Sales Business Authorization and Legal Compliance

Which of the following statements about authorization for the medicine-sales business is correct?

1. Authorization for the medicine-sales business is divided into four types: pharmacy, store-based retail business, home-delivery retail business, and wholesale business.
2. A person who has obtained wholesale business authorization is permitted to sell pharmaceuticals directly to members of the general public as a business.
3. Authorization for the medicine-sales business is divided into three types: store-based retail business, home-delivery retail business, and wholesale business.
4. For a pharmacy to sell pharmaceuticals, it must obtain medicine-sales business authorization separately from its pharmacy establishment authorization.

Which of the following statements about the medicine-sales business, among other matters, is incorrect?

1. A pharmacy owner or a store-based retailer must not sell or supply pharmaceuticals by any method other than sale or supply through the store.
2. Pharmacy establishment authorization or medicine-sales business authorization loses its effect upon the passage of five years unless renewed.
3. Only a person who has obtained store-based retail business or home-delivery retail business authorization may sell pharmaceuticals to members of the general public.
4. Unless a person is a pharmacy owner or a person who has obtained medicine-sales business authorization, that person must not sell or supply pharmaceuticals, or store or display them for the purpose of sale or supply, as a business.

Which of the following statements about a pharmacy is correct?

1. In addition to prescription pharmaceuticals, a pharmacy may handle designated-guidance-required pharmaceuticals and over-the-counter medicines.
2. Pharmacy establishment authorization is granted by the Minister of Health, Labour and Welfare.
3. A place that handles pharmaceuticals may use the name "pharmacy" even without obtaining establishment authorization as a pharmacy.
4. A pharmacy that dispenses prescriptions is not positioned as a healthcare-providing facility.

Which of the following statements about a store-based retail business is correct?

1. Store-based retail business authorization is granted, store by store, by the prefectural governor of the location of the store (or, if that location is within the area of a city that establishes a health center or a special ward, by the mayor or the head of the ward).
2. A store operated under store-based retail business authorization may dispense prescriptions, the same as a pharmacy, if a pharmacist is engaged there.
3. A designated-guidance-required pharmaceutical may be sold or supplied by a registered seller even when no pharmacist is present at that store.
4. A person who has obtained store-based retail business authorization is permitted to sell all pharmaceuticals, including a prescription pharmaceutical used based on a physician's or dentist's prescription, in addition to designated-guidance-required pharmaceuticals and over-the-counter medicines.

Which of the following statements about the store manager of a store-based retail business is incorrect?

1. A store manager must give the store-based retailer, in writing, any opinion necessary to prevent harm to public health and hygiene.
2. The manager of a store that sells or supplies a Class 2 or Class 3 pharmaceutical must be a pharmacist.
3. The manager of a store that sells or supplies a designated-guidance-required pharmaceutical or a Class 1 pharmaceutical must, in principle, be a pharmacist.
4. At a store selling or supplying a Class 1 pharmaceutical, when a pharmacist cannot be made the store manager, if a registered seller meeting the prescribed requirements is made the store manager instead, a pharmacist assisting the store manager must be assigned.

Which of the following statements about a home-delivery retail business is correct?

1. A home-delivery retail business is a sales format in which pharmaceuticals are left in advance at the purchaser's home or the like, and the right to claim payment does not arise until after the purchaser has used them ("use first, pay later," or sen'yo-kori).
2. It is provided that, regardless of the area in which delivery is intended, obtaining authorization from any single prefectural governor allows a person to conduct home-delivery sales anywhere in the country.
3. A home-delivery retail business may sell or supply a designated-guidance-required pharmaceutical.
4. The (delivery box) left at the purchaser's home or the like legally constitutes storage.

Which of the following statements about a home-delivery retail business is incorrect?

1. A home-delivery retailer must not sell an over-the-counter medicine other than one meeting standards such as being unlikely to change over time (the home-delivery product category standards).
2. If a home-delivery retailer wishes to sell pharmaceuticals through sale or supply at a store, that retailer must separately obtain pharmacy establishment authorization or store-based retail business authorization.
3. For the home delivery of a Class 1 pharmaceutical, it must be sold or supplied by a pharmacist, and if no pharmacist is engaged in the home-delivery business, a Class 1 pharmaceutical cannot be sold or supplied.
4. A home-delivery retail business may open a pharmaceutical's package and sell it in divided portions.

Which of the following statements about a home-delivery retailer or its delivery staff is correct?

1. A home-delivery retailer or its delivery staff must not engage in the home delivery of pharmaceuticals unless they have received, and carry, an identification card issued by the prefectural governor of their place of residence.
2. As long as the identification card is kept at the business office, there is no need to carry it while engaging in home delivery.
3. It is sufficient for a home-delivery retailer or its delivery staff to report to the governor of the prefecture whose area includes the area in which delivery activity was conducted within 30 days after having engaged in the home delivery of pharmaceuticals.
4. The identification card carried while engaging in home delivery is issued by the Minister of Health, Labour and Welfare.

Which of the following statements about the divided-portion sale of a pharmaceutical is correct?

1. The act of dividing pharmaceuticals into smaller portions in advance and selling them at a specific purchaser's request is also recognized as divided-portion sale.
2. For a pharmaceutical sold in divided portions, there is no need to display or state the container labeling matters or the package insert entries.
3. A pharmacy, a store-based retail business, and a wholesale business may, at a specific purchaser's request, open a pharmaceutical's packaging and sell it in divided portions.
4. A home-delivery retail business is permitted to open a pharmaceutical's package and sell it in divided portions.

Which of the following statements about a wholesale business, among other matters, is correct?

1. A wholesale seller is permitted to sell pharmaceuticals directly to members of the general public as a business.
2. A wholesale business is not permitted to open a pharmaceutical's packaging and sell it in divided portions.
3. If a store-based retailer wishes to sell pharmaceuticals by home delivery, no separate authorization is needed.
4. A wholesale business is a business format that sells pharmaceuticals to a pharmacy, another medicine-sales business, a pharmaceutical company, a medical institution, or the like.

Which of the following statements about pharmacist-absent hours is incorrect?

1. Even during pharmacist-absent hours, the pharmaceuticals a registered seller may sell are Class 2 pharmaceuticals or Class 3 pharmaceuticals.
2. During pharmacist-absent hours, a pharmacy owner must close the dispensing room and post the matters to be posted concerning pharmacist-absent hours in an easily visible location inside the pharmacy and in an easily visible location outside the pharmacy.
3. Hours during which a pharmacist is constantly absent due to duties as a school pharmacist or other pre-scheduled regular duties are also recognized as pharmacist-absent hours.
4. "Pharmacist-absent hours" refers to the hours during opening hours when a pharmacist engaged in dispensing at that pharmacy is unavoidably and temporarily absent from that pharmacy because that pharmacist is carrying out duties at a location other than that pharmacy.

Which of the following statements about a community-collaboration pharmacy, a specialized-medical-institution-collaboration pharmacy, and a health-support pharmacy is correct?

1. A community-collaboration pharmacy may use that designation upon receiving certification from the Minister of Health, Labour and Welfare.
2. A "health-support pharmacy" refers to a pharmacy that has the functions necessary to collaborate with other healthcare-providing facilities and provide guidance based on specialized pharmacological knowledge for each category of illness or injury.
3. When a pharmacy owner displays that a pharmacy is a health-support pharmacy, that pharmacy must conform to the standards set by the Minister of Health, Labour and Welfare.
4. A specialized-medical-institution-collaboration pharmacy is certified uniformly regardless of the category of illness or injury, and that certification is carried out by the prefectural governor of its location.

Which of the following statements about sales staff corresponding to risk classification is correct?

1. A Class 1 pharmaceutical may be sold or supplied by a registered seller.
2. A designated-guidance-required pharmaceutical and a Class 1 pharmaceutical may be sold or supplied by a registered seller, if one is present, even when no pharmacist is at that store.
3. A pharmacy owner or a store-based retailer must have a pharmacist sell or supply a designated-guidance-required pharmaceutical.
4. A Class 2 pharmaceutical may not be sold or supplied by a registered seller, and may only be sold or supplied by a pharmacist.

Which of the following statements about providing information when selling or supplying a Class 1 pharmaceutical is correct?

1. A pharmacy owner or a store-based retailer must have the pharmacist engaged in the sale or supply of the pharmaceutical provide the necessary information using a document stating the prescribed matters.
2. There is no need to use a document for providing information; it is sufficient for the pharmacist to do so orally.
3. The provision of information for a Class 1 pharmaceutical may also be carried out by a registered seller in addition to a pharmacist.
4. A pharmacy owner or a store-based retailer is only under a duty to endeavor to have the pharmacist engaged in the sale or supply of the pharmaceutical provide the necessary information (a duty of effort).

Which of the following statements about providing information when selling or supplying a Class 2 pharmaceutical is correct?

1. No particular provision under the Act is set for the provision of information.
2. The provision of information for a Class 2 pharmaceutical may not be carried out by a registered seller, and may only be carried out by a pharmacist.
3. There is a duty to endeavor to have the pharmacist or registered seller engaged in the sale or supply of the pharmaceutical provide the necessary information.
4. Providing information using a document stating the prescribed matters by the pharmacist engaged in the sale or supply of the pharmaceutical is mandatory.

Which of the following statements about providing information when selling or supplying a Class 3 pharmaceutical is correct?

1. Even if a purchaser raises a question, there is no obligation to provide information for a Class 3 pharmaceutical.
2. The Act provides that there is a duty to endeavor to have a pharmacist or registered seller provide the necessary information (a duty of effort).
3. It is desirable to have a pharmacist or registered seller provide the necessary information, but there is no particular provision under the Act.
4. Providing information using a document is mandatory.

Which of the following statements about responding when a purchaser of a pharmaceutical, among others, raises a question is correct?

1. Because no particular provision under the Act is set for providing information for a Class 3 pharmaceutical, there is no obligation to provide information even when a question is raised by a person intending to make a purchase.
2. Responding when a question is raised by a person intending to purchase a Class 2 pharmaceutical is not a mandatory duty but a duty of effort.
3. When a person intending to purchase an over-the-counter medicine raises a question, a pharmacy owner, store-based retailer, or home-delivery retailer must sell or supply it only after providing information.
4. Responding to a question raised by a person intending to purchase a designated-guidance-required pharmaceutical may be carried out not only by a pharmacist but also by a registered seller engaged in pharmaceutical affairs work.

Which of the following statements about the exception to providing information for a Class 1 pharmaceutical is correct?

1. The document-based provision of information for a Class 1 pharmaceutical can never be omitted, regardless of the purchaser's intention, under any circumstances.
2. Even for a designated-guidance-required pharmaceutical, if the person purchasing or receiving it expresses an intention that no explanation is needed, it may be sold without the pharmacist providing information or guidance based on pharmacological knowledge.
3. If the person purchasing or receiving it expresses an intention that no explanation is needed, a registered seller may judge that it will be used appropriately and thereby omit the provision of information for the Class 1 pharmaceutical.
4. If the person purchasing the Class 1 pharmaceutical expresses an intention that no explanation is needed, and the pharmacist judges that the Class 1 pharmaceutical concerned is recognized as being used appropriately, the provision of information is not required by law.

Which of the following, among the methods a pharmacy owner or store-based retailer must have a pharmacist follow when selling a designated-guidance-required pharmaceutical, is incorrect?

1. If the person intending to purchase requests it, being able to sell it without limit on quantity.
2. Having the pharmacist convey to the person intending to purchase the name of the pharmacist who sold the designated-guidance-required pharmaceutical, and the name of the pharmacy or store and its telephone number and other contact information.
3. Confirming that the person intending to purchase the designated-guidance-required pharmaceutical is the person intending to use it.
4. Having the pharmacist confirm that the person who received the information and guidance has understood its content and has no questions, before selling it.

Which of the following is NOT listed in the Guide among the matters a pharmacist must be made to confirm in advance when providing information for a Class 1 pharmaceutical?

1. Whether pregnant, and if pregnant, the number of weeks of pregnancy
2. Age
3. The occupation of the person intending to make the purchase
4. Status of use of other drugs or pharmaceuticals

Which of the following statements about records made when a pharmaceutical is sold is correct?

1. When a Class 2 or Class 3 pharmaceutical is sold, recording the product name, quantity, date and time of sale, and the like in a document and retaining it for two years is mandatory.
2. The retention period for the document when a designated-guidance-required pharmaceutical is sold is not two years but five years.
3. Recording the contact information of the purchaser of a pharmaceutical in a document and retaining it for two years is mandatory.
4. When a store-based retailer sells a designated-guidance-required pharmaceutical or a Class 1 pharmaceutical, it must record the product name, quantity, date and time of sale, and the like in a document, and retain it for two years.

Which of the following statements about the display of designated-guidance-required pharmaceuticals is correct?

1. A designated-guidance-required pharmaceutical must be displayed in display equipment that a person intending to make a purchase, among others, can directly touch by hand — that is, in a place where it can be freely picked up.
2. A designated-guidance-required pharmaceutical must be displayed in display equipment inside the designated-guidance-required-pharmaceutical display area, except in a case such as displaying it in locked display equipment.
3. A designated-guidance-required pharmaceutical may be displayed intermixed with an over-the-counter medicine.
4. A pharmacy owner or store-based retailer may store or display pharmaceuticals without distinguishing them from other items such as food, quasi-drugs, and cosmetics.

Which of the following statements about the display of a designated Class 2 pharmaceutical is correct?

1. A designated Class 2 pharmaceutical must always be displayed in locked display equipment.
2. A designated Class 2 pharmaceutical must be displayed within 10 meters of "equipment for providing information."
3. If necessary measures are taken to prevent a person intending to purchase a pharmaceutical, among others, from entering within 3 meters of the display equipment displaying the designated Class 2 pharmaceutical, it may be displayed outside the range of 7 meters.
4. A designated Class 2 pharmaceutical must be displayed within 7 meters of "equipment for providing information," except in a case such as displaying it in locked display equipment.

Which of the following statements about the display, among other matters, of pharmaceuticals is incorrect?

1. When a home-delivery retailer displays over-the-counter medicines, that person must display them by category — Class 1, Class 2, and Class 3 pharmaceutical — and must arrange for delivery so that they are not intermixed.
2. When a pharmacy owner or store-based retailer displays over-the-counter medicines, that person must display a Class 1, Class 2, and Class 3 pharmaceutical so that they are not intermixed.
3. Even when a Class 1 pharmaceutical is displayed in locked display equipment, the Class 1 pharmaceutical display area must be closed during hours when the Class 1 pharmaceutical is not sold.
4. A pharmacy owner or store-based retailer must close the place where a designated-guidance-required pharmaceutical or an over-the-counter medicine is normally displayed or handed over, during hours when it is not sold or supplied.

Which of the following statements about specified sale (tokutei hanbai) is correct?

1. "Specified sale" refers to the sale or supply, by a pharmacy or store, of a pharmaceutical to a person located somewhere other than that pharmacy or store, and includes not only a designated-guidance-required pharmaceutical and an over-the-counter medicine but also a prescription pharmaceutical used based on a physician's or dentist's prescription.
2. "Specified sale" refers to the sale or supply, by a pharmacy or store, of a designated-guidance-required pharmaceutical (excluding a specified designated-guidance-required pharmaceutical), an over-the-counter medicine, or a pharmacy-manufactured-and-marketed pharmaceutical (excluding one that is a poisonous or powerful drug), to a person located somewhere other than that pharmacy or store.
3. A specified designated-guidance-required pharmaceutical, among designated-guidance-required pharmaceuticals, can be sold through specified sale.
4. A pharmacy-manufactured-and-marketed pharmaceutical that is a poisonous or powerful drug can be sold through specified sale.

When advertising specified sale using the internet, which of the following pieces of information is NOT listed in the Guide as something that must be displayed prominently on the website?

1. The expiration date of a pharmacy-manufactured-and-marketed pharmaceutical, designated-guidance-required pharmaceutical (excluding a specified designated-guidance-required pharmaceutical), or over-the-counter medicine sold through specified sale
2. A photograph of the main exterior appearance of the pharmacy or store
3. A photograph showing the display condition of pharmacy-manufactured-and-marketed pharmaceuticals, designated-guidance-required pharmaceuticals (excluding a specified designated-guidance-required pharmaceutical), or over-the-counter medicines
4. A floor plan of the interior of the pharmacy or store

Which of the following statements about the method of specified sale is correct?

1. When advertising specified sale using the internet, it must be done on a website that the prefectural governor or the like and the Minister of Health, Labour and Welfare can readily view.
2. When conducting specified sale, even if a person intending to make a purchase requests a consultation response in person or by telephone, it is sufficient to respond by email.
3. When conducting specified sale, it is acceptable to ship a pharmaceutical obtained from another pharmacy or store directly, and there is no need for it to be a pharmaceutical stored or displayed at that pharmacy or store.
4. In advertising for specified sale, there is no need to indicate pharmaceuticals by risk classification.

Which of the following is NOT an ingredient (in each case excluding an external preparation) for which the Minister of Health, Labour and Welfare has set a quantity as a designated abuse-prevention pharmaceutical?

1. Ephedrine
2. Dextromethorphan
3. Bromovalerylurea
4. Acetaminophen

Which of the following statements about the matters that must be confirmed in advance when selling a designated abuse-prevention pharmaceutical is correct?

1. If a person intending to purchase a designated abuse-prevention pharmaceutical at that pharmacy or the like is under 18 years of age, that person's name must be confirmed.
2. There is no need to confirm in advance the status of purchase or transfer of that designated abuse-prevention pharmaceutical and any other designated abuse-prevention pharmaceutical.
3. Even when a person intends to purchase a quantity exceeding that set by the Minister of Health, Labour and Welfare, there is no need to confirm in advance the reason for that purchase.
4. There is no need to confirm the age of the person intending to make the purchase.

Which of the following statements about the sale of a designated abuse-prevention pharmaceutical is correct?

1. The quantity set by the Minister of Health, Labour and Welfare for pseudoephedrine (excluding an external preparation) is a single package, and one not exceeding 5 days' worth (7 days' worth for a preparation recognized as having an efficacy or effect as a cold remedy or an oral rhinitis medicine) based on the method and dosage.
2. Even when information cannot be provided or in other cases where appropriate use cannot otherwise be considered assured, a designated abuse-prevention pharmaceutical can still be sold.
3. If the person intending to make the purchase so wishes, a designated abuse-prevention pharmaceutical can be sold at one time in an amount for any number of days, exceeding the quantity set by the Minister of Health, Labour and Welfare.
4. The quantity set by the Minister of Health, Labour and Welfare for codeine (excluding an external preparation) is a single package, and one not exceeding 10 days' worth (14 days' worth for a preparation recognized as having an efficacy or effect as a cold remedy or an oral rhinitis medicine) based on the method and dosage.

Which of the following statements about the method by which a pharmacy owner or store-based retailer displays a designated abuse-prevention pharmaceutical (limited to a Class 2 or Class 3 pharmaceutical) is correct?

1. The method of displaying a designated abuse-prevention pharmaceutical is limited to either display in display equipment inside the designated-abuse-prevention-pharmaceutical display area, or display within 1.2 meters of the equipment for providing information with a pharmacist or registered seller engaged in pharmaceutical affairs work continually stationed at that equipment.
2. A designated abuse-prevention pharmaceutical must always be displayed in locked display equipment, regardless of whether it is inside the designated-abuse-prevention-pharmaceutical display area.
3. When displaying it within 7 meters of the equipment for providing information, there is no need to continually station a pharmacist or registered seller at that equipment.
4. It must be displayed either in display equipment inside the designated-abuse-prevention-pharmaceutical display area, or within 7 meters of the equipment for providing information with a pharmacist or registered seller engaged in pharmaceutical affairs work continually stationed at that equipment.

Which of the following statements about the medication notebook (okusuri techo) is correct?

1. Even when a person intending to use a designated-guidance-required pharmaceutical does not have a medication notebook, there is no need to recommend having one, or to provide information using the notebook.
2. The medication notebook is a notebook that allows unified, chronological management of a person's medication history and other information, and it is important to record a designated-guidance-required pharmaceutical in it as well.
3. There is no need to record a designated-guidance-required pharmaceutical in the medication notebook.
4. The medication notebook is only for recording medications dispensed at a medical institution, and is not for recording the use of a designated-guidance-required pharmaceutical or an over-the-counter medicine.

Which of the following statements about the provision of Article 66 of the Act concerning the advertising of pharmaceuticals is correct?

1. No one may advertise, describe, or disseminate a false or exaggerated article concerning the name, manufacturing method, efficacy, effect, or performance of a pharmaceutical, whether explicitly or implicitly.
2. It is provided that advertising, describing, or disseminating an article that could be mistaken for having been endorsed by a physician or other person does not fall under a false or exaggerated article, as long as its content is factual.
3. An explicitly false advertised article is prohibited, but an implicitly false one is not prohibited.
4. Only the pharmaceutical company that commissioned the advertisement is subject to the prohibition on exaggerated advertising, among other things.

Which of the following statements about the advertising, among other things, of a pharmaceutical before approval is correct?

1. Advertising for the sale of over-the-counter medicines does not include a flyer or POP advertisement used for sales promotion at a pharmacy, store-based retail business, or home-delivery retail business.
2. No penalty is provided for a person who advertises in violation of the provisions of Article 66 or Article 68.
3. No one may advertise the name, manufacturing method, efficacy, effect, or performance of a pharmaceutical before approval.
4. For a pharmaceutical before approval, it may be advertised as long as only its name is given.

Which of the following statements about determining whether something falls under advertising for a pharmaceutical is correct?

1. If the intent to attract customers (to promote a customer's desire to purchase) is clear, this is judged to fall under advertising even without meeting other requirements.
2. Unlike being in a state that can be perceived by the general public, making clear the trade name (brand name) of a specific pharmaceutical is not included among the requirements for falling under advertising.
3. It is judged to fall under advertising if any one of the following three requirements is met: (1) the intent to attract customers (to promote a customer's desire to purchase) is clear; (2) the trade name (brand name) of a specific pharmaceutical is made clear; and (3) it is in a state that can be perceived by the general public.
4. It is judged to fall under advertising when all of the following requirements are met: (1) the intent to attract customers (to promote a customer's desire to purchase) is clear; (2) the trade name (brand name) of a specific pharmaceutical is made clear; and (3) it is in a state that can be perceived by the general public.

Which of the following statements about the surcharge (kachokin) system related to the advertising of pharmaceuticals is correct?

1. There is a surcharge system under which the Minister of Health, Labour and Welfare orders a person who has made a false or exaggerated advertisement concerning the name, manufacturing method, efficacy, effect, or performance of a pharmaceutical, medical device, or the like to pay a surcharge equal to 4.5% of the sales amount of the target product during the period of the violation.
2. There is a surcharge system under which the Minister of Health, Labour and Welfare orders a person who has made a false or exaggerated advertisement concerning the name, manufacturing method, efficacy, effect, or performance of a pharmaceutical, medical device, or the like to pay a surcharge equal to 10% of the sales amount of the target product during the period of the violation.
3. An order to pay a surcharge is issued by the prefectural governor, based on the sales amount of the target product.
4. The surcharge system covers only advertising of a pharmaceutical before approval.

Which of the following statements about the appropriateness of advertising in light of the standards for appropriate advertising of pharmaceuticals, among other things, is correct?

1. An advertisement stating that a medical professional, medical institution, public institution, organization, or the like has officially recognized, recommended, or selected the product is permitted as long as it is factual.
2. An advertising expression such as (no side effect no matter how much is taken) carries a risk of promoting excessive consumption or abuse, but does not fall under a false or exaggerated advertisement.
3. Advertising with the so-called "restriction wording" (shibari hyogen), which limits the constitution or the like of the person using it, attached to the efficacy/effect of a kampo formula preparation, omitted, is in principle not permitted.
4. An expression that guarantees the certainty of a pharmaceutical's efficacy or safety is deemed a false or exaggerated advertisement only when explicit.

Which of the following statements about methods of selling a pharmaceutical is correct?

1. Selling pharmaceuticals combined together when their efficacy and effect overlap is considered appropriate from the standpoint of purchaser convenience.
2. In a combination sale, the legally required labeling matters stated on the outer box, among other places, of each individual pharmaceutical need not be visible from outside the container used for the combination sale.
3. Selling a pharmaceutical with a premium such as character merchandise is permitted as long as it stays within the limits of the Act against Unjustifiable Premiums and Misleading Representations.
4. Giving a pharmaceutical as a prize drawing or premium is permitted as long as it stays within the limits of the Act against Unjustifiable Premiums and Misleading Representations.

Which of the following statements about supervisory guidance by an administrative agency is correct?

1. The penalty for a person who refuses, obstructs, or evades an on-site inspection or collection by a pharmaceutical affairs inspector is imprisonment of not more than three years.
2. The prefectural governor or the like may have a designated official (a pharmaceutical affairs inspector) enter a place where a pharmacy owner or medicine-sales business operator handles pharmaceuticals as a business, and collect an item suspected of being an unapproved, unauthorized pharmaceutical, an unfit pharmaceutical, or a mislabeled pharmaceutical, among others, limited to the minimum quantity necessary for testing.
3. Even when an employee, including a pharmacist or registered seller, fails without justifiable reason to answer a question from a pharmaceutical affairs inspector, no penalty applies.
4. A pharmaceutical affairs inspector is appointed not by the Minister of Health, Labour and Welfare, the prefectural governor, the mayor of a city that establishes a health center, or the head of a special ward, but by the pharmacists' association from among its members, and has the authority to enter a place where a pharmacy owner or medicine-sales business operator handles pharmaceuticals as a business and conduct an inspection.

Which of the following statements about administrative dispositions and consultation and complaint desks is incorrect?

1. Even when a manufacturing and marketing business operator of a pharmaceutical or the like learns that its use presents a risk of causing or spreading harm to public health and hygiene, that operator may not take measures such as disposal, recall, or suspension of sale unless ordered to do so by an administrative agency.
2. When the Minister of Health, Labour and Welfare finds it necessary to prevent the occurrence or spread of harm to public health and hygiene caused by a pharmaceutical, the Minister may order a pharmacy owner or medicine-sales business operator to take emergency measures, such as temporarily suspending the sale or supply of the pharmaceutical.
3. Complaints, among other things, from consumers concerning the advertising, sales methods, and the like of a pharmacy or medicine-sales business are received not only by the administrative agency's pharmaceutical affairs division, health center, or pharmaceutical affairs supervisory office, but also by private organizations such as the National Consumer Affairs Center of Japan, local consumer affairs centers, and consumer groups.
4. When a pharmacy owner or medicine-sales business operator has engaged in conduct violating pharmaceutical affairs laws or regulations, the prefectural governor or the like may, when finding it necessary to prevent the occurrence or spread of harm to public health and hygiene, order that person to take measures necessary to improve the operation of its business.