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Notice of the Comprehensive Division of the State Food and Drug Administration on Carrying out the Rehabilitation Work of the Licensed Pharmacists of Drug Retail Enterprises

The State Food and Drug Administration General Department is responsible for the implementation of drug retailers licensed pharmacists

Notice of rectification of "certificate of identity"

Drug Supervision Comprehensive Medicine Tube [2019] No. 22

Published on March 19, 2019

Drug Administration of the provinces, autonomous regions and municipalities directly under the Central Government, Xinjiang Construction Corps Market Supervision Administration:

On the evening of March 15, the Central Radio and Television General Station exposed the problems of “licensing” for licensed pharmacists in some pharmaceutical retail enterprises in Chongqing, and not selling prescription drugs without prescription, which caused bad social impact. In order to fully implement the "four most stringent" requirements of drug supervision and severely crack down on the "certificate of certifying" behavior of licensed pharmacists, it is now decided to carry out a six-month "reissue" behavior of licensed pharmacists in drug retail enterprises nationwide. The relevant work requirements are hereby notified as follows:

First, the goal of remediation

Through rectification, it investigates and exposes a group of drug retailers and employees who violate laws and regulations, effectively curbs the phenomenon of “hanging the certificate”, forms a high-pressure situation and strong deterrence of strict investigation, and further regulates the order of drug operations and the practice of licensed pharmacists. To ensure the safety and effectiveness of the people's medication.

Second, remediation content

On the basis of the centralized urban and rural junctions and the pharmacy clinics in rural areas in 2017, all localities should conduct a “review” and follow the “Notice of the State Food and Drug Administration on Strengthening the Post-Marketing Supervision of Drugs in 2019” ( The State Administration of Traditional Chinese Medicine (2019) No. 7) requires that the organization conduct supervision and inspection of pharmaceutical retail enterprises, focusing on investigating and handling illegal and illegal business operations such as “certificate of escrow” by licensed pharmacists. It is necessary to combine the “certificate of resignation” of pharmaceutical retail enterprises with the daily supervision and inspection contents such as standardized purchase channels and strict bill management, and urge pharmaceutical retail enterprises to improve the quality management and pharmaceutical service levels.

Third, work arrangements

(1) Self-inspection and rectification stage

All drug retail enterprises have carried out self-examination in accordance with the "Measures for the Administration of Drug Circulation Supervision and Management" and "Standards for the Administration of Quality of Pharmaceutical Products". They have taken effective measures to take the initiative to carry out rectification of problems such as the lack of equipment for licensed pharmacists and the sale of prescription drugs without prescription. The self-inspection and rectification of enterprises shall be reported to the department in charge of drug supervision at the prefecture (or county) level before April 30, 2019.

All licensed pharmacists who are registered to practice in pharmaceutical retail enterprises must also carry out self-examination. All licensed pharmacists who have “certificate of identity” and cannot be on-the-job should immediately correct or apply for cancellation of the licensed pharmacist before April 30, 2019. Registration Certificate.

(2) Supervision and inspection stage

Since May 1, 2019, the provincial bureaus have organized supervision and inspection of drug retail enterprises in the administrative region, and have handled the following requirements:

1. Anyone who finds that a drug retail enterprise has a “cash-certified” licensed pharmacist shall revoke its “Quality Management Standard for Pharmaceutical Administration” according to the serious violation of the “Quality Management Standards for Pharmaceutical Administration”.

2. Anyone who finds that a pharmaceutical retail enterprise fails to be equipped with a licensed pharmacist as required shall be investigated and punished according to the provisions of Article 78 of the Drug Administration Law of the People's Republic of China; at the same time, the enterprise shall be included in the annual key inspection object for follow-up inspection or Flight check.

3. Anyone who finds that a pharmaceutical retail enterprise fails to sell prescription drugs according to the regulations shall be punished in accordance with the provisions of Article 38 of the Measures for the Supervision and Administration of Drug Distribution.

4. Any licensed pharmacist who has found that there is a “certificate of hang-up” shall revoke his “Practicing Pharmacist Registration Certificate” and record it in the National Licensed Pharmacist Registration Management Information System and make it public; before the above-mentioned bad information record is revoked, it cannot be registered again. Practice.

Fourth, the relevant requirements

(1) Extensive publicity and guidance. All provincial bureaus should actively organize social propaganda through the opportunity of media exposure to create a good public opinion atmosphere for rectification work. It is necessary to raise awareness of the industry's policy requirements for licensed pharmacists, and initiate self-inspection and rectification; it is necessary to raise awareness of the importance of licensed pharmacists in safeguarding drug safety and improving quality management, and strengthen social supervision.

(2) Strict supervision and inspection. The provincial bureaus should supervise and urge the supervisory departments at all levels in the administrative region to attach great importance to strengthening the daily supervision of the local drug business enterprises and severely investigate and punish the licensed drugstores for drug retailers. The department in charge of drug supervision at the city (or county) level shall strictly check and check the newly opened drug retail enterprises. If there are no conditions, the drug business license may not be issued.

(3) Promoting social co-governance. The departments responsible for drug supervision at each city (or county) level shall combine the practice registration information of the national licensed pharmacist registration management information system to improve the pertinence and effectiveness of supervision and inspection. In the case of a drug retail enterprise that has a licensed pharmacist's “certificate”, it shall notify the local medical insurance management department and other departments to cancel the medical insurance fixed-point qualification and form a joint disciplinary mechanism. For the verified “Certificate of License” licensed pharmacist, the “Practicing Pharmacist Registration Certificate” will be revoked and publicly disclosed. It is necessary to incorporate the “cash-in-charge” licensed pharmacists into the “blacklist” of credit management, and actively explore long-term mechanisms for joint disciplinary action and joint strikes.

(4) Implementing supervisory responsibilities. The provincial bureaus supervise and supervise the rectification work, implement the responsibility for territorial supervision, and grasp the first-level level and implement it at all levels. It is necessary to strengthen investigation and research, and strengthen guidance, supervision and inspection in a targeted manner to ensure that the rectification work is effective. In areas where the work is weak and the remediation effect is not good, it should be notified and criticized.

Before September 30, 2019, the provincial bureaus summarized the rectification work of the licensed pharmacists in the administrative area and reported them to the Drug Supervision Department of the State Food and Drug Administration.

Contact: Guo Weiwei, Deng Dongfang

Tel: 010-88331034

National Drug Administration Bureau

March 17, 2019

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