In order for you to get the qualification certificate faster, I have carefully compiled the classic test questions for the 2019 Licensed Pharmacist Pharmaceutical Regulations for you. Come and try it and see how many points you can get? I hope Can be helpful to you.
2019 Classic Examination Questions on Pharmaceutical Regulations for Practicing Pharmacists
Example Question - Best Multiple Choice Question The business scope approved by a pharmacy’s “Pharmaceutical Business License” is “Chinese patent medicines, Chinese herbal pieces, chemical Pharmaceutical preparations, antibiotic preparations”. The business scope approved in the "Drug Business License" provided by the supplier is "biochemical drugs, Chinese herbal medicines, Chinese herbal medicine pieces, biological products (excluding preventive biological products), chemical raw materials, Chinese patent medicines, chemical pharmaceutical preparations, antibiotics Preparations, Category II Psychotropic Drug Preparations", the business mode is "wholesale". The drugs that the pharmacy can purchase from this supplier are ( )
A. Antibiotic preparations and proprietary Chinese medicines
B. Class II psychotropic drugs and chemical preparations
C. Antibiotic raw materials and traditional Chinese medicine pieces
D. Blood products and biochemical drugs
『Correct answer』A
Example question-best multiple choice question According to the "Measures for the Administration of Pharmaceutical Business Licenses", the circumstances under which the "Pharmaceutical Business License" is canceled by the original issuing authority do not include ( ).
A. The validity period of the "Pharmaceutical Business License" has expired and the license has not been renewed
B. The person in charge of a pharmaceutical business enterprise accepts the financial resources of other business enterprises during drug purchase and sales activities, which constitutes a crime
C. The "Pharmaceutical Business License" has been revoked, withdrawn, revoked, withdrawn or surrendered in accordance with the law
D. Force majeure makes it impossible to implement the permitted matters of the "Pharmaceutical Business License"
『Correct answer』B
Example question-Multiple-choice question The contents of the supervision and inspection of the "Pharmaceutical Business License" holders by the drug regulatory department include ( ).
A. Implementation of drug patents
B. Implementation of "Good Manufacturing Practices for Pharmaceuticals"
C. Changes in warehouse conditions
D. Internal labor security measures within the enterprise
『Correct answer』BC
Example question - Compatibility multiple choice question
A. Change the registered address of the pharmaceutical business
B. Change the person in charge of procurement of the pharmaceutical operating enterprise
C. Change the pharmaceutical operating mode
D. Change the organizational structure of the pharmaceutical operating enterprise
1. Changes that are permitted in the "Drug Business License" do not require a new "Pharmaceutical Business License" ( ).
『Correct answer』A
2. Changes that are permitted in the "Pharmaceutical Business License" require a new "Pharmaceutical Business License" according to regulations ( ).
『Correct answer』C
Example question - Comprehensive analysis multiple-choice question
The drug regulatory department found during the supervision and inspection of A pharmaceutical operating enterprise that the enterprise " The business mode approved by the "Pharmaceutical Business License" is retail (chain) and the business scope is Chinese herbal medicine pieces, Chinese patent medicines, chemical preparations, and antibiotics. The "Pharmaceutical Business License" was issued on October 8, 2014, and the inspectors were on-site During the examination, the biological product human albumin was placed on the shelf.
1. If enterprise A needs to continue operating after the validity period of the "Pharmaceutical Business License" expires, the time limit for the enterprise to apply for the renewal of the "Pharmaceutical Business License" is ( ).
A. July 8, 2019 to October 8, 2019
B. April 7, 2019 to October 7, 2019
C. October 7, 2019 to April 7, 2020
D. October 8, 2019 to January 8, 2020
『Correct answer』B
『Answer Analysis』The drug business license is valid for 5 years. When the validity period of the license expires, an application for renewal of the license shall be made 6 months before the expiration date of the license.
2. Regarding the behavior of placing human albumin on the shelves, the correct statement is ( ).
A. Human albumin is a Western medicine preparation and does not exceed the business scope of the enterprise's license
B. Selling biological products in violation of regulations is an act of operating pharmaceuticals beyond the license
p>
C. Human serum albumin has not been sold and should not be punished according to the business scope
D. Displaying biological products for unknown reasons is not a violation of the quality management regulations for pharmaceutical operations
『Correct answer』B
『Answer analysis』Those engaged in drug retail: The "business category" should be verified first; determine the applicant's qualifications to deal in prescription drugs or over-the-counter drugs, and Class B over-the-counter drugs, and be in business The scope shall be clarified, and then the specific business scope shall be determined.
Human albumin is a biological product. Drug operating enterprise A is operating pharmaceuticals beyond its license. B was elected.
Classic test questions
Example question - Best multiple choice question According to the "Good Manufacturing Practice for Pharmaceutical Products", the statement about the receipt or acceptance of drugs by a pharmaceutical wholesale enterprise is incorrect ( ).
A. For biological products subject to batch release management, unpacking inspection is not required during sampling acceptance
B. For drugs with abnormal packaging, retail shipments, and LCLs, the sampling acceptance should be opened during sampling acceptance Carton inspection to the smallest package
C. If refrigerated and frozen medicines are in a cool warehouse awaiting inspection, they should be inspected as soon as possible and sent to the cold storage as soon as possible if they pass the inspection
D. Refrigerated and frozen medicines When medicines arrive, the transportation method, temperature records during transportation, transportation time and other quality control conditions should be checked. Those that do not meet the temperature record requirements should be rejected
『Correct answer』C
Example question-best choice question According to the "Regulations on the Management of Proprietary Labels for OTC Drugs (Interim), the statement about the proprietary labels of over-the-counter drugs is incorrect ( )
A. The red proprietary label can be used as a Class A business Guidelines for over-the-counter drug companies
B. The proprietary logo patterns for over-the-counter drugs are divided into red and green
C. The red proprietary logo is used for Class A over-the-counter drugs
D. The green proprietary label is used for Class B over-the-counter drugs
『Correct answer』A
Example question-compatibility multiple-choice question
A. Have a bachelor's degree or above, Licensed pharmacist qualification and more than three years of drug operation quality management work experience
B. Have a bachelor's degree or above in preventive medicine, pharmacy, microbiology or medicine, etc.
C. Have a degree in pharmacy or medicine A technical secondary school degree or above in medicine, biology, chemistry or other related majors
D. A technical secondary school degree or above in pharmacy or a college degree or above in medicine, biology, chemistry or other related majors
According to the "Drug Operation Quality Management" Specification", in pharmaceutical wholesale enterprises
1. The minimum academic qualifications or qualifications that quality management staff should possess are ( ).
『Correct answer』D
2. The minimum academic qualifications or qualifications that acceptance and maintenance staff should possess are ( ).
『Correct answer』C
3. The minimum academic qualifications or qualifications that procurement staff should possess are ( ).
『Correct answer』C
Example question - Compatibility multiple choice question
A. It is not necessary to open the minimum package
B. It is not necessary to open the box for inspection
C. The minimum package should be inspected
D. At least one minimum package should be inspected
According to the "Good Manufacturing Practice for Pharmaceutical Products" implemented in June 2013 , the requirements for drug wholesale enterprises to conduct sampling inspection for each arriving drug are
(1) Drugs with the same batch number: ( )
『Correct answer』D
(2) APIs with complete outer packaging and sealing: ( )
『Correct answer』B
(3) Biological products subject to batch release management: ( )
『Correct answer』B
(4) Drugs for which manufacturers have special quality control requirements: ( )
『Correct answer』A
Example question - Compatibility multiple choice question
A. Green sign
B. Blue sign
C. Red sign
D. Yellow labels
Store medicines in manual warehouses, and implement color label management according to quality status
1. When preparing to go out of the warehouse for sale, you should put up ( ).
『Correct answer』A
2. Drugs returned by enterprises should be labeled ( ).
『Correct answer』D
3. Drugs that have expired should be reported ( ).
『Correct answer』C
Classic test questions
Example question-single choice question According to the "Good Manufacturing Practice for Pharmaceutical Products", what are the requirements for drug storage and maintenance? , the correct one is ( ).
A. Chinese herbal medicines and Chinese herbal medicine pieces must be stored in separate inventories
B. Drugs with different batch numbers must be stored in separate inventories
C. Drugs and non-drugs must be stored separately Inventory storage
D. External medicines and other drugs must be stored in separate inventories
『Correct answer』A
Example question-single choice question A pharmaceutical retail company displays goods The wrong approach is ( ).
A. Toxic traditional Chinese medicine varieties are displayed in special windows
B. Drugs are classified and displayed according to dosage forms, uses and storage requirements
C. External use drugs and other drugs Place them separately
D. Centralized storage of dismantled medicines and dismantling counters or special areas
『Correct answer』A
Example question-multiple choice questions based on 2013 1 According to the "Pharmaceutical Operations Quality Management Standards" released in March, when an employee takes leave and needs to change shifts, a pharmaceutical retail company is not allowed to have other positions perform duties on its behalf ().
A. Quality management position
B. Pharmaceutical service position
C. Prescription review position
D. Prescription dispensing position
p>
『Correct answer』AC
Example question - Multiple choice question on compatibility
A. Review
B. Regular cleaning
C. Clean up and record
D. Correct names
According to the "Good Manufacturing Practice for Pharmaceutical Products" implemented in June 2013, retail pharmacies operating traditional Chinese medicine pieces
(1) In order to prevent the pieces from becoming wormy, moldy, and deteriorating, the cabinets where the pieces of traditional Chinese medicine are placed should be: ( )
『Correct answer』B
(2) Different batch numbers Before putting the Chinese medicine pieces into buckets, you should: ( )
『Correct answer』C
(3) In order to prevent mishandling or cross-cutting, before putting the Chinese medicine pieces into buckets, you should: ( )
『Correct answer』A
Example question - best multiple choice question According to the "Good Manufacturing Practice for Pharmaceutical Products", the statement about the retail sales management of pharmaceutical retail enterprises is wrong ( ).
A. Personnel responsible for dismantling and selling drugs should undergo special training before they can engage in dismantling and selling
B. During the period of dismantling and selling drugs, the original packaging and instructions should be retained
C. The usage and dosage of drugs sold in parts should be explained, but there is no need to provide the original or copy of the drug instructions to the buyer
D. The name, specification, quantity, and Information such as usage and dosage, batch number, expiry date, and pharmacy name
『Correct answer』C
Classic test questions
Example questions-best-choice questions are based on the "General Office of the State Council" "Several Opinions on Further Reforming and Improving Policies for the Production, Circulation and Use of Drugs", regarding the regulations on drug purchase and sales activities, what does not comply with the regulations is ( ).
A. Strictly crack down on illegal activities such as leasing licenses, false transactions, false invoices, etc.
B. Strictly punish illegal enterprises and medical institutions in accordance with the law, and seriously hold relevant responsible persons accountable ; If suspected of committing a crime, transfer it to the judicial authorities in a timely manner
C. Confirmed violations of laws and regulations will be recorded in bad drug procurement records, credit records of enterprises and institutions, and personal credit records and disclosed in accordance with regulations. Public hospitals 1 Drugs from relevant companies are not allowed to be purchased during the year
D. Medical representatives can only engage in academic promotion, technical consulting and other activities, and are not allowed to undertake drug sales tasks. Their untrustworthy behavior will be recorded in personal credit records
"Correct answer" C
"Answer analysis" Improve relevant laws and regulations, and record the confirmed violations of laws and regulations in drug procurement records, credit records of enterprises and institutions, and personal credit records, and make them public in accordance with regulations. Hospitals are not allowed to purchase drugs from related companies within 2 years.
Example question - best multiple choice question According to the "Measures for the Supervision and Administration of Drug Circulation", the following behaviors of drug production and operating enterprises are in compliance with the regulations ( ).
A. Use Internet transactions to sell prescription drugs directly to the public
B. Provide a place for others to operate drugs in the name of the company
C. Provide others with a place to operate drugs in the name of the company
C. The company operates drugs in the name of the company and provides the company's bills
D. Sign a drug sales contract at a drug exhibition or expo
『Correct answer』D
[Answer Analysis] Drug production and operating enterprises are not allowed to sell drugs off-the-shelf through exhibitions, expos, trade fairs, order fairs, product promotion meetings, etc. Spot sales are not allowed, but sales contracts can be signed.
Example question - Best multiple choice question According to the "Measures for the Supervision and Administration of Drug Circulation", the wrong statement about the purchase and sale of drugs by drug production and operating enterprises is ( ).
A. Pharmaceutical production and operating enterprises shall be responsible for their drug purchase and sales activities
B. Pharmaceutical production and operating enterprises may send sales personnel to engage in drug purchase and sales activities in the name of the enterprise
C. Drug manufacturers can sell drugs produced by their own companies
D. Drug manufacturers can sell drugs produced by their own companies under license
『Correct answer』D
『Answer Analysis』Pharmaceutical manufacturers can only sell drugs produced by the company, and are not allowed to sell drugs produced by the company on commission or produced by others.
Example question - Best multiple choice question According to the provisions of the "Internet Drug Transaction Service Approval (Trial)", the wrong statement about Internet drug transactions is ( ).
A. Enterprises that provide Internet transaction services must strictly review the legality of drugs participating in Internet transactions
B. Enterprises that provide Internet transaction services to individual consumers can sell their own products online All drugs operated
C. Drug manufacturers that conduct Internet transactions with other companies other than members of the company through their own websites can only trade drugs produced by the company
D. Drug operating companies that provide Internet drug trading services on their own websites are not allowed to use their own websites to provide other Internet trading services
『Correct Answer』B
『Answer Analysis』Provide Internet drugs to individual consumers Enterprises that provide trading services can only sell over-the-counter drugs operated by the enterprise online, and are not allowed to sell drugs to other enterprises or medical institutions. Therefore, B's statement is wrong.
Example question-Multiple choice questions on compatibility
A. Detoxification drug information
B. Drug information
C. Drug advertisement
D. Medical device information
According to the "Measures for the Administration of Internet Drug Information Services"
1. What shall not be published on websites that provide Internet drug information services are: ( )
『Correct answer』A
2. It can be published on websites that provide Internet drug information services, but its content should be reviewed and approved by the drug regulatory department: ( )
『Correct answer』C