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On August 17, the State Drug Administration issued the Notice on Regulating the Use of Practicing Pharmacists in Drug Retail Enterprises (Draft for Comments) (hereinafter referred to as the Notice) and solicited opinions from the public.
"Notice" requires to further standardize the pharmaceutical retail enterprises pharmaceutical technical staffing requirements, continue to promote the use of licensed pharmacists, and actively play the important role of practicing pharmacists in ensuring the safety and effectiveness of public drug use.
document indicates that the transition period for licensed pharmacists can be extended to 2025, but the relevant departments have not relaxed the examination of licensed licensed licensed pharmacists, certified licensed pharmacists will be directly blacklisted and implement multi-sectoral joint disciplinary.
" In principle, a pharmaceutical retail enterprise that operates prescription drugs or Class A over-the-counter drugs shall be equipped with a practicing pharmacist, and a pharmaceutical retail enterprise that operates only Class B over-the-counter drugs shall be equipped with a business personnel who have passed the examination and appraisal organized by the drug supervision and administration department.
" In view of the fact that there are not enough practicing pharmacists in some areas and it is difficult to equip them, the provincial drug regulatory departments may formulate policies for the implementation of differentiated use of practicing pharmacists and set up a transition period without reducing the overall proportion of existing practicing pharmacists.
the transition period, pharmaceutical retail enterprises are allowed to equip other pharmaceutical technicians to assume the duties of practicing pharmacists in areas where there is a significant gap in practicing pharmacists, and the transition period does not exceed 2025.
"On November 23, 2015, the Drug Administration issued a Notice on the Management of the Use of Existing Pharmaceutical Pharmacists," which stated that the 12th Five-Year Plan for National Drug Safety proposed that all retail pharmacies be fully staffed with practicing pharmacists by the end of 2015, but due to the insufficient number of practicing pharmacists and uneven distribution, it is difficult to achieve the objectives of the Plan.
documents show that in 2016-2020, the transition policy for pharmaceutical pharmacists will be implemented over a five-year period.
that all retail pharmacies are fully staffed with licensed pharmacists will be in place from 1 January 2021, pharmaceutical operators will be required to have licensed pharmacists.
the previous requirements of January 1, 2021, compared with the current 2025 transition period, it can be seen that the number of licensed pharmacists is extended by another four years.
document extends the transition period for practicing pharmacists, and once the draft is ready, it will undoubtedly be good for the vast majority of drug retail enterprises, at least temporarily alleviating the survival crisis of some enterprises.
the relevant departments of the practice of pharmacists to register the examination has not been relaxed.
1, establish archives and strengthen supervision.
the departments responsible for drug supervision in each city and county shall strengthen the management of pharmaceutical technicians in their jurisdictions, register the situation of pharmaceutical technical personnel in drug retail enterprises in accordance with the provisions, and establish relevant information files.
To implement the four most stringent regulatory requirements, strictly audit and control new drug retail enterprises, strengthen supervision and inspection of the equipment and on-the-job practice of practicing pharmacists (or pharmacy technicians) and urge them to perform their duties and responsibilities.
2, "registered" into the blacklist, multi-sector joint disciplinary.
pharmaceutical retail enterprises that are not equipped according to regulations and are not in place for rectification shall be investigated and dealt with in accordance with the law, and their business scope of prescription drugs and Class A over-the-counter drugs shall be reduced in accordance with the provisions.
To check the "registered" practicing pharmacists to enter the national registered pharmacists registration management information system, revoke their registration certificates and resolutely expose;
Data from the National Drug Administration's Center for the Qualification of Practicing Pharmacists show that as of the end of June 2020, the number of registered practicing pharmacists nationwide was 541,965, an increase of 8,679 month-on-month, with 3.9 pharmacists per 10,000 population, and 491,071 practicing pharmacists registered in pharmaceutical retail enterprises, accounting for 90.6% of the total number of registrations.
According to the statistics of Mina network and forward-looking industry research institute, the number of pharmacies nationwide reached 480,000 in 2019, according to the Ministry of Commerce issued in November 2018 "national retail pharmacy classification and classification management guidance (draft for comments)" put forward "two types of retail pharmacies equipped with at least one practicing pharmacist, three types of retail pharmacies equipped with at least 2 practicing pharmacists" requirements, the number of practicing pharmacists face a certain gap, the number of practicing pharmacists to become a means of operation.
fact, this is not the first time the State Drug Administration has regulated practicing pharmacists.
March 2019, the State Drug Administration called for nationwide action to crack down on the registration of practicing pharmacists.
2019 CCTV 315 party exposed some drug retail enterprises in Chongqing City, practicing pharmacists "hang up", do not sell prescription drugs by prescription and other issues, the State Drug Administration on March 19 issued "on the development of pharmaceutical retail enterprises practicing pharmacists "certificate" behavior rectification work notice", carried out a six-month registration of the general rectification.
, Anhui, Jiangxi, Fujian, Jiangsu, Liaoning, Shaanxi, Hebei, Shanxi and other provinces and cities have also exposed the practice of pharmacists "certificate" situation.
Taking Guangdong Province as an example, through the practice of pharmacists "registered" behavior rectification, during the special rectification period, the number of practicing pharmacists in the province who voluntarily cancelled the registration certificate reached 3,143, and 174 pharmaceutical retail enterprises that confirmed the existence of practicing pharmacists "registered" behavior were punished by the sale of certificates.
also found that 756 businesses did not sell prescription drugs as required.
this sweeping country's licensing of practicing pharmacists continues, in the future or there will be more registered licensed licensed practitioners will be announced to cancel the certificate.
the transformation and upgrading of practicing pharmacists and retail pharmacies is imminent.
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