by ICONESCompounded preparations: definition, regulatory framework and control
A magistral (compounded) preparation is a medicine prepared for a specific patient, on prescription, when no available proprietary medicine is suitable. Definition, differences with officinal and hospital preparations, applicable rules and the place of analytical control.
- The French Public Health Code (article L.5121-1) distinguishes three types of preparations: magistral, hospital and officinal.
- A magistral preparation is intended for a specific patient, on medical prescription.
- All three fall under the ANSM's Good Preparation Practices, 2023 edition.
- In hospital pharmacies, injectable chemotherapies prepared for a given patient are the typical example: every IV bag is unique.
- The more individualized a preparation, the more checking the finished product matters.
What is a magistral preparation?
The French Public Health Code defines a magistral preparation as a medicine prepared according to a medical prescription intended for a specific patient, when no suitable proprietary medicine is available. It is prepared extemporaneously in a pharmacy or, where the regulations allow, subcontracted.
Three elements characterize it: a prescription, an identified patient, and a preparation designed for that patient, whether in terms of dose, form, concentration or excipients.
Magistral, hospital, officinal: three categories
Article L.5121-1 of the Public Health Code distinguishes three categories of preparations, all of which are subject to the Good Preparation Practices.
The regulatory framework
All three categories fall under the Good Preparation Practices (BPP) published by the ANSM, whose 2023 edition has been in force since 20 September 2023. Among other things, the guide requires:
- a risk analysis for each preparation;
- complete documentation: preparation record and batch record;
- controls adapted to the risk, during and at the end of preparation;
- release pronounced and signed by a pharmacist.
For sterile preparations and those containing hazardous substances, such as cytotoxics, BPP guidelines 1 and 2 are added to the general chapters.
Risks specific to compounding
A magistral preparation is, by nature, unique. It therefore accumulates points of failure:
- individualized calculations: body surface area, renal function, dose adjustments, rounding;
- a change of molecule, volume or solvent from one preparation to the next;
- few opportunities to standardize actions, hence a high cognitive load.
Visual double-checking quickly reaches its limits. In a simulation run at Geneva University Hospitals, 3 dose errors out of 7 went unnoticed (Carrez et al., 2017). Two IV bags with different concentrations look identical to the naked eye. Read our analysis: compounding and dose banding.
Checking a compounded preparation
The BPP leave the choice of methods open, provided they are proportionate to the risk. Visual, gravimetric or video control, laboratory chromatography (HPLC), rapid analytical control of the finished product: each approach has its strengths and blind spots. Only analysis of the finished product answers the three questions that matter:
The QCRx® performs these three checks in under 70 seconds, directly on the finished preparation, and archives a time-stamped report that goes into the batch record. Release takes place without waiting for a laboratory result.
You do pure compounding? That is precisely where analytical control is most valuable.
Frequently asked questions
What is a magistral preparation?+
What is the difference between a magistral and an officinal preparation?+
Who can make a magistral preparation?+
Must a magistral preparation be checked?+
- French Public Health Code, article L.5121-1
- ANSM, Good Preparation Practices, 2023 edition (decision of 21 July 2023)
- Carrez L. et al., J Oncol Pharm Pract, 2017: simulation of visual double-checking at Geneva University Hospitals
- SFPO, 2019 recommendations on the preparation of injectable anticancer drugs (no. 17 and no. 41)