article 49 the production and sale of inferior drugs are prohibited. If the contents of pharmaceutical ingredients do not meet the national drug standards, they are inferior drugs. Drugs under any of the following circumstances shall be punished as inferior drugs: (1) Failing to indicate the expiration date or changing the expiration date; (2) Failing to indicate or change the production batch number; (three) beyond the validity period; (4) The packaging materials and containers that come into direct contact with drugs are not approved; (5) Adding colorants, preservatives, spices, correctants and auxiliary materials without authorization; (six) other do not meet the requirements of drug standards. What are the provisions on pharmaceutical management in medical institutions in the Drug Administration Law?
chapter iv pharmaceutical management of medical institutions
article 22
medical institutions must be equipped with qualified pharmaceutical technicians according to law. Non-pharmaceutical technicians may not directly engage in pharmaceutical technical work.
article 23
the preparation of pharmaceutical preparations by medical institutions must be examined and approved by the health administrative department of the local province, autonomous region or municipality directly under the central government, and approved by the pharmaceutical supervisory and administrative department of the province, autonomous region or municipality directly under the central government, and a Pharmaceutical Preparation License for Medical Institutions will be issued. No preparation may be prepared without the Pharmaceutical Preparation License of Medical Institution.
the pharmaceutical preparation license for medical institutions should indicate the validity period, and re-examine and issue the license when it expires.
Article 24
When preparing preparations, medical institutions must have facilities, management systems, inspection instruments and sanitary conditions that can guarantee the quality of preparations.
article 25
preparations prepared by medical institutions should be varieties that are clinically needed by their own units but are not available in the market, and can only be prepared after being approved by the local people's pharmaceutical supervisory and administrative departments of provinces, autonomous regions and municipalities directly under the central government. The prepared preparations must be inspected for quality in accordance with regulations; Qualified, with a doctor's prescription in this medical institution. Under special circumstances, with the approval of the pharmaceutical supervisory and administrative department of the State Council or the people of provinces, autonomous regions and municipalities directly under the Central Government, preparations prepared by medical institutions can be used among designated medical institutions.
preparations prepared by medical institutions shall not be sold in the market.
Article 26
When purchasing drugs, medical institutions must establish and implement the system of incoming inspection and acceptance, and verify the drug conformity certificate and other marks; Do not meet the requirements, shall not be purchased and used.
article 27
pharmaceutical personnel in medical institutions must check prescriptions, and the drugs listed in prescriptions shall not be changed or substituted without authorization. Prescriptions with incompatibility or overdose should be refused to be prepared; When necessary, it can be prepared only after being corrected or re-signed by the prescriber.
Article 28
Medical institutions must formulate and implement a drug storage system, and take necessary measures such as cold storage, anti-freezing, moisture prevention, insect prevention and rat prevention to ensure the quality of drugs. The provisions of the Drug Administration Law on the responsibilities of medical institutions and medical personnel
should be in this: Baike. Baidu./View/13252.htm # 2 What are the provisions of the Drug Administration Law and its implementing regulations for preparations made by many medical institutions
Medical institutions need to be approved by the drug supervision and administration of provinces, autonomous regions and municipalities directly under the Central Government before making preparations.
the preparations of medical institutions must be those that are not available in the market but are needed clinically by our unit.
Self-made preparations made by medical institutions need to meet the relevant requirements of GMP, and can only be prescribed by doctors for use in this unit after passing the quality inspection.
pharmaceutical preparations of medical institutions shall not be advertised or sold in the market
in case of emergency, preparations prepared by medical institutions can be used among needed medical institutions with the approval of the drug regulatory authorities at or above the provincial level. Can the preparations of medical institutions be used in branches in different places?
Under special circumstances, with the approval of the drug regulatory authorities of the State Council or the people of provinces, autonomous regions and municipalities directly under the Central Government, preparations prepared by medical institutions can be used among designated medical institutions.
Questions related to the Drug Administration Law and the crime of producing and selling counterfeit drugs
The above two answers are not comprehensive. Please ask Baidu:
On May 13th, 29, the Supreme People's Court and the Supreme People's Procuratorate promulgated the Interpretation on Several Issues Concerning the Specific Application of Laws in Handling Criminal Cases of Producing and Selling Fake Drugs and Inferior Drugs (Fa Shi (29) No.9)
You can find us here: Are the Regulations for the Implementation of the Drug Administration Law a law?
The Regulations for the Implementation of the Drug Administration Law promulgated by the State Council are administrative regulations. Article 1499 of the Drug Administration Law
There are only 16 articles in the Drug Administration Law of the People's Republic of China.
1. Article 9:
Pharmaceutical production enterprises must organize production in accordance with the good manufacturing practice formulated by the State Council Pharmaceutical Supervision and Administration Department in accordance with this Law. The pharmaceutical supervisory and administrative department shall certify whether the pharmaceutical production enterprises meet the requirements of good manufacturing practice in accordance with the regulations; Certification certificates will be issued to those who pass the certification.
the specific implementation measures and steps of good manufacturing practice are stipulated by the drug supervision and administration department of the State Council.
2. Article 49:
It is forbidden to produce and sell inferior drugs.
if the content of pharmaceutical ingredients does not meet the national drug standards, it is inferior.
Drugs in any of the following circumstances shall be punished as inferior drugs:
(1) The expiration date is not indicated or changed;
(2) failing to indicate or change the production batch number;
(3) beyond the validity period;
(4) The packaging materials and containers that come into direct contact with drugs are not approved;
(5) adding colorants, preservatives, spices, correctants and auxiliary materials without authorization;
(6) others that do not meet the requirements of drug standards. How many chapters and articles are there in the implementation regulations of the Drug Administration Law?
the regulations for the implementation of the drug administration law of the people's Republic of China have 1 chapters and 86 articles. Chapter X Supplementary Provisions Article 86 These Regulations shall come into force as of September 15, 22. According to the drug administration law, evaluating the Roche Tamiflu incident
DE is not required by law for pharmaceutical enterprises to purchase drugs, that is to say, DE can be done or not. Answer your question sincerely, please accept it, thank you.