Pharmaceutical Affairs Act Violation Assistance Case | Sale of Medicine by a Non-Pharmacist, No Charge on the Pharmaceutical Affairs Act Violation

The case began when a customer visited the pharmacy complaining of neck pain.

At the time, the husband, who was the pharmacist, selected the medicine in the dispensary, then signaled with his eyes for his wife, the pharmacy clerk at the counter, to hand the medicine over.

The wife delivered it to the customer and completed the payment. This scene was filmed by a third party, and a report was filed stating that “a non-pharmacist directly sold the medicine.”

The video did not capture the specific scene of the pharmacist’s instruction, so from the outside it could appear as if the employee had sold the medicine on her own while the pharmacist was away.

As a result, the investigative authorities could interpret the conduct as a “sale by a non-pharmacist,” and the client couple faced the risk of criminal punishment and an administrative disposition for violation of the Pharmaceutical Affairs Act.

The key issue in this case was whether it was an “independent sale by a non-pharmacist” or “an assisting act carried out under the pharmacist's supervision and instruction.”

Accordingly, from the outset the medical specialist attorney set the essence of the case as “whether there was instruction and supervision by the pharmacist” and focused on systematically collecting evidence to prove this.

To prove that, at the time of the incident, the pharmacist was in a position to attend to patients from the dispensary and supervise the entire process, the medical attorney submitted visual materials, including the pharmacy's internal layout, the distance between the dispensary and the counter, and a location from which the line of sight could be secured.

In addition, by confirming the fact and statements that the pharmacist was performing dispensing work while wearing a gown and name tag, the attorney dispelled the misunderstanding of an ‘absence of the pharmacist’.

In addition, by submitting records showing that the pharmacist conducted transactions with a pharmaceutical company before and after the time of the incident, the attorney objectively proved that the pharmacist did not leave the pharmacy during that time.

The medical attorney submitted an opinion stating that, in a situation where there was a specific instruction from the pharmacist and the pharmacist made the final decision to sell immediately thereafter, the act of a non-pharmacist simply handing over the medication and processing the payment does not constitute an ‘independent sale’ under the Pharmaceutical Affairs Act.

In particular, by submitting the pharmacy’s operating rules and internal manual as evidence, the attorney explained that the authority to select medication and decide whether to sell rests entirely with the pharmacist and that the employee is in a structure where she cannot make independent judgments.

Supreme Court, decided October 9, 1998, 98Do1967, summary of the decision

By citing the above Supreme Court precedent, the attorney emphasized the point that a sale carried out under the implied or presumed direction of a pharmacist may legally be regarded as a sale by the pharmacist.

The attorney also highlighted the point that the medicine in question fell within the category of general (over-the-counter) medicines that cannot cause serious harm to public health, thereby reducing its weight in the assessment of unlawfulness.

To highlight the point that the pharmacy had been operated for decades on the basis of trust with local residents, the firm submitted residents’ petitions and a joint signature, along with statements from many people that “the pharmacist was always present at the pharmacy.”

This served as important material for fully excluding the possibility of the pharmacist’s absence and non-involvement.

A violation of the Pharmaceutical Affairs Act is a serious matter that directly concerns the qualification to sell pharmaceuticals and public health, and even a small error or misunderstanding can lead to criminal punishment and an administrative disposition.

In particular, a situation that appears on its face to be a violation, such as a 'sale by a non-pharmacist,' carries a significant risk of an unfavorable determination if the evidence is insufficient, even where the pharmacist's instruction and supervision were in fact present.

Accordingly, an accurate organization of the facts, interpretation of the legal principles, and the securing of physical evidence to support them at an early stage are crucial.

At Daeryun LLC, a specialized attorney is promptly assigned from immediately after the incident occurs, and establishes and carries out a defense strategy suited to the client's situation.

Through this, we support the client in dispelling unnecessary misunderstandings and protecting their honor and business foundation as a pharmacist.

If you need professional assistance in connection with your case, please feel free to entrust your case at any time through a 🔗legal consultation appointment.