# An Adequate Pharmaceutical Quality System for Personalized Preparation
## 2 Personalized Preparation Quality: Definitions and Legislation
Similarly, Resolution CM/Res (2016) 1 [16] on quality and safety requirements for medicines for the special needs of patients prepared in pharmacy aims to bring about unification in the legislation of all countries. This standard recommends that the GMP Guide be used as a reference for an appropriate quality system for \"high-risk preparations\", and that the PIC/S GPP Guide be used for \"low-risk preparations\". Analyses of the impact of this resolution on different European countries have been conducted [17; 18; 19]. The European regulatory framework for personalized preparations (with references also to regulations in the United States) is duly covered in the review by [PERSON] et al. [3]. In its conclusions, it proposes, at a European level, to allow pharmacies to prepare medicinal products on behalf of other pharmacies, certify high-risk preparations (e.g., sterile ones), and provide the patient with a leaflet detailing essential information. It further concludes that it is time to modernize how personalized preparations are regulated. It should be noted that everything proposed in this review article is complied with in the Spanish legislative framework: pharmacies can prepare products on behalf of other pharmacies; the needs and requirements to be included in leaflets accompanying magistral and official formulas are included in legislation; and in March 2022 the Spanish Agency for Medicines and Health Products and the Ministry of Health announced--in a public consultation--a proposed Royal Decree (RD) to modify RD175/2001, though no draft is yet available. For this reason, Spanish national legislation is used to frame the regulations governing the compounding of personalized preparations and to enable the subsequent discussion about the requirements of the pharmaceutical quality system, which is the main objective of this article. The legislation applied in Spain to the quality of personalized preparations can be found in Table 1:  
\begin{table}
\begin{tabular}{c c c} \hline
**Law/Norm** & **What It Regulates** & **Observations** \\ \hline  & & It includes a section that states that magistral formulas and official formulas are legally recognized medicines, prepared by or under the direction of a pharmacist, and dispensed from a pharmacy or pharmaceutical service, complete with sufficient information to guarantee they are correctly identified (including the name of the pharmacist who has prepared them), conserved and safely used. \\ \hline  & & This is a turning point in legislation on personalized preparations. It introduces regulations for proper production and quality assurance applied to compounding laboratories. They are considered the minimum that every compounding laboratory must meet to ensure the quality of the medicines it manufactures. There are certain “gaps” in them which are detailed in this article. \\ \hline Royal Decree 905/2003, of 11 July [22]: & Modifies the sole transitional provision of Royal Decree 175/2001. & It was published to extend the deadline for the adaptation of laboratories to the requirements of RD175/2001. \\ \hline  & & Currently, 3 rd edition of the formulary. It contains 81 monographs on raw material, 57 on official formulas, and 29 typified magistral formulas: standardized \\ and SSI/23/2015 [23] & Spanish Pharmacopoeia are passed. & Compounding approved by the Formulary and Pharmacopoeia Commission (collected in the National Formulary). \\ \hline  & & There are circumstances in which the clinical data that support a certain therapeutic use for an already authorized drug are not included as an officially approved indication. Very relevant in areas with intense research activity and the pace of evolving scientific knowledge that precedes the procedures to incorporate them as an official indication. There are also conditions of use in clinical practice that are not contemplated in authorization for the medicine, given an absence of commercial interest for undertaking studies pursuant to its authorization.