A. Four years for reference
B. Three-year reference
C. Two-year reference
D. One-year reference
Correct answer d
When a pharmaceutical wholesale enterprise sells compound preparations containing ephedrine, it shall verify the buyer's qualification certificate and the buyer's identity certificate before selling, track and verify the arrival of the drug, and keep the verification record for future reference after the drug is valid for one year.
2. The annual production, procurement, supply and preparation plan of toxic drugs is formulated and issued by which of the following departments according to medical needs.
A. U.S. Food and Drug Administration states
B. Provincial Drug Administration
C. Health sector
D. Agricultural authorities in the State Council
Correct answer b
The annual production, procurement, supply and preparation plan of toxic drugs shall be formulated and issued by the provincial drug supervision and administration department according to the medical needs.
3.a. It is forbidden to engage in pharmaceutical production and business activities for five years.
B. it is forbidden to engage in pharmaceutical production and business activities within ten years.
C. revocation of practice certificate
D. Administrative sanctions for dismissal
According to the Drug Administration Law
1) If a drug marketing license holder, the person-in-charge of a drug production enterprise or drug trading enterprise, the purchaser and other relevant personnel accept property or other illegitimate interests from other drug marketing license holders, drug production enterprises, drug trading enterprises or agents in the purchase and sale of drugs, their illegal income shall be confiscated and they shall be punished according to law; If the circumstances are serious, the relevant personnel shall be punished for their qualifications.
Correct answer a
Article 142, paragraph 1 of the Drug Administration Law stipulates the penalties for drug marketing license holders, responsible persons of drug manufacturing enterprises, drug trading enterprises, purchasing personnel and other relevant personnel. This article stipulates that if drug marketing license holders, responsible persons, procurement personnel and other relevant personnel accept property or other illegitimate interests from other drug marketing license holders, drug manufacturing enterprises, drug trading enterprises or their agents during the purchase and sale of drugs, their illegal income shall be confiscated and punished according to law; If the circumstances are serious, it is forbidden to engage in pharmaceutical production and business activities within five years.
4.A pharmaceutical manufacturer in province A and province B published a drug advertisement in a newspaper in province C, which was inconsistent with the approved content, claiming that? Blood pressure dropped on the day of taking it, and palpitation disappeared after taking it for 3 days. After taking 15 days, the dosage decreased, and all indexes returned to normal without side effects. Is safety guaranteed? . The drug advertisement examination organ shall verify that the advertisement is a false drug advertisement and impose administrative punishment. It is understood that the drug advertisement examination organs in provinces A and C are drug supervision and administration departments.
1) if pharmaceutical manufacturer b refuses to accept the administrative punishment involved in this case, the department that can file an administrative reconsideration is
A.c Provincial Drug Administration
B. Provincial Market Supervision Administration
C. Provincial Drug Administration
D. Provincial Market Supervision Administration
Correct answer b
The administrative punishment shall be handled by the administrative organ in the place where the illegal act occurred (C province), and the administrative reconsideration shall be handled by the punishment organ at the next higher level. The next level of the Drug Administration of C Province is the Market Supervision Administration of C Province. So the answer is B.
5. The responsibilities of the Pharmaceutical Affairs Management and Pharmacotherapeutics Committee of medical institutions include
Determine the drug list and prescription set of this medical institution.
B. Implement the drug cost accounting and accounting management system of this medical institution.
C unified procurement and supply of drugs for clinical use in this medical institution.
D. guide the clinical departments of this medical institution to use drugs rationally.
Correct answer advertisement
The responsibilities of the Pharmaceutical Affairs Management and Drug Treatment Committee include: 1. Implement relevant laws and regulations. 2. Formulate the drug prescription set and the basic drug supply catalogue of this medical institution; 3. Guide clinical rational drug use; 4. Analyze and evaluate the risk of drug use, and provide suggestions and guidance; 5. Establish a drug selection system; 6. Supervise and guide the use and management of specially managed drugs; 7. Training medical personnel on legal and rational drug use knowledge; 8 to publicize the knowledge of safe drug use to the public.
6. The statement about drug standards is wrong.
A. National drug standards include statutory standards and non-statutory standards.
B National drug standards are compiled and published by China Food and Drug Inspection Institute.
C enterprise standards are the internal control standards of enterprises, and all indicators shall not be lower than the national drug standards.
D The quality standard recorded in China Pharmacopoeia is the highest standard of drug quality.
Correct answer, ABD
Drug standards are divided into statutory standards and non-statutory standards. The legal standard is the national drug standard including China Pharmacopoeia, so A is wrong;
China Pharmacopoeia belongs to the national drug standard and is compiled by the National Pharmacopoeia Committee. B, error;
Drug registration standards meet the technical requirements of China Pharmacopoeia, not lower than those of China Pharmacopoeia, so D is wrong.
7. The stages of new drug development are as follows
A. Pre-clinical research stage
B. Clinical stage
C. production and post-marketing research
D. Adverse reaction monitoring stage
Correct answer ABC
The research and development of new drugs is divided into three stages: the first stage is preclinical research, which mainly includes the discovery and screening of new active ingredients, pharmacological efficacy research and toxicological experiments (safety evaluation tests); The second stage is the clinical trial of new drugs. The third stage is production and post-marketing research.
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