Quality aspects for individualized compounded medications in different US and EU settings.

Quality aspects for individualized compounded medications in different US and EU settings.

Pharmacy compounding or the preparation of individualized medications is becoming more relevant now than ever when it comes to satisfying the unique needs of patients who otherwise would not have access to the required medication, due to the lack of tailor made drug products, shortages of the market, some treatment requirements, etc.

The United States Pharmacopoeia (USP) is a independent, scientific, non-profit organization whose objective is to develop public standards in order to establish the identity, concentration, quality and purity of medicines, setting the bar for scientific rigor.

Compounding pharmacists have basic references and accurate guidelines in the USP Reference Standards that help ensure the quality of the compounding preparations. It establishes the correct procedures, methods and practices for the formulations as well as Drug Monographs for compounding formulations for which there is no commercially available drug product.

In this conference, the guidelines and USP chapters that are of paramount importance for establishing good practices in compounding, as well as its importance and practical approach in community Pharmacy are disussed.

In Spain, GMPs in compounding were a turning point thanks to which the concept of Quality in the elaboration of individualized compounded medications was definitively installed since 2001.

This implies the need to include in university study plans the legal, administrative and assistance aspects that surround the compounding practices beyond the mere training in pharmaceutical technology.

In Europe, compounded medications are legislated, but coexist in very different scenarios. In countries such as Spain, they have always been widely used and nowadays their importance is recognized, while in other countries their presence is becoming smaller.

It is particularly important for those patients that require a continuty in treatment based on the administration of compounded medications after being discharged from the hospital.

The need to maintain the criteria at hospital and outpatient level with the consequent communication between pharmacists of both settings is evident. It is necessary to carry out an analysis of the circumstances, both technical and legal, that encompass the continuation and accomplishement of the patient’s treatments.
Besides, communication with physicians is essential, along with the training they receive on the prescription of compounded medications. These aspects are to be highlighted because of its importance and its little presence in their education curriculum.


Pharmacy compounding
Compounded medications
Pharmaceutical formulations
Individualized medications
Reference Standards


Conference 1

Title: United States Pharmacopoeia (USP) Reference Standards and its implementation in Pharmaceutical Compounding both in US and internationally

Speaker: Marisol López

Institution: University of Puerto Rico, School of Pharmacy; Faculty American College of Apot

E-mail: mlopezrx@gmail.com

Conference 2

Title: Quality for compounding activities in Community Pharmacy in Spain and other EU countries.

Speaker: Rafael Puerto Cano

Institution: LaSEMI – President (Spanish Society of Individualized Drugs)

E-mail: r.puerto@cofm.es

Conference 3

Title: Hospitalized patient versus discharged patient. Relevant aspects in individualized

Speaker: Aquilino Corral Aragón

Institution: Community Pharmacist. Compounding expert..

E-mail: formulacion@farmaciamagistral.com


Name: Rafael Puerto Cano / Luis Marcos Nogales

Institution: LaSEMI – President (Spanish Society of Individualized Drugs)

E-mail:  r.puerto@cofm.es