FOR PHARMACISTS · SCIENTIFIC COLLECTION 10.0310 monographs · 36 SOPs · 22 forms
Sikaliascompounding.grSikalias Greek Formulary
Home / Final decision register

Final decision register

Decision, evidence and criteria for each special case.

Download decision register · PDF

CGR-BP-002

Aqueous Cream

Final editorial decision

The wax prerequisite is fulfilled by an accepted lot of supplier-qualified pharmacopoeial anionic wax matched to the reference composition. In-house wax manufacture is not necessary to implement this monograph. The 35-day figure remains a conditional general ceiling, not experimental stability or an assigned batch BUD. Phenoxyethanol 1% w/w: justify suitability in the final formulation and container. MHRA reports irritation with SLS-containing aqueous cream, especially in children and leave-on use. Apply the shortest supported limit, including the remaining BUD of any compounded base.

Required evidence

  • Defined and approved supplier grade of anionic BP wax, with routine acceptance of the actual lot; accepted other ingredients and the exact reference formula/process.
  • Justified finished-form category, defined container/storage, homogeneity and source-specific QC. For a preserved aqueous form, justify preservative suitability at the final pH and in the complete composition.
  • For a compounded base, record its actual preparation date, release and remaining BUD. The new final mixture does not reset the base dating clock.
  • Assess phenoxyethanol suitability in the final composition. Retain MHRA advice on possible irritation with SLS-containing aqueous cream, especially in children and leave-on use.

Closure criteria

  • Close the research dependency on in-house wax by explicitly adopting the defined purchased pharmacopoeial grade. Incoming acceptance remains a routine requirement of actual compounding.
  • Actual release requires the completed batch record, acceptable applicable QC and a signed BUD assessment applying the shortest supported limit.
  • Do not apply a numerical default unless its category, compatible temperature and formulation suitability are supported. A new specific study is needed for extension or an unresolved physical/chemical concern, not merely to present a conditional default.

Scope

Final editorial decision dated 14 October 2026. This is not a certificate of laboratory results or actual batch release.

Sources and references

  1. USP General Chapter <795> FAQs, November 1 2023Questions 52, 60, 61, 62, 63; printed pp.11,14
  2. VVF manufacturer: Emulsifying WaxesProduct table: Vegarol EW 200; compare EW 100 and EW 300
  3. Croda Pharma manufacturer: Crodex A pharmaProduct description and pharmacopoeia compliance
  4. British Pharmacopoeia: Content Usage Licence for Individual UsersSections1,4 and5
  5. MHRA — Aqueous cream: may cause skin irritationAdvice for healthcare professionals

CGR-BP-003

Benzyl Benzoate Application

Final editorial decision

The wax prerequisite is fulfilled by an accepted lot of supplier-qualified pharmacopoeial anionic wax matched to the reference composition. In-house wax manufacture is not necessary to implement this monograph. The 14-day figure remains a conditional general ceiling, not experimental stability or an assigned batch BUD. The 14-day reference requires 2–8 °C and adequate refrigerated physical suitability. Verify homogeneity/redispersibility and absence of irreversible separation; do not transfer this limit to room temperature. Apply the shortest supported limit, including the remaining BUD of any compounded base.

Required evidence

  • Defined and approved supplier grade of anionic BP wax, with routine acceptance of the actual lot; accepted other ingredients and the exact reference formula/process.
  • Justified finished-form category, defined container/storage, homogeneity and source-specific QC. For a preserved aqueous form, justify preservative suitability at the final pH and in the complete composition.
  • For a compounded base, record its actual preparation date, release and remaining BUD. The new final mixture does not reset the base dating clock.
  • Use a refrigerated default only with supported physical suitability at 2–8 °C: homogeneity/redispersibility and no irreversible separation. Do not transfer it to room temperature.

Closure criteria

  • Close the research dependency on in-house wax by explicitly adopting the defined purchased pharmacopoeial grade. Incoming acceptance remains a routine requirement of actual compounding.
  • Actual release requires the completed batch record, acceptable applicable QC and a signed BUD assessment applying the shortest supported limit.
  • Do not apply a numerical default unless its category, compatible temperature and formulation suitability are supported. A new specific study is needed for extension or an unresolved physical/chemical concern, not merely to present a conditional default.

Scope

Final editorial decision dated 14 October 2026. This is not a certificate of laboratory results or actual batch release.

Sources and references

  1. USP General Chapter <795> FAQs, November 1 2023Questions 52, 60, 61, 62, 63; printed pp.11,14
  2. VVF manufacturer: Emulsifying WaxesProduct table: Vegarol EW 200; compare EW 100 and EW 300
  3. Croda Pharma manufacturer: Crodex A pharmaProduct description and pharmacopoeia compliance
  4. British Pharmacopoeia: Content Usage Licence for Individual UsersSections1,4 and5

CGR-BP-004

Buffered Cream

Final editorial decision

The wax prerequisite is fulfilled by an accepted lot of supplier-qualified pharmacopoeial anionic wax matched to the reference composition. In-house wax manufacture is not necessary to implement this monograph. The 35-day figure remains a conditional general ceiling, not experimental stability or an assigned batch BUD. Confirm final pH 5.7–6.3, homogeneity and chlorocresol suitability in the exact formulation. An aluminium tube requires a suitable internal lacquer. Apply the shortest supported limit, including the remaining BUD of any compounded base.

Required evidence

  • Defined and approved supplier grade of anionic BP wax, with routine acceptance of the actual lot; accepted other ingredients and the exact reference formula/process.
  • Justified finished-form category, defined container/storage, homogeneity and source-specific QC. For a preserved aqueous form, justify preservative suitability at the final pH and in the complete composition.
  • For a compounded base, record its actual preparation date, release and remaining BUD. The new final mixture does not reset the base dating clock.
  • Final pH within 5.7–6.3, suitable preservation and homogeneity. An aluminium tube requires suitable internal lacquer.

Closure criteria

  • Close the research dependency on in-house wax by explicitly adopting the defined purchased pharmacopoeial grade. Incoming acceptance remains a routine requirement of actual compounding.
  • Actual release requires the completed batch record, acceptable applicable QC and a signed BUD assessment applying the shortest supported limit.
  • Do not apply a numerical default unless its category, compatible temperature and formulation suitability are supported. A new specific study is needed for extension or an unresolved physical/chemical concern, not merely to present a conditional default.

Scope

Final editorial decision dated 14 October 2026. This is not a certificate of laboratory results or actual batch release.

Sources and references

  1. USP General Chapter <795> FAQs, November 1 2023Questions 52, 60, 61, 62, 63; printed pp.11,14
  2. VVF manufacturer: Emulsifying WaxesProduct table: Vegarol EW 200; compare EW 100 and EW 300
  3. Croda Pharma manufacturer: Crodex A pharmaProduct description and pharmacopoeia compliance
  4. British Pharmacopoeia: Content Usage Licence for Individual UsersSections1,4 and5

CGR-BP-014

Emulsifying Ointment

Final editorial decision

The wax prerequisite is fulfilled by an accepted lot of supplier-qualified pharmacopoeial anionic wax matched to the reference composition. In-house wax manufacture is not necessary to implement this monograph. The 180-day figure remains a conditional general ceiling, not experimental stability or an assigned batch BUD. Justify nonaqueous-base classification from the exact composition and accepted material quality. Low wax aw alone is not a measured aw result for the finished ointment. Apply the shortest supported limit, including the remaining BUD of any compounded base.

Required evidence

  • Defined and approved supplier grade of anionic BP wax, with routine acceptance of the actual lot; accepted other ingredients and the exact reference formula/process.
  • Justified finished-form category, defined container/storage, homogeneity and source-specific QC. For a preserved aqueous form, justify preservative suitability at the final pH and in the complete composition.
  • For a compounded base, record its actual preparation date, release and remaining BUD. The new final mixture does not reset the base dating clock.
  • Nonaqueous classification concerns the exact finished ointment; wax data alone are not presented as a measured finished-ointment aw value.

Closure criteria

  • Close the research dependency on in-house wax by explicitly adopting the defined purchased pharmacopoeial grade. Incoming acceptance remains a routine requirement of actual compounding.
  • Actual release requires the completed batch record, acceptable applicable QC and a signed BUD assessment applying the shortest supported limit.
  • Do not apply a numerical default unless its category, compatible temperature and formulation suitability are supported. A new specific study is needed for extension or an unresolved physical/chemical concern, not merely to present a conditional default.

Scope

Final editorial decision dated 14 October 2026. This is not a certificate of laboratory results or actual batch release.

Sources and references

  1. USP General Chapter <795> FAQs, November 1 2023Questions 52, 60, 61, 62, 63; printed pp.11,14
  2. VVF manufacturer: Emulsifying WaxesProduct table: Vegarol EW 200; compare EW 100 and EW 300
  3. Croda Pharma manufacturer: Crodex A pharmaProduct description and pharmacopoeia compliance
  4. British Pharmacopoeia: Content Usage Licence for Individual UsersSections1,4 and5

CGR-BP-015

Emulsifying Wax

Final editorial decision

Preferred implementation route: obtain pharmacopoeial anionic emulsifying wax from an approved supplier, with documented type and composition match to the cited BP material. Accept the actual lot only with its CoA, identity/quality checks, storage instructions and valid expiry or justified retest date. Nonionic NF wax and cetomacrogol wax are not interchangeable. For purchased material use the approved supplier dating and after-opening conditions; do not invent a compounded-preparation BUD. Retain the historical preparation method as a reference. No numerical dating is established here for in-house production: the 4 mL process-water input and residual-water specification are not aw measurements.

Required evidence

  • Approved pharmaceutical material specification: anionic cetostearyl-alcohol/sodium-lauryl-sulfate wax, matched in type, composition and functionality to the cited BP material.
  • Actual lot CoA, incoming identity/quality acceptance, supplier traceability, expiry or justified retest date, storage/after-opening conditions and SDS.
  • Alternatively, for in-house manufacture: real batch record, specification compliance and aw-category evidence for representative finished wax using a suitable method.

Closure criteria

  • Close the research decision by specifying procurement of the correct pharmacopoeial grade. Supplier examples establish availability, not acceptance of an actual lot.
  • Complete routine purchased-lot acceptance against the approved specification, CoA and identity/quality checks. Nonionic NF wax or cetomacrogol wax is not an automatic substitute.
  • For in-house manufacture, residual water and cessation of frothing do not establish the aw category. Use suitable finished-matrix evidence with a decision rule accounting for measurement uncertainty.

Scope

Final editorial decision dated 14 October 2026. This is not a certificate of laboratory results or actual batch release.

Sources and references

  1. USP General Chapter <795> FAQs, November 1 2023Questions 52, 60, 61, 62, 63; printed pp.11,14
  2. VVF manufacturer: Emulsifying WaxesProduct table: Vegarol EW 200; compare EW 100 and EW 300
  3. Croda Pharma manufacturer: Crodex A pharmaProduct description and pharmacopoeia compliance
  4. British Pharmacopoeia: Content Usage Licence for Individual UsersSections1,4 and5

CGR-BP-025

Zinc and Coal Tar Paste

Final editorial decision

The wax prerequisite is fulfilled by an accepted lot of supplier-qualified pharmacopoeial anionic wax matched to the reference composition. In-house wax manufacture is not necessary to implement this monograph. The 180-day figure remains a conditional general ceiling, not experimental stability or an assigned batch BUD. Starch constitutes 38% w/w and requires appropriate quality/moisture control. If final aw category remains uncertain, measure a representative finished paste using suitable sample preparation and equilibration. Apply the shortest supported limit, including the remaining BUD of any compounded base.

Required evidence

  • Defined and approved supplier grade of anionic BP wax, with routine acceptance of the actual lot; accepted other ingredients and the exact reference formula/process.
  • Justified finished-form category, defined container/storage, homogeneity and source-specific QC. For a preserved aqueous form, justify preservative suitability at the final pH and in the complete composition.
  • For a compounded base, record its actual preparation date, release and remaining BUD. The new final mixture does not reset the base dating clock.
  • Check starch quality and relevance of evidence to the final paste. If the aw category remains uncertain, obtain a representative measurement on a suitably equilibrated sample.

Closure criteria

  • Close the research dependency on in-house wax by explicitly adopting the defined purchased pharmacopoeial grade. Incoming acceptance remains a routine requirement of actual compounding.
  • Actual release requires the completed batch record, acceptable applicable QC and a signed BUD assessment applying the shortest supported limit.
  • Do not apply a numerical default unless its category, compatible temperature and formulation suitability are supported. A new specific study is needed for extension or an unresolved physical/chemical concern, not merely to present a conditional default.

Scope

Final editorial decision dated 14 October 2026. This is not a certificate of laboratory results or actual batch release.

Sources and references

  1. USP General Chapter <795> FAQs, November 1 2023Questions 52, 60, 61, 62, 63; printed pp.11,14
  2. VVF manufacturer: Emulsifying WaxesProduct table: Vegarol EW 200; compare EW 100 and EW 300
  3. Croda Pharma manufacturer: Crodex A pharmaProduct description and pharmacopoeia compliance
  4. British Pharmacopoeia: Content Usage Licence for Individual UsersSections1,4 and5

CGR-BP-033

Flexible Collodion

Final editorial decision

Final evidence decision: no product-specific study was found establishing a numerical BUD for this exact in-house formulation and container. Prefer the exact required pharmacopoeial material from an approved supplier, with an acceptable lot CoA, dating and after-opening instructions. Different pharmacopoeial formulas and methylated laboratory variants are not automatically interchangeable. In-house production requires a volatile-compatible aw assessment and written method/matrix safety suitability. Low aw does not establish solvent retention, chemical stability, seal integrity or peroxide control. No arbitrary 180-day period is assigned. This is a completed reference monograph, not certification of a released batch.

Required evidence

  • Use qualified commercial Collodion BP against an approved specification. CGR-FR-006 is not an established automatic substitute.
  • Exact identity/composition of the required pharmacopoeial material, specification, actual lot CoA, supplier dating/instructions and a suitable tight container. Another pharmacopoeial formula or methylated laboratory variant is not presumed equivalent.
  • For the in-house final mixture, establish the aw category using a method resistant to volatile-solvent interference and written safety/suitability confirmation for ether and the actual matrix.
  • Suitable controls for ether/ethanol loss, closure integrity, appearance, applicable assays/residue and film formation. Apply fire and peroxide controls according to the material and supplier instructions.

Closure criteria

  • Procurement and routine acceptance of the exact required grade closes the material-selection question; it does not automatically establish new dating after mixing, modification or repacking.
  • Low aw resolves microbial-category uncertainty only. It does not establish solvent retention, chemical stability, closure integrity or adequate peroxide control.
  • Publish this monograph as a final specialist reference without a new numerical stock BUD. Actual use requires supported quality and a safe process. Same-session use does not replace identity, composition and safety requirements.

Scope

Final editorial decision dated 14 October 2026. This is not a certificate of laboratory results or actual batch release.

Sources and references

  1. USP General Chapter <795> FAQs, November 1 2023Questions 52, 60, 61, 62, 63; printed pp.11,14
  2. ANSM: Collodion, Formulaire national 1994pp.1–2, content limits; ethanol test; storage
  3. Addium/AQUALAB manufacturer: TDL2 volatile-sample water activity methodMeasurement principle, volatile samples, water-selective laser
  4. CDC/NIOSH Pocket Guide: Ethyl etherPhysical properties, incompatibilities and reactivities
  5. British Pharmacopoeia: Content Usage Licence for Individual UsersSections1,4 and5

CGR-FR-006

Collodion Ph. Fr.

Final editorial decision

Final evidence decision: no product-specific study was found establishing a numerical BUD for this exact in-house formulation and container. Prefer the exact required pharmacopoeial material from an approved supplier, with an acceptable lot CoA, dating and after-opening instructions. Different pharmacopoeial formulas and methylated laboratory variants are not automatically interchangeable. In-house production requires a volatile-compatible aw assessment and written method/matrix safety suitability. Low aw does not establish solvent retention, chemical stability, seal integrity or peroxide control. No arbitrary 180-day period is assigned. This is a completed reference monograph, not certification of a released batch. This record does not specify a commercial pyroxylin grade or assay basis. Before any preparation, obtain evidence for dry-polymer content and the identity/amount of wetting agent, reconciled with the final specifications. Do not treat 5 g of unspecified wetted material as 5 g dry polymer or dry the material to correct the arithmetic. Same-session use does not remove this requirement.

Required evidence

  • Define the exact pharmaceutical pyroxylin grade, dry-polymer assay basis and identity/amount of wetting agent. Reconcile material balances with final specifications of 5.0–6.0% w/w pyroxylin and 17.5–21.0% w/w anhydrous ethanol.
  • Exact identity/composition of the required pharmacopoeial material, specification, actual lot CoA, supplier dating/instructions and a suitable tight container. Another pharmacopoeial formula or methylated laboratory variant is not presumed equivalent.
  • For the in-house final mixture, establish the aw category using a method resistant to volatile-solvent interference and written safety/suitability confirmation for ether and the actual matrix.
  • Suitable controls for ether/ethanol loss, closure integrity, appearance, applicable assays/residue and film formation. Apply fire and peroxide controls according to the material and supplier instructions.

Closure criteria

  • Pyroxylin assay basis and solvent balance remain real prerequisites before any in-house preparation. Do not dry pyroxylin to correct the arithmetic. Same-session use does not remove this prerequisite.
  • Procurement and routine acceptance of the exact required grade closes the material-selection question; it does not automatically establish new dating after mixing, modification or repacking.
  • Low aw resolves microbial-category uncertainty only. It does not establish solvent retention, chemical stability, closure integrity or adequate peroxide control.
  • Publish this monograph as a final specialist reference without a new numerical stock BUD. Actual use requires supported quality and a safe process. Same-session use does not replace identity, composition and safety requirements.

Scope

Final editorial decision dated 14 October 2026. This is not a certificate of laboratory results or actual batch release.

Sources and references

  1. USP General Chapter <795> FAQs, November 1 2023Questions 52, 60, 61, 62, 63; printed pp.11,14
  2. ANSM: Collodion, Formulaire national 1994pp.1–2, content limits; ethanol test; storage
  3. Addium/AQUALAB manufacturer: TDL2 volatile-sample water activity methodMeasurement principle, volatile samples, water-selective laser
  4. CDC/NIOSH Pocket Guide: Ethyl etherPhysical properties, incompatibilities and reactivities

CGR-FR-008

Oleo-calcareous cream Ph. Fr.

Final editorial decision

Final development reference — not an executable patient-compounding protocol.

The official ANSM text limits heating to 30 °C while requiring wool fat and white soft paraffin to be melted at 30 °C. This source inconsistency is recorded. An arbitrary higher temperature or unverified cold process is not adopted. The composition is presented solely for documentation and development.

No numerical BUD is assigned to this development entry. The source supplies no specific duration. An aw result or general dating rule does not resolve the unsupported process. Any future production version requires an approved method, container, storage conditions and dating justification.

Required evidence

  • ANSM clarification/correction or separately identified local development protocol addressing melting at 30 °C.
  • Specifications and CoAs for wool fat, petrolatum and calcium hydroxide solution matching Ph. Fr.
  • Protocol and actual results for structure/uniformity, calcium identification, microbial quality and container compatibility at the stated storage conditions.

Closure criteria

  • The exact process is reproducible for actual materials without unsupported heating above 30 °C; any modified method is declared separately.
  • Actual tests meet prospectively approved specifications; the selected duration and temperature are supported and approved for the batch.

Scope

Final editorial decision dated 14 October 2026. This is not a certificate of laboratory results or actual batch release.

Sources and references

  1. ANSM, Formulaire national 2007, Crème oléocalcaireSingle page, PREPARATION
  2. USP General Chapter <795> FAQs, updated 1 November 2023Q52, Q54–56, Q58–65, PDF pp.11–15

CGR-ES-015

Urea cream 15% AEMPS

Final editorial decision

Final development reference — not an executable patient-compounding protocol.

PO/029 requires emulsification without heating, whereas its EX010 vehicle requires both phases to be heated to 70–75 °C. This edition does not combine these conflicting instructions into an unsupported recipe. Another commercial vehicle or incorporation sequence is a separate adaptation requiring its own documentation.

AEMPS states 3 calendar months in a well-closed opaque jar below 25 °C. This is recorded as the source instruction and is not assigned as a production BUD while the exact process is unsupported. No new stability study or aw measurement is claimed.

Required evidence

  • AEMPS clarification or separate development resolving PO029 no-heating versus EX010 70–75 °C.
  • Identified EX010 non-ionic self-emulsifying grade with complete technical evidence and supplier instructions.
  • Actual exact-formula study of urea/degradation, pH, crystallization, uniformity, emulsion structure and preservation in an opaque jar.

Closure criteria

  • Clear achievable addition sequence and urea temperature exposure, without undeclared solvent or a changed vehicle labelled as unchanged source monograph.
  • Results satisfy justified prospectively approved limits throughout the adopted period below 25 °C; actual batch release is signed.

Scope

Final editorial decision dated 14 October 2026. This is not a certificate of laboratory results or actual batch release.

Sources and references

  1. AEMPS FN/2003/PO/029, Urea, crema al 15% dePDF p.2, sections 3–7; p.3 patient leaflet
  2. AEMPS FN/2003/EX/010, Emulsión O/A no iónica 1PDF p.2, sections 3–4
  3. AEMPS PN/L/FF/002/00, Elaboración de emulsionesPDF pp.3–5; §4.1, 4.4, 4.6
  4. USP General Chapter <795> FAQs, updated 1 November 2023Q52, Q54–56, Q58–65, PDF pp.11–15

CGR-BP-041

Compound Benzoic Acid Ointment

Final editorial decision

The wax prerequisite is fulfilled by an accepted lot of supplier-qualified pharmacopoeial anionic wax matched to the reference composition. In-house wax manufacture is not necessary to implement this monograph. The 180-day figure remains a conditional general ceiling, not experimental stability or an assigned batch BUD. Verify uniform distribution of both acids and the source assay specifications. Changing the base requires reassessment and is not automatically covered by the reference ceiling. Apply the shortest supported limit, including the remaining BUD of any compounded base.

Required evidence

  • Defined and approved supplier grade of anionic BP wax, with routine acceptance of the actual lot; accepted other ingredients and the exact reference formula/process.
  • Justified finished-form category, defined container/storage, homogeneity and source-specific QC. For a preserved aqueous form, justify preservative suitability at the final pH and in the complete composition.
  • For a compounded base, record its actual preparation date, release and remaining BUD. The new final mixture does not reset the base dating clock.
  • Verify uniform distribution of both acids and compliance with source-specific specifications. A changed base requires reassessment.

Closure criteria

  • Close the research dependency on in-house wax by explicitly adopting the defined purchased pharmacopoeial grade. Incoming acceptance remains a routine requirement of actual compounding.
  • Actual release requires the completed batch record, acceptable applicable QC and a signed BUD assessment applying the shortest supported limit.
  • Do not apply a numerical default unless its category, compatible temperature and formulation suitability are supported. A new specific study is needed for extension or an unresolved physical/chemical concern, not merely to present a conditional default.

Scope

Final editorial decision dated 14 October 2026. This is not a certificate of laboratory results or actual batch release.

Sources and references

  1. USP General Chapter <795> FAQs, November 1 2023Questions 52, 60, 61, 62, 63; printed pp.11,14
  2. VVF manufacturer: Emulsifying WaxesProduct table: Vegarol EW 200; compare EW 100 and EW 300
  3. Croda Pharma manufacturer: Crodex A pharmaProduct description and pharmacopoeia compliance
  4. British Pharmacopoeia: Content Usage Licence for Individual UsersSections1,4 and5

CGR-BE-027

Crotamiton Emulsion 10% w/w

Final editorial decision

Documented FTM reference monograph — exact composition and source duration.

The wax is defined exactly as 80% cetostearyl alcohol and 20% cetomacrogol 1000. Use an identified pharmaceutical grade with documented composition. An anionic emulsifying wax or another blend is not an automatic substitute. The source and formula were reverified; release always concerns the actual batch.

FTM 2010 states 2 calendar months at 15–25 °C in the specified 300 mL amber-glass bottle for a 200 g preparation. After opening: up to 2 calendar months, always within the overall use-by date. This is a specific official historical formulary instruction, not a new experimental study. The responsible pharmacist adopts the duration only for the exact formula, process, container and storage, applying any shorter limit. No aw measurement has been made and the website does not automatically assign a batch BUD.

Amber-glass bottle as specified by the source; 15–25 °C. Shake before use. A different temperature or container requires separate assessment.

Required evidence

  • Controlled official FTM D-I-4-b-2 with exact composition and original approximately 70 °C process.
  • Specification and supplier evidence/CoA for 80% cetostearyl alcohol +20% cetomacrogol 1000 wax; a controlled intermediate record if locally compounded.
  • Record of source applicability, actual compounding, storage and release.

Closure criteria

  • The source record and exact wax definition are documented; this closes the documentary identity issue without claiming laboratory testing.
  • The batch uses the exact formula and original 300 mL amber-glass bottle/200 g at 15–25 °C; applicable quality checks and pharmacist approval pass.
  • Reference duration up to 2 calendar months; after opening up to 2 months only within the overall date. Batch dating applies the shortest supported limit.

Scope

Final editorial decision dated 14 October 2026. This is not a certificate of laboratory results or actual batch release.

Sources and references

  1. FAMHP/AFMPS, Formulaire Thérapeutique Magistral 2010, D-I-4-b-2PDF pp.267–268 (zero-index pages 266–267), D-I-4-b-2.1–2.2; general analytical norms PDF p.15
  2. USP General Chapter <795> FAQs, updated 1 November 2023Q52, Q54–56, Q58–65, PDF pp.11–15

CGR-BR-013

Aluminium hydroxide 6% w/v suspension

Final editorial decision

Final historical development reference. Preserve the ANVISA 2012 formulation and its provenance. The individual entry specifies room-temperature storage without a numerical period. Sodium benzoate in the ingredient list does not establish adequate preservation in the final antacid matrix. No BUD, batch calculator or dispensing label is issued. Refrigeration or arbitrary acidification changes the evaluated conditions or formulation function and is not adopted as a literature-based solution.

Required evidence

  • Identified master-formula revision, hydroxide grade and potency basis, actual-lot CoAs, final container/closure and dosing device.
  • Approved exact-matrix development report: actual pH, suitable content and acid-neutralisation-capacity methods, withdrawal uniformity, sedimentation/redispersibility, microbial quality and preservation evidence.
  • Actual duration study in final packaging at the claimed temperature. Any proposed refrigeration requires separate physical and dose-delivery suitability at 2–8 °C.

Closure criteria

  • Applicable monograph specifications, methods and per-test limits are approved before the study. Water activity is not used as a substitute for stability or preservation.
  • All required criteria are met through the proposed period, using a suitable microbial method and documented review of deviations.
  • A signed final report supports a defined period, package and temperature. The responsible pharmacist separately approves the actual batch.

Scope

Final editorial decision dated 14 October 2026. This is not a certificate of laboratory results or actual batch release.

Sources and references

  1. ANVISA Formulário Nacional, 2nd edition, revision 02 (2012), historical editionPrinted pp.84–86 / PDF pp.84–862026-10-14
  2. EMA Questions and answers on benzoic acid and benzoates used as excipientsOfficial indexed extract: activity in acidic conditions, pH 2.5–4.52026-10-14
  3. ANVISA Formulário Nacional catalogueCurrent third-edition catalogue; not an exact-formula study2026-10-14

CGR-BR-014

Aluminium hydroxide 6% and magnesium hydroxide 4% w/v suspension

Final editorial decision

Final historical development reference. Preserve the ANVISA 2012 formulation and its provenance. The individual entry specifies room-temperature storage without a numerical period. Sodium benzoate in the ingredient list does not establish adequate preservation in the final antacid matrix. No BUD, batch calculator or dispensing label is issued. Refrigeration or arbitrary acidification changes the evaluated conditions or formulation function and is not adopted as a literature-based solution.

Required evidence

  • Identified master-formula revision, hydroxide grade and potency basis, actual-lot CoAs, final container/closure and dosing device.
  • Approved exact-matrix development report: actual pH, suitable content and acid-neutralisation-capacity methods, withdrawal uniformity, sedimentation/redispersibility, microbial quality and preservation evidence.
  • Actual duration study in final packaging at the claimed temperature. Any proposed refrigeration requires separate physical and dose-delivery suitability at 2–8 °C.

Closure criteria

  • Applicable monograph specifications, methods and per-test limits are approved before the study. Water activity is not used as a substitute for stability or preservation.
  • All required criteria are met through the proposed period, using a suitable microbial method and documented review of deviations.
  • A signed final report supports a defined period, package and temperature. The responsible pharmacist separately approves the actual batch.

Scope

Final editorial decision dated 14 October 2026. This is not a certificate of laboratory results or actual batch release.

Sources and references

  1. ANVISA Formulário Nacional, 2nd edition, revision 02 (2012), historical editionPrinted pp.84–86 / PDF pp.84–862026-10-14
  2. EMA Questions and answers on benzoic acid and benzoates used as excipientsOfficial indexed extract: activity in acidic conditions, pH 2.5–4.52026-10-14
  3. ANVISA Formulário Nacional catalogueCurrent third-edition catalogue; not an exact-formula study2026-10-14

CGR-FR-032

Flucytosine 50 mg/mL oral suspension

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

  1. ANSM hospital-compounding monograph: flucytosine 50 mg/mL oral suspensionpp.1–5; source date discrepancy retained2026-10-14

CGR-ES-047

Water-in-silicone emulsion EX006

Final editorial decision

Final base-development reference — not an executable compounding protocol.

EX006 does not identify its 5% self-emulsifying silicone base. That description does not establish product selection, active content or process. The composition remains a development reference. A specific commercial implementation requires a separate identity, complete technical evidence and the manufacturer's procedure.

AEMPS states 6 calendar months below 30 °C in an opaque jar protected from moisture. This remains source information and is not assigned as an executable BUD for an unidentified base. An external silicone phase does not demonstrate low aw. Adding an active produces a finished preparation requiring its own assessment.

Required evidence

  • AEMPS clarification identifying the exact silicone-base product or separately identified commercial implementation with complete composition/active fraction.
  • Supplier instructions for the exact 5% base, 15% cyclomethicone, 3% glycerol, 2% NaCl and EX001 system; recorded order, temperature, addition rate and mixing.
  • Actual W/Si emulsion-type, uniformity, structure, preservation and container-compatibility evidence throughout the stated period.

Closure criteria

  • Uniquely identified grade with pharmaceutical suitability and demonstrated compatibility; a shared INCI or likely trade name is insufficient.
  • The process and actual results satisfy prospectively approved specifications. Every change is declared an adaptation and every active-containing finished preparation has its own assessment.

Scope

Final editorial decision dated 14 October 2026. This is not a certificate of laboratory results or actual batch release.

Sources and references

  1. AEMPS FN/2003/EX/006, Emulsión A/SPDF p.2, sections 3–7
  2. AEMPS PN/L/FF/002/00, Elaboración de emulsionesPDF pp.3–5; §4.1, 4.4, 4.6
  3. USP General Chapter <795> FAQs, updated 1 November 2023Q52, Q54–56, Q58–65, PDF pp.11–15