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(영문) 대법원 2006. 1. 26. 선고 2005도7505 판결

[약사법위반][공2006.3.1.(245),372]

Main Issues

Where a pharmacist who holds a license for preparation of herb drugs prepares herb drugs, whether the pharmacist is obligated to enter and preserve the preparation records prescribed in Article 25-2 of the Pharmaceutical Affairs Act (negative)

Summary of Judgment

Considering the legislative background of Article 25-2 of the Pharmaceutical Affairs Act that imposes an obligation on a pharmacist to enter and keep a preparation record book, equity between a pharmacist and a pharmacist who has a license for preparation of herb drugs, Article 25-2 of the Pharmaceutical Affairs Act on entry and preservation of a pharmacist’s preparation record book shall not apply where a pharmacist who has a license for preparation of herb drugs prepares herb drugs.

[Reference Provisions]

Article 25-2 (1) and Article 77 subparagraph 1 of the Pharmaceutical Affairs Act

Escopics

Defendant

upper and high-ranking persons

Prosecutor

Judgment of the lower court

Daejeon District Court Decision 2005No1137 Decided September 16, 2005

Text

The appeal is dismissed.

Reasons

The grounds of appeal are examined.

1. The court below maintained the first instance court's decision that Article 25-2 (1) of the Pharmaceutical Affairs Act does not apply to the case where a pharmacist who prepared a drug at a pharmacy prepares the drug at the pharmacy, and entered the preparation records in which the prescribed matters are stated and preserved, and if the pharmacist violates this provision, he shall be punished pursuant to Article 77 (1) of the Pharmaceutical Affairs Act. However, the court below rejected the prosecutor's appeal by maintaining the first instance court's decision that the above provision

2. As stated in the Pharmaceutical Affairs Act, "drugs" are defined as "those listed in the Korean Pharmacopoeia, which are used for the purpose of diagnosis, treatment, mitigation, treatment or prevention of diseases of human beings or animals, which are not appliances, machinery or equipment, and which are not appliances, machinery or equipment (excluding cosmetics)" (Article 2 (4)), and "her herb drugs" are defined as "one-way extraction from animals, plants or minerals, which are primarily built, cut or dried in their original form" (Article 2 (5). 2 of the Pharmaceutical Affairs Act is defined as "one-way medicine" (Article 2 (4) of the same Act, and whose concept is defined as "one-way medicine" and "six-way medicine" shall not be defined as "one-way medicine" and "two-way pharmaceutical affairs" shall be defined as "two-eight-four or more pharmaceutical affairs (excluding pharmaceutical affairs related to pharmaceutical affairs for the purpose of diagnosis, treatment, treatment or prevention of human beings or animals" (Article 2 (2) of the Pharmaceutical Affairs Act), and thus, it shall be defined as "one-half or more pharmaceutical affairs related to pharmaceutical affairs," (excluding pharmaceutical affairs related to be defined as "two-half drugs".

However, considering that Article 25-2 of the Pharmaceutical Affairs Act imposes an obligation to enter and preserve a preparation book on a pharmacist, it is necessary to prepare grounds for disclosing the responsibility when a pharmaceutical accident occurs in the process of amendment of the Pharmaceutical Affairs Act (Act No. 651), which is enforced on August 14, 2001, to fill out and preserve the preparation of medicine (Article 21 of the Medical Service Act) and the issuance of prescription (Article 18-2 of the Medical Service Act) that are newly established in response to the assertion that it is necessary for a pharmacist to fill out the preparation and preservation of herb drugs, and that the same provision is not applied to the preparation and preservation of herb drugs that are established in accordance with the premise that the issuance of prescription for herb pharmacists is not enforced due to such legislation, and that the above provision of the Pharmaceutical Affairs Act, which is a pharmacist or herb pharmacist, is not applicable to the pharmaceutical pharmacist's license newly established in accordance with the above provision of the Pharmaceutical Affairs Act for the purpose of protecting the herb pharmacist's qualifications as a pharmacist or herb pharmacist's newly established or amended provision of the Pharmaceutical Act.

The court below is just in its decision that the portion of the pharmaceutical medicine under the Pharmaceutical Affairs Act is not included in the pharmaceutical product, but it is not appropriate to determine that Article 25-2 of the Pharmaceutical Affairs Act does not apply where a pharmacist who holds a herb pharmacist prepares herb drugs. Accordingly, it is not erroneous in the misapprehension of legal principles that affected the conclusion of the judgment, as otherwise

3. Therefore, the appeal is dismissed. It is so decided as per Disposition by the assent of all participating Justices on the bench.

Justices Yang Sung-tae (Presiding Justice)