Final editorial decision
Final specialist hospital-compounding reference. Retain the exact source tablet form and vehicle; another dosage form, capsule or vehicle requires separate evaluation. The source environment, exposure-control and dedicated-equipment conditions are implementation requirements, not certified by publication. Ninety days at 15–25 °C protected from light is recorded as the source instruction, not a Sikalias study result or automatic USP extension. The website does not issue an actual batch BUD or dispensing label.
Required evidence
- Approved facility/equipment evidence against source requirements, H360 exposure assessment, appropriate powder containment, staff training and verified cleaning.
- Identity of the exact source tablet, vehicle, lots, container and closure; applicability to the source and any required full licensed analytical chapter.
- Actual batch test report with suitable methods, an appropriately accurate oral/enteral dosing device and evidence applicability for the selected period.
Closure criteria
- The source specifies pH 4.0–5.0, content 90.0–110.0% and compliance with its applicable uniformity test. Record actual results, method and signature. Theoretical osmolality is not reported as measured.
- Facility, protection and cleaning evidence is approved for this operation. The general presence of a laboratory or clean area is insufficient.
- Justify the selected period for the exact formulation/container. If the USP framework is selected, assess its extension conditions independently; the ANSM period does not automatically prove USP compliance.
Scope
Final editorial decision dated 14 October 2026. This is not a certificate of laboratory results or actual batch release.
Sources and references
- ANSM hospital-compounding monograph: flucytosine 50 mg/mL oral suspensionpp.1–5; source date discrepancy retained2026-10-14
REFERENCE FORMULA
Reference formula
Reference basis: 30 mL
| Ingredient | Source quantity | Scaled quantity |
|---|---|---|
| Ancotil flucytosine 500 mg tablets | 3 δισκία / tablets | — |
| Ora-Blend | q.s. ad 30 mL | — |
Prerequisite formulations
No separate prerequisite monograph is listed.
Documentation
Preparation description
Homogeneous whitish suspension. [1]
Action and use
Antifungal. [1]
Specifications
pH 4–5; assay 90–110%. Before rotor/stator treatment, source reports 95% of particles at 56–224 μm. Check the original for remaining uniformity/particle-size tests. [1]
Light
For the finished product the source specifies:
Amber type II glass with suitable closure, 15–25 °C, protected from light. [1]
Amber type II glass with suitable closure, 15–25 °C, protected from light. [1]
Air and oxidation
No oxidative stability study of the finished mixture or inert-atmosphere requirement is provided. Use the source container. [1]
Water and solubility
No quantitative hydrolytic stability limit is given for this formula. Retain the prescribed water amount and quality. [1]
Humidity
No numerical relative-humidity limit is given for the finished product. Prevent raw-material wetting and condensation entering the container. [1]
Temperature
For the finished product the source specifies:
Amber type II glass with suitable closure, 15–25 °C, protected from light. [1]
Amber type II glass with suitable closure, 15–25 °C, protected from light. [1]
pH and compatibility
Specification of this preparation, not a demonstrated stability range:
pH 4–5; assay 90–110%. Before rotor/stator treatment, source reports 95% of particles at 56–224 μm. Check the original for remaining uniformity/particle-size tests. [1]
pH 4–5; assay 90–110%. Before rotor/stator treatment, source reports 95% of particles at 56–224 μm. Check the original for remaining uniformity/particle-size tests. [1]
Other interactions
No complete compatibility test with added actives or alternative excipients is provided. Substitutions require separate evidence. [1]
Ingredient-specific information
Identity and weighing basis:
• Ancotil flucytosine 500 mg tablets: 3 δισκία / tablets.
• Ora-Blend: q.s. ad 30 mL.
The specified chemical forms/grades belong to the exact source formula. [1]
• Ancotil flucytosine 500 mg tablets: 3 δισκία / tablets.
• Ora-Blend: q.s. ad 30 mL.
The specified chemical forms/grades belong to the exact source formula. [1]
Staff protection
Risk assessment
SPECIAL FACILITY: source requires an isolator or suitable unidirectional airflow in a grade D environment and dedicated equipment. It identifies reproductive toxicity category 1B (H360). Assess operator/environmental protection. This is a non-sterile oral product.
The source’s specialist conditions are prerequisites; a general weighing sheet or ordinary compounding bench is insufficient.
Reference batch: 30 mL. First ingredient: Ancotil flucytosine 500 mg tablets, 3 δισκία / tablets. Independently check chemical form, units and every scale conversion before weighing.
Redispersibility is critical: homogenise before subdivision, check for hard sediment and verify that the graduated oral syringe delivers the required volume without blockage/air. Clarity is not an acceptance criterion for a suspension.
For the local assessment record quantity per preparation, work frequency, duration of open handling, potential exposure routes and effectiveness of controls. These are assessment inputs; no fictitious final risk score is assigned.
Release checkpoint: sample representative locations and early/late filling; record settling or separation and redispersibility. Verify delivery of the intended amount; visual uniformity alone does not demonstrate API uniformity. [1], [6], [8]
The source’s specialist conditions are prerequisites; a general weighing sheet or ordinary compounding bench is insufficient.
Reference batch: 30 mL. First ingredient: Ancotil flucytosine 500 mg tablets, 3 δισκία / tablets. Independently check chemical form, units and every scale conversion before weighing.
Redispersibility is critical: homogenise before subdivision, check for hard sediment and verify that the graduated oral syringe delivers the required volume without blockage/air. Clarity is not an acceptance criterion for a suspension.
For the local assessment record quantity per preparation, work frequency, duration of open handling, potential exposure routes and effectiveness of controls. These are assessment inputs; no fictitious final risk score is assigned.
Release checkpoint: sample representative locations and early/late filling; record settling or separation and redispersibility. Verify delivery of the intended amount; visual uniformity alone does not demonstrate API uniformity. [1], [6], [8]
Compounding conditions
BUD rationale
Final specialist hospital-compounding reference. Retain the exact source tablet form and vehicle; another dosage form, capsule or vehicle requires separate evaluation. The source environment, exposure-control and dedicated-equipment conditions are implementation requirements, not certified by publication. Ninety days at 15–25 °C protected from light is recorded as the source instruction, not a Sikalias study result or automatic USP extension. The website does not issue an actual batch BUD or dispensing label. [1]
Prerequisites
No separately registered base is required. Any commercial vehicle remains the exact named product in the formula table. [1]
Equipment
Balance with suitable minimum weight, mortar/pestle or homogeniser, mixing vessels, spatulas, thermometer for heated processes and volumetric equipment for mL quantities.
Calibrated pH meter and suitable check buffers. [1]
Calibrated pH meter and suitable check buffers. [1]
Compounding method
After qualifying the required specialist facility, preferably within one day: triturate three flucytosine 500 mg tablets using dedicated mortar/pestle to powder <226 µm under the source exposure controls. Transfer to a preferably sterile single-use container. Add Ora-Blend to a final volume of 30 mL. Homogenise with a suitable disperser such as rotor/stator. Pack in an amber type II glass bottle with a tamper-evident screw cap. Final-product sterility is not established. [1]
Observations
SPECIAL FACILITY: source requires an isolator or suitable unidirectional airflow in a grade D environment and dedicated equipment. It identifies reproductive toxicity category 1B (H360). Assess operator/environmental protection. This is a non-sterile oral product.
Execution is permitted only after the actual facility, protective enclosure and dedicated equipment are documented to meet the ANSM requirements and local exposure assessment. This edition does not certify that they exist at the pharmacy. [1]
Execution is permitted only after the actual facility, protective enclosure and dedicated equipment are documented to meet the ANSM requirements and local exposure assessment. This edition does not certify that they exist at the pharmacy. [1]
Container and packaging
Amber type II glass bottle with a tamper-evident screw cap. [1]
Quality control
pH 4–5; assay 90–110%. Theoretical osmolality 1790–2423 mOsm/kg, not an actual batch result. Before dispersion, 95% of particles 56–224 µm. Content uniformity by Ph. Eur. 2.9.6 test B and an appropriate USP method; full chapters are required.
Record the method, acceptance criterion, actual result and reviewer separately in F-005. A critical specification failure requires quarantine and investigation under SOP-015; retesting needs justification. [1], [8]
Record the method, acceptance criterion, actual result and reviewer separately in F-005. A critical specification failure requires quarantine and investigation under SOP-015; retesting needs justification. [1], [8]
Storage
Amber type II glass with suitable closure, 15–25 °C, protected from light. [1]
Dispensing
This entry does not generate a label or authorise patient dispensing. Consult its final decision and implementation criteria. [1]
Labelling
No dispensing label is issued by this entry. [1]
final_decision
Final specialist hospital-compounding reference. Retain the exact source tablet form and vehicle; another dosage form, capsule or vehicle requires separate evaluation. The source environment, exposure-control and dedicated-equipment conditions are implementation requirements, not certified by publication. Ninety days at 15–25 °C protected from light is recorded as the source instruction, not a Sikalias study result or automatic USP extension. The website does not issue an actual batch BUD or dispensing label. [1]
Independent Greek/English adaptation and organisation of facts from the cited source. This is not an official translation or publisher endorsement.
Sources and references
- ANSM — Monographie de préparation magistrale (outside Formulaire national)Mise à jour 30/06/2022; ασυμφωνία ημερομηνίας εξωφύλλου / cover-date discrepancyPDF pp. 1–5master formula2026-09-10
- PN/L/PG/002/00 INDUMENTARIAΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–5general staff protection2026-09-10
- ASHP — USP <795> Key Changes2023pp. 1–3: scope, water activity and staff precautionsprofessional guidance; not the licensed USP chapter2026-09-12
- Texas State Board of Pharmacy — adopted 22 TAC §291.131, nonsterile compoundingTexas Register, 7 June 2024Beyond-use dating: aw categories, 14/35/90/180 days, limits and extensionspublic regulatory implementation of USP <795> BUD framework; not Greek law2026-09-12
- Illinois IDFPR — Nonsterile Compounding Self-Inspection ReportPublic checklist, retrieved 12 September 2026pp. 15–16, Establishing beyond-use datesPublic regulatory implementation of USP <795>; not Greek law; general limits and requirements for extension2026-09-12
- NIOSH — Managing Hazardous Drug Exposures: Information for Healthcare Settings2023; DHHS (NIOSH) 2023-130Risk assessment; printed pp. 27–33, activity/formulation control tableWorkplace exposure, hierarchy of controls and activity-specific PPE; US government public-domain document2026-09-12
- USP — Compounding Standards and Beyond-Use Dates, 2022 updateNovember 2022, published by USP; public copy hosted by Mississippi Boardpp. 1–2; nonsterile tableRisk-based default categories; not product-specific stability or Greek law2026-09-12
- PIC/S — Guide to Good Practices for the Preparation of Medicinal Products in Healthcare EstablishmentsPE 010-4, 1 March 2014Chapters 1–9; Annex 2 (nonsterile liquids, creams, ointments)Professional quality-system framework; not automatic national legal adoption or certification2026-09-12
- USP — General Chapter <795> FAQs (official, updated 1 November 2023)Updated 1 November 2023; retrieved 14 October 2026Q52, Q61–64; use with the applicable full chapterWater-activity classification, component dating and BUD documentation; general professional framework, not a Greek legal adoption or formula-specific study2026-10-14