circumstances shall not be allowed to engage in the production and operation of drugs within ten years for the directly responsible supervisory personnel and other directly responsible personnel. Raw and auxiliary materials, packaging materials, and production equipment used exclusively by the producer for the production of counterfeit or substandard drugs shall be confiscated.
Referring to Article 77 of the Law of the People's Republic of China on the Administration of Medicines, the notification of penalties for counterfeit or substandard medicines must contain the results of the quality inspection conducted by the medicine inspection organization; however, except for the cases stipulated in Article 48, paragraph 3, subparagraphs (a), (b), (e), (f), and Article 49, paragraph 3, of the present Law.
Referring to Article 17 of the Drug Administration Law of the People's Republic of China*** and the People's Republic of China, drug business enterprises purchasing drugs must establish and implement a system of inspection and acceptance of purchases, and inspection of certificates of conformity of medicines and other markings; those that do not meet the prescribed requirements shall not be purchased.
Referring to the "Chinese People's Republic of China *** and the State Drug Administration Law" Article 18, the drug business enterprises purchase and sale of drugs, there must be a true and complete record of purchase and sale. Purchase and sale records must indicate the generic name of the drug, dosage form, specifications, batch number, expiration date, manufacturer, purchase (sale) unit, purchase (sale) quantity, purchase (sale) price, purchase (sale) date and the State Council drug supervision and management department of the other contents of the provisions.
Haibei State Food and Drug Administration - Chinese People's Republic of China and the State Drug Administration Law