Notice of the State Food and Drug Administration on Regulating the Appointment and Use of Licensed Pharmacists in Pharmaceutical Retail Enterprises Guo Yao Jian Yao Guan (2020) No. 25

The Drug Administration of all provinces, autonomous regions, and municipalities directly under the Central Government, and the Drug Administration of Xinjiang Production and Construction Corps:

A licensed pharmacist is a professional force that carries out drug quality management and provides pharmaceutical services, and is an important guarantee for rational drug use
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In recent years, the State Food and Drug Administration has continuously strengthened the construction of the licensed pharmacist system and team building, continued to promote the deployment and use of licensed pharmacists, and actively played the important role of licensed pharmacists in ensuring the safe and effective use of medicines for the public

1.
Adhere to the policy of appointing licensed pharmacists and steadily improve the level of appointing pharmacists

The provision of licensed pharmacists by pharmaceutical retail companies in accordance with regulations is a basic requirement for maintaining the safety of drug use by the public, as well as a practical need to realize the "Healthy China" strategy and promote the high-quality development of the industry
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The "Drug Administration Law" stipulates that to engage in drug business activities, there should be pharmacists or other pharmaceutical technicians who have been certified according to law

In view of the current situation of insufficient licensed pharmacists in some areas and difficulty in equipping them, the provincial drug supervision and administration department can formulate and implement a policy of differentiated deployment of licensed pharmacists and set a transition period without reducing the overall ratio of existing licensed pharmacists.

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During the transition period, for areas where there is a significant gap in licensed pharmacists, pharmaceutical retail companies are allowed to deploy other pharmacy technicians to assume the duties of licensed pharmacists, and the transition period will not exceed 2025

2.
Detailed implementation of the requirements for the provision of licensed pharmacists, and strengthen the implementation of supervision and inspection responsibilities

The provincial drug supervision and administration department shall formulate specific implementation plans according to the actual situation of the licensed pharmacists and pharmacy technicians in the administrative area, combined with factors such as business varieties, business scales, regional differences, and drug safety risks, and promote licensed pharmacists in stages and regions Equipped and used, and steadily increased the proportion of licensed pharmacists in pharmaceutical retail enterprises
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The transition policy and implementation plan for the differentiated deployment and use of licensed pharmacists formulated by the provincial drug supervision and administration department shall be disclosed to the public in a timely manner, and publicity and guidance shall be carried out

During the transition period, the departments responsible for drug supervision in each city and county shall strengthen the management of pharmaceutical technicians in the administrative area, register the provision of pharmaceutical technicians in pharmaceutical retail enterprises in accordance with regulations, and establish relevant information files
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It is necessary to implement the "four most stringent" requirements, strictly review and control newly established pharmaceutical retail companies; strengthen the supervision and inspection of the allocation and on-the-job practice of licensed pharmacists (or pharmaceutical technicians), and urge them to perform their duties due diligence

3.
Effectively play the role of licensed pharmacists and continue to strengthen team building

Practicing pharmacists in drug retail companies shall be responsible for the drug quality management of their companies, supervise the implementation of relevant laws, regulations and specifications for drug management; be responsible for prescription review and supervision of deployment, provide the public with reasonable drug use guidance and consulting services; be responsible for collecting and feeding back information on adverse drug reactions and other pharmacy Work
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Pharmaceutical retail companies must strictly implement the relevant provisions of the "Drug Administration Law," and while adhering to the principle of appointing licensed pharmacists, they must also give full play to the role of licensed pharmacists

All localities should attach great importance to the construction of licensed pharmacists, formulate relevant policies to guide pharmaceutical technicians to actively participate in the licensed pharmacist qualification examination, and increase the proportion of licensed pharmacists in the administrative area year by year; standardize the continuing education of licensed pharmacists, and promote the continuous updating of professional knowledge of licensed pharmacists , To better play its role; it is necessary to explore the establishment of a multi-sectoral policy linkage mechanism to promote the use of licensed pharmacists and the healthy development of the licensed pharmacist team
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This notice will be implemented from January 1, 2021
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If the previous requirements for the provision and use of licensed pharmacists in pharmaceutical retail companies are inconsistent with this notice, this notice shall apply

State Food and Drug Administration

November 19, 2020