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.

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