GSp regulates whether pharmacies can handle injections

No. GSP is the English abbreviation of "Good Practice for Pharmaceutical Operations". According to the relevant regulations, the new version of the pharmacy GSP certification.

It will be fully implemented by the end of 2015. Some of the retail pharmacies whose "Drug Business License" or "Drug Business Quality Management Practice Certification" expired before December 31, 2013 will complete the new version of GSP certification before June 30, 2014. The rest must be certified by December 31, 2015.

All drug regulations and systems do not stipulate that pharmacies cannot sell injections, but it is true that pharmacies have almost no injections for the following reasons:

1.All injections require a prescription, and pharmacies cannot receive the corresponding prescriptions;

2.Injections are risky, and some pharmacies voluntarily do not sell them in order to avoid risks;

3.The authorities in some areas directly banned the sale of injections in pharmacies due to choking and food waste;

The drug sales law stipulates that the following conditions are required to set up a drug manufacturing enterprise: (1) Pharmaceutical technicians, engineering and technical personnel and corresponding skilled workers who have been qualified in accordance with the law; (2) Have a plant, facilities and sanitary environment suitable for its drug production; (3) Have the institutions, personnel and necessary posture imitation equipment that can carry out quality management and quality inspection of the drugs produced; (4) Rules and regulations for the quality of drugs.

Article 51 of the Drug Administration Law.

To engage in drug wholesale activities, it shall be approved by the people's drug regulatory department of the province, autonomous region or municipality directly under the Central Government to obtain a drug business license. To engage in drug retail activities, it shall be approved by the local people's drug regulatory department at or above the county level where it is located, and obtain a drug business license. Without a drug business license and a certificate, no drug business shall be dealt.

The drug business license shall indicate the validity period and business scope, and shall be re-examined and issued upon expiration.

In addition to the conditions stipulated in Article 52 of this Law, the drug regulatory department shall also follow the principle of facilitating the purchase of Dazi drugs by the masses in the implementation of drug business licenses.

If the drug trading enterprise fails to implement GSP in accordance with the regulations, it shall be given a warning and ordered to make corrections within a time limit; where corrections are not made within the time limit, it shall be ordered to suspend production or business for rectification, and a fine of between 5,000 and 20,000 RMB shall be imposed; If the circumstances are serious, the drug business license shall be revoked.

1) Enterprises that have not passed the GSP certification and belong to the rectification within a time limit shall submit a rectification report to the certification center of the bureau within 3 months and apply for review; If it is unqualified, it can re-apply for GSP certification after 6 months from the date of issuance of the notice.

2) If the drug manufacturer, business enterprise, drug non-clinical safety evaluation research institution, and drug clinical trial institution fail to implement the "Good Manufacturing Practice for Drugs", "Good Management Practice for Drug Operation", "Good Management Practice for Non-clinical Research", and "Good Practice for Drug Clinical Trials" in accordance with the regulations, they shall be given a warning and ordered to make corrections within a time limit; where corrections are not made within the time limit, it shall be ordered to suspend production or business for rectification, and a fine of between 5,000 and 20,000 RMB shall be imposed; If the circumstances are serious, the "Drug Production License", "Drug Business License" and the qualifications of drug clinical trial institutions shall be revoked.

The following are the provisions of the Good Manufacturing Practice (GSP) on personnel requirements:

Section 2: Personnel Management.

Article 124: Personnel engaged in drug business and quality management shall meet the qualification requirements stipulated in relevant laws and regulations and this specification, and shall not be prohibited by relevant laws and regulations.

Article 125: The legal representative of an enterprise or the person in charge of an enterprise shall have the qualifications of a licensed pharmacist.

Enterprises shall, in accordance with the relevant provisions of the state, appoint licensed pharmacists to be responsible for prescription review and guidance on the rational use of drugs.

Article 126: Quality management, acceptance, and procurement personnel shall have a degree in pharmacy or medicine, biology, chemistry, or other related majors, or have professional and technical titles in pharmacy. Personnel engaged in the quality management, acceptance and procurement of traditional Chinese medicine decoction pieces shall have a technical secondary school degree or above in traditional Chinese medicine or a professional and technical title of junior or above in traditional Chinese medicine.

Salespeople should have a high school education or above or meet the conditions stipulated by the provincial food and drug supervision and administration. The dispensing personnel of traditional Chinese medicine decoction pieces shall have a technical secondary school degree or above in traditional Chinese medicine or have the qualification of traditional Chinese medicine dispenser.

Article 127: Personnel in all positions of the enterprise shall receive pre-job training and continuing training in relevant laws and regulations as well as professional knowledge and skills of drugs to meet the requirements of this specification.

Article 128: Enterprises shall formulate an annual training plan and conduct training in accordance with the training management system, so that relevant personnel can correctly understand and perform their duties. Training work shall be recorded and archives shall be established.

Article 129: Enterprises should provide conditions for personnel selling drugs under special management, drugs with special management requirements of the state, and refrigerated drugs to receive appropriate training, so that they can master the relevant laws, regulations and professional knowledge.

Article 130: In the business premises, the staff of the enterprise shall wear neat and hygienic work clothes.

Article 131: Enterprises shall conduct pre-job and annual health examinations for personnel who are in direct contact with drugs, and establish health records. Those who suffer from infectious diseases or other diseases that may contaminate drugs must not engage in work that directly comes into contact with drugs.

Article 132: Items and personal belongings unrelated to business activities should not be stored in the drug storage and display areas, and no behaviors affecting the quality and safety of drugs should be stored in the work area.

Supplementary note: The drug regulatory departments of various localities may have special requirements, for example, Guangdong Province has the "Administrative Measures for the Classification and Classification of Drug Retail Enterprises (Trial)" in 2018, and the difference in personnel requirements is quantity. In terms of qualifications, the terms are the same as those of GSP.

Therefore, it is also necessary to pay attention to the management documents of local drug regulatory departments.

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1. The enterprise shall sell the drug to the legitimate purchasing unit, and verify the supporting documents of the purchasing unit, the identity certificates of the purchasing personnel and the delivery personnel, so as to ensure that the drug sales flow is true and legal. The delivery address of the drug should be consistent with the address on the "Drug Production License" or "Drug Business License" or "Medical Institution Practice License" of the purchasing unit.

2. Pharmaceutical business enterprises: provide copies of "Drug Business License", "Business License", "Drug Business Quality Management Standards" certification certificates, etc.;

3. If it is a medical institution, a copy of the "Medical Institution Practice License" shall be provided;

4. A copy of the purchaser's power of attorney, etc.

Some also contain special drugs such as ephedrine, and the ephedrine power of attorney and bank certificate are also required, all of which need to be stamped with the official seal.