Radiopharmacy is defined as the application of pharmaceutical practice to the study, preparation, control and dispensing of radiopharmaceutical products, both within on an industrial and hospital scale.

From the point of view of Radiopharmacy, radiopharmaceutical products are defined as any product that when prepared for use with a diagnostic or therapeutic aim, contains one or more radionuclides (radioactive isotopes)

In general, a radiopharmaceutical comprises two different parts: the support molecule to which the radionucleide is bound and that conditions the metabolic route of the radiopharmaceutical within the organism and the so-called radionuclide that emits radiation allowing the external detection of the radiopharmaceutical and the qualitative and/or quantitative valuation of the process studied.

There are also radiopharmaceuticals of an ionic nature, in which the radionuclide determines the metabolic route of the compound.

Legal aspects of Radiopharmaceuticals

Law 25/1990, of December 20 of Medicine (Section VI, articles 51, 52 and 53) deems radiopharmaceuticals to be drug products, therefore they are subject to pharmaceutical legislation as with other drug products.

As a result of this Law and transposition of the European Directive 89/343/CEE, the Royal Decree 479/1993, of April 2 is published in our country regulating radiopharmaceutical products for human use. This RD establishes the necessary requirements to ensure observance of the safety criteria, efficacy and quality of the authorisation, production and control of the radiopharmaceuticals, as well as the criteria for use of a radiopharmaceutical prepared at the time of use.

As well as RD 479/1993, the clinical use of radiopharmaceuticals in Spain must comply with the legal measures on the protection against ionising radiation of persons subject to examinations or medical treatment (RD 1132/1990, of September 14 and RD 815/2001, of July 13), ), or for the protection of public health and of the workers (RD 783/2001, July 6, whereby the Ruling on health protection against ionising radiation is approved).

Likewise, the Royal Decree 1841/1997 of December 5 that applies to all care units of nuclear medicine, establishes the quality criteria in nuclear medicine, ensuring optimisation of the administration of radiopharmaceuticals and the radiological protection of the patient.

Clinical indications of radiopharmaceuticals for human use currently authorised in Spain

You can access said information in the article published in no. 26 of 2003 of the magazine “Seguridad Nuclear” of the Consejo de Seguridad Nuclear (CSN) ("Nuclear Safety" of the Nuclear Safety Council)