Pharmaceutical Legislation and Administration - Chemistry of Cosmetics Products

The legislative part of the course aims to provide the knowledge of national and international legislation governing the private and public pharmaceutical service.

The part of the pharmaceutical administration is intended to prepare the student to the practical management (regulatory and economic) of the pharmacy.

The part of chemistry of cosmetic products aims to make the students gain the basic knowledge of the physico-chemical, technological and functional properties of the main classes of cosmetic products; to provid. In addition, the course provides the students with the basic notions of legislation and marketing of cosmetic products.The theoretical knowledge will be integrated with laboratory activities concerning the main formulations addressed in the course.

Pharmaceutical legislation and Administration: frontal lessons. Should teaching be carried out in mixed mode or remotely, it may be necessary to introduce changes with respect to previous statements, in line with the programme planned and outlined in the syllabus.

Chemistry of Cosmetic Products: frontal lessons and practical laboratory. Should teaching be carried out in mixed mode or remotely, it may be necessary to introduce changes with respect to previous statements, in line with the programme planned and outlined in the syllabus.

Information for students with disabilities and / or SLD

To guarantee equal opportunities and in compliance with the laws in force, interested students can ask for a personal interview in order to plan any compensatory and / or dispensatory measures, based on the teaching objectives and specifications needs. It is also possible to contact the CInAP contact person (Center for Active and Participatory Integration - Services for Disabilities and / or SLD) of the Department of Drug and Health Sciences.

Attendance of the course is mandatory.

It is gained attending at least 70% of the

lessons.

PROGRAM

PHARMACEUTICAL LEGISLATION

National and International Health Organization - O.M.S., EMA, F.I.P. National Health Service - Law 833/78 and  subsequent modifications. Organs of the State, the Region and responsibilities of the Local Health Units. Italian Drug Agency (AIFA). Convention for the delivery of pharmaceutical care. The pharmacist in A.S.L. and hospitals.

Practice of health professions and arts, and activities subject to health surveillance - Orders and Provincial Colleges. Requirements, Registration in the professional register. Disciplinary power of the Order. Professional ethics. Regional Federations, National Federation (F.O.F.I.), National Institute of Security and Support Pharmacists (E.N.P.A.F.). Private pharmacy and conventional relationship with SSN. National collective agreement for the regulation D.P.R. July 8, 1998.

The exercise of the profession of pharmacist - Practice of pharmacy. Shipping recipes. Official Italian Pharmacopoeia XII ed. National Rates of medicines. Holding and shipping of poisonous substances. Mandatory equipment in pharmacy (substances, equipment, registers and documents).

Discipline of the inspections -Definition and general characteristics of the inspection. Types of inspections (preventive, ordinary and extraordinary). Inspection of A.S.P. Self-inspection of the pharmacy.

Professional skills and responsabilities of the pharmacist - Criminal, administrative, civil and disciplinary responsabilities. The sanzionatory system.

Regulations on the Pharmaceutical Service - Public and private pharmacies. Classification of private pharmacies (urban and rural). Territorial pharmacy regulatory (Pianta Organica). Alternative systems (branch pharmacy, interim management, dispensary).

Assignments of pharmaceutical sites that have become vacant or newly created (competitions, duties of successor pharmacist in the vacant pharmacy).

The management of the Pharmacy -  Management of the private pharmacy. Corporate management. Informal and formal replacing of the owner.

Regulation on the manufacturing and trade for medicinal products for human use - Administrative classification of medicinal products for human use. Industrial medicinal products: AIC, pre-packaged drugs, industrial products other than the product. Generics. The pharmacovigilance activities. 

Dispensation to the public of medicinal products for human use - System of dispensing medicinal products to the public: repeatable prescription (RR), non-repeatable (RNR), limitative (RL), ministerial tracing prescription (RMR). Medicines obtained without a prescription: OTC (Over the Counter) and SP.

Rules relating to the promotion and the presentation of medicines - Generality, scientific information to health professionals, publicity to the general public. The presentation of the medicinal product: package insert and label.

Regulations concerning narcotic and psychotropic drugs - D.P.R. 309/90 and subsequent modifications (Testo Unico of the laws on the regulation of drugs and psychotropic substances). Law 8 February 2001, n. 12 (Regulations to facilitate the use of analgesic opioids in pain therapy). Law of 21 February 2006, no. 49.

Medicinal products for veterinary use

Administrative classification. System of dispensation.

Rules concerning the Medical and Surgical Products, Medical devices and Sanitary Stuff. Rules concerning the field of homeopathic, dietary and herbal remedies

PHARMACEUTICAL ADMINISTRATION

Computerized management of the pharmacy

The merchandising in pharmacy- Definition, objectives and functions.

The stock management - Stocks, turnover rate, returns to vendors, monitoring deadlines, ASSINDE expired or not.

The economic management of the pharmacy.

CHEMISTRY OF COSMETIC PRODUCTS WITH PRACTICAL EXERCISES

Course syllabus

Marketing and legislation of cosmetic products

Definition of the cosmetic products according to the European legislation; evaluation of the safety and the effectiveness of cosmetic products; the Italian and the European cosmetic markets; cosmetic product advertisement.

The skin and its appendages

Structure and physiological functions of the skin and its appendages (sweat and sebaceous glands, hair, nails). The hydro-lipidic film. The natural moisturizing factor (NMF).  Biosynthesis of melanin: mechanisms and functions. Percutaneous absorption of cosmetic ingredients.

Cosmetic raw materials

INCI and CTFA nomenclatures.

Oils, fats and waxes: characteristics and uses. Surfactants and emulsifiers: definitions, classifications, characteristics and uses.  Rheological additives: characteristics and uses. Cosmetic preservatives and antioxidants. Colors and pigments. Perfumes and fragrances. Active compounds used in the cosmetic fields.

Basic cosmetic formulations

Characteristics, preparations and uses of cosmetic monophasic systems: aqueous and hydroalcoholic solutions; oil solutions; surfactant-based systems; aqueous and oil gels; powders; molded anhydrous lipids.

Characteristics, preparations and uses of cosmetic biphasic systems: O/W emulsions, W/O emulsions; anhydrous and hydrated pastes.

Characteristics, preparations and uses of cosmetic colloidal systems: liposomes, cyclodextrins, nanoparticles.

Personal care products

Skin care products; bath products; hair care products; sunscreen products; deodorants and antiperspirants; dentifrices.

Make-up products

Properties of the main make-up products.

PHARMACEUTICAL LEGISLATION AND ADMINISTRATION

M. Marchetti, P. Minghetti - Legislazione Farmaceutica - Ambrosiana 9°Ed.

G. Barberini, L. Casettari - Legislazione farmaceutica nella pratica professionale - Piccin - Nuova Libraria 2021

N. Loliscio  - La farmacia. Un campo minato. Il manuale del farmacista. Guida pratica 2022 - Esculapio

R. Giampietri - Farmacia @ Marketing -Editoriale Giornalidea 1992.

Giorgio Lorenzo Colombo - Economia e gestione della farmacia - Casa Editrice Selecta Medica 2002.

Massimiliano du Ban - La qualità in Farmacia - Editoriale Giornalidea 1999.

F.U.I. Edizione XII

CHEMISTRY OF COSMETIC PRODUCTS

1. Proserpio G., Le basi della Cosmetologia, SEPEM, 1992.

2. Proserpio G., Chimica e Tecnica Cosmetica, Sinerga, 1993.

3. Proserpio, Ambreck, Ceoloni, Il prontuario del cosmetologo, Tecniche Nuove, 2001.

Cosmetic Product Chemistry exam: written exam consisting of five open questions and three questions on chemical structure and nomenclature of cosmetic active ingredients. The exam lasts 1 hour.

Pharmaceutical Legislation and Administration

• Merchandising
• The territorial distribution of pharmacies and its revision
• D.P.R. 309/90 and subsequent amendments 
• Formal and informal substitution of the pharmacy owner
• Veterinary prescription

Chemistry of Cosmetic Products

• Suncreen agents
• Cosmetic preservatives
• Structure and functions of the skin
• Anionic surfactants: properties and uses in cosmetics
• Emulsions: definition, identification and preparation