The State Food and Drug Administration issued an announcement to once again clarify that self-service drug vending machines are not allowed to sell Class A over-the-counter drugs and prescription drugs, whether it means that relevant projects in some areas have been stopped at the drug regulatory level. For example, "self-service pharmacies" that sell prescription drugs in retail pharmacies and hospitals, or even undertake dual-channel drugs in national talks?
Source | Pharmaceutical Cloud Studio
On April 22, the State Food and Drug Administration issued the "Announcement on Further Improving the Work Related to the Supervision and Administration of Drug Operation" (No. 48 of 2024), which is a further refinement of the "Measures for the Supervision and Administration of the Quality of Drug Operation and Use" (Order No. 84) since the official implementation.
The Announcement further refines the relevant regulations, for example, clarifying that self-service drug vending machines are not allowed to sell Class A over-the-counter drugs and prescription drugs:
Pharmaceutical retail enterprises may set up self-service drug vending machines to sell Class B non-prescription drugs in accordance with drug storage requirements, and the address of the self-service drug vending machines shall be indicated under the "business address" of the license. Self-service drug vending machines are not allowed to sell Class A over-the-counter drugs and prescription drugs. The enterprise quality management system shall cover the self-service drug vending machines, and the drug sales, replacement, inspection and drug expiration date management of the self-service drug vending machines shall be incorporated into the enterprise computer system.
According to incomplete statistics, Hubei, Guangxi, Chongqing, Jiangxi, Gansu, Tibet and other places have issued documents for automatic drug vending machines, allowing automatic drug vending machines to sell over-the-counter drugs, and some areas also allow automatic drug vending machines to be laid in public places such as airports, stations, and residential areas.
Earlier (July 2015), Wuhan approved Wuhan Ma Yinglong Pharmacy Chain Co., Ltd. to set up automatic drug vending machines on a pilot basis, and the first batch of pilot automatic drug vending machines were set up in three Sinopec gas station convenience stores in Toudao Street, Jiang'an District, Hejiadun, Jianghan District, and Qinyuan Road, Wuchang District. In order to ensure the safety of drugs, the first batch of pilot vending machines can only operate over-the-counter drugs (excluding ephedrine compound preparations).
Source: Hubei Provincial Food and Drug Administration
In November 2022, the Jiangxi Provincial Food and Drug Administration issued the "Opinions on Supporting the Development of Pharmaceutical Retail Chain Enterprises (Trial)", which clearly states that "drug retail chain enterprises are supported to open 24-hour vending machines in large public places (including airports, railway stations, subway stations, and public medical institutions above the second level), and only sell Class B non-prescription drugs and medical devices (Class I, Class II medical devices exempt from business filing, disposable medical masks), and prohibit the sale of prescription drugs." ”
Source: Jiangxi Provincial Food and Drug Administration
In October 2022, the Gansu Provincial Food and Drug Administration issued an announcement on soliciting opinions and suggestions on the "Gansu Provincial Regulations on the Administration of Drugs in Vending Machines", pointing out that vending machines can only sell Class B non-prescription drugs in the business scope of the "Drug Business License" of retail pharmacies. The vending machine cannot sell prescription drugs (including traditional Chinese medicine decoction pieces), Class A over-the-counter drugs, drugs with special storage requirements, and drugs with special management requirements (such as drug compound preparations with special management).
Source: Gansu Provincial Food and Drug Administration
In December 2019, the Guangxi Food and Drug Administration issued the "Regulations on the Administration of Drug Sales by Vending Machines (Trial)", which allows drug vending machines to sell non-prescription drugs, but not prescription drugs (including traditional Chinese medicine decoction pieces), Class A non-prescription drugs, etc.
Source: Guangxi Zhuang Autonomous Region Food and Drug Administration
The above provinces have made it clear that self-service drug vending machines are not allowed to sell prescription drugs, so are there any other provinces that allow the sale of prescription drugs?
For example, Shaanxi Province issued a draft of relevant documents for comments, sending relevant signals: vending machines can not only sell over-the-counter drugs, but also sell prescription drugs on the premise of ensuring the authenticity and legitimacy of prescriptions.
In June 2023, the Shaanxi Provincial Food and Drug Administration issued the "Shaanxi Provincial Regulations on the Administration of Drug Sales by Vending Machines (Trial)" for public comment. Article 6 of the Consultation Paper clarifies that:
Drug vending machines can sell prescription and over-the-counter medications. Drugs that do not meet the storage conditions of vending machines and drugs with special or special management requirements shall not be sold in vending machines.
However, only a summary of the solicitation of opinions was published in the follow-up (5 rationalization opinions and suggestions were absorbed. No official draft has been found.
Source: Shaanxi Provincial Food and Drug Administration
Hebei went a step further and issued the Notice of the Hebei Provincial Medical Security Bureau on Setting Up "Self-service Pharmacies" to Further Facilitate the Purchase of Drugs by the Insured People (hereinafter referred to as the "Hebei Notice") in October 2023, allowing self-service drug vending equipment to sell relevant drugs.
Hebei's "Notice" pointed out that "self-service pharmacy" refers to the self-service drug vending equipment that can provide 24-hour service for the insured people with outpatient guarantee pharmacies and "dual-channel" pharmacies for negotiated drugs as the main body, relying on physical pharmacies in required places. The "Notice" also clarifies the scope of self-service pharmacies, including designated medical institutions, outpatient protection pharmacies, and dual-channel pharmacies:
1. The "dual-channel" pharmacies of negotiated drugs can set up "self-service pharmacies" in designated medical institutions, and the sale of drugs is limited to national negotiated drugs;
2. Outpatient guarantee pharmacies and "dual-channel" pharmacies for negotiation drugs can set up "self-service pharmacies" in densely populated residential areas, supermarkets, universities, office areas, etc., and reasonably equip the supply of negotiated drugs, chronic disease drugs, common disease drugs and other drugs in the medical insurance catalog according to the setting place and the needs of different insured people, so as to meet the daily drug needs and emergency use of the insured people.
In order to implement the policy, Hebei's "Notice" pointed out that the establishment of "self-service pharmacies" is an important popular project to facilitate the purchase of drugs by the insured people. All co-ordinating districts should attach great importance to this work, take this work as an important part of the second batch of theme education, strengthen organization and leadership, carefully arrange deployment, and make every effort to promote implementation.
So, after the issuance of Announcement No. 48 of the State Food and Drug Administration, will the relevant projects be affected?
The original text of the announcement is attached:
Announcement of the State Food and Drug Administration on further improving the work related to the supervision and management of drug operation
(48 of 2024)
The Measures for the Supervision and Administration of the Quality of Drug Operation and Use (Order No. 84 of the State Administration for Market Regulation, hereinafter referred to as the "Measures") have been promulgated and implemented. In order to further strengthen the supervision of drug business links, standardize the management of drug business licenses, and ensure the quality and safety of drug business links, the relevant matters are hereby announced as follows:
1. If an application for the establishment of a new drug wholesale enterprise is applied, it shall have a self-operated warehouse that is suitable for its business varieties and scale, and meets the requirements of modern logistics stipulated by the drug regulatory department at or above the provincial level, and shall be operated and managed by the personnel of the enterprise. Encourage newly established pharmaceutical wholesale enterprises to integrate existing resources and enhance industry concentration and management modernization.
2. Those who apply for the establishment of a new drug retail enterprise (except for those that only sell Class B non-prescription drugs) shall be equipped with licensed pharmacists or other qualified pharmaceutical technicians who are suitable for the scale and variety of business operations. Pharmaceutical retail enterprises applying for the operation of blood products and cell therapy biological products shall have quality assurance capabilities and product information traceability capabilities that are compatible with the varieties they operate. Pharmaceutical retail enterprises dealing in cell therapy biological products shall also have the conditions for interconnection and interoperability with electronic prescription information of designated medical institutions, and the licensed pharmacists shall have a bachelor's degree or above in clinical medicine, preventive medicine, immunology, microbiology and other majors, and have undergone training and assessment by relevant product marketing authorization holders.
3. Upon the expiration of the validity period of the drug business license, the drug wholesale enterprises applying for re-examination and issuance of the license shall, in principle, meet the relevant requirements of the "Measures". The provincial drug regulatory departments can formulate acceptance rules in combination with the actual situation, and guide drug wholesale enterprises to gradually achieve modern logistics conditions through facilities and equipment upgrades, resource integration, etc.
4. Pharmaceutical wholesale enterprises that have obtained the business scope of chemical drugs may operate chemical raw materials. Pharmaceutical retail enterprises dealing in poppy husk traditional Chinese medicine decoction pieces shall be separately marked in the business scope of "traditional Chinese medicine decoction pieces", such as "traditional Chinese medicine decoction pieces (containing poppy husks)". If a drug retail enterprise deals in toxic Chinese medicine decoction pieces, it shall be separately marked in the business scope of "Chinese medicine decoction pieces", such as "Chinese medicine decoction pieces (including toxic Chinese medicine decoction pieces)".
If a pharmaceutical business enterprise deals in refrigerated or frozen drugs, it shall be marked separately under the scope of business, such as "chemical drugs (including refrigerated and frozen drugs)" or "chemical drugs (including refrigerated drugs)".
The drug business license of the drug retail chain headquarters shall indicate "retail (chain headquarters)" under the business mode.
5. Drug regulatory departments at all levels shall strengthen the management of drug business licenses, and upload the information to the national drug regulatory data sharing platform within 10 days after the completion of the issuance, re-examination and issuance, change, revocation, revocation, cancellation and other matters, and update the relevant enterprise license information in a timely manner. If an application for cancellation of a drug business license is filed, the case has not been closed or the administrative penalty decision has not been fulfilled, it shall not be cancelled.
6. Pharmaceutical retail chain enterprises shall purchase drugs from the headquarters and distribute them to the chain stores under their jurisdiction. In accordance with the provisions of Articles 45 and 46 of the Measures, if storage and distribution are entrusted, the headquarters shall review and check the entrusted enterprises and manage them in a unified manner.
Pharmaceutical wholesale enterprises and drug retail chain enterprises of the same legal entity shall, in accordance with the quality management standards for drug business, establish a drug wholesale and retail quality management system respectively, equip a computer system that meets the requirements of the whole process management and quality control of drug business, set up warehouses that can meet the actual needs of wholesale and retail chain operations, and take effective measures to prevent drug confusion and errors.
7. Pharmaceutical retail enterprises may set up self-service drug vending machines to sell Class B non-prescription drugs in accordance with drug storage requirements, and the address of the self-service drug vending machines shall be indicated under the "business address" of the license. Self-service drug vending machines are not allowed to sell Class A over-the-counter drugs and prescription drugs. The enterprise quality management system shall cover the self-service drug vending machines, and the drug sales, replacement, inspection and drug expiration date management of the self-service drug vending machines shall be incorporated into the enterprise computer system.
8. If the marketing authorization holder and the drug trading enterprise entrust the storage and transportation, they shall sign an entrusted quality agreement with the entrusted party, clarify the quality management responsibilities of both parties, and conduct quality audits on the entrusted party on a regular basis, and the computer system of the entrusting party's drug business and the entrusted party's warehousing and logistics system shall realize the necessary data docking. If the storage and transportation of refrigerated and frozen drugs are entrusted, the entrusting party shall also regularly review the storage conditions, means of transportation, mode of transportation, process temperature control and data record management of the entrusted party.
9. If a drug wholesale enterprise sets up a warehouse across provinces (autonomous regions and municipalities), the drug regulatory department of the province (autonomous region, municipality) where the warehouse is located shall consult with the drug regulatory department of the province (autonomous region, municipality) where the warehouse is located for approval, and if it meets the requirements, it shall be handled according to the change of warehouse address; If the headquarters of a pharmaceutical retail chain enterprise applies for additional warehouses, it shall be handled with reference.
10. Encourage drug trading enterprises to carry out electronic exchange and management of the first data. The qualification materials such as the first enterprise, the first variety, the purchasing unit, and the inspection report stamped with the electronic signature or electronic seal in accordance with the law shall have the same effect as the paper materials.
11. Drug regulatory departments at all levels should make full use of 5G networks, big data and other technical means to strengthen supervision and management, encourage the industry to use information technology to improve the level of quality management, and guide and promote the upgrading of the drug circulation industry. It is necessary to focus on the varieties selected in the national centralized procurement, biological products and other varieties, and accelerate the promotion of the whole process of drug information traceability. It is necessary to actively explore the use of information technology to monitor the on-the-job situation of licensed pharmacists and other pharmaceutical technicians to improve the level of pharmaceutical services.
12. In accordance with the requirements of the Measures and this announcement, the drug regulatory departments at all levels may formulate supporting documents in combination with the actual work, refine the relevant content around strict business license access, implement the main responsibility of enterprises, strengthen the supervision of business activities, and improve the inspection mechanism, improve the work process and standards, and improve the efficiency of drug business supervision.
13. This announcement shall come into force on the date of promulgation.
The announcement is hereby made.
State Food and Drug Administration
April 18, 2024