20 19 classic questions on pharmacists' pharmaceutical affairs regulations
Example-Best Multiple-choice Questions The business scope approved by the Pharmaceutical Business License of a drugstore is "Chinese patent medicine, Chinese herbal pieces, chemical pharmaceutical preparations and antibiotic preparations". The business scope approved in the Pharmaceutical Business License provided by the supplier is "biochemical drugs, Chinese herbal medicines, Chinese herbal pieces, biological products (excluding preventive biological products), chemical raw materials, Chinese patent medicines, chemical pharmaceutical preparations, antibiotic preparations and psychotropic drugs of category II", and the business mode is "wholesale". Pharmacy can purchase drugs from suppliers is ()
A. Antibiotic preparations and Chinese patent medicines
B. Psychotropic drugs and chemical preparations in category II
C. raw materials of antibiotics and traditional Chinese medicine decoction pieces
D. Blood products and biochemical drugs
"correct answer" a
Example-the best multiple-choice questions According to the Measures for the Administration of Drug Business License, those whose Drug Business License has been cancelled by the original issuing authority do not include ().
A. The Drug Business License has not been renewed upon expiration.
B the person in charge of a pharmaceutical trading enterprise accepts the finance of other trading enterprises in the purchase and sale of drugs, which constitutes a crime.
The Drug Business License has been revoked, withdrawn, revoked, withdrawn or cancelled according to law.
D. Matters permitted in the Pharmaceutical Trading License cannot be implemented due to force majeure.
"correct answer" b
Example-multiple-choice drug supervision and management departments to have a "drug business license" of the enterprise supervision and inspection content is ().
A. Implementation of drug patents
B. Implementing the "Good Manufacturing Practices"
C. Changes in warehouse conditions
D. Labor security measures within enterprises
"correct answer" BC
Example-Compatibility Multiple Choice Questions
A. change the registered address of a pharmaceutical trading enterprise
B. Change the person in charge of procurement of pharmaceutical trading enterprises
C. Changing the way drugs are handled
D. change the organizational structure of pharmaceutical trading enterprises
1. Yes () belongs to the change of the permitted items in the Pharmaceutical Trading License, and it is not necessary to apply for the Pharmaceutical Trading License again.
"correct answer" a
2. Belong to the "drug business license" licensing matters change, should be in accordance with the provisions, to apply for the "drug business license" is ().
"correct answer" c
Example-comprehensive analysis multiple choice questions
During the supervision and inspection of pharmaceutical trading enterprise A, the pharmaceutical supervisory and administrative department found that the business mode approved in the Pharmaceutical Trading License of this enterprise is retail (chain), and its business scope covers Chinese herbal pieces, Chinese patent medicines, chemical preparations and antibiotics. The time for issuing the Drug Business License is 20 14 10.08. When inspectors carry out on-site inspection, the biological product human albumin is put on the shelf.
1. If Enterprise A needs to continue its business after the expiry of the validity period of the Drug Business License, the time limit for the enterprise to apply for renewal of the Drug Business License is ().
A. July 8th 20 19 to July 8th 20 19 10.
B. April 7th 20 19 to April 7th 20 19 10.
C. 20 19 10 202017 October to 7 April
D.2019101October 8 to 202010/October 8.
"correct answer" b
The validity period of the Drug Business License is 5 years. Upon the expiration of the validity period, an application for renewal of the license shall be filed six months before the expiration of the license.
2. Regarding the behavior of putting human albumin on the shelves, the correct statement is ().
Human albumin A belongs to western medicine preparation, which is not beyond the business scope of enterprise license.
Illegal sale of biological products is an act of dealing in drugs beyond the license.
C human albumin has not been sold, so it should not be punished according to the business scope.
D. displaying biological products for unknown reasons is not a violation of the quality management norms of pharmaceutical business.
"correct answer" b
"Answer analysis" is engaged in drug retail: the "business category" should be approved first; Determine the applicant's qualification to operate prescription drugs or over-the-counter drugs and Class B over-the-counter drugs, and make it clear in the business scope, and then verify the specific business scope.
Human albumin belongs to biological products, and pharmaceutical enterprise A belongs to the behavior of operating drugs beyond the license, and B is elected.
Classic test questions
Example-the best multiple-choice question According to the "Quality Management Standard for Pharmaceutical Trading", the statement that pharmaceutical wholesale enterprises receive or accept drugs is wrong ().
Biological products subject to batch issuance management shall not be opened for sampling and acceptance.
B. For drugs with abnormal packaging, odd and LCL, unpacking inspection of minimum packaging shall be carried out during sampling acceptance.
C. If the refrigerated and frozen drugs are to be inspected in the cold storage, they should be accepted as soon as possible and sent to the cold storage as soon as they are qualified.
D. When the refrigerated and frozen drugs arrive, the quality control conditions such as the mode of transportation, temperature records during transportation, transportation time, etc. shall be checked, and those that do not meet the requirements of temperature records shall be rejected.
"correct answer" c
Example-the best multiple-choice question According to the Regulations on the Management of OTC Private Brands (Provisional), the statement about OTC Private Brands is wrong ().
A. The red proprietary logo can be used as a guiding logo for enterprises engaged in Class A OTC drugs.
B the proprietary logo patterns of B.OTC drugs are divided into red and green.
C. The red patent mark is used for OTC drugs of Class A..
D. the green patent mark is used for class b OTC drugs.
"correct answer" a
Example-Compatibility Multiple Choice Questions
Bachelor degree or above, licensed pharmacist qualification and more than three years experience in drug management quality management.
B bachelor degree or above in preventive medicine, pharmacy, microbiology or medicine.
C have a secondary school education or above in pharmacy or medicine, biology or chemistry.
Technical secondary school degree in pharmacy or college degree or above in medicine, biology, chemistry and other related majors.
According to the "Quality Management Standard for Pharmaceutical Trading", among pharmaceutical wholesale enterprises,
1. The minimum education or qualification required for quality management personnel is ().
"correct answer" d
2. Acceptance and maintenance personnel should have the minimum education or qualification requirements is ().
"correct answer" c
3. Purchasing personnel should have the minimum education or qualification requirements is ().
"correct answer" c
Example-Compatibility Multiple Choice Questions
A. the smallest package may not be opened.
B.you don't have to open the box to check.
C. check the minimum package.
At least one minimum package should be checked.
According to the "Quality Management Standard for Pharmaceutical Trading" implemented in June 20 13, the requirements of pharmaceutical wholesale enterprises for sampling and acceptance of drugs every time they arrive are as follows
(1) Drugs with the same batch number: ()
"correct answer" d
(2) Raw materials with complete packaging and sealing: ()
"correct answer" b
(3) Batch issuance of biological products under management: ()
"correct answer" b
(4) Drugs with special quality control requirements of production enterprises: ()
"correct answer" a
Example-Compatibility Multiple Choice Questions
A. Green sign
B. Blue sign
C. Red sign
D. Yellow sign
Drugs are put into storage by manual operation, and color-coded management is implemented according to quality conditions.
1. Those ready for outbound sales should be hung up ().
"correct answer" a
2. The drugs returned by the enterprise should be hung ().
"correct answer" d
3. If the drug has expired, it should be hanged ().
"correct answer" c
Classic test questions
Example-multiple-choice questions According to the "Quality Management Standards for Pharmaceutical Trading", the statement about the requirements for drug storage and maintenance is correct ().
A. Chinese herbal medicines and Chinese herbal pieces must be stored separately.
B. Drugs with different batch numbers must be stored separately.
Drugs and non-drugs must be stored separately.
D drugs for external use must be stored separately from other drugs.
"correct answer" a
Example-multiple choice The wrong way for a pharmaceutical retail enterprise to display goods is ().
A. toxic Chinese medicine varieties are displayed in special windows.
B drugs are displayed in categories according to dosage forms, uses and storage requirements.
C drugs for external use should be placed separately from other drugs.
D. The disassembled drugs shall be stored centrally, and the disassembled drugs shall be stored in the counter or special area.
"correct answer" a
Example-multiple-choice questions According to the "Quality Management Standard for Pharmaceutical Trading" issued on June 20 13, when employees of pharmaceutical retail enterprises need to be transferred from their posts, the post where other posts are not allowed to perform their duties on their behalf is ().
A. Quality management positions
B. Pharmaceutical service posts
C. Prescription review post
D. Prescription deployment post
"correct answer" AC
Example-Compatibility Multiple Choice Questions
A. Review
B. Clean the bucket regularly.
C. empty the bucket and record it.
D. Correct the names and words
Retail pharmacies that operate Chinese herbal pieces in accordance with the "Quality Management Standards for Pharmaceutical Trading" implemented in June 20 13.
(1) In order to prevent Chinese herbal pieces from moth-eaten, mildew and deterioration, the cabinet bucket for storing Chinese herbal pieces should be: ()
"correct answer" b
(2) Before loading different batches of Chinese herbal pieces, you should: ()
"correct answer" c
(3) In order to prevent cross-fighting, Chinese herbal pieces should be: ()
"correct answer" a
Example-the best multiple-choice question According to the "Quality Management Standard for Pharmaceutical Trading", the statement about sales management of pharmaceutical retail enterprises is wrong ().
A. The personnel in charge of drug sales shall receive special training before engaging in drug sales.
The original packaging and instructions should be kept during the sale of drugs.
C. The usage and dosage should be stated when the drugs are sold separately, but it is not required to provide the original or photocopy of the drug instructions to the buyers.
D information such as drug name, specification, quantity, usage and dosage, batch number, expiration date, drug name, etc. shall be indicated on the package of drugs sold.
"correct answer" c
Classic test questions
Example-the best multiple-choice questions According to "Several Opinions of the General Office of the State Council on Further Reforming and Perfecting the Policy of Drug Production, Circulation and Use", the provisions on drug purchase and sale activities are inconsistent with the provisions ().
A. Severely crack down on illegal acts such as renting licenses, false transactions, and false invoicing.
B severely punish enterprises and medical institutions that violate laws and regulations according to law, and seriously investigate the responsibilities of relevant responsible persons; Suspected of a crime, promptly transferred to judicial organs.
C. The verified violations of laws and regulations shall be recorded in the bad records of drug purchase, credit records of enterprises and institutions and personal credit records and made public according to regulations. Public hospitals shall not purchase drugs from relevant enterprises within 1 year.
D medical representatives can only engage in academic promotion, technical consultation and other activities, and may not undertake the task of drug sales, and their dishonesty is recorded in personal credit records.
"correct answer" c
"Answer Analysis" improves relevant laws and regulations, and records the verified illegal acts in the bad records of drug procurement, credit records of enterprises and institutions and personal credit records and makes them public according to regulations. Public hospitals shall not purchase drugs from relevant enterprises within 2 years.
Example-the best multiple-choice questions According to the Measures for the Supervision and Administration of Drug Circulation, the following behaviors of pharmaceutical production and operation enterprises meet the requirements ().
A. selling prescription drugs directly to the public through internet transactions.
B. provide a place for others to deal in drugs in the name of the enterprise.
C. providing the bills of this enterprise for others to deal in drugs in the name of this enterprise.
D. signing drug sales contracts at drug fairs.
"correct answer" d
Pharmaceutical production and operation enterprises shall not sell drugs on the spot by means of exhibitions, expositions, trade fairs, order fairs, product promotion meetings, etc. There is no spot sale, but a sales contract can be signed.
Example-the best multiple-choice question According to the Measures for the Supervision and Administration of Drug Circulation, the statement about the purchase and sale of drugs by pharmaceutical production and operation enterprises is wrong ().
Pharmaceutical production and marketing enterprises shall be responsible for the purchase and sale of pharmaceuticals.
B pharmaceutical production and trading enterprises can send sales personnel to engage in drug purchase and sale activities in the name of the enterprise.
C. pharmaceutical production enterprises can sell the drugs produced by their own enterprises.
Pharmaceutical manufacturing enterprises can sell the drugs they produce.
"correct answer" d
[Answer analysis] Pharmaceutical manufacturing enterprises can only sell drugs produced by their own enterprises, and may not sell drugs commissioned by their own enterprises or produced by others.
Example-the best multiple-choice question According to the Provisions on the Examination and Approval of Internet Drug Trading Services (Trial), the wrong statement about Internet drug trading is ().
1. Enterprises providing Internet trading services must strictly examine the legality of drugs traded on the Internet.
B an enterprise that provides internet trading services to individual consumers can sell all the drugs it deals in online.
C pharmaceutical production enterprises can only trade drugs produced by their own enterprises if they conduct internet transactions with enterprises other than their own members through their own websites.
D pharmaceutical trading enterprises that provide internet drug trading services through their own websites shall not use their own websites to provide other internet trading services.
"correct answer" b
Enterprises that provide Internet drug trading services to individual consumers can only sell over-the-counter drugs operated by themselves online, and may not sell drugs to other enterprises or medical institutions. So, B is wrong.
Example-Compatibility Multiple Choice Questions
A. Drug information
B. Drug information
C. Drug advertisements
D. Medical equipment information
According to the Measures for the Administration of Internet Drug Information Services
1. The website providing Internet drug information service shall not publish: ()
"correct answer" a
2. It can be published on the website that provides Internet drug information service, but its content shall be examined and approved by the drug supervision and administration department: ()
"correct answer" c