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Pharmaceutical Chemistry and Technology

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TECNOLOGIA FARMACEUTICA 1 - LEGISLAZIONE FARMACEUTICA E LABORATORIO GALENICO M - Z
Module LEGISLAZIONE FARMACEUTICA E LABORATORIO GALENICO

Academic Year 2025/2026 - Teacher: DEBORA CONCETTA SANTONOCITO

Expected Learning Outcomes

To transfer to the student the fundamental knowledge regarding pharmaceutical legislation and the socioeconomic aspects of medicine.

Course Structure

According to the RDA, Art. 12 - University Educational Credits (CFU), within the standard workload of 25 hours of total commitment for a student, corresponding to one credit, the following can be included:

a) 7 hours dedicated to lectures or equivalent educational activities and the remaining hours to individual study;

b) at least 12 and no more than 15 hours dedicated to classroom exercises or equivalent assisted activities (laboratories) and the remaining hours to study and personal revision.

Required Prerequisites

No specific prerequisites are required.

Attendance of Lessons

Compulsory attendance in accordance with the regulations of the Degree Program in CTF, as specified at the following link:
http://www.dsf.unict.it/corsi/lm-13_ctf/regolamento-didattico

Information for students with disabilities and/or learning disorders (DSA)

To ensure equal opportunities and in compliance with current legislation, interested students may request a personal meeting in order to plan any compensatory and/or dispensatory measures, based on the learning objectives and their specific needs.

Students may also contact the CInAP (Center for Active and Participatory Inclusion – Services for Students with Disabilities and/or Learning Disorders) representative of our Department, Prof. Santina Chiechio.

Detailed Course Content

Pharmaceutical Legislation: Health Professions and Pharmacy Practice; Administrative Classification of Pharmacies and the Territorial System; Organization of Public Pharmacies and Other Establishments Involved in Dispensing and Pharmacy Operations; Classification of Medicinal Products (Legislative Decree 219/2006); The Authorization System for the Production and Marketing of Medicines; Regulations on Narcotic and Psychotropic Substances: Prescription for Narcotics, Pharmacist’s Duties: Purchasing, Storing, Disposal Procedures, Documentation Requirements, Management of Entry-Exit Registers and Purchase Orders; Regulations on Doping Substances: Pharmacist's Duties; Regulations on Veterinary Medicinal Products: Veterinary Medical Prescription and Electronic Veterinary Prescription, Traceability and Pharmacovigilance of Veterinary Medicines, Animal Health Products; Regulations on the Marketing of Homeopathic Remedies, Herbal Medicines, Dietary Supplements, Medical Devices, Medical-Surgical Supplies, and Health Articles.

Pharmaceutical Laboratory: Management of Human Medicines and the Dispensing Discipline for Public Use of Medicinal Products; Official Italian Pharmacopoeia; Management of Poisons: Storage Methods and Pharmacist's Duties; Pharmaceutical Preparations (Magistral or Official Preparations): Preparation and Quality Control of Customized Medicines in the Pharmacy Laboratory, based on Medical Prescription or Pharmacopoeias; Pricing and Application of Good Preparation Practices.

Additionally, seminar activities will be carried out on:

  • Oxygen and Oxygen Therapy: Storage and Instructions for Administration Methods

  • Vaccines: Recommended Vaccinations and Vaccination Calendar; Pre-vaccination Triage; Preparation and Administration of Vaccines in Pharmacies; Management of Emergencies and Adverse Reactions to Vaccination

  • Digital Health and Drug Traceability: Information Flows and the New Health Information System (NSIS) - Electronic Health Record (EHR) and Pharmaceutical Dossier - Databases; Unique Identification of Medicine Packaging; Monitoring of Services Delivered in Direct Distribution and on Behalf of Others.

  • Relationship with the Citizen: Patient Counseling, Correct Information, Health Education, Promotion of Healthy Lifestyles; Screening Campaigns, Disease Prevention, and Vaccination Prophylaxis.

Learning Assessment

Learning Assessment Procedures

Oral examination. The exam dates are published on the Department website.

Examples of frequently asked questions and / or exercises

  1. Define the different types of medical prescriptions and indicate for which categories of medicines they are required.

  2. Explain the administrative classification of medicines under Legislative Decree 219/2006.

  3. Summarize the contents of the Tables of the Italian Official Pharmacopoeia.

  4. Compare public and private pharmacies in terms of administrative and managerial aspects.

  5. Describe the main components of a Marketing Authorization Application (MAA) dossier.