A pharmacy sells inferior drugs without fines of 100,000

A pharmacy had no intention of selling counterfeit and inferior drugs and was exempted from fines of 100,000

Selling inferior drugs, pharmacies are exempt from fines of 100,000

Recently, Raoyang County, Hengshui City, Hebei Province issued a notice stating that a pharmacy in the county was suspected of selling inferior drugs, but it fulfilled its statutory responsibility.

According to the notice, on November 4, 2019, the pharmacy purchased 10 boxes of Guanxinjing capsules of a certain brand (after inspection, the drug did not meet the regulations) and sold them all, the value of which was 200 yuan, and the illegal income was 55 yuan

The supervisory department believes that the pharmacy violated relevant regulations and was suspected of selling inferior drugs and should be given an administrative fine of 100,000 yuan

However, given that the pharmacy fulfilled its statutory responsibilities, it did not intentionally cause drug quality problems, and there is evidence that it is inevitable that the pharmacy sells inferior drugs

The relevant evidence is as follows:

A copy of the relevant drug purchase receipts from the pharmacy, certifying the purchase channels and quantity of the batch of drugs involved in Guanxinjing Capsules

One copy of the supplier’s qualifications and purchase inspection records for the batch of drugs involved in Guanxinjing Capsules, certifying the implementation of the drugstore’s purchase channels and purchase inspection record system for the drugs involved in the case

The inspection report of the Hengshui Comprehensive Inspection and Testing Center proves that the "loading difference" in the inspection items of the batch of drugs involved in Guanxinjing capsules sold by the pharmacy does not meet the requirements

One copy of the inspection report of the drug company involved in the case, proving that the manufacturer has passed the inspection results of the batch of drugs involved

Based on the above facts, in accordance with the relevant penal provisions of the "Regulations on the Implementation of the Drug Administration Law", the regulatory authorities impose the following penalties on pharmacies:

Ordered to correct relevant illegal acts, and confiscated 55 yuan of illegal gains

Exempt from other administrative penalties

These illegal acts in pharmacies are exempt from punishment

A review found that non-subjective sales of counterfeit and inferior medicines by pharmacies often occur.

1.

Penalties: confiscation of illegal income; the minimum administrative fine of 1.

Circumstances of exemption from punishment: it does not violate the relevant provisions of the "Drug Administration Law" and the "Implementation Regulations of the Drug Administration Law", and there is sufficient evidence to prove that it has no intention of selling, and other administrative penalties are exempted

2.

Punishment: order to make corrections and give a warning; if the circumstances are serious, the drug registration certificate shall be revoked
.

Penalty-free circumstances: 1.
No subjective intention, does not affect the safety and effectiveness of the medication, will not mislead consumers, and make corrections in time, without causing harmful consequences; 2.
The first violation of the law, the harmful consequences are minor and the consequences are corrected in time
.

3.
Adverse drug reactions, not reported as required

Penalties: order to make corrections within a time limit and give a warning; if no corrections are made within the time limit, order to suspend production and business for rectification, and impose a fine of 50,000 to 500,000
.

Penalty-free circumstances: 1.
The circumstances are minor and corrected in time, and no harmful consequences have been caused; 2.
The first violation of the law and the harmful consequences are minor and corrected in time
.

4.
Use of persons who are prohibited from engaging in medical device business activities

Penalties: order to make corrections and give a warning; if they refuse to make corrections, they will be ordered to suspend production and business until the license is revoked
.

Penalty-free circumstances: 1.
The circumstances are minor and corrected in time, and no harmful consequences have been caused; 2.
The first violation of the law and the harmful consequences are minor and corrected in time
.

5.
Dealing in cosmetics and employing personnel who are not allowed to engage in cosmetics business activities

Penalties: order to make corrections and give warnings; if they refuse to make corrections, they will be ordered to suspend production and business until the cosmetics permit and the qualification certificate of the inspection agency are revoked
.

Penalty-free circumstances: 1.
The circumstances are minor and corrected in time, and no harmful consequences have been caused; 2.
The first violation of the law and the harmful consequences are minor and corrected in time
.

Other illegal acts can also be exempted from punishment

Regarding the contents of the above list, how to judge whether the consequences of illegal actions by pharmacies are minor?

The Hainan Drug Administration stated that for the “exemption list” in the area of ​​drug supervision in the province, law enforcement and case handling agencies should make comprehensive judgments based on the facts and evidence of the case.
The list can be used as the content of administrative penalty judgments and should not be directly used as the legal basis for administrative penalty.

.

If the illegal act of the pharmacy is on the list, but at the same time violates other clauses, it can be punished in accordance with the relevant regulations
.

The Hainan Drug Administration also mentioned that for violations not on the list, the facts, nature, circumstances, and degree of social harm of the violations should also be considered comprehensively, combined with relevant laws and regulations, to determine whether they can be exempted from punishment or applied for mitigation
.