Compounding Pharmacy

Code:

MI075177

Acronym:

FARMAG

Keywords
Classification	Keyword
OFICIAL	Technological Sciences

Instance: 2025/2026 - 2S

Active?	Yes
Responsible unit:	Pharmaceutical Technology Laboratory
Course/CS Responsible:	MSc in Pharmaceutical Sciences

Cycles of Study/Courses

Acronym	No. of Students	Study Plan	Curricular Years	Credits UCN	Credits ECTS	Contact hours	Total Time
MICF	9	MICF - Transition Study Plan 2023/24 - 2024/25 - 2025/26	4	-	3	26	81

Teaching language

Portuguese

Objectives

This Curricular Unit aims to provide students with advanced education on technical, scientific, and regulatory fields related to Compounded Medicines, with the primary objective of ensuring the acquisition of solid scientific foundations and the development of professional skills essential for compounding, dispensing, and counselling on these medicines, both in Community Pharmacy and Hospital Pharmacy.

Learning outcomes and competences

Learning outcomes

At the end, the student should be able to:

1) master the technical, scientific and regulatory aspects inherent to compounded medicines;

2) to properly compound both non-sterile and sterile medicines in their different pharmaceutical dosage forms, including parenteral nutrition admixtures and cytotoxic medicines, adopting appropriate technical procedures in each specific context to ensure the obtention of medicines that meet standards of quality, safety and efficacy, in full compliance with the applicable regulatory requirements;

3) to properly counsel and dispense compounded medicines, taking into account the nature of the products and the pathophysiological profile of the patients.

Skills

At the end, the student should have developed the professional skills essential for compounding, dispensing and counselling on the different types of compounded medicines, both in Community Pharmacy and Hospital Pharmacy.

Working method

Presencial

Pre-requirements (prior knowledge) and co-requirements (common knowledge)

The syllabus of the Curricular Unit was designed on the assumption that students have knowledge on Anatomy, Histology, Physiology, Biochemistry, Pharmaceutical Chemistry, Microbiology, Pharmacology, Immunology, Pharmaceutical Technology, Biopharmacy and Pharmacokinetics, Pathophysiology and Pharmacotherapy.

Program

1)

Definitions and concepts in Compounding Pharmacy.

The importance of contemporary compounding in the therapy. Reasons for preparing medicines on a small scale at the community and hospital pharmacies.

Compounding medicines: part of the Pharmacy Practice. Roles and responsibilities of pharmacists.

Pharmaceutical compounding and patient-centered healthcare. Individualizing therapy: personalization of medicines composition and dosage forms to the pathophysiological profile of the patient. Medical areas in which prescribing compounded medicines is more frequent.

Pharmaceutical Compounding and Pharmaceutical Care. The concept of Clinical Compounding: clinical dispensing compounded medications. Pharmacotherapeutic follow-up of patients. Pharmacovigilance.

Emerging areas in the field of Pharmaceutical Compounding. Impact of Pharmacogenomics and Personalized Medicine. 3D printing of medicines.

2)

Bibliographic sources supporting the preparation and quality control of compounded medicines. Galenic formularies and their importance. The Portuguese Galenic Formulary. The United Sates Pharmacopoeia. The European Pharmacopoeia. Monographs of compounded medicines, standards, recommendations and information.

3)

Compounding non-sterile and sterile medicines.

Quality of raw materials, packaging materials and finished products. Quality assurance. Quality manual. Standard operating procedures.

Calculations.

Pharmaceutical aspects related to small scale preparation of the different dosage forms.

Compounding cytotoxic medicines.

Compounding total and partial parenteral nutrition.

Packaging and labeling of compounded medicines.

Pharmaceutical incompatibilities.

Stability and beyond-use dates of compounded medicines.

Study of specific formulas of compounded medications and discuss of related pharmacotherapeutic and pharmaceutical aspects.

Fractionation and repackaging industrialized medicines.

4)

Regulatory issues related to Pharmacy Compounding.

Practical aspects of the legislation applicable to compounded medicines: scope, Officinal Preparations and Magistral Formulas, responsibilities of physicians and pharmacists, raw materials authorized, use of industrialized medicines, preparation of compounded medicines in advance, hiring by hospitals the preparation of compounded medications, supply of raw materials.

Good Compounding Practices in Community and Hospital Pharmacies: definitions and concepts, standards relating to Personnel, Facilities and Equipment, Documentation, Raw Materials, Packaging Materials, Compounding, Quality Control, Labeling.

Calculating the price of compounded medicines.

General system of State reimbursement of the price of compounded medicines.

Elimination of outdated raw materials.

Mandatory literature

Barbosa Carlos Maurício; Estudo comparativo de formulários galénicos. ISBN: 972-98579-3-8
Barbosa, C.M. (Coord.); Formulário Galénico Português, CETMED - ANF, 2001
Barbosa, C.M. (Coord.); Formulário Galénico Português, CETMED - ANF, 2005
Allen Loyd V.; The^art, science, and technology of pharmaceutical compounding
US Pharmacopeial Convention USP; USP Pharmacists' Pharmacopeia 2008-2009, USP UNITED STATES PHARMACOPEIAL CONV.
DR; Legislação aplicável
IJPC; International Journal of Pharmaceutical Compouding
Pinto, Susana; Desenvolvimento Galénico de um Veículo para a Preparação de Suspensões de Benzoato de Metronidazol, Faculdade de Farmácia da Univ. Porto, 2006
Soares, MA (Coord.); Medicamentos Não Prescritos - Aconselhamento Farmacêutico, Farm. Portuguesa, 2002 (Barbosa, C.M. "Aspectos Farmacêuticos da Terapêutica Dermatológica", Chap. 34)
Artigos científicos de carácter especializado; entregues pelo Professor

Complementary Bibliography

Trissel, L.A. ; Trissel’s Stability of Compounded Formulations, 5th Edition, American Pharmacists Association, 2012. ISBN: 9781582121673
Nahata, M.C.; and Pai, V.B.; Pediatric Drug Formulations, 6th Ed., Harvey Whitney Books, 2011. ISBN: 978-0-929375-32-8

Teaching methods and learning activities

Theoretical classes: 2 x 50 minutes / week.

Practical / Laboratory classes / Study Visits: 2 hours / week.

In addition to the scheduled class times, the Professor is available to meet with students at previously agreed times.

keywords

Health sciences > Pharmacological sciences
Health sciences > Pharmacological sciences > Pharmacy
Technological sciences > Technology > Pharmaceutical technology
Technological sciences

Evaluation Type

Distributed evaluation with final exam

Assessment Components

designation	Weight (%)
Exame	50,00
Trabalho de campo	50,00
Total:	100,00

Amount of time allocated to each course unit

designation	Time (hours)
Estudo autónomo	48,00
Frequência das aulas	32,00
Trabalho de campo	20,00
Total:	100,00

Eligibility for exams

The attendance to the theoretical classes and practical/laboratory classes is a prerequisite for obtaining frequency and, therefore, for the admission of the students to the final exam of the Unit.

According to the FFUP Student Assessment Standards, the student fulfils the attendance requirements if the number of absences to theoretical classes and practical/laboratory classes not exceed 25% of scheduled classes.

Calculation formula of final grade

COMPONENTS OF THE EVALUATION:

DISTRIBUTED COMPONENT (0-20) – valued on the basis of the works presented by students along the term (50%);

FINAL EXAM (0-20) – written exam covering all theoretical and practical subjects (50%).

 

FINAL GRADE CALCULATION (0-20):

Final Exam Mark x 0.5   +   Distributed Component Mark x 0.5

Students with a final grade equal to or higher than 9.5 (0-20) are considered approved.

Students with a final grade less than 9.5 (0-20) are considered failed.

Special assessment (TE, DA, ...)

In accordance with the FFUP Student Assessment Standards and the applicable legislation.

Classification improvement

Students can improve their final exam mark, in accordance with the FFUP Student Assessment Standards.

The mark obtained in the distributed component is not subject to improvement.

Observations

Given the scientific and also professional character intended for this Curricular Unit, 1/3 of the classes are held at the Pharmacy Department of the Hospital de São João (Oporto), aiming to promote the contact of students with the professional reality and allow the realization of practical work in real conditions, namely in the areas of compounding cytotoxic drugs, eye drops, intravitreal injectables, parenteral nutrition, paediatric medicines, etc.

 

Acceptance conditions for mobility students

Only students who understand Portuguese are accepted in the Unit, provided that there are places not filled by students regularly attending the MICF at FFUP.