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Revista de la OFIL

On-line version ISSN 1699-714XPrint version ISSN 1131-9429

Abstract

PASCUAL-MASIA, L  and  MARTINEZ-GALAN, F. The future of drug compounding: comments on the Real Decreto 175/2001 modification project. Rev. OFIL·ILAPHAR [online]. 2022, vol.32, n.4, pp.371-374.  Epub Oct 23, 2023. ISSN 1699-714X.  https://dx.doi.org/10.4321/s1699-714x20220004000010.

Aim:

In March 2022, the Spanish Agency of Medicines and Medical Devices and the Ministry of Health presented for public consultation the project of Real Decreto to modify the RD175/2001, which regulates the compounding of magistral formulas and formulations typified in the National Formulary. This work intends to signify what the new regulation shouldconsider boosting compounding under a higher quality standard.

Method:

Current state of art of compounding in Spain has been studied, just as quality techniques and concepts developed in pharmaceutical industry at an international level.

Results:

Compounding needs to be considered as one between all the activities developed by Pharmacy Services lity assurance to permit a wider classification for the presentations, using resources in a more efficient way and commensurate to the commitment of each Service with compounding.

Conclusion:

Accordingly, the new Real Decreto should acknowledge that the quality of the medicines which reach patients should be the primal objective of this activity.

Keywords : Preparation; quality assurance; regulation; actualization; pharmacy practice.

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