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

Module LEGISLAZIONE FARMACEUTICA E LABORATORIO GALENICO

1. Knowledge and understanding
The student will be able to identify and define the main regulations governing the professional activities of pharmacists and to understand the principles and procedures underlying the preparation of the main types of compounded pharmaceutical formulations.

2. Applying knowledge and understanding
At the end of the course, the student will be able to apply fundamental knowledge of pharmaceutical legislation and correctly prepare the main types of compounded pharmaceutical preparations, in accordance with current regulations and established procedures.

3. Making judgements
The student will be able to critically evaluate the application of regulations governing the professional activities of pharmacists and to identify the most appropriate formulation strategies according to the characteristics and intended use of compounded pharmaceutical preparations.

4. Communication skills
The student will be able to clearly and appropriately present the results of their studies and discuss the knowledge and skills acquired, using appropriate technical and scientific terminology, including in the context of an examination or discussion with an examination board.

5. Learning skills
The student will develop the ability to independently retrieve relevant bibliographic material and scientific sources and to update their knowledge and skills through the consultation of specialised databases and relevant scientific literature.

Lectures and individual laboratory practical sessions. The course programme also includes dedicated seminar sessions. Should the course be delivered in a blended or fully remote format, the necessary adjustments may be made to the arrangements described above in order to ensure compliance with the programme outlined in the syllabus.

Students may use AI as a tool to support their studies, in compliance with applicable legislation, including regulations concerning copyright and the use of intellectual works, as described in Section 5.1 of the guidelines (https://www.unict.it/it/ateneo/cidia-centro-l%E2%80%99informatica-la-digitalizzazione-e-l%E2%80%99intelligenza-artificiale).

No particular prerequisites are required.

Attendance is mandatory, as established by the Academic Regulations of the Degree Programme. Absences are permitted for no more than 30% of the total number of teaching hours, taking into account all forms of course delivery.

Further information is available in the Academic Regulations of the Degree Programme.

Information for Students with Disabilities and/or Specific Learning Disorders (SLD)

To ensure equal opportunities and in compliance with current legislation, students concerned may request a personal meeting in order to plan any appropriate compensatory and/or exemption measures, taking into account the learning objectives and their specific needs.

Students may also contact the CInAP (Centre for Active and Participatory Integration – Disability and/or Specific Learning Disorders Services) faculty contact person for our Department, Prof. Santina Chiechio.

Pharmaceutical Legislation: Healthcare professions and the practice of pharmacy; Administrative classification of pharmacies and the territorial distribution system; Organization of community pharmacies and other establishments authorized to dispense medicinal products and practice pharmacy; Classification of medicinal products (Legislative Decree 219/2006); The authorization system for the manufacture and marketing of medicinal products; Regulations concerning narcotic and psychotropic substances: prescriptions for narcotic drugs, pharmacists’ obligations regarding purchase, storage and disposal procedures, formal requirements for completing and maintaining documentation, management of the incoming/outgoing register and purchase vouchers; Regulations concerning doping substances: pharmacists’ obligations; Regulations concerning veterinary medicinal products: veterinary prescriptions and electronic veterinary prescriptions, traceability and pharmacovigilance of veterinary medicinal products, and animal health and welfare feed; Regulations governing the marketing of homeopathic medicinal products, herbal medicinal products, food supplements, medical devices, medical-surgical products and healthcare items.

Compounding Laboratory: Management of medicinal products for human use and regulations governing the dispensing of medicinal products to the public; Italian Official Pharmacopoeia; Management of poisons: storage procedures and pharmacists’ obligations; Extemporaneous magistral and officinal preparations: preparation and quality control of personalized medicinal products in the pharmacy laboratory, based on medical prescriptions or Pharmacopoeias; Pricing and application of Good Preparation Practices.

The following seminar activities will also be offered:

• Oxygen and oxygen therapy: storage and instructions on methods of administration.
• Vaccines: Recommended vaccinations and vaccination schedules; pre-vaccination triage; preparation and administration of vaccines in pharmacies; management of emergencies and adverse reactions following vaccination.
• Digital healthcare and medicinal product traceability: information flows and the New Health Information System (NSIS); Electronic Health Record (EHR) and pharmaceutical dossier; databases; unique identification of medicinal product packages; monitoring of services provided through direct distribution and distribution on behalf of the National Health Service.
• Patient relations: patient counseling, provision of accurate information, health education, promotion of healthy lifestyles; screening and disease prevention campaigns, and vaccination prophylaxis.

According to the University Educational Regulations (RDA), Article 12 – University Educational Credits (CFU), each credit corresponds to a standard workload of 25 hours of overall student commitment, which may include:

a) 7 hours devoted to lectures or equivalent teaching activities, with the remaining hours dedicated to individual study;

b) at least 12 and no more than 15 hours devoted to classroom exercises or equivalent supervised activities (laboratory work), with the remaining hours dedicated to individual study and personal reworking of the course content.

1. P. MINGHETTI - Legislazione Farmaceutica – undicesima edizione - Casa Editrice Ambrosiana
2. F.U.I. XII  Ed.
3. LOLISCIO N. La farmacia un campo minato - Il manuale del farmacista - Guida pratica 2025 - Società Editrice Esculapio

Learning is assessed through an oral examination and an individual practical laboratory examination.

The oral examination generally consists of three questions focusing on topics related to pharmaceutical legislation. The practical examination consists of a combined assessment involving the preparation of a pharmaceutical formulation followed by its calculation and pricing according to the applicable pharmaceutical tariff.

The oral examination lasts approximately 30 minutes, while the practical examination lasts approximately 4 hours.

The final examination grade is based on equally weighted assessment criteria, consistent with the expected learning outcomes described according to the Dublin Descriptors.

The final grade therefore takes into account the following aspects:

Quality of knowledge, skills and competences demonstrated:

• appropriateness, accuracy and consistency of knowledge;
• appropriateness, accuracy and consistency of skills;
• appropriateness, accuracy and consistency of competences.

Presentation and communication skills:

• clarity and effectiveness of expression;
• appropriate use of discipline-specific terminology;
• logical reasoning and coherence in linking the different elements of the subject matter;
• ability to connect different topics, identify common elements and develop a coherent overall framework, with particular attention to the structure, organisation and logical connections within the presentation;
• ability to summarise information, also through the use of discipline-specific symbols and graphical representation of concepts and notions, such as formulas, diagrams and equations.

Interpersonal skills:

• willingness to engage in discussion and interaction with the lecturer during the oral examination.

Personal skills:

• critical thinking;
• self-assessment skills;
• problem-solving skills;
• decision-making skills.

Grading criteria

Based on the criteria described above, the assessment may be expressed as follows:

Fail: The student does not demonstrate the minimum level of knowledge required of the main topics covered in the course. Their ability to use discipline-specific terminology is very limited or absent, and they are unable to independently apply the knowledge acquired.

18–21: The student demonstrates a minimum level of knowledge of pharmaceutical legislation and a limited ability to integrate and critically analyse the situations presented. The student is able to present the topics with sufficient clarity, although command of discipline-specific terminology is limited.

22–25: The student demonstrates a fair knowledge of pharmaceutical legislation, although mainly limited to the core topics. They are able to integrate and critically analyse the situations presented, although not always in a fully coherent manner, and present the topics with reasonable clarity and a fair command of discipline-specific terminology.

26–28: The student demonstrates good knowledge of pharmaceutical legislation and is able to integrate and critically analyse the situations presented in a coherent and logical manner. They are able to solve relatively complex problems with a good degree of autonomy and present the topics clearly, using appropriate discipline-specific terminology.

29–30 cum laude: The student demonstrates an in-depth knowledge of pharmaceutical legislation and is able to promptly and accurately integrate and critically analyse the situations presented, independently solving problems, including those of a high degree of complexity. The student demonstrates excellent communication skills and an excellent command of discipline-specific terminology.

The assessment of learning may also be conducted remotely, where circumstances so require.

Information for students with disabilities and/or Specific Learning Disorders (SLD)

In order to ensure equal opportunities and in compliance with current legislation, students concerned may request an individual consultation to discuss and plan any appropriate compensatory and/or dispensatory measures, according to the learning objectives and their specific needs.

Students may contact Prof. Santina Chiechio (santina.chiechio@unict.it), also in her capacity as the CInAP (Centro per l’Inclusione Attiva e Partecipata – Services for Students with Disabilities and/or Specific Learning Disorders) contact person for the Department of Drug and Health Sciences.

Further information is available on the CInAP website and through the Department's designated contact person.

Examination dates

Examination dates are published on the Degree Programme website:

https://www.dsf.unict.it/it/corsi/lm-13_ctf/calendario-esami

1. Define the different types of medical prescription and explain for which category of drugs it is mandatory

2. The administrative classification of medicines according to law 219/2006 

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

4. The public pharmacy and the private pharmacy: what are the differences in administrative and management terms?

5. What are the characteristics of a dossier for the AIC request?