The official clarification that opening a pharmacy must follow the spatial layout requirements

Not long ago, the Hubei Provincial Drug Administration proposed in the "Six Measures on Deeply Optimizing the Business Environment to Promote the High-quality Development of the Biopharmaceutical Industry", including "removing the restrictions on the business area and spacing of retail pharmacies, and relaxing the conditions for licensed pharmacists to practice in multiple locations.
" "And many other measures, a few days ago, the Hubei Food and Drug Administration reissued the document "Hubei Province Social Pharmacy Business Activities Access Management Implementation Measures" (hereinafter referred to as the "Measures") to further refine the access management of social pharmacy business activities
.
Site selection should be guided by the spatial layout Although the aforementioned documents state that the spacing restrictions will be lifted, it is not the operator who decides the location for opening a store
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The "Measures" stipulate that, in addition to complying with the provisions of Article 5 of these Implementation Measures, engaging in drug retail activities should follow the principle of facilitating the purchase of medicines by the masses, follow the requirements of "demand-oriented, classified guidance, market-determined, safe and controllable", combined with local permanent residents The number of population, region, traffic conditions and actual needs should be rationally arranged for social pharmacy outlets
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The municipal drug supervision and administration department shall, in conjunction with relevant departments, formulate the "Guidelines for the Spatial Layout of Social Pharmacy Networks" in its administrative region, update it regularly and report it to the provincial drug administration for the record
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The "Measures" emphasize that if the space layout requirements are not met, it is generally not allowed to open a new social pharmacy
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This also means that although the spacing restrictions have been loosened, the location selection of retail pharmacies is still limited by the "spatial layout".
It is worth noting that the "measures" also propose three types of situations that may not comply with the spatial layout requirements.
For example, drug retail chain enterprises add chain stores; social pharmacies set up in medical institutions that provide pharmacy professional services for patients, namely DTP pharmacies; promise to provide advanced pharmacy services in accordance with the "Hubei Province Social Pharmacy Quality and Service Management Guidelines"
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In fact, regarding the setting of spatial layout, Shanghai issued relevant policies in 2018
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In the "Guidelines for the Spatial Layout of Drug Retail Networks in Shanghai", it is proposed that "the layout of retail pharmacies in general residential areas, the layout of retail pharmacies in important medical institutions agglomeration areas, the layout of retail pharmacies in municipal and regional medical centers, and the layout of retail pharmacies in municipal commercial centers ” and other four sections of the guide map layout, further optimize and improve the spatial layout of retail pharmacies, so as to “fit the layout and development, and match the supply and demand”
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It is not difficult to understand that Hubei's move is also for the same purpose
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In addition, the "Measures" also set up a "fast track" for the approval of these pharmacies.
Those engaged in drug retail activities should accelerate the approval if they have any of the following circumstances: they are opened in remote suburbs and areas below rural townships; in newly built large residential communities , the drug retail service blank area is opened; the population of the residential area is greater than or equal to 3,000, and there is no social pharmacy
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In terms of staffing of pharmacy service personnel, the "Measures" clarify that to open a social pharmacy, the pharmacy service capacity should be assessed by itself in accordance with the "Guidelines for the Quality and Service Management of Social Pharmacy in Hubei Province", and the pharmacy service capacity of social pharmacies should be managed according to the classification of drugs.
Requirements, refer to the "Hubei Province Social Pharmacy Supervision and Administration Measures" to scientifically and reasonably allocate licensed pharmacists and other pharmacy technicians
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According to the scale of social pharmacies, pharmacy service sites that provide basic pharmacy services and advanced pharmacy services should generally set up drug treatment management sites to conduct drug treatment management and drug consultation, and to ensure the privacy of special patients or consumers’ consultation and dialogue
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A pharmacist's desk may be established only for primary pharmacy services
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When necessary, a special area for public health and drug knowledge education can be set up
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Professional pharmacies such as DTP pharmacies can set up pharmacist outpatient clinics, and with the approval of the health department, they can set up specialized outpatient clinics for chronic disease and special disease physicians
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Social pharmacies operating Chinese herbal decoction pieces can set up Chinese medicine clinics in drug retail sites upon filing with the health department, and can also set up independent Chinese medicine decoction rooms
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In terms of supervision, the Hubei Food and Drug Administration has made it clear that the grading of pharmaceutical service capabilities is subject to dynamic management, and the validity period is generally 3 years
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During the period, comprehensive evaluation and adjustment shall be made according to the results of routine inspection and drug GSP compliance inspection
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Hubei Food and Drug Administration requires that when drug supervision and management departments at all levels conduct supervision and inspection, if they find that social pharmacies are engaged in drug retail activities that are not suitable for their pharmaceutical service capabilities, they should immediately take administrative measures.

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If there is evidence that social pharmacies intentionally provide fake or inferior drugs in pharmaceutical services, they shall not be rated as advanced pharmaceutical service capability levels, and relevant inspection and confirmation information shall be made public
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These pharmacies implement the reporting system In the "Measures", Hubei Food and Drug Administration also stipulates several types of situations for implementing the reporting system, as well as the form and frequency of inspections
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According to the "Measures for the Supervision and Administration of Social Pharmacies of Hubei Province", a reporting system shall be implemented for the business activities of social pharmacies under one of the following circumstances: Internet drug sales
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Undertaking the storage and distribution business such as "online order store pickup" and "online order store delivery"
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Conducting Internet pharmacy services (remote review, remote consultation), or entrusting a third-party platform to provide related pharmacy services
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Entrusting pharmaceutical third-party logistics companies (according to pharmaceutical third-party logistics companies) to carry out drug storage and distribution
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Set up a remote pharmacy (medicine cabinet)
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Pharmacy services such as decoction of traditional Chinese medicine and recycling of discarded medicines are provided
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The licensing inspection of the drug retail chain enterprise's application for the issuance of the drug business license shall be organized and implemented by the provincial drug regulatory department or drug inspection agency
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If the number of stores of a pharmaceutical retail chain enterprise is less than or equal to 30, the random inspection shall be carried out according to the proportion of 20%, but not less than 3; if the number of stores of the pharmaceutical retail chain enterprise is more than 30, the random inspection shall be carried out according to the proportion of 10%, but not less than 6 ; The drug regulatory department at the city and county level where the store is located shall cooperate with the provincial drug regulatory department or drug inspection agency that organizes the inspection; if the drug retail chain enterprise store under random inspection is established across provinces (autonomous regions, municipalities directly under the Central Government), it is necessary to The provincial drug administrations that organize licensing inspections may carry out joint inspections
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When applying for the renewal of the drug business license under any of the following circumstances, the drug GSP compliance inspection shall be carried out in combination with the social pharmacy supervision and inspection standards: the business scope includes second-class psychotropic drugs, toxic drugs and other special management drugs, refrigerated and frozen drugs, etc.
In addition, serious or major defects have been found in routine inspections; those who have not received drug GSP compliance inspection in the past five years, or who have failed the drug GSP conformity inspection or have been downgraded in the level of social pharmacy pharmacy service capabilities; Substandard drugs or other major illegal acts subject to administrative punishment by the drug supervision and management department; historical data of supervision and inspection in the past five years show that there are risks of business varieties, serious defects or administrative measures, integrity problems, etc.
, and it is deemed necessary to organize on-site inspections ; There are complaints and reports during the publicity of the renewal license; the written review of the application materials for renewal of the license does not meet the requirements; the drug laws and regulations and other regulations should conduct on-site inspections
.