Μητρώο πηγών
Πλήρεις παραπομπές και εντοπιστές της έκδοσης.
Πηγές και παραπομπές
- British Pharmacopoeia 2016 — Aqueous Calamine Cream2016PDF pp. 1–1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- FN/2003/PA/028 ÓXIDO DE ZINCΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–2ingredient action2026-09-10
- FN/2003/PA/008 CALAMINAΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–2ingredient action2026-09-10
- PN/L/PG/002/00 INDUMENTARIAΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–5general staff protection2026-09-10
- European Commission SCCS — Opinion on Phenoxyethanol, SCCS/1575/166 October 2016pp. 6–7; physicochemical dataingredient facts2026-09-12
- ILO/WHO — International Chemical Safety Card 0538: 2-PhenoxyethanolAugust 2003Hazards, prevention, physical/chemical propertiesingredient facts2026-09-12
- MHLW — Japanese Pharmacopoeia XVIII: Liquid ParaffinJP XVIII, 2021; English textPrinted p. 1477; Description; Containers and storageraw-material monograph2026-09-12
- 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> FAQsUpdated 1 November 2023Questions 52, 54–56, 60–62; PDF pp. 11–14Primary clarification of aw classification, extension prerequisites and compounded-component BUDs; not automatic Greek legal adoption2026-10-14
- EMA — Excipients in the labelling and package leaflet, Annex Revision 5Published 5 December 2025EN and EL worksheets: arachis oil, wool fat, cetostearyl/cetyl alcohol, chlorocresolCurrent primary excipient warnings; used as a scientific labelling reference, without claiming MAH obligations automatically apply to a compounded prescription2026-10-14
- British Pharmacopoeia 2016 — Aqueous Cream2016PDF pp. 1–1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- MHRA — Aqueous cream: may cause skin irritationMarch 2013 article, published 11 December 2014Sodium lauryl sulfate; leave-on useclinical safety2026-09-12
- MHLW — Japanese Pharmacopoeia XVIII: White PetrolatumJP XVIII, 2021; English textPrinted p. 1501; Description; Containers and storageraw-material monograph2026-09-12
- British Pharmacopoeia 2016 — Emulsifying Ointment2016PDF pp. 1–1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- MHLW — Japanese Pharmacopoeia XVIII: Sodium Lauryl SulfateJP XVIII, 2021; English textPrinted p. 1718; Description; Containers and storageraw-material monograph2026-09-12
- British Pharmacopoeia 2016 — Emulsifying Wax2016PDF pp. 1–2; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- British Pharmacopoeia 2016 — Benzyl Benzoate Application2016PDF pp. 1–1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- FN/2003/PA/004 ALMIDÓN DE TRIGORetrieved source editionSections 4, 6–10ingredient facts2026-09-12
- British Pharmacopoeia 2016 — Buffered Cream2016PDF pp. 1–1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- MHLW — Japanese Pharmacopoeia XVIII: Citric Acid HydrateJP XVIII, 2021; English textPrinted p. 769; Description; Containers and storageraw-material monograph2026-09-12
- British Pharmacopoeia 2016 — Calamine and Coal Tar Ointment2016PDF pp. 1–1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- CDC/NIOSH — Pocket Guide to Chemical Hazards: Ethyl alcoholRetrieved source editionFull cited procedureingredient facts2026-09-12
- British Pharmacopoeia 2016 — Strong Coal Tar Solution2016PDF pp. 1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- MHLW — Japanese Pharmacopoeia XVIII: Polysorbate 80JP XVIII, 2021; English textPrinted p. 1550; Description; Containers and storageraw-material monograph2026-09-12
- British Pharmacopoeia 2016 — Calamine Lotion2016PDF pp. 1–1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- FN/2003/PA/013 GLICEROLΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–2raw material or occupational2026-09-10
- CDC/NIOSH — Pocket Guide to Chemical Hazards: PhenolRetrieved source editionFull cited procedureingredient facts2026-09-12
- FDA — Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene GlycolMay 2023, revision 1Recommendations; section on pharmacy compoundingraw material quality2026-09-12
- British Pharmacopoeia 2016 — Calamine Ointment2016PDF pp. 1–1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- British Pharmacopoeia 2016 — Calcium Hydroxide Solution2016PDF pp. 1–1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- FN/2003/PA/016 HIDRÓXIDO DE CALCIOΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–2raw material or occupational2026-09-10
- British Pharmacopoeia 2016 — Cetomacrogol Emulsifying Ointment2016PDF pp. 1–1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- British Pharmacopoeia 2016 — Cetomacrogol Emulsifying Wax2016PDF pp. 1–2; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- British Pharmacopoeia 2016 — Cetrimide Cream2016PDF pp. 1–1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- Thornton & Ross — Care Antiseptic First Aid Cream, SmPC10 April 2026Sections 2, 5.1 and 6.2; PL 00240/6277Ringredient incompatibilities; not compounded stability2026-09-12
- British Pharmacopoeia 2016 — Compound Zinc Paste2016PDF pp. 1–1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- British Pharmacopoeia 2016 — Dithranol Ointment2016PDF pp. 1–2; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- FDA — Water Activity (aw) in FoodsInspection Technical Guide 39, 16 April 1984; website copy accessed 2026-09-12Definition; sorption behaviour; measurement equipmentMetrological principles only. Food regulatory thresholds and old instrument recommendations are not pharmaceutical BUD rules2026-09-12
- British Pharmacopoeia 2016 — Glycerol Suppositories2016PDF pp. 1–1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- Nakagawa T, Oyama T. Molecular Basis of Water Activity in Glycerol–Water MixturesFrontiers in Chemistry. 2019;7:731Table 1; DOI 10.3389/fchem.2019.00731Full text read. Glycerol/water experimental system; not a stability study of suppositories or starch glycerolate2026-09-12
- British Pharmacopoeia 2016 — Hydrous Ointment2016PDF pp. 1–1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- British Pharmacopoeia 2016 — Wool Alcohols Ointment2016PDF pp. 1–1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- British Pharmacopoeia 2016 — Magnesium Sulfate Paste2016PDF pp. 1–1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- CDC/NIOSH — Pocket Guide to Chemical Hazards: PhenolΔιαθέσιμο κείμενο / Retrieved textOfficial referenceraw material or occupational2026-09-10
- British Pharmacopoeia 2016 — Methyl Salicylate Ointment2016PDF pp. 1–1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- FN/2003/PA/032 SALICILATO DE METILOΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–2raw material or occupational2026-09-10
- British Pharmacopoeia 2016 — Simple Ointment2016PDF pp. 1–1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- British Pharmacopoeia 2016 — Sodium Bicarbonate Ear Drops2016PDF pp. 1–1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- FN/2003/PA/005 BICARBONATO DE SODIOΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–2raw material or occupational2026-09-10
- British Pharmacopoeia 2016 — Syrup2016PDF pp. 1–1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- MHLW — Japanese Pharmacopoeia XVIII: SucroseJP XVIII, 2021; English textPrinted p. 1748; Description; Containers and storageraw-material monograph2026-09-12
- British Pharmacopoeia 2016 — Zinc and Castor Oil Ointment2016PDF pp. 1–1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- FN/2003/PA/031 RICINO, ACEITE VIRGEN DEΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–2raw material or occupational2026-09-10
- British Pharmacopoeia 2016 — Zinc and Coal Tar Paste2016PDF pp. 1–1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- British Pharmacopoeia 2016 — Zinc and Ichthammol Cream2016PDF pp. 1–1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- FN/2003/PA/028 ÓXIDO DE ZINCRetrieved source editionSections 4, 6–10ingredient facts2026-09-12
- British Pharmacopoeia 2016 — Zinc Cream2016PDF pp. 1–1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- FN/2003/PA/016 HIDRÓXIDO DE CALCIORetrieved source editionSections 4, 6–10ingredient facts2026-09-12
- British Pharmacopoeia 2016 — Zinc and Salicylic Acid Paste2016PDF pp. 1–1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- FN/2003/PA/033 SALICÍLICO, ÁCIDOΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–2raw material or occupational2026-09-10
- British Pharmacopoeia 2016 — Zinc Ointment2016PDF pp. 1–1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- British Pharmacopoeia 2016 — Alcoholic Iodine Solution2016PDF pp. 1–1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- FN/2003/PA/018 IODURO DE POTASIOΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–2raw material or occupational2026-09-10
- FN/2003/PA/017 IODOΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–2raw material or occupational2026-09-10
- CDC/NIOSH — Pocket Guide to Chemical Hazards: Ethyl alcoholΔιαθέσιμο κείμενο / Retrieved textOfficial referenceraw material or occupational2026-09-10
- Allan MC, Mauer LJ. Dataset of water activity measurements of alcohol:water solutions using a Tunable Diode LaserData in Brief. 2017;12:364–369Table 1; ethanol/water at 25 °C; DOI 10.1016/j.dib.2017.04.017Full text read. Binary-mixture water activity; volume ratios before mixing, not finished medicinal-product shelf life2026-09-12
- CDC — Chemical Disinfectants: Alcohol28 November 2023; 2008 guidelineAlcohol: Overview and Microbicidal activityAlcohol antimicrobial context; not a finished-product preservative challenge test2026-09-12
- British Pharmacopoeia 2016 — Aqueous Iodine Oral Solution2016PDF pp. 1–1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- British Pharmacopoeia 2016 — Aluminium Acetate Ear Drops2016PDF pp. 1–1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- British Pharmacopoeia 2016 — Flexible Collodion2016PDF pp. 1–2; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- CDC/NIOSH — Pocket Guide to Chemical Hazards: Ethyl etherΔιαθέσιμο κείμενο / Retrieved textOfficial referenceraw material or occupational2026-09-10
- British Pharmacopoeia 2016 — Benzoin Inhalation2016PDF pp. 1–1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- British Pharmacopoeia 2016 — Compound Benzoin Tincture2016PDF pp. 1–1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- British Pharmacopoeia 2016 — Peppermint Spirit2016PDF pp. 1–1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- Formulaire Thérapeutique Magistral, édition 2010 — B-II-1-a.72010PDF pp. 85master formula2026-10-14
- Formulaire Thérapeutique Magistral, édition 2010 — B-II-1-a.92010PDF pp. 87master formula2026-10-14
- MHLW — Japanese Pharmacopoeia XVIII: D-MannitolJP XVIII, 2021; English textPrinted p. 1298; Description; Containers and storageraw-material monograph2026-09-12
- Formulaire Thérapeutique Magistral, édition 2010 — B-I-3-a.102010PDF pp. 46master formula2026-10-14
- MHLW — Japanese Pharmacopoeia XVIII: Methyl ParahydroxybenzoateJP XVIII, 2021; English textPrinted p. 1343; Description; Containers and storageraw-material monograph2026-09-12
- MHLW — Japanese Pharmacopoeia XVIII: Propyl ParahydroxybenzoateJP XVIII, 2021; English textPrinted p. 1601; Description; Containers and storageraw-material monograph2026-09-12
- Formulaire Thérapeutique Magistral, édition 2010 — B-I-3-a.7–82010PDF pp. 43–44master formula2026-10-14
- Formulaire Thérapeutique Magistral, édition 2010 — B-I-3-a.11–122010PDF pp. 47–48master formula2026-10-14
- EMA — Questions and answers on propylene glycol used as an excipient, EMA/CHMP/704195/20139 October 2017Sections 1–3 and annexingredient facts2026-09-12
- MHLW — Japanese Pharmacopoeia XVIII: Propylene GlycolJP XVIII, 2021; English textPrinted p. 1600; Description; Containers and storageraw-material monograph2026-09-12
- Formulaire Thérapeutique Magistral, édition 2010 — B-I-3-a.102010PDF pp. 46master formula2026-09-10
- Formulaire Thérapeutique Magistral, édition 2010 — B-I-3-a.42010PDF pp. 40master formula2026-10-14
- Formulaire Thérapeutique Magistral, édition 2010 — B-II-3-a.22010PDF pp. 104master formula2026-10-14
- Formulaire Thérapeutique Magistral, édition 2010 — D-I-4-d-12010PDF pp. 275–276master formula2026-10-14
- Formulaire Thérapeutique Magistral, édition 2010 — D-II-1-g-12010PDF pp. 377–378master formula2026-10-14
- FN/2003/PA/015 HIDROCORTISONA, ACETATO DEΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–2raw material or occupational2026-09-10
- MHLW — Japanese Pharmacopoeia XVIII: Hydrocortisone AcetateJP XVIII, 2021; English textPrinted p. 1114; Description; Containers and storageraw-material monograph2026-09-12
- Formulaire Thérapeutique Magistral, édition 2010 — B-I-3-a.7–82010PDF pp. 43–44master formula2026-09-10
- Formulaire Thérapeutique Magistral, édition 2010 — D-VI-b-12010PDF pp. 469–470master formula2026-10-14
- FN/2003/PA/039 UREAΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–2raw material or occupational2026-09-10
- Formulaire Thérapeutique Magistral, édition 2010 — B-I-3-a.42010PDF pp. 40master formula2026-09-10
- Formulaire Thérapeutique Magistral, édition 2010 — D-VI-b-22010PDF pp. 473–474master formula2026-10-14
- Formulaire Thérapeutique Magistral, édition 2010 — D-VII-a-12010PDF pp. 487–488master formula2026-10-14
- FN/2003/PA/024 METRONIDAZOLΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–2raw material or occupational2026-09-10
- MHLW — Japanese Pharmacopoeia XVIII: MetronidazoleJP XVIII, 2021; English textPrinted p. 1354; Description; Containers and storageraw-material monograph2026-09-12
- Formulaire Thérapeutique Magistral, édition 2010 — B-I-3-a.11–122010PDF pp. 47–48master formula2026-09-10
- Formulaire Thérapeutique Magistral, édition 2010 — D-VII-d-12010PDF pp. 499–500master formula2026-10-14
- Formulaire Thérapeutique Magistral, édition 2010 — E-I-1-a-12010PDF pp. 521–522master formula2026-10-14
- NIOSH List of Hazardous Drugs in Healthcare Settings, 2024Διαθέσιμο κείμενο / Retrieved textPDF pp. 1–40raw material or occupational2026-09-10
- MHLW — Japanese Pharmacopoeia XVIII: SpironolactoneJP XVIII, 2021; English textPrinted p. 1737; Description; Containers and storageraw-material monograph2026-09-12
- NIOSH List of Hazardous Drugs in Healthcare Settings, 20242024 list; publication 2025-103Table 2, printed pp. 17 and 22Clobazam and spironolactone listing; not a potency or therapeutic efficacy ranking2026-09-12
- Formulaire Thérapeutique Magistral, édition 2010 — F-I-1-b-12010PDF pp. 585–586master formula2026-10-14
- MHLW — Japanese Pharmacopoeia XVIII: OmeprazoleJP XVIII, 2021; English textPrinted p. 1446; Description; Containers and storageraw-material monograph2026-09-12
- Formulaire Thérapeutique Magistral, édition 2010 — H-I-1-a-12010PDF pp. 711–712master formula2026-10-14
- Formulaire Thérapeutique Magistral, édition 2010 — K-I-4-a-12010PDF pp. 871–872master formula2026-10-14
- Formulaire Thérapeutique Magistral, édition 2010 — K-I-4-b-22010PDF pp. 879–880master formula2026-10-14
- Formulaire Thérapeutique Magistral, édition 2010 — L-II-b-12010PDF pp. 933–934master formula2026-10-14
- Formulaire Thérapeutique Magistral, édition 2010 — M-IV-2-b-12010PDF pp. 1037–1038master formula2026-10-14
- MHLW — Japanese Pharmacopoeia XVIII: MiconazoleJP XVIII, 2021; English textPrinted p. 1357; Description; Containers and storageraw-material monograph2026-09-12
- Alcool iodé à 1 pour cent (2007) (15/02/2012)2007PDF pp. 1–2master formula2026-10-14
- Cérat cosmétique (2010) (15/02/2012)2010PDF pp. 1–2master formula2026-10-14
- FN/2003/PA/003 ALMENDRAS, ACEITE VIRGEN DEΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–2raw material or occupational2026-09-10
- FN/2003/PA/006 BÓRAXΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–2raw material or occupational2026-09-10
- MHRA — Emollients and risk of severe and fatal burns: new resources available26 August 2020; updated 20 May 2021Fabric contamination and fire riskclinical safety2026-09-12
- EMA — Excipients in the labelling and package leaflet, Annex Revision 5Published 5 December 2025EN and EL worksheets: boric acid and borates (updated 29 March 2022)Boron exposure/age-specific scientific warnings; dose assessment, not permission to use this formula2026-10-14
- Cérat de Galien (2010) (15/02/2012)2010PDF pp. 1–2master formula2026-10-14
- Cérat de Galien modifié (2010) (15/02/2012)2010PDF pp. 1–2master formula2026-10-14
- Cérat glycériné (2012) (15/02/2012)2012PDF pp. 1–1master formula2026-10-14
- Collodion (1994) (15/02/2012)1994PDF pp. 1–2master formula2026-10-14
- Comprimés placebo à usage thérapeutique (2007) (15/02/2012)2007PDF pp. 1–1master formula2026-10-14
- Crème oléocalcaire (2007) (15/02/2012)2007PDF pp. 1–1master formula2026-10-14
- Gélules de carmin de cochenille (2010) (15/02/2012)2010PDF pp. 1–2master formula2026-10-14
- EFSA — Scientific Opinion on the re-evaluation of cochineal, carminic acid, carmines (E120)2015Conclusions: allergy and proteinaceous impurities; EFSA Journal 13(11):4288Allergen hazard evidence only; food ADI is not a medical diagnostic dose limit2026-10-14
- Gélules de nadolol (1 mg à 50 mg) (2021) (08/01/2021)2021PDF pp. 1–3master formula2026-10-14
- MHLW — Japanese Pharmacopoeia XVIII: NadololJP XVIII, 2021; English textPrinted p. 1394; Description; Containers and storageraw-material monograph2026-09-12
- Glycérolé d'amidon (2007) (15/02/2012)2007PDF pp. 1–2master formula2026-10-14
- Glycérolé à l'oxyde de zinc (2007) (15/02/2012)2007PDF pp. 1–2master formula2026-10-14
- FN/2003/PA/028 ÓXIDO DE ZINCΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–2raw material or occupational2026-09-10
- FN/2003/PA/013 GLICEROLRetrieved source editionSections 4, 6–10ingredient facts2026-09-12
- Gélules placebo à usage thérapeutique (2007) (15/02/2012)2007PDF pp. 1–2master formula2026-10-14
- Gélules de spironolactone 0,5 à 25 mg (2021) (08/01/2021)2021PDF pp. 1–4master formula2026-10-14
- Gélules de chlorure de sodium (0,5 g - 1 g) (2021) (08/01/2021)2021PDF pp. 1–2master formula2026-10-14
- MHLW — Japanese Pharmacopoeia XVIII: Sodium ChlorideJP XVIII, 2021; English textPrinted p. 1702; Description; Containers and storageraw-material monograph2026-09-12
- Gélules de chlorhydrate d'amiodarone (5 mg à 200 mg) (2021) (08/01/2021)2021PDF pp. 1–3master formula2026-10-14
- MHLW — Japanese Pharmacopoeia XVIII: Amiodarone HydrochlorideJP XVIII, 2021; English textPrinted p. 450; Description; Containers and storageraw-material monograph2026-09-12
- Gélules de bicarbonate de sodium (0,125 g - 0.25 g - 0,5 g - 1g) (2007) (15/02/2012)2007PDF pp. 1–2master formula2026-10-14
- Liniment calcaire (2007) (15/02/2012)2007PDF pp. 1–1master formula2026-10-14
- FN/2003/PA/027 OLIVA, ACEITE VIRGEN DEΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–2raw material or occupational2026-09-10
- Pommade à l'acide salicylique (2007) (15/02/2012)2007PDF pp. 1–2master formula2026-10-14
- Pâte à l'oxyde de zinc (2007) (23/10/2020)2007PDF pp. 1–2master formula2026-10-14
- Potion gommeuse (2012) (15/02/2012)2012PDF pp. 1–3master formula2026-10-14
- Sirop simple (1992) (15/02/2012)1992PDF pp. 1–2master formula2026-09-10
- Pommade cupro-zincique (2008) (15/02/2012)2008PDF pp. 1–3master formula2026-10-14
- FN/2003/PA/035 SULFATO DE COBRE PENTAHIDRATOΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–2raw material or occupational2026-09-10
- Pommade camphrée (10 pour cent - 20 pour cent) (2007) (15/02/2012)2007PDF pp. 1–2master formula2026-10-14
- FN/2003/PA/002 ALCANFOR RACÉMICOΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–2raw material or occupational2026-09-10
- Pommade à l'oxyde de zinc (2007) (15/02/2012)2007PDF pp. 1–2master formula2026-10-14
- Pâte zincique à l'eau (2007) (15/02/2012)2007PDF pp. 1–2master formula2026-10-14
- Sirop placebo à usage thérapeutique (2007) (15/02/2012)2007PDF pp. 1–3master formula2026-10-14
- Solution buvable de glycérol à 0,644 g/mL (2014) (01/07/2014)2014PDF pp. 1–2master formula2026-10-14
- FN/2003/EX/002 CREMA BASE DE BEELER2003PDF pp. 1–2master formula2026-10-14
- MHLW — Japanese Pharmacopoeia XVIII: CetanolJP XVIII, 2021; English textPrinted p. 722; Description; Containers and storageraw-material monograph2026-09-12
- FN/2003/EX/025 SOLUCIÓN CONCENTRADA DE HIDROXIBENZOATOS2003PDF pp. 2master formula2026-09-10
- FN/2017/EX/028 AGUA CONSERVANTE SIN PROPILENGLICOL2017PDF pp. 1–2master formula2026-10-14
- PN/L/FF/007/00 ELABORACIÓN DE SOLUCIONESΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–6preparation sop2026-09-10
- PN/L/CP/001/00 DETERMINACIÓN DE PHΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–5qc method2026-09-10
- FN/2019/EX/029 JARABE SIMPLE (84% P/V) CON CONSERVANTE2019PDF pp. 1–2master formula2026-10-14
- PN/L/FF/004/00 ELABORACIÓN DE JARABESΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–6preparation sop2026-09-10
- SEFH — Manual de Farmacotecnia2023p. 71, Table 2; p. 177 preservatives; p. 302 microbiologyProfessional society manual: corroborates EX029 listed ingredient masses; not an AEMPS erratum or stability experiment2026-09-12
- FN/2023/EX/030 GEL DE CARMELOSA SODICA ORAL AL 1%2023PDF pp. 1–2master formula2026-10-14
- PN/L/FF/003/00 ELABORACIÓN DE GELESΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–6preparation sop2026-09-10
- PN/L/CP/003/00 DETERMINACIÓN DE EXTENSIBILIDADΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–6qc method2026-09-10
- FN/2003/FMT/019 METRONIDAZOL, GEL DE2003PDF pp. 1–3master formula2026-10-14
- FN/2014/FMT/022 HIDROCLOROTIAZIDA 2 MG/ML SUSPENSIÓN ORAL2014PDF pp. 1–6master formula2026-10-14
- PN/L/FF/008/00 ELABORACIÓN DE SUSPENSIONESΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–6preparation sop2026-09-10
- MHLW — Japanese Pharmacopoeia XVIII: HydrochlorothiazideJP XVIII, 2021; English textPrinted p. 1112; Description; Containers and storageraw-material monograph2026-09-12
- FN/2018/FMT/024 CAPTOPRIL 1 MG/ML SOLUCIÓN ORAL2018PDF pp. 1–6master formula2026-10-14
- EMA — Questions and answers on benzoic acid and benzoates, EMA/CHMP/508189/20139 October 2017Preservative pH and neonatal safetyingredient facts2026-09-12
- MHLW — Japanese Pharmacopoeia XVIII: Sodium BenzoateJP XVIII, 2021; English textPrinted p. 1698; Description; Containers and storageraw-material monograph2026-09-12
- MHLW — Japanese Pharmacopoeia XVIII: CaptoprilJP XVIII, 2021; English textPrinted p. 622; Description; Containers and storageraw-material monograph2026-09-12
- SEFH Farmacotecnia — Captoprilo 1 mg/mL, solución oral18 December 2021, version 3pp. 1–4: pH ≤3.5, minimal headspace, 3 months / 30 days in usematching master formula and BUD2026-09-12
- FN/2018/FMT/025 FUROSEMIDA 2 MG/ML SOLUCIÓN ORAL2018PDF pp. 1–6master formula2026-10-14
- MHLW — Japanese Pharmacopoeia XVIII: FurosemideJP XVIII, 2021; English textPrinted p. 1049; Description; Containers and storageraw-material monograph2026-09-12
- FN/2021/FMT/036 ENALAPRIL MALEATO 1 MG/ML SOLUCIÓN ORAL2021PDF pp. 1–6master formula2026-10-14
- MHLW — Japanese Pharmacopoeia XVIII: Enalapril MaleateJP XVIII, 2021; English textPrinted p. 924; Description; Containers and storageraw-material monograph2026-09-12
- FN/2003/EX/022 JARABE SIMPLE (84% P/V). Modificado 20202003 / αναθ. 2020PDF pp. 2master formula2026-09-10
- FN/2022/FMT/038 AMLODIPINO 0,5 MG/ML SOLUCIÓN ORAL2022PDF pp. 1–6master formula2026-10-14
- MHLW — Japanese Pharmacopoeia XVIII: Amlodipine BesilateJP XVIII, 2021; English textPrinted p. 456; Description; Containers and storageraw-material monograph2026-09-12
- SEFH Farmacotecnia — Amlodipino 0,5 mg/mL, solución oralPDF accessed 12 September 2026pp. 1–3: 25 mL syrup; 60 days refrigerated; excipient rationalematching master formula and BUD2026-09-12
- FN/2024/FMT/040 HIDROCORTISONA 1 MG/ML SUSPENSIÓN ORAL2024PDF pp. 1–8master formula2026-10-14
- FN/2003/PA/014 HIDROCORTISONAΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–2raw material or occupational2026-09-10
- MHLW — Japanese Pharmacopoeia XVIII: HydrocortisoneJP XVIII, 2021; English textPrinted p. 1113; Description; Containers and storageraw-material monograph2026-09-12
- FN/2024/FMT/041 GABAPENTINA 50 MG/ML SOLUCIÓN ORAL2024PDF pp. 1–6master formula2026-10-14
- SEFH Farmacotecnia — Gabapentina 50 mg/mL, solución oralPDF accessed 12 September 2026pp. 1–4: preparation, pH, container, 60 days / 30 days in usematching master formula and BUD2026-09-12
- FN/2024/FMT/042 CITRATO SÓDICO Y ACIDO CÍTRICO SOLUCIÓN ORAL2024PDF pp. 1–6master formula2026-10-14
- FN/2003/PO/024 SALIVA ARTIFICIAL2003PDF pp. 1–4master formula2026-10-14
- FN/2003/PO/029 UREA, CREMA AL 15% DE2003PDF pp. 1–3master formula2026-10-14
- FN/2006/PO/039 MINOXIDIL AL 2%, SOLUCIÓN DE. Modificado 20242006 / αναθ. 2024PDF pp. 1–4master formula2026-10-14
- British Pharmacopoeia 2016 — Cetrimide Emulsifying Ointment2016PDF pp. 1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- British Pharmacopoeia 2016 — Chloroxylenol Solution2016PDF pp. 1–2; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- British Pharmacopoeia 2016 — Coal Tar Solution2016PDF pp. 1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- British Pharmacopoeia 2016 — Compound Benzoic Acid Ointment2016PDF pp. 1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- MHLW — Japanese Pharmacopoeia XVIII: Benzoic AcidJP XVIII, 2021; English textPrinted p. 523; Description; Containers and storageraw-material monograph2026-09-12
- British Pharmacopoeia 2016 — Compound Aluminium Paste2016PDF pp. 1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- CDC/NIOSH — Pocket Guide to Chemical Hazards: Aluminum (elemental metal)Διαθέσιμο κείμενο / Retrieved textOfficial referenceraw material or occupational2026-09-10
- British Pharmacopoeia 2016 — Compound Glucose, Sodium Chloride and Sodium Citrate Oral Solution2016PDF pp. 1–2; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- British Pharmacopoeia 2016 — Soap Spirit2016PDF pp. 1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- British Pharmacopoeia 2016 — Concentrated Anise Water2016PDF pp. 1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- British Pharmacopoeia 2016 — Concentrated Camphor Water2016PDF pp. 1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- British Pharmacopoeia 2016 — Concentrated Cinnamon Water2016PDF pp. 1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- British Pharmacopoeia 2016 — Benzoic Acid Solution2016PDF pp. 1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- Formulaire Thérapeutique Magistral 2010 — B-I-3-b.3–42010PDF pp. 54–55, 72master formula2026-10-14
- Formulaire Thérapeutique Magistral 2010 — B-I-3-a.92010PDF pp. 45, 63master formula2026-10-14
- Formulaire Thérapeutique Magistral 2010 — D-I-3-a-12010PDF pp. 225–226master formula2026-10-14
- Formulaire Thérapeutique Magistral 2010 — D-I-3-b-12010PDF pp. 237–238master formula2026-10-14
- Formulaire Thérapeutique Magistral 2010 — D-I-3-b-22010PDF pp. 241–242master formula2026-10-14
- Formulaire Thérapeutique Magistral 2010 — B-I-3-b.3–42010PDF pp. 54–55, 72master formula2026-09-10
- Formulaire Thérapeutique Magistral 2010 — D-I-4-b-12010PDF pp. 263–264master formula2026-10-14
- Formulaire Thérapeutique Magistral 2010 — B-I-3-a.92010PDF pp. 45, 63master formula2026-09-10
- Formulaire Thérapeutique Magistral 2010 — D-I-4-b-22010PDF pp. 267–268master formula2026-10-14
- Formulaire Thérapeutique Magistral 2010 — D-I-2-a-12010PDF pp. 209–210master formula2026-10-14
- Formulaire Thérapeutique Magistral 2010 — D-I-2-b-12010PDF pp. 213–214master formula2026-10-14
- FN/2003/PA/012 ERITROMICINAΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–3raw material or occupational2026-09-10
- MHLW — Japanese Pharmacopoeia XVIII: HydroxypropylcelluloseJP XVIII, 2021; English textPrinted p. 1123; Description; Containers and storageraw-material monograph2026-09-12
- Formulaire Thérapeutique Magistral 2010 — D-I-2-b-22010PDF pp. 217–218master formula2026-10-14
- Formulaire Thérapeutique Magistral 2010 — E-I-2-a-12010PDF pp. 527–528master formula2026-10-14
- Formulaire Thérapeutique Magistral 2010 — J-1-b-12010PDF pp. 815–816master formula2026-10-14
- Formulaire Thérapeutique Magistral, édition 2010 — B-II-1-a.92010PDF pp. 87master formula2026-09-10
- Formulaire Thérapeutique Magistral 2010 — I-IV-1-a-12010PDF pp. 787–788master formula2026-10-14
- Formulaire Thérapeutique Magistral 2010 — E-II-a-12010PDF pp. 551–552master formula2026-10-14
- Formulaire Thérapeutique Magistral 2010 — F-V-1-a-12010PDF pp. 621–623master formula2026-10-14
- Formulaire Thérapeutique Magistral 2010 — K-III-a-12010PDF pp. 895–896master formula2026-10-14
- MHLW — Japanese Pharmacopoeia XVIII: AciclovirJP XVIII, 2021; English textPrinted p. 407; Description; Containers and storageraw-material monograph2026-09-12
- Formulaire Thérapeutique Magistral 2010 — K-II-1-a-12010PDF pp. 887–888master formula2026-10-14
- Formulaire Thérapeutique Magistral 2010 — M-I-1-a-12010PDF pp. 959–960master formula2026-10-14
- Formulaire Thérapeutique Magistral 2010 — D-VII-b-12010PDF pp. 491–492master formula2026-10-14
- Formulaire Thérapeutique Magistral 2010 — M-III-3-a-12010PDF pp. 1009–1010master formula2026-09-10
- 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
- FN/2003/EX/001 AGUA CONSERVANTE2003PDF pp. 2master formula2026-09-10
- FN/2003/EX/010 EMULSIÓN O/A NO IÓNICA 12003PDF pp. 2master formula2026-09-10
- FN/2003/EX/011 EMULSIÓN O/A NO IÓNICA 22003PDF pp. 2master formula2026-09-10
- FN/2003/EX/020 GEL NEUTRO2003PDF pp. 2master formula2026-09-10
- FN/2003/FMT/001 ACETATO DE ALUMINIO, SOLUCIÓN DE2003PDF pp. 2–3master formula2026-09-10
- FN/2003/PA/001 ACÉTICO GLACIAL, ÁCIDOΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–2raw material or occupational2026-09-10
- FN/2003/FMT/003 ÁCIDO ACÉTICO, GOTAS ÓTICAS DE2003PDF pp. 2master formula2026-09-10
- FN/2003/FMT/008 GEL ANESTÉSICO DE LIDOCAÍNA2003PDF pp. 2master formula2026-09-10
- FN/2003/PA/020 LIDOCAÍNA, HIDROCLORURO DEΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–2raw material or occupational2026-09-10
- FN/2003/FMT/013 HIDROCORTISONA, CREMA DE2003PDF pp. 2master formula2026-09-10
- FN/2003/FMT/016 LIDOCAÍNA VISCOSA2003PDF pp. 2master formula2026-09-10
- FN/2003/FMT/017 LUGOL DÉBIL, SOLUCIÓN DE. Modificado 20252003 / αναθ. 2025PDF pp. 2master formula2026-09-10
- FN/2019/FMT/026 CLONIDINA CLORHIDRATO 20 MICROGRAMOS (MCG)/ML SOLUCIÓN ORAL2019PDF pp. 2–3master formula2026-09-10
- MHLW — Japanese Pharmacopoeia XVIII: Clonidine HydrochlorideJP XVIII, 2021; English textPrinted p. 789; Description; Containers and storageraw-material monograph2026-09-12
- FN/2020/FMT/027 ISONIAZIDA 50 MG/ML SOLUCIÓN ORAL2020PDF pp. 2master formula2026-09-10
- FN/2020/FMT/028 ETAMBUTOL CLORHIDRATO 50 MG/ML SOLUCIÓN ORAL2020PDF pp. 2master formula2026-09-10
- FN/2020/FMT/029 PIRIDOXINA CLORHIDRATO 25 MG/ML SOLUCIÓN ORAL2020PDF pp. 2master formula2026-09-10
- FN/2020/FMT/030 DEXAMETASONA 1 MG/ML SOLUCIÓN ORAL2020PDF pp. 2master formula2026-09-10
- FN/2021/FMT/032 HIDRALAZINA CLORHIDRATO 10 MG/ML SOLUCIÓN ORAL2021PDF pp. 2master formula2026-09-10
- FN/2021/FMT/033 ÁCIDO FÓLICO 1 MG/ML SOLUCIÓN ORAL2021PDF pp. 2master formula2026-09-10
- FN/2021/FMT/034 TIAMINA CLORHIDRATO 100 MG/ML SOLUCIÓN ORAL2021PDF pp. 2master formula2026-09-10
- FN/2021/FMT/035 RIBOFLAVINA 25 MG/ML SOLUCIÓN ORAL2021PDF pp. 2master formula2026-09-10
- FN/2003/PO/015 CLORHEXIDINA, SOLUCIÓN ACUOSA AL 0,1% DE2003PDF pp. 2master formula2026-09-10
- FN/2003/PA/010 CLORHEXIDINA, DISOLUCIÓN DE DIGLUCONATO DEΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–3raw material or occupational2026-09-10
- FN/2006/PO/038 EOSINA AL 2%, SOLUCIÓN ACUOSA DE2006PDF pp. 2master formula2026-09-10
- FN/2006/PO/042 SULFATO DE ZINC, SOLUCIÓN AL 0,1% DE2006PDF pp. 2master formula2026-09-10
- Japanese Pharmacopoeia XVIII — Absorptive CreamXVIII / 2021 • παλαιότερη / earlierPDF pp. 417 (έντυπη / printed 815)master formula2026-09-10
- PMDA — JP publication schedule / Frequently Asked QuestionsCurrent official schedule, retrieved 14 October 2026JP19 published 10 April 2026; English edition scheduled within one yearEdition status only; not a comparison of individual JP19 monographs2026-10-14
- Japanese Pharmacopoeia XVIII — Hydrophilic CreamXVIII / 2021 • παλαιότερη / earlierPDF pp. 417–418 (έντυπη / printed 815–816)master formula2026-09-10
- MHLW — Japanese Pharmacopoeia XVIII: Stearyl AlcoholJP XVIII, 2021; English textPrinted p. 1744; Description; Containers and storageraw-material monograph2026-09-12
- Japanese Pharmacopoeia XVIII — Macrogol OintmentXVIII / 2021 • παλαιότερη / earlierPDF pp. 3–4 (έντυπη / printed 1286–1287)master formula2026-09-10
- Japanese Pharmacopoeia XVIII — Hydrophilic PetrolatumXVIII / 2021 • παλαιότερη / earlierPDF pp. 219 (έντυπη / printed 1502)master formula2026-09-10
- Nationwide Children’s Hospital — Pharmacy Services, institutional compounding formula10/2025PDF pp. 1–2master formula2026-09-10
- DailyMed / NLM: ACETAZOLAMIDE TABLET [STRIDES PHARMA SCIENCE LIMITED]SPL published Aug 20, 2026Indications / warnings / pharmacologyActive-drug clinical warnings and pharmacology only; not the compounded formula, starting-product interchangeability or stability2026-09-10
- Allen LV Jr, Erickson MA III. Stability of acetazolamide, allopurinol, azathioprine, clonazepam, and flucytosine in extemporaneously compounded oral liquidsPrimary study; abstract readAm J Health Syst Pharm. 1996;53:1944–1949; DOI 10.1093/ajhp/53.16.1944Abstract only; chemical/physical evidence; applicability is appraised in the BUD field2026-09-12
- Nationwide Children’s Hospital — Pharmacy Services, institutional compounding formula01/2026PDF pp. 1–2master formula2026-09-10
- DailyMed / NLM: ALLOPURINOL TABLET [DR. REDDY'S LABORATORIES LIMITED]SPL published Sep 07, 2026Indications / warnings / pharmacologyActive-drug clinical warnings and pharmacology only; not the compounded formula, starting-product interchangeability or stability2026-09-10
- MHLW — Japanese Pharmacopoeia XVIII: AllopurinolJP XVIII, 2021; English textPrinted p. 430; Description; Containers and storageraw-material monograph2026-09-12
- Nationwide Children’s Hospital — Pharmacy Services, institutional compounding formula03/2025PDF pp. 1–2master formula2026-09-10
- DailyMed / NLM: AMIODARONE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]SPL published Aug 07, 2026Indications / warnings / pharmacologyActive-drug clinical warnings and pharmacology only; not the compounded formula, starting-product interchangeability or stability2026-09-10
- Nationwide Children’s Hospital — Pharmacy Services, institutional compounding formula11/2025PDF pp. 1–2master formula2026-09-10
- DailyMed / NLM: ATENOLOL TABLET [REMEDYREPACK INC.]SPL published Sep 07, 2026Indications / warnings / pharmacologyclinical class only2026-09-10
- MHLW — Japanese Pharmacopoeia XVIII: AtenololJP XVIII, 2021; English textPrinted p. 491; Description; Containers and storageraw-material monograph2026-09-12
- Nationwide Children’s Hospital — Pharmacy Services, institutional compounding formula02/2026PDF pp. 1–2master formula2026-09-10
- DailyMed / NLM: BETHANECHOL CHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]SPL published Feb 12, 2026Indications / warnings / pharmacologyclinical class only2026-09-10
- Allen LV Jr, Erickson MA III. Stability of bethanechol chloride, pyrazinamide, quinidine sulfate, rifampin, and tetracycline hydrochloride in extemporaneously compounded oral liquidsPrimary study; abstract readAm J Health Syst Pharm. 1998;55:1804–1809; DOI 10.1093/ajhp/55.17.1804Abstract only; chemical/physical evidence; applicability is appraised in the BUD field2026-09-12
- Nationwide Children’s Hospital — Pharmacy Services, institutional compounding formula05/2020PDF pp. 1–2master formula2026-09-10
- DailyMed / NLM: CARVEDILOL TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY]SPL published Aug 28, 2026Indications / warnings / pharmacologyActive-drug clinical warnings and pharmacology only; not the compounded formula, starting-product interchangeability or stability2026-09-10
- Nationwide Children’s Hospital — Pharmacy Services, institutional compounding formula09/2025PDF pp. 1–2master formula2026-09-10
- DailyMed / NLM: CELECOXIB CAPSULE [MULLAN PHARMACEUTICAL INC.]SPL published Sep 02, 2026Indications / warnings / pharmacologyActive-drug clinical warnings and pharmacology only; not the compounded formula, starting-product interchangeability or stability2026-09-10
- Donnelly RF et al. Stability of celecoxib oral suspensionPrimary study; abstract readCan J Hosp Pharm. 2009;62:464–468; DOI 10.4212/cjhp.v62i6.844Abstract only; chemical/physical evidence; applicability is appraised in the BUD field2026-09-12
- Nationwide Children’s Hospital — Pharmacy Services, institutional compounding formula08/2025PDF pp. 1–2master formula2026-09-10
- DailyMed / NLM: CINACALCET TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]SPL published Aug 31, 2026Indications / warnings / pharmacologyActive-drug clinical warnings and pharmacology only; not the compounded formula, starting-product interchangeability or stability2026-09-10
- Thomson K, Hutchinson DJ, Chablani L. Stability of extemporaneously prepared cinacalcet oral suspensionsPrimary study; abstract readAm J Health Syst Pharm. 2018;75:e236–e240; DOI 10.2146/ajhp170072Abstract only; chemical/physical evidence; applicability is appraised in the BUD field2026-09-12
- Nationwide Children’s Hospital — Pharmacy Services, institutional compounding formula09/2025PDF pp. 1–2master formula2026-09-10
- DailyMed / NLM: LAMOTRIGINE TABLET, FILM COATED, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]SPL published Aug 20, 2026Indications / warnings / pharmacologyActive-drug clinical warnings and pharmacology only; not the compounded formula, starting-product interchangeability or stability2026-09-10
- Nationwide Children’s Hospital — Pharmacy Services, institutional compounding formula01/2025PDF pp. 1–2master formula2026-09-10
- DailyMed / NLM: NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH 107, LLC]SPL published Aug 10, 2026Indications / warnings / pharmacologyActive-drug clinical warnings and pharmacology only; not the compounded formula, starting-product interchangeability or stability2026-09-10
- Geiger CM, Sorenson B, Whaley P. Stability Assessment of 10 Active Pharmaceutical Ingredients Compounded in SyrSpend SFPrimary study; abstract readInt J Pharm Compd. 2015;19:420–427; PMID 26775449Abstract only; chemical/physical evidence; applicability is appraised in the BUD field2026-09-12
- Nationwide Children’s Hospital — Pharmacy Services, institutional compounding formula11/2025PDF pp. 1–2master formula2026-09-10
- DailyMed / NLM: QUINIDINE SULFATE (QUINIDINE SULFATE TABLET) TABLET [EPIC PHARMA, LLC]SPL published Dec 21, 2023Indications / warnings / pharmacologyclinical class only2026-09-10
- Nationwide Children’s Hospital — Pharmacy Services, institutional compounding formula11/2025PDF pp. 1–2master formula2026-09-10
- DailyMed / NLM: RIFABUTIN CAPSULE [REMEDYREPACK INC.]SPL published Sep 02, 2026Indications / warnings / pharmacologyclinical class only2026-09-10
- Haslam JL et al. Stability of rifabutin in two extemporaneously compounded oral liquidsPrimary study; abstract readAm J Health Syst Pharm. 1999;56:333–336; DOI 10.1093/ajhp/56.4.333Abstract only; chemical/physical evidence; applicability is appraised in the BUD field2026-09-12
- Nationwide Children’s Hospital — Pharmacy Services, institutional compounding formula11/2025PDF pp. 1–2master formula2026-09-10
- DailyMed / NLM: TINDAZOLE (TINIDAZOLE) TABLET, FILM COATED [REMEDYREPACK INC.]SPL published Aug 20, 2026Indications / warnings / pharmacologyclinical class only2026-09-10
- Nationwide Children’s Hospital — Pharmacy Services, institutional compounding formula11/2025PDF pp. 1–2master formula2026-09-10
- DailyMed / NLM: VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]SPL published Aug 24, 2026Indications / warnings / pharmacologyActive-drug clinical warnings and pharmacology only; not the compounded formula, starting-product interchangeability or stability2026-09-10
- Allen LV Jr, Erickson MA III. Stability of labetalol hydrochloride, metoprolol tartrate, verapamil hydrochloride, and spironolactone with hydrochlorothiazide in extemporaneously compounded oral liquidsPrimary study; abstract readAm J Health Syst Pharm. 1996;53:2304–2309; DOI 10.1093/ajhp/53.19.2304Abstract only; chemical/physical evidence; applicability is appraised in the BUD field2026-09-12
- IWK Health — Pharmacy, institutional compounding formula13/06/2017PDF pp. 1master formula2026-09-10
- DailyMed / NLM: BACLOFEN TABLET [REMEDYREPACK INC.]SPL published Sep 07, 2026Indications / warnings / pharmacologyclinical class only2026-09-10
- MHLW — Japanese Pharmacopoeia XVIII: BaclofenJP XVIII, 2021; English textPrinted p. 510; Description; Containers and storageraw-material monograph2026-09-12
- Allen LV Jr, Erickson MA III. Stability of baclofen, captopril, diltiazem hydrochloride, dipyridamole, and flecainide acetate in extemporaneously compounded oral liquidsPrimary study; abstract readAm J Health Syst Pharm. 1996;53:2179–2184; DOI 10.1093/ajhp/53.18.2179Abstract only; chemical/physical evidence; applicability is appraised in the BUD field2026-09-12
- IWK Health — Pharmacy, institutional compounding formula02/04/2019PDF pp. 1master formula2026-09-10
- DailyMed / NLM: CLOBAZAM SUSPENSION [SUN PHARMACEUTICAL INDUSTRIES, INC.]SPL published Jul 15, 2026Indications / warnings / pharmacologyActive-drug clinical warnings and pharmacology only; not the compounded formula, starting-product interchangeability or stability2026-09-10
- Buontempo F et al. Extemporaneous clobazam suspensions for paediatric use prepared from commercially available tablets and pure drugPrimary study; abstract readFarm Hosp. 2013;37:103–110; DOI 10.7399/FH.2013.37.2.117Abstract only; chemical/physical evidence; applicability is appraised in the BUD field2026-09-12
- IWK Health — Pharmacy, institutional compounding formula13/06/2017PDF pp. 1master formula2026-09-10
- DailyMed / NLM: DIAZOXIDE SUSPENSION [PAR HEALTH USA, LLC]SPL published Aug 10, 2026Indications / warnings / pharmacologyActive-drug clinical warnings and pharmacology only; not the compounded formula, starting-product interchangeability or stability2026-09-10
- Friciu M et al. Stability of Diazoxide in Extemporaneously Compounded Oral SuspensionsPrimary study; full text readPLoS One. 2016;11:e0164577; methods, figures 4/6, conclusionFull text; chemical/physical evidence; applicability is appraised in the BUD field2026-09-12
- IWK Health — Pharmacy, institutional compounding formula13/06/2017PDF pp. 1master formula2026-09-10
- EMA domperidone-containing medicines referral2014 referralNausea/vomiting and cardiac risk; not historical paediatric dosingclinical context2026-09-10
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- DailyMed / NLM: GLYCOPYRROLATE TABLET [PAR HEALTH USA, LLC]SPL published Aug 06, 2026Indications / warnings / pharmacologyActive-drug clinical warnings and pharmacology only; not the compounded formula, starting-product interchangeability or stability2026-09-10
- Cober MP et al. Stability of extemporaneously prepared glycopyrrolate oral suspensionsPrimary study; abstract readAm J Health Syst Pharm. 2011;68:843–845; DOI 10.2146/100247Abstract only; chemical/physical evidence; applicability is appraised in the BUD field2026-09-12
- IWK Health — Pharmacy, institutional compounding formula20/06/2017PDF pp. 1master formula2026-09-10
- DailyMed / NLM: LISINOPRIL TABLET [REMEDYREPACK INC.]SPL published Aug 06, 2026Indications / warnings / pharmacologyActive-drug clinical warnings and pharmacology only; not the compounded formula, starting-product interchangeability or stability2026-09-10
- Nahata MC et al. Stability of lisinopril in two liquid dosage formsPrimary study; abstract readAnn Pharmacother. 2004;38:396–399; DOI 10.1345/aph.1D415Abstract only; chemical/physical evidence; applicability is appraised in the BUD field2026-09-12
- IWK Health — Pharmacy, institutional compounding formula20/06/2017PDF pp. 1master formula2026-09-10
- DailyMed / NLM: PREDNISONE TABLET [MAJOR PHARMACEUTICALS]SPL published Sep 07, 2026Indications / warnings / pharmacologyActive-drug clinical warnings and pharmacology only; not the compounded formula, starting-product interchangeability or stability2026-09-10
- Friciu M et al. Stability of Prednisone in Oral Mix Suspending VehiclePrimary study; abstract readInt J Pharm Compd. 2015;19:337–339; PMID 26625571Abstract only; chemical/physical evidence; applicability is appraised in the BUD field2026-09-12
- New Zealand Compounding Working Group — NZ standardised oral formulation batch sheet; hosted by PSNZ1.2 / 01/02/2023PDF pp. 1–2master formula2026-09-10
- melatoninΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–14clinical class only2026-09-10
- Johnson CE et al. Stability of an extemporaneous alcohol-free melatonin suspensionPrimary study; abstract readAm J Health Syst Pharm. 2011;68:420–423; DOI 10.2146/ajhp100274Abstract only; chemical/physical evidence; applicability is appraised in the BUD field2026-09-12
- New Zealand Compounding Working Group — NZ standardised oral formulation batch sheet; hosted by PSNZ4.0 / 31/12/2025PDF pp. 1–2master formula2026-09-10
- New Zealand Compounding Working Group — NZ standardised oral formulation batch sheet; hosted by PSNZ1.0 / 04/09/2025PDF pp. 1–2master formula2026-09-10
- DailyMed / NLM: SOTALOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]SPL published Aug 31, 2026Indications / warnings / pharmacologyActive-drug clinical warnings and pharmacology only; not the compounded formula, starting-product interchangeability or stability2026-09-10
- Nahata MC et al. Stability of sotalol in two liquid formulations at two temperaturesPrimary study; abstract readAnn Pharmacother. 2003;37:506–509; DOI 10.1345/aph.1C333Abstract only; chemical/physical evidence; applicability is appraised in the BUD field2026-09-12
- New Zealand Compounding Working Group — NZ standardised oral formulation batch sheet; hosted by PSNZ4.0 / 20/03/2025PDF pp. 1–2master formula2026-09-10
- DailyMed / NLM: TERBINAFINE (TERBINAFINE HYDROCHLORIDE TABLET) TABLET [AMERISYN LLC]SPL published Aug 07, 2026Indications / warnings / pharmacologyActive-drug clinical warnings and pharmacology only; not the compounded formula, starting-product interchangeability or stability2026-09-10
- New Zealand Compounding Working Group — NZ standardised oral formulation batch sheet; hosted by PSNZ3.0 / 21/01/2025PDF pp. 1–2master formula2026-09-10
- DailyMed / NLM: DIPYRIDAMOLE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]SPL published Apr 29, 2026Indications / warnings / pharmacologyclinical class only2026-09-10
- New Zealand Compounding Working Group — NZ standardised oral formulation batch sheet; hosted by PSNZ5.0 / 21/01/2025PDF pp. 1–2master formula2026-09-10
- DailyMed / NLM: FLECAINIDE ACETATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]SPL published Aug 17, 2026Indications / warnings / pharmacologyclinical class only2026-09-10
- MHLW — Japanese Pharmacopoeia XVIII: Flecainide AcetateJP XVIII, 2021; English textPrinted p. 1012; Description; Containers and storageraw-material monograph2026-09-12
- New Zealand Compounding Working Group — NZ standardised oral formulation batch sheet; hosted by PSNZ4.0 / 11/02/2025PDF pp. 1–2master formula2026-09-10
- DailyMed / NLM: PHENOBARBITAL TABLET [REMEDYREPACK INC.]SPL published Sep 03, 2026Indications / warnings / pharmacologyclinical class only2026-09-10
- ANVISA — Formulário Nacional da Farmacopeia Brasileira, 2ª edição, Revisão 02 (2012)2012, 2nd ed., Rev. 02 — supersededPDF pp. 202master formula2026-09-10
- ANVISA — Formulário Nacional da Farmacopeia Brasileira, 2ª edição, Revisão 02 (2012)2012, 2nd ed., Rev. 02 — supersededPDF pp. 203master formula2026-09-10
- ANVISA — Formulário Nacional da Farmacopeia Brasileira, 2ª edição, Revisão 02 (2012)2012, 2nd ed., Rev. 02 — supersededPDF pp. 201master formula2026-09-10
- ANVISA — Formulário Nacional da Farmacopeia Brasileira, 2ª edição, Revisão 02 (2012)2012, 2nd ed., Rev. 02 — supersededPDF pp. 210master formula2026-09-10
- ANVISA — Formulário Nacional da Farmacopeia Brasileira, 2ª edição, Revisão 02 (2012)2012, 2nd ed., Rev. 02 — supersededPDF pp. 180master formula2026-09-10
- ANVISA — Formulário Nacional da Farmacopeia Brasileira, 2ª edição, Revisão 02 (2012)2012, 2nd ed., Rev. 02 — supersededPDF pp. 182master formula2026-09-10
- ANVISA — Formulário Nacional da Farmacopeia Brasileira, 2ª edição, Revisão 02 (2012)2012, 2nd ed., Rev. 02 — supersededPDF pp. 185master formula2026-09-10
- ANVISA — Formulário Nacional da Farmacopeia Brasileira, 2ª edição, Revisão 02 (2012)2012, 2nd ed., Rev. 02 — supersededPDF pp. 174master formula2026-09-10
- ANVISA — Formulário Nacional da Farmacopeia Brasileira, 2ª edição, Revisão 02 (2012)2012, 2nd ed., Rev. 02 — supersededPDF pp. 171master formula2026-09-10
- ANVISA — Formulário Nacional da Farmacopeia Brasileira, 2ª edição, Revisão 02 (2012)2012, 2nd ed., Rev. 02 — supersededPDF pp. 206master formula2026-09-10
- Greenspan L. Humidity fixed points of binary saturated aqueous solutionsJ Res Nat Bur Stand A. 1977;81A:89–96Table 2, sodium chloride, 25 °CPrimary metrology; saturated NaCl equilibrium humidity. US government publication2026-09-12
- ANVISA — Formulário Nacional da Farmacopeia Brasileira, 2ª edição, Revisão 02 (2012)2012, 2nd ed., Rev. 02 — supersededPDF pp. 83master formula2026-09-10
- ANVISA — Formulário Nacional da Farmacopeia Brasileira, 2ª edição, Revisão 02 (2012)2012, 2nd ed., Rev. 02 — supersededPDF pp. 78master formula2026-09-10
- ANVISA — Formulário Nacional da Farmacopeia Brasileira, 2ª edição, Revisão 02 (2012)2012, 2nd ed., Rev. 02 — supersededPDF pp. 84master formula2026-09-10
- ANVISA — Formulário Nacional da Farmacopeia Brasileira, 2ª edição, Revisão 02 (2012)2012, 2nd ed., Rev. 02 — supersededPDF pp. 86master formula2026-09-10
- ANVISA — Formulário Nacional da Farmacopeia Brasileira, 2ª edição, Revisão 02 (2012)2012, 2nd ed., Rev. 02 — supersededPDF pp. 98master formula2026-09-10
- ANVISA — Formulário Nacional da Farmacopeia Brasileira, 2ª edição, Revisão 02 (2012)2012, 2nd ed., Rev. 02 — supersededPDF pp. 196master formula2026-09-10
- ANSM — Monographie de préparation magistrale (outside Formulaire national)v2 • 12/12/2023PDF pp. 1–7; αναλυτικά παραρτήματα / analytical annexesmaster formula2026-09-10
- ANSM — Monographie de préparation magistrale (outside Formulaire national)v1 • 13/04/2026; note v2 • 18/05/2026PDF pp. 1–8; note σελ. / p. 2master formula2026-09-10
- ANSM — Aprépitant 20 mg/mL, suspension buvable à partir de gélules dosées à 80 mgVersion 1, 13 April 2026pp. 1–8; composition, preparation, quality control and storageFull 80 mg capsule monograph; 16 mL vehicle added; bottle net-mass checks2026-09-12
- EDQM PaedForm Working Party — Aprepitant: expert opinion on extemporaneous formulations2024pp. 1–5, formulation comparison and evidence limitationsExpert opinion, not an adopted European Pharmacopoeia monograph. No microbiological/in-use data for the reviewed formulations2026-09-12
- ANSM — Monographie de préparation magistrale (outside Formulaire national)v1 • 14/10/2024PDF pp. 1–7; αναλυτικά παραρτήματα / analytical annexesmaster formula2026-09-10
- 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
- ANSM — Monographie de préparation magistrale (outside Formulaire national)v2 • 16/06/2025PDF pp. 1–9; note 1–6master formula2026-09-10
- ANSM — Note d’informations relatives à la monographie: Sertraline 25 et 50 mg, gélules réalisées à partir de MPUP de sertraline chlorhydrateΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–6technical notice2026-09-10
- ANSM — Monographie de préparation magistrale (outside Formulaire national)v3 • 31/07/2025; note v1 • 31/07/2025PDF pp. 1–7; note 1–5master formula2026-09-10
- FN/2003/EX/003 CREMA CONSISTENTE HIDRÓFILA 1FN/2003 • ηλεκτρονικό κείμενο με NIPO 2020/2022 / electronic text with NIPO 2020/2022PDF pp. 2master formula2026-09-10
- PN/L/FF/002/00 ELABORACIÓN DE EMULSIONESΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–6preparation sop2026-09-10
- FN/2003/EX/004 CREMA CONSISTENTE HIDRÓFILA 2FN/2003 • ηλεκτρονικό κείμενο με NIPO 2020/2022 / electronic text with NIPO 2020/2022PDF pp. 2master formula2026-09-10
- FN/2003/EX/007 EMULSIÓN O/A ANIÓNICAFN/2003 • ηλεκτρονικό κείμενο με NIPO 2020/2022 / electronic text with NIPO 2020/2022PDF pp. 2master formula2026-09-10
- FN/2003/EX/009 EMULSIÓN O/A FLUIDA NO IÓNICAFN/2003 • ηλεκτρονικό κείμενο με NIPO 2020/2022 / electronic text with NIPO 2020/2022PDF pp. 2master formula2026-09-10
- FN/2003/EX/012 EMULSIÓN O/A NO IÓNICA 3FN/2003 • ηλεκτρονικό κείμενο με NIPO 2020/2022 / electronic text with NIPO 2020/2022PDF pp. 2master formula2026-09-10
- FN/2003/EX/005 EMULSIÓN A/OFN/2003 • ηλεκτρονικό κείμενο με NIPO 2020/2022 / electronic text with NIPO 2020/2022PDF pp. 2master formula2026-09-10
- FN/2003/EX/006 EMULSIÓN A/SFN/2003 • ηλεκτρονικό κείμενο με NIPO 2020/2022 / electronic text with NIPO 2020/2022PDF pp. 2master formula2026-09-10
- FN/2003/EX/008 EMULSIÓN O/A FLUIDA ANIÓNICAFN/2003 • ηλεκτρονικό κείμενο με NIPO 2020/2022 / electronic text with NIPO 2020/2022PDF pp. 2master formula2026-09-10
- FN/2003/EX/013 EXCIPIENTE N.º 1 PARA CÁPSULASFN/2003 • ηλεκτρονικό κείμενο με NIPO 2020/2022 / electronic text with NIPO 2020/2022PDF pp. 2master formula2026-09-10
- PN/L/OF/002/00 MEZCLADO DE POLVOSΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–6preparation sop2026-09-10
- FN/2003/EX/014 EXCIPIENTE N.º 2 PARA CÁPSULASFN/2003 • ηλεκτρονικό κείμενο με NIPO 2020/2022 / electronic text with NIPO 2020/2022PDF pp. 2master formula2026-09-10
- MHLW — Japanese Pharmacopoeia XVIII: TalcJP XVIII, 2021; English textPrinted p. 1772; Description; Containers and storageraw-material monograph2026-09-12
- FN/2003/EX/015 GEL ADHESIVO ORALFN/2003 • ηλεκτρονικό κείμενο με NIPO 2020/2022 / electronic text with NIPO 2020/2022PDF pp. 2master formula2026-09-10
- FN/2003/EX/016 GEL DE CARMELOSA SÓDICAFN/2003 • ηλεκτρονικό κείμενο με NIPO 2020/2022 / electronic text with NIPO 2020/2022PDF pp. 2master formula2026-09-10
- FN/2003/EX/017 GEL DE METILCELULOSAFN/2003 • ηλεκτρονικό κείμενο με NIPO 2020/2022 / electronic text with NIPO 2020/2022PDF pp. 2master formula2026-09-10
- FN/2003/EX/018 GEL FLUIDO DE METILCELULOSAFN/2003 • ηλεκτρονικό κείμενο με NIPO 2020/2022 / electronic text with NIPO 2020/2022PDF pp. 2master formula2026-09-10
- FN/2003/EX/019 GEL HIDROALCOHÓLICO DE METILCELULOSAFN/2003 • ηλεκτρονικό κείμενο με NIPO 2020/2022 / electronic text with NIPO 2020/2022PDF pp. 2master formula2026-09-10
- FN/2003/EX/021 GEL NEUTRO HIDROALCOHOLICOFN/2003 • ηλεκτρονικό κείμενο με NIPO 2020/2022 / electronic text with NIPO 2020/2022PDF pp. 2master formula2026-09-10
- FN/2003/EX/023 MAGMA DE BENTONITAFN/2003 • ηλεκτρονικό κείμενο με NIPO 2020/2022 / electronic text with NIPO 2020/2022PDF pp. 2master formula2026-09-10
- FN/2003/EX/026 SOLUCIÓN HIDROALCOHÓLICA 1FN/2003 • ηλεκτρονικό κείμενο με NIPO 2020/2022 / electronic text with NIPO 2020/2022PDF pp. 2master formula2026-09-10
- FN/2003/EX/027 SOLUCIÓN HIDROALCOHÓLICA 2FN/2003 • ηλεκτρονικό κείμενο με NIPO 2020/2022 / electronic text with NIPO 2020/2022PDF pp. 2master formula2026-09-10
- FN/2003/PO/001 ACEITE ALCANFORADOFN/2003 • ηλεκτρονικό κείμενο με NIPO 2020/2022 / electronic text with NIPO 2020/2022PDF pp. 2–3master formula2026-09-10
- FN/2003/PO/003 ACEITE SALICILADO CON ALCOHOLFN/2003 • ηλεκτρονικό κείμενο με NIPO 2020/2022 / electronic text with NIPO 2020/2022PDF pp. 2–4master formula2026-09-10
- FN/2003/PO/004 ACEITE SALICILADO SIN ALCOHOLFN/2003 • ηλεκτρονικό κείμενο με NIPO 2020/2022 / electronic text with NIPO 2020/2022PDF pp. 2–4master formula2026-09-10
- FN/2003/PO/008 AGUA TIMOLADAFN/2003 • ηλεκτρονικό κείμενο με NIPO 2020/2022 / electronic text with NIPO 2020/2022PDF pp. 2–3master formula2026-09-10
- FN/2003/PA/037 TIMOLΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–2raw material or occupational2026-09-10
- FN/2003/PO/012 ALCOHOL MENTOLADO AL 5%FN/2003 • ηλεκτρονικό κείμενο με NIPO 2020/2022 / electronic text with NIPO 2020/2022PDF pp. 2–3master formula2026-09-10
- FN/2003/PA/021 MENTOL RACÉMICOΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–2raw material or occupational2026-09-10
- FN/2003/PO/014 CALAMINA, LOCIÓN DEFN/2003 • ηλεκτρονικό κείμενο με NIPO 2020/2022 / electronic text with NIPO 2020/2022PDF pp. 2–4master formula2026-09-10
- FN/2003/PA/008 CALAMINAΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–2raw material or occupational2026-09-10
- FN/2003/PO/017 PASTA AL AGUAFN/2003 • ηλεκτρονικό κείμενο με NIPO 2020/2022 / electronic text with NIPO 2020/2022PDF pp. 2–3master formula2026-09-10
- PN/L/FF/005/00 ELABORACIÓN DE PASTASΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–6preparation sop2026-09-10
- FN/2003/PO/018 PASTA LASSARFN/2003 • ηλεκτρονικό κείμενο με NIPO 2020/2022 / electronic text with NIPO 2020/2022PDF pp. 2–4master formula2026-09-10
- FN/2003/PO/020 POLVOS DE ÓXIDO DE ZINC MENTOLADOSFN/2003 • ηλεκτρονικό κείμενο με NIPO 2020/2022 / electronic text with NIPO 2020/2022PDF pp. 2–3master formula2026-09-10
- FN/2003/PO/031 VASELINA MENTOLADAFN/2003 • ηλεκτρονικό κείμενο με NIPO 2020/2022 / electronic text with NIPO 2020/2022PDF pp. 2–3master formula2026-09-10
- PN/L/FF/006/00 ELABORACIÓN DE POMADASΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–6preparation sop2026-09-10
- FN/2003/FMT/002 ACETATO DE HIDROCORTISONA Y FENOL, CREMA DEFN/2003/FMT/002Master formula §§3–4; packaging/storage §5; description §6; period §7; use/precautions §§8–12 and patient leafletspecific formulation2026-09-10
- PN/L/FF/002/00 ELABORACIÓN DE EMULSIONESPN/L/FF/002/00§4.3 environment; §4.4 method; §4.6 controlsgeneral procedure2026-09-10
- PN/L/PG/002/00 INDUMENTARIAPN/L/PG/002/00Clothing and protective equipmentgeneral procedure2026-09-10
- FN/2003/PA/028 ÓXIDO DE ZINCFN/2003/PA/028Raw-material properties, handling and incompatibilitiesraw material2026-09-10
- FN/2003/PA/021 MENTOL RACÉMICOFN/2003/PA/021Raw-material properties, handling and incompatibilitiesraw material2026-09-10
- CDC/NIOSH — Pocket Guide to Chemical Hazards: PhenolOfficial agency pageRaw-material properties, handling and incompatibilitiesspecific formulation2026-09-10
- FN/2003/PA/015 HIDROCORTISONA, ACETATO DEFN/2003/PA/015Raw-material properties, handling and incompatibilitiesraw material2026-09-10
- FN/2003/FMT/004 ÁCIDO SALICÍLICO Y TRIAMCINOLONA ACETÓNIDO, CREMA DEFN/2003/FMT/004Master formula §§3–4; packaging/storage §5; description §6; period §7; use/precautions §§8–12 and patient leafletspecific formulation2026-09-10
- FN/2003/PA/033 SALICÍLICO, ÁCIDOFN/2003/PA/033Raw-material properties, handling and incompatibilitiesraw material2026-09-10
- FN/2003/FMT/020 NITRATO DE PLATA, SOLUCIÓN AL 2% DEFN/2003/FMT/020Master formula §§3–4; packaging/storage §5; description §6; period §7; use/precautions §§8–12 and patient leafletspecific formulation2026-09-10
- PN/L/FF/007/00 ELABORACIÓN DE SOLUCIONESPN/L/FF/007/00§4.3 environment; §4.4 method; §4.6 controlsgeneral procedure2026-09-10
- FN/2003/PA/026 NITRATO DE PLATAFN/2003/PA/026Raw-material properties, handling and incompatibilitiesraw material2026-09-10
- FN/2003/PO/013 ALCOHOL TÁNICOFN/2003/PO/013Master formula §§3–4; packaging/storage §5; description §6; period §7; use/precautions §§8–12 and patient leafletspecific formulation2026-09-10
- CDC/NIOSH — Pocket Guide to Chemical Hazards: Ethyl alcoholWeb page reviewed 30 October 2019Physical properties: solubility and vapour pressure; CAS 64-17-5Properties of ethanol raw material; process implications are editorial, not finished-formula stability evidence2026-09-12
- FN/2003/PA/036 TÁNICO, ÁCIDOFN/2003/PA/036Raw-material properties, handling and incompatibilitiesraw material2026-09-10
- FN/2003/PO/022 POMADA ANALGÉSICA DE MENTOL Y SALICILATO DE METILOFN/2003/PO/022Master formula §§3–4; packaging/storage §5; description §6; period §7; use/precautions §§8–12 and patient leafletspecific formulation2026-09-10
- PN/L/FF/006/00 ELABORACIÓN DE POMADASPN/L/FF/006/00§4.3 environment; §4.4 method; §4.6 controlsgeneral procedure2026-09-10
- FN/2003/PA/032 SALICILATO DE METILOFN/2003/PA/032Raw-material properties, handling and incompatibilitiesraw material2026-09-10
- FN/2003/PO/027 SULFATO DE COBRE, SOLUCIÓN AL 0,1% DEFN/2003/PO/027Master formula §§3–4; packaging/storage §5; description §6; period §7; use/precautions §§8–12 and patient leafletspecific formulation2026-09-10
- FN/2003/PA/035 SULFATO DE COBRE PENTAHIDRATOFN/2003/PA/035Raw-material properties, handling and incompatibilitiesraw material2026-09-10
- FN/2006/PO/035 ALCOHOL DE ROMERO AL 5%FN/2006/PO/035Master formula §§3–4; packaging/storage §5; description §6; period §7; use/precautions §§8–12 and patient leafletspecific formulation2026-09-10
- FN/2006/PO/041 POMADA DE BÁLSAMO DE PERÚFN/2006/PO/041Master formula §§3–4; packaging/storage §5; description §6; period §7; use/precautions §§8–12 and patient leafletspecific formulation2026-09-10
- FN/2003/PA/031 RICINO, ACEITE VIRGEN DEFN/2003/PA/031Raw-material properties, handling and incompatibilitiesraw material2026-09-10
- FN/2003/PO/009 ALCOHOL ALCANFORADOFN/2003/PO/009Master formula §§3–4; packaging/storage §5; description §6; period §7; use/precautions §§8–12 and patient leafletspecific formulation2026-09-10
- FN/2003/PA/002 ALCANFOR RACÉMICOFN/2003/PA/002Raw-material properties, handling and incompatibilitiesraw material2026-09-10
- CDC/NIOSH — Pocket Guide to Chemical Hazards: Ethyl alcoholOfficial agency pageRaw-material properties, handling and incompatibilitiesspecific formulation2026-09-10
- FN/2003/PO/026 SOLUCIÓN RUBEFACIENTEFN/2003/PO/026Master formula §§3–4; packaging/storage §5; description §6; period §7; use/precautions §§8–12 and patient leafletspecific formulation2026-09-10
- FN/2003/PA/037 TIMOLFN/2003/PA/037Raw-material properties, handling and incompatibilitiesraw material2026-09-10
- MHLW — JP XVIII: White Ointment JP2021JP XVIII (2021), printed p. 1921; General Rules for Preparations 11-4, p. 20specific formulation2026-09-10
- MHLW — JP XVIII, General Rules for Preparations202111-4 Ointments and 11-2 Cutaneous liquids, printed p. 20; Other Preparations 3 Spirits, p. 22; General Noticesgeneral procedure2026-09-10
- MHLW — JP XVIII: Zinc Oxide Ointment JP 20% w/w2021JP XVIII (2021), printed pp. 1929–1930; General Rules 11-4, p. 20specific formulation2026-09-10
- MHLW — JP XVIII: Ethanol for Disinfection JP2021JP XVIII (2021), printed pp. 966–967; starting Ethanol pp. 964–965specific formulation2026-09-10
- MHLW — JP XVIII: Iodine Tincture JP 6% with potassium iodide 4%2021JP XVIII (2021), printed p. 1170, Iodine Tincturespecific formulation2026-09-10
- FN/2003/PA/017 IODOFN/2003/PA/017Raw-material properties, handling and incompatibilitiesraw material2026-09-10
- FN/2003/PA/018 IODURO DE POTASIOFN/2003/PA/018Raw-material properties, handling and incompatibilitiesraw material2026-09-10
- MHLW — Japanese Pharmacopoeia XVIII: Zinc Oxide Starch Powder JP 50% w/wJP XVIII, 2021; English textPrinted p. 1930; General Rules for Preparations: Powdersmaster formula, description, tests and container2026-09-12
- PN/L/PG/002/00 INDUMENTARIARetrieved source editionFull cited procedureingredient facts2026-09-12
- MHLW — Japanese Pharmacopoeia XVIII: Sulfur and Camphor Lotion JPJP XVIII, 2021; English textPrinted pp. 1756–1757master formula, description, tests and container2026-09-12
- FN/2003/PA/002 ALCANFOR RACÉMICORetrieved source editionSections 4, 6–10ingredient facts2026-09-12
- MHLW — Japanese Pharmacopoeia XVIII: SulfurJP XVIII, 2021; English textPrinted p. 1756; Description; Containers and storageraw-material monograph2026-09-12
- MHLW — Japanese Pharmacopoeia XVIII: Salicylic Acid Spirit JP 3% w/vJP XVIII, 2021; English textPrinted p. 1669; General Rules for Preparations: Spiritsmaster formula, description, tests and container2026-09-12
- FN/2003/PA/033 SALICÍLICO, ÁCIDORetrieved source editionSections 4, 6–10ingredient facts2026-09-12
- MHLW — Japanese Pharmacopoeia XVIII: Salicylated Alum Powder JP 3% w/wJP XVIII, 2021; English textPrinted pp. 1670–1671; General Rules for Preparations: Powdersmaster formula, description, tests and container2026-09-12
- MHLW — Japanese Pharmacopoeia XVIII: Hydrocortisone Acetate 0.5% and Diphenhydramine Base 0.5% Ointment JPJP XVIII, 2021; English textPrinted p. 1115: Hydrocortisone and Diphenhydramine Ointment; General Rules: Ointmentsmaster formula, description, tests and container2026-09-12
- FN/2003/PA/015 HIDROCORTISONA, ACETATO DERetrieved source editionSections 4, 6–10ingredient facts2026-09-12
- MHLW — Japanese Pharmacopoeia XVIII: DiphenhydramineJP XVIII, 2021; English textPrinted p. 870; Description; Containers and storageraw-material monograph2026-09-12
- MHLW — Japanese Pharmacopoeia XVIII: Acrinol Hydrate 1% and Zinc Oxide Ointment JPJP XVIII, 2021; English textPrinted pp. 416–417; Acrinol Hydrate pp. 414–415; General Rules: Ointmentsmaster formula, description, tests and container2026-09-12
- MHLW — Japanese Pharmacopoeia XVIII: Zinc Oxide OilJP XVIII, 2021, English textPrinted p. 1929; PDF p. 646Master formula, description, identification, assay and container2026-09-12
- MHLW — Japanese Pharmacopoeia XVIII: Olive OilJP XVIII, 2021, English textPrinted pp. 2081–2082; PDF pp. 143–144Identity and quality of the selected fixed oil; congealing at 0–6 °C; acid value ≤1.02026-09-12
- MHLW — Japanese Pharmacopoeia XVIII: Acrinol and Zinc Oxide OilJP XVIII, 2021, English textPrinted pp. 415–416; PDF pp. 17–18Master formula, description, identification, assay and container2026-09-12
- ANSM — Alcool coloré bleu patenté V (60 pour cent V/V) (2010) (15/02/2012)2010p 1 Definition; p 1 Production; p 1 Characters; pp 1–2 Identification/Test/Assay; p 2 Therapeutic classExact master formula, preparation, specifications and stated storage2026-10-14
- PIC/S — Guide to Good Practices for the Preparation of Medicinal Products in Healthcare EstablishmentsPE 010-4, 2014Chapters 3–6; Annex 2Process records, facilities, contamination control and release; not a product stability study2026-10-13
- USP expert presentation — Nonsterile Compounding: Beyond-use dates14 September 2023PDFpp 10–11, slides 19–22Public official expert explanation of USP 795 default categories; no exact-product experimental evidence2026-10-13
- INRS — Éthanol, fiche toxicologique 48November 2019pp 1–3 and recommendationspp 7–9Ethanol identity, volatility, flammability and handling; pure-substance properties are not finished-product measurements2026-10-13
- EMA/European Commission — Excipients in labelling and the package leaflet, annexRevision 5,5 December 2025English worksheet: ethanol rows 38–43; wool fat row 114Excipient labelling; not efficacy or stability of this compound2026-10-13
- USP — General Chapter <795> Frequently Asked QuestionsNovember 1, 2023 FAQ; rechecked 14 October 2026Questions 52, 54–56, 61, 64–66General category/extension rules only; not exact-product stability evidence.2026-10-14
- ANSM — Bâtons au nitrate d'argent à 633 mg/g (2012) (15/02/2012)2012p 1 Definition; p 1 Production; pp 1–2 Identification/Assay; p 2 Conservation; p 2 PrecautionsExact master formula, preparation, specifications and stated storage2026-10-14
- ILO/WHO — International Chemical Safety Card 1116, silver nitrateApril 2024Hazards, chemical dangers and environmentRaw silver-nitrate occupational and environmental hazards2026-10-13
- ILO/WHO — International Chemical Safety Card 0184, potassium nitrateOctober 2001Hazards, chemical dangers and exposureRaw potassium-nitrate oxidant and dust hazards2026-10-13
- ANSM — Pommade à l'argent colloïdal (2007) (15/02/2012)2007p 1 Definition; p 1 Preparation; pp 1–2 Identification/Test/Assay; p 1 Preparation versus p 2 Conservation; p 2 Therapeutic classExact master formula, preparation, specifications and stated storage2026-10-14
- WHO/IPCS — Silver and silver compounds: environmental aspectsCICAD 44;2002Environmental exposure and risk characterizationControl of silver-containing waste; does not establish topical efficacy or finished-mixture CLP class2026-10-13
- ANSM — Teinture d'aubépine (1989) (14/02/2012)1989p 1 opening recipe; p 1 opening procedure; pp 1–2 Characters/Identification/Test; 2 ConservationExact master formula, preparation, specifications and stated storage2026-10-14
- EMA — Guideline on quality of herbal medicinal products/traditional herbal medicinal productsEMA/HMPC/CHMP/CVMP/201116/2005 Rev 3;18 January 2022Herbal-substance/preparation control, specifications and stability sectionsBotanical identity, fingerprints, extraction specifications and stability principles2026-10-13
- EMA/HMPC — Crataegus spp., folium cum floreEMA/HMPC/159075/2014; adopted 2016§2 preparations;§4.1–4.9Exact herbal-preparation scope, traditional indications and clinical precautions;2025 draft is not substituted for this adopted text2026-10-13
- ANSM — Teinture d'hamamelis (1989) (14/02/2012)1989p 1 opening recipe; p 1 opening procedure; pp 1–2 Characters/Identification/Test; 2 ConservationExact master formula, preparation, specifications and stated storage2026-10-14
- EMA/HMPC — Hamamelis virginiana L., foliumEMA/HMPC/114586/2008; adopted 2009§2 preparations;§4.1–4.9Fresh/dried leaf and extraction-solvent distinctions; no automatic dose transfer2026-10-13
- ANSM — Extrait d'aubepine (fluide) (1989) (14/02/2012)1989p 1 opening recipe; p 1 opening procedure; pp 1–2 Characters/Identification/Test; 2 ConservationExact master formula, preparation, specifications and stated storage2026-10-14
- ANSM — Extrait d'hamamélis fluide (1989) (14/02/2012)1989p 1 opening recipe; p 1 opening procedure; pp 1–2 Characters/Identification/Test; 2 ConservationExact master formula, preparation, specifications and stated storage2026-10-14
- ANSM — Extrait de passiflore fluide (1992) (14/02/2012)1992p 1 opening recipe; p 1 opening procedure; pp 1–3 Characters/Identification/Test/Assay; 3 ConservationExact master formula, preparation, specifications and stated storage2026-10-14
- EMA/HMPC — Passiflora incarnata L., herbaEMA/HMPC/669740/2013; adopted 2014§2 preparations;§4.1–4.9Extract-specific traditional-use scope; French 1:1/60% preparation does not match listed 1:1 solvents2026-10-14
- AEMPS — Formulario Nacional — FN/2003/FMT/005 ÁCIDO SALICÍLICO Y TRIAMCINOLONA ACETÓNIDO, GEL DECurrent AEMPS standalone PDF; code FN/2003/FMT/005PDF p 2 §§3–7; subsequent safety and patient informationExact formulation, process, source shelf life and formulation-specific precautions; independent factual compilation, not official translation.2026-10-14
- DailyMed — Triamcinolone acetonide cream USP 0.1%, NuCare labelRetrieved 13 October 2026Clinical pharmacology; precautions/general and paediatric useActive-class dermal absorption and steroid toxicity. Commercial cream is not the AEMPS gel; potency or BUD is not transferred.2026-10-13
- CDC/NIOSH Pocket Guide — Ethyl alcoholPage reviewed 30 October 2019; retrieved 13 October 2026Flammability, incompatibilities and personal protectionEthanol raw-material handling; not a measured flash point or hazard classification of the finished mixture.2026-10-13
- USP — Compounding Standards and Beyond-Use DatesNovember 2022 USP publication, public copy hosted by Mississippi Boardp 2 nonsterile comparison tableGeneral category limits only; not product-specific stability, antimicrobial effectiveness or Greek law.2026-10-13
- AEMPS — Formulario Nacional — FN/2003/FMT/006 COLODIÓN CON ÁCIDO SALICÍLICO Y ÁCIDO LÁCTICOCurrent AEMPS standalone PDF; code FN/2003/FMT/006PDF p 2 §§3–7; subsequent safety and patient informationExact formulation, process, source shelf life and formulation-specific precautions; independent factual compilation, not official translation.2026-10-14
- CDC/NIOSH Pocket Guide — Ethyl etherPage reviewed 30 October 2019; retrieved 13 October 2026CAS 60-29-7; incompatibilities, fire risk, exposure and protectionDiethyl ether raw-material hazards; no finished-product stability/BUD claim.2026-10-13
- Thornton & Ross — Duofilm SmPCText revised 25 June 2021; retrieved 13 October 2026§§4.3–4.6 and 6.1Primary authorised product information for a different salicylic/lactic collodion. Corroborates local toxicity precautions; composition, dose, shelf life and solvent percentage are not transferred.2026-10-13
- AEMPS — Formulario Nacional — FN/2003/FMT/007 ERITROMICINA, CREMA DECurrent AEMPS standalone PDF; code FN/2003/FMT/007PDF p 2 §§3–7; subsequent safety and patient informationExact formulation, process, source shelf life and formulation-specific precautions; independent factual compilation, not official translation.2026-10-14
- AEMPS — Formulario Nacional — FN/2003/EX/010 EMULSIÓN O/A NO IÓNICA 1Current AEMPS standalone PDF; code FN/2003/EX/010PDF p 2 §§3–7; subsequent safety and patient informationExact formulation, process, source shelf life and formulation-specific precautions; independent factual compilation, not official translation.2026-10-13
- NICE NG 198 — Acne vulgaris: managementCurrent recommendation retrieved 13 October 2026Recommendation 1.5.11; rationale on antibiotic monotherapyOfficial clinical guideline: avoid antibiotic monotherapy for acne; no formulation or stability claim. Indexed official recommendation and rationale retrieved; direct page access intermittently 403.2026-10-13
- DailyMed — ERYGEL erythromycin topical gel 2% labelLabel revisedJune 2018; listing marketing end 30 September 2025; retrieved 13 October 2026Description, contraindications, warnings, precautionsPrimary archived product label supporting erythromycin identity/solubility and topical safety, not evidence of current marketing or this cream BUD.2026-10-13
- AEMPS — Formulario Nacional — FN/2003/EX/001 AGUA CONSERVANTECurrent AEMPS standalone PDF; code FN/2003/EX/001PDF p 2 §§3–7; subsequent safety and patient informationExact formulation, process, source shelf life and formulation-specific precautions; independent factual compilation, not official translation.2026-10-14
- AEMPS — Formulario Nacional: HIDROCLORURO DE METADONA, SOLUCIÓN AL 1% DEFN/2003/FMT/011; current standalone PDF retrieved 2026-10-13PDF p. 2, sections 3–7; subsequent clinical and patient sectionsExact master formula, preparation, source specifications, container and source-specific period; independently adapted, not an official translation2026-10-14
- AEMPS CIMA — Eptadone 5 mg/mL solución oral, SmPCCurrent CIMA version retrieved 2026-10-13Sections 4.1–4.9Current oral-methadone pharmacological hazards only; different strength/excipients; no formulation or BUD transfer2026-10-13
- Álvaro-Alonso EA et al. — Physicochemical and Microbiological Stability of Two Oral Solutions of Methadone Hydrochloride 10 mg/mLMolecules 2022;27: 2812. DOI 10.3390/molecules 27092812; full textTable 1, sections 2.2–2.4 and 3; M 1 onlyMatching API/strength/water composition; previously sterilized amber-glass containers; 91-day study; pH and process differences prevent unconditional extension2026-10-14
- Ministerio de Sanidad — Guía de buenas prácticas de preparación de medicamentos en servicios de farmacia hospitalariaJune 2014; official AEMPS copyAnnexes 3–4, PDF pp. 51–58; especially pp. 54–57Risk-based controls, nonsterile preparation, packaging, independent checks and conservative fallback; Spanish hospital guidance, not Greek legislation2026-10-13
- AEMPS — Formulario Nacional: HIDROCLORURO DE MORFINA, SOLUCIÓN ORAL DEFN/2003/FMT/012; current standalone PDF retrieved 2026-10-13PDF p. 2, sections 3–7; subsequent clinical and patient sectionsExact master formula, preparation, source specifications, container and source-specific period; independently adapted, not an official translation2026-10-14
- AEMPS CIMA — Oramorph 20 mg/mL solución oral, SmPCCurrent CIMA version retrieved 2026-10-13Sections 4.3–4.9; substance/route scope onlyOral morphine hazards and interactions; commercial product is morphine sulfate with different excipients; no salt-equivalence, dose or stability transfer2026-10-13
- Pourroy B et al. — Availability of Morphine Oral Solution for Childhood Cancer Patients in Low-Income Countries: Compounding and Stability Study in a Cote d’Ivoire University Teaching HospitalJ Pain Symptom Manage 2020;59: e 10–e 13. DOI 10.1016/j.jpainsymman.2019.10.005Bibliographic record retrieved; publisher search extract identifies 1 mg/mL; full text not available in this reviewStudy identified but not sufficiently matched or fully appraised; does not support extending this 10 mg/mL hydrochloride formula2026-10-13
- AEMPS — Formulario Nacional — FN/2003/FMT/015 LIDOCAÍNA COMPUESTA, SUSPENSIÓN BUCAL DECurrent AEMPS standalone PDF; code FN/2003/FMT/015PDF p 2 §§3–7; subsequent safety and patient informationExact formulation, process, source shelf life and formulation-specific precautions; independent factual compilation, not official translation.2026-10-14
- DailyMed — Lidocaine viscous 2% label, RemedyRepackUpdated 3 September 2026Boxed warning; warnings; precautions/information for patientsMucosal lidocaine systemic toxicity and 60-minute post-use food restriction; different 2% product, no direct efficacy orBUD equivalence.2026-10-13
- DailyMed — Diphenhydramine HCl oral solution 12.5 mg/5 mLCurrent label retrieved 13 October 2026Warnings: drowsiness, alcohol/sedatives and other diphenhydramine productsSwallowed diphenhydramine safety; not clinical validation of this buccal mixture.2026-10-13
- FDA — Do not use oral viscous lidocaine for teething painSafety communication 26 June 2014; retrieved 13 October 2026Safety announcement and information for health professionalsPaediatric teething hazard;2% marketed oral viscous product. No dosing orBUD transfer.2026-10-13
- AEMPS — Formulario Nacional: FENOBARBITAL 10 MG/ML SOLUCIÓN ORALFN/2021/FMT/031; current standalone PDF retrieved 2026-10-13PDF p. 2, sections 3–7; subsequent clinical and patient sectionsExact master formula, preparation, source specifications, container and source-specific period; independently adapted, not an official translation2026-10-14
- AEMPS CIMA — Gardenal 50 mg comprimidos, SmPCCurrent CIMA version retrieved 2026-10-13Sections 4.3–4.9Phenobarbital clinical hazards only; tablet excipients, tablet dose and shelf life do not transfer2026-10-13
- AEMPS — FN/2017/EX/028 Agua conservante sin propilenglicolCurrent standalone AEMPS PDF; retrieved 2026-10-13PDF p.2, composition and observationsExact preservative-water dependency; paraben amounts and documented pH activity range, not final-product AET2026-10-14
- FDA — Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene GlycolMay 2023 Revision 1SectionsI andIV; recommendations covering pharmacy compoundersSpecific glycerol/noncrystallising sorbitol quality and supply-chain risk; US recommendations, not Greek statutory requirements2026-10-13
- AEMPS — Formulario Nacional, FN/2003/FMT/037: Hidrato de cloral, enemaModificado 2022PDF pp. 2–4; §§3–12 and patient leafletExact master formula, source method, container, 15-day closed-container period and route-specific safety2026-10-14
- MHRA — Chloral hydrate, cloral betaine (Welldorm): restriction of paediatric indication6 October 2021Advice for healthcare professionals; Off-label use for sedation in childrenCurrent clinical context; prolonged metabolite half-life in infants. UK oral-product authorisation is not a rectal authorisation.2026-10-13
- ILO/WHO — International Chemical Safety Card 0234: Chloral hydrateApril 2013 card; accessed 2026Prevention; Chemical dangers; Exposure and health effectsOccupational handling of chloral hydrate CAS 302-17-0; raw-material hazards, not a finished-mixture CLP classification.2026-10-13
- Marlborough Pharmaceuticals — Chloral Hydrate 500 mg/5 mL Oral Solution, SmPCSmPC revised 17 August 2026; emc update 24 August 2026Sections 4.1–4.6, 4.8, 5.2Authorised oral-product safety. Its excipients, dosing and shelf-life are not substituted for this compounded formulation.2026-10-13
- Yoshida N, Arai K, Kohda Y. Stability of Chloral Hydrate in Aqueous Solution for Rectal Use. Jpn J Hosp Pharm. 2000;26: 198–2012000; DOI 10.5649/jjphcs 1975.26.198Full text pp.198–201, especially preparation p.199 and Tables 1–25% chloral hydrate in distilled water for injection, without acacia or saline; nonmatching formulation. Chemical assay and pH, not preservation validation.2026-10-13
- AEMPS — Formulario Nacional, FN/2003/FMT/039: Hidrato de cloral, jarabeModificado 2022PDF pp.2–6; §§3–12 and patient leafletExact 10% preserved master formula; pH 4–5; amber glass; 90-day closed and 30-day in-use periods; neonatal vehicle variation requires separate assessment2026-10-14
- AEMPS — Formulario Nacional, FN/2019/EX/029: Jarabe simple (84% P/V) con conservante2019 monograph, public standalone PDFPDF p.2; §§3–8Dependency CGR-ES-003: sucrose vehicle with methyl- and propylparaben. Its characteristics and period do not independently validate the finished medicated syrup.2026-10-14
- Bustos-Fierro C et al. Stability evaluation of 7% chloral hydrate syrup contained in mono and multi-dose bottles under room and refrigeration conditions. Farm Hosp. 2013;37: 4–92013; DOI 10.7399/FH.2013.37.1.96Full text pp.4–9; Materials and Methods, Tables 1–2 and AppendixPrimary 7% syrup study with different vehicle/flavour/pH; not a matched study for the AEMPS 10% preserved strawberry formula.2026-10-13
- AEMPS, Formulario Nacional — ACEITE GOMENOLADO (FN/2003/PO/002)FN/2003 source identifier; current standalone official PDF accessed 2026-10-13PDF pp. 2–3; composition, specific method, storage, validity and patient leafletMaster composition, preparation and source-specific conditions. Independently written factual adaptation; not an official translation or endorsement. No laboratory testing performed for this document.2026-10-14
- French public medicines database — HUILE GOMENOLEE 2 POUR CENT, solution pour instillation nasale, SmPCSmPC 17 February 2026; page accessed 13 October 2026Sections 2, 4.3–4.6, 6.1Identification of pharmaceutical niaouli essential oil (Melaleuca quinquenervia) and terpene-related hazards. This nasal medicine has an additional excipient and is not the Spanish cutaneous formula; its doses, age limit and shelf life are not transferred.2026-10-13
- AEMPS — Elaboración de soluciones (PN/L/FF/007/00)Official FN procedure, version 00, accessed 2026-10-13Sections 5–6: environment, preparation, packaging, finished-product checksOfficial general dosage-form procedure; exact formula method takes precedence; batch-level tests are distinct from tests actually performed.2026-10-13
- USP — Compounding Standards and Beyond-Use DatesNovember 2022 update, official USP fact sheet hosted by Mississippi Board of PharmacyNonsterile preparation BUD overview and category tableGeneral BUD framework; an AEMPS source period is not automatically a USP–NF monograph exception, and no measured water activity is implied.2026-10-13
- AEMPS, Formulario Nacional — ÁCIDO TÁNICO, SOLUCIÓN DE (FN/2003/PO/005)FN/2003 source identifier; current standalone official PDF accessed 2026-10-13PDF pp. 2–3; composition, specific method, storage, validity and patient leafletMaster composition, preparation and source-specific conditions. Independently written factual adaptation; not an official translation or endorsement. No laboratory testing performed for this document.2026-10-14
- AEMPS — Ácido tánico (FN/2003/PA/036)FN/2003; standalone official PDF accessed 2026-10-13PDF p. 2Raw-material identity, physical properties, incompatibilities and route-specific precautions; raw-material assay limits are not finished-product specifications.2026-10-13
- AEMPS — Glicerol (FN/2003/PA/013)FN/2003; standalone official PDF accessed 2026-10-13PDF p. 2Raw-material identity, physical properties, incompatibilities and route-specific precautions; raw-material assay limits are not finished-product specifications.2026-10-13
- ILO/WHO International Chemical Safety Card 0044 — Ethanol (anhydrous)May 2018Identity; hazards/prevention; physical properties; chemical dangers; notesOccupational hazards of the identified raw material. Neat-material flash points and toxicity are not measured finished-mixture properties.2026-10-13
- ILO/WHO International Chemical Safety Card 0624 — GlycerolApril 2006Identity; hazards/prevention; physical properties; chemical dangers; notesOccupational hazards of the identified raw material. Neat-material flash points and toxicity are not measured finished-mixture properties.2026-10-13
- AEMPS, Formulario Nacional — AGUA BORICADA (FN/2003/PO/006)FN/2003 source identifier; current standalone official PDF accessed 2026-10-13PDF pp. 2–3; composition, specific method, storage, validity and patient leafletMaster composition, preparation and source-specific conditions. Independently written factual adaptation; not an official translation or endorsement. No laboratory testing performed for this document.2026-10-14
- AEMPS — Ácido bórico (FN/2003/PA/007)FN/2003; standalone official PDF accessed 2026-10-13PDF p. 2Raw-material identity, physical properties, incompatibilities and route-specific precautions; raw-material assay limits are not finished-product specifications.2026-10-13
- ILO/WHO International Chemical Safety Card 0991 — Boric acidApril 2014Identity; hazards/prevention; physical properties; chemical dangers; notesOccupational hazards of the identified raw material. Neat-material flash points and toxicity are not measured finished-mixture properties.2026-10-13
- EMA — Boric acid and borate used as excipients: supporting report, Rev. 1EMA/CHMP/765436/2012 Rev.1, 11 November 2021; published 28 July 2022Summary; pharmacokinetics and dermal absorption; developmental/reproductive toxicity; pp. 3–6 and safety discussionBoron toxicology and exposure assessment. Excipient guidance does not itself establish an active topical product dose, BUD or an efficacy claim.2026-10-13
- AEMPS, Formulario Nacional — ALCOHOL BORICADO (A SATURACIÓN) (FN/2003/PO/010)FN/2003 source identifier; current standalone official PDF accessed 2026-10-13PDF pp. 2–3; composition, specific method, storage, validity and patient leafletMaster composition, preparation and source-specific conditions. Independently written factual adaptation; not an official translation or endorsement. No laboratory testing performed for this document.2026-10-14
- AEMPS, Formulario Nacional — ALCOHOL IODADO (FN/2003/PO/011)FN/2003 source identifier; current standalone official PDF accessed 2026-10-13PDF pp. 2–4; composition, specific method, storage, validity and patient leafletMaster composition, preparation and source-specific conditions. Independently written factual adaptation; not an official translation or endorsement. No laboratory testing performed for this document.2026-10-14
- AEMPS — Iodo (FN/2003/PA/017)FN/2003; standalone official PDF accessed 2026-10-13PDF p. 2Raw-material identity, physical properties, incompatibilities and route-specific precautions; raw-material assay limits are not finished-product specifications.2026-10-13
- ILO/WHO International Chemical Safety Card 0167 — IodineApril 2004Identity; hazards/prevention; physical properties; chemical dangers; notesOccupational hazards of the identified raw material. Neat-material flash points and toxicity are not measured finished-mixture properties.2026-10-13
- AEMPS, Formulario Nacional — GLICEROLADO DE ALMIDÓN (FN/2003/PO/016)FN/2003 source identifier; current standalone official PDF accessed 2026-10-13PDF pp. 2–3; composition, specific method, storage, validity and patient leafletMaster composition, preparation and source-specific conditions. Independently written factual adaptation; not an official translation or endorsement. No laboratory testing performed for this document.2026-10-14
- AEMPS — Almidón de trigo (FN/2003/PA/004)FN/2003; standalone official PDF accessed 2026-10-13PDF p. 2Raw-material identity, physical properties, incompatibilities and route-specific precautions; raw-material assay limits are not finished-product specifications.2026-10-13
- AEMPS — Elaboración de geles (PN/L/FF/003/00)Official FN procedure, version 00, accessed 2026-10-13Sections 5–6: environment, preparation, packaging, finished-product checksOfficial general dosage-form procedure; exact formula method takes precedence; batch-level tests are distinct from tests actually performed.2026-10-13
- AEMPS, Formulario Nacional — PERMANGANATO DE POTASIO, SOLUCIÓN AL 1/10.000 DE (FN/2003/PO/019)FN/2003 source identifier; current standalone official PDF accessed 2026-10-13PDF pp. 2–4; composition, specific method, storage, validity and patient leafletMaster composition, preparation and source-specific conditions. Independently written factual adaptation; not an official translation or endorsement. No laboratory testing performed for this document.2026-10-14
- AEMPS — Permanganato de potasio (FN/2003/PA/029)FN/2003; standalone official PDF accessed 2026-10-13PDF p. 2Raw-material identity, physical properties, incompatibilities and route-specific precautions; raw-material assay limits are not finished-product specifications.2026-10-13
- ILO/WHO International Chemical Safety Card 0672 — Potassium permanganateNovember 2016Identity; hazards/prevention; physical properties; chemical dangers; notesOccupational hazards of the identified raw material. Neat-material flash points and toxicity are not measured finished-mixture properties.2026-10-13
- NHS England — Inadvertent oral administration of potassium permanganateNatPSA/2022/003/NHSPS, 5 April 2022pp. 1–2, alert and required actionsCurrent route, ingestion-prevention, storage and patient-information controls for topical potassium permanganate; not a stability study.2026-10-13
- AEMPS, Formulario Nacional — POMADA ALCANFORADA (FN/2003/PO/021)FN/2003 source identifier; current standalone official PDF accessed 2026-10-13PDF pp. 2–3; composition, specific method, storage, validity and patient leafletMaster composition, preparation and source-specific conditions. Independently written factual adaptation; not an official translation or endorsement. No laboratory testing performed for this document.2026-10-14
- AEMPS — Alcanfor racémico (FN/2003/PA/002)FN/2003; standalone official PDF accessed 2026-10-13PDF p. 2Raw-material identity, physical properties, incompatibilities and route-specific precautions; raw-material assay limits are not finished-product specifications.2026-10-13
- ILO/WHO International Chemical Safety Card 1021 — CamphorJuly 2003Identity; hazards/prevention; physical properties; chemical dangers; notesOccupational hazards of the identified raw material. Neat-material flash points and toxicity are not measured finished-mixture properties.2026-10-13
- AEMPS — Elaboración de pomadas (PN/L/FF/006/00)Official FN procedure, version 00, accessed 2026-10-13Sections 5–6: environment, preparation, packaging, finished-product checksOfficial general dosage-form procedure; exact formula method takes precedence; batch-level tests are distinct from tests actually performed.2026-10-13
- AEMPS — Formulario Nacional: POVIDONA IODADA, SOLUCIÓN DEFN/2003/PO/023; current standalone PDFPDF p.2 formula/method/container/BUD; subsequent patient and safety sectionsMaster formula; independently adapted, not an official translation2026-10-14
- AEMPS CIMA — Betadine 100 mg/mL solución cutánea, SmPCText revisionAugust 2022; retrieved 2026-10-13Sections 4.3–4.6,6.1–6.2Current topical-povidone-iodine hazards/incompatibilities; commercial excipients, container and 2-year shelf life do not transfer2026-10-13
- Ministerio de Sanidad — Guía de buenas prácticas de preparación de medicamentos en servicios de farmacia hospitalariaJune 2014; official AEMPS copyAnnexes 3–4, PDF pp.51–58Nonsterile preparation risk assessment, equipment, packaging and quality controls; not Greek legislation2026-10-13
- AEMPS — Formulario Nacional, FN/2003/PA/030 Povidona iodadaCurrent standalone PDF retrieved 13 October 2026PDF p. 2, sections 3–5 and 10–11Raw-material identity, dry-basis available-iodine specification, solubility, light/closure protection and incompatibilities; not final-product BUD or clinical-dose authorisation2026-10-13
- AEMPS — Formulario Nacional: SOLUCIÓN PARA GARGARISMOS (FN/2003/PO/025)2003 source code; current standalone PDF accessed 2026PDF pp.2–3, §§3–12 and patient leafletExact formula, process, finished appearance, source dating and route-specific precautions.2026-10-14
- EMA — Questions and answers on boric acid and borates used as excipients, Rev.1Adopted 11 November 2021; published 26 July 2022pp.3–6; §3, §5 and conversion annexBoron toxicity, age-related exposure warnings and conversion factors. Excipient guidance informs safety appraisal; not authorisation of these boron-active preparations.2026-10-13
- ILO/WHO — ICSC 0567: Sodium borate, decahydrateApril 2014Chemical identity; prevention; exposure effectsCAS 1303-96-4; borax hydrate identity and occupational handling.2026-10-13
- AEMPS — FN/2003/PA/006: Bórax2003 source code; current standalone PDFPDF p.2, §§3–10Decahydrate identity; pharmacotechnical and safety information. Historical use descriptions do not override current boron safety appraisal.2026-10-13
- ABDA/AMK — Bedenkliche Rezepturarzneimittel, Stand Juni 20251 July 2025Recommendations; table entry Borsäure sowie deren Ester und SalzePrimary professional safety position: benefit–risk concerns and boron thresholds. German context, not Greek law and not a globally binding ban.2026-10-13
- Medsafe — Boron-containing excipients and fertility concerns, MARC 18610 June 2021pp.4–6, 14–18Regulatory evidence review and absorption uncertainty; its quoted 2017 warning wording is superseded by EMA Rev.1.2026-10-13
- AEMPS — Formulario Nacional: TALCO MENTOLADO (FN/2003/PO/028)2003 source code; current standalone PDF accessed 2026PDF pp.2–3, §§3–12 and patient leafletExact formula, process, finished appearance, source dating and route-specific precautions.2026-10-14
- AEMPS — FN/2003/PA/021: Mentol racémico2003 source code; current standalone PDFPDF p.2 §§3–10Racemic identity, approximately 34 °C melting point, solubility, eutectic incompatibilities and avoidance of nasal/mucosal contact.2026-10-13
- AEMPS/BOE — Formulario Nacional, second edition, October 2019 updateOctober 2019Printed p.515 (PDF 529); patient leaflet p.517 (PDF 531)Historical factual corroboration only: talco mentolado explicitly 1%, menthol 1 g/talc to 100 g. No protected layout or prose reproduced.2026-10-14
- IARC — Volume 136: evaluation of talc and acrylonitrile5 July 2024pp.1–3, talc evaluationTalc Group 2A hazard evaluation; separate from asbestos-containing talc. Hazard classification is not an individual dose-risk estimate.2026-10-13
- FDA — TalcCurrent page accessed 13 October 2026Asbestos: what it is and how to prevent its occurrence; testing summariesPotential asbestos contamination and importance of material selection/testing. Cosmetic surveillance does not validate a pharmaceutical batch.2026-10-13
- CDC/NIOSH — Talc, containing no asbestos and less than 1% quartzPocket Guide page accessed 13 October 2026Exposure routes, symptoms, target organs, preventionOccupational respirable-dust hazard; not NIOSH hazardous-drug classification.2026-10-13
- AEMPS — Formulario Nacional: VASELINA BORICADA (FN/2003/PO/030)2003 source code; current standalone PDF accessed 2026PDF pp.2–3, §§3–12 and patient leafletExact formula, process, finished appearance, source dating and route-specific precautions.2026-10-14
- ILO/WHO — ICSC 0991: Boric acidApril 2014Prevention; chemical dangers; exposure effectsCAS 10043-35-3; occupational dust and reproductive hazards; raw-material precautions.2026-10-13
- MHRA — Emollients: risk of severe and fatal burns18 December 2018Advice for healthcare professionals and patientsFire risk from paraffin-containing residues on clothing, bedding and dressings.2026-10-13
- AEMPS — Formulario Nacional: VASELINA SALICÍLICAFN/2003/PO/032; current standalone PDFPDF p.2 formula/method/container/BUD; subsequent patient and safety sectionsMaster formula; independently adapted, not an official translation2026-10-14
- ILO/WHO — ICSC0563 Salicylic acidNovember 2023Handling, classification, chemical properties and exposure effectsRaw salicylic acid powder hazards; not finished 5% mixture classification or BUD2026-10-13
- MHRA — Emollients: risk of severe and fatal burns18 December 2018; clarification 26 August 2020Advice for healthcare professionals; mechanism of riskFabric-residue ignition risk, including paraffin-containing preparations; not finished-product flash-point measurement2026-10-13
- AEMPS — Formulario Nacional: AGUA DE ALIBOURFN/2006/PO/034; current standalone PDFPDF p.2 formula/method/container/BUD; subsequent patient and safety sectionsMaster formula; independently adapted, not an official translation2026-10-14
- ILO/WHO — ICSC1416 Copper(II) sulfate pentahydrateNovember 2023Hazards, handling, storage, environmental effectsHydrated copper-salt occupational hazard; not a classification of finished diluted mixture2026-10-13
- ILO/WHO — ICSC0349 Zinc sulfate heptahydrateOctober 2001; current cardHandling, physical properties, environmentExact hydrated zinc-salt hazard; not finished-product stability2026-10-13
- ILO/WHO — ICSC1021 CamphorJuly 2003; current official card retrieved 2026Properties, handling and health effects; note on racemic formCamphor volatility/limited water solubility and ingestion/exposure hazards, not formulation stability2026-10-13
- ILO/WHO — ICSC0044 Ethanol (anhydrous)May 2018Fire/explosion; handling; chemical incompatibilitiesRaw ethanol hazards; numerical anhydrous flash point is not assigned to finished mixtures2026-10-13
- AEMPS — Formulario Nacional: ALCOHOL GLICERINADOFN/2006/PO/036; current standalone PDFPDF p.2 formula/method/container/BUD; subsequent patient and safety sectionsMaster formula; independently adapted, not an official translation2026-10-14
- AEMPS — FN/2003/EX/027 Solución hidroalcohólica 2Current standalone sourcePDFp.2 composition/methodVehicle component charges 70 mL ethanol 96% plus 30 mL water; no final-volume top-up specified2026-10-13
- FDA — DEG/EG testing of high-risk components including glycerinMay 2023 Revision 1SectionsI andIVGlycerol raw-material identity, supply-chain and DEG/EG controls; not a Greek statutory requirement2026-10-13
- NICE — CG179 Pressure ulcers: prevention and managementCurrent official indexed recommendations retrieved 2026-10-13Adult and paediatric recommendations on skin massage; official indexed search text retrieved, full-page fetch blockedDo not offer skin massage/rubbing for pressure-ulcer prevention; not evidence for this historical formula2026-10-13
- NHS — Sore nipples, Best Start in LifeCurrent public guidance retrieved 2026-10-13Causes and early assessmentNipple pain often requires attachment/clinical assessment; does not validate glycerinated alcohol2026-10-13
- AEMPS — Formulario Nacional: CREMA ANALGÉSICA DE SALICILATO DE METILO, MENTOL Y ALCANFORFN/2006/PO/037; current standalone PDFPDF p.2 formula/method/container/BUD; subsequent patient and safety sectionsMaster formula; independently adapted, not an official translation2026-10-14
- AEMPS — FN/2003/EX/011 Emulsión O/A no iónica 2Current standalone sourcePDFp.2 entire base formulaExact cetearyl alcohol/liquid paraffin/polysorbate 80/propylene glycol/preserved-water base; not finished analgesic preservation validation2026-10-13
- Health Canada — Safety review of menthol/methyl salicylate/capsaicin topical pain relievers and serious skin burns13 February 2017; page 4 May 2017Key messages and conclusionsClass safety signal for menthol-containing topical products; no frequency or efficacy claim for this exact formula2026-10-13
- FDA — Clinical Review NDA22029/S-012 Salonpas20 February 2013Section 8 postmarketing experience; heat/burn discussionHeat-associated topical salicylate/menthol harm; patch composition/efficacy and age authorisation do not transfer2026-10-13
- AEMPS — Formulario Nacional: POLVOS PÉDICOS (FN/2006/PO/040)2006 source code; current standalone PDF accessed 2026PDF pp.2–3, §§3–12 and patient leafletExact formula, process, finished appearance, source dating and route-specific precautions.2026-10-14
- AEMPS — FN/2003/PA/037: Timol2003 source code; current standalone PDFPDF p.2 §§3–10Thymol solubility, ingestion hazard and incompatibilities; does not establish efficacy or BUD of the powder.2026-10-13
- CDC/NIOSH — Ethyl alcoholPocket Guide page reviewed 30 October 2019Physical properties; flammability; incompatibilitiesEthanol raw solvent hazard; not a measured classification of the finished powder.2026-10-13
- AEMPS — Formulario Nacional — ÁLOE DE BARBADOS, CAPSULAS DURAS DEFN/2003/POF/001; standalone PDF in current official catalogue; NIPO 134-20-002-3 / 090-22-245-5PDF p.2, §§3–7; subsequent precautions and patient leafletExact capsule composition, process, packaging, storage and source period; historical clinical instructions reassessed against HMPC2026-10-14
- EMA/HMPC — Aloe barbadensis Mill., folii succus siccatusEMA/HMPC/625788/2015; final, 22 November 2016§§2–4; §5.3Adopted clinical and safety assessment; only the herbal preparation and route specified in that document2026-10-14
- AEMPS — Elaboración de cápsulas durasPN/L/FF/001/00; current official standalone PDFPDF pp.3–5, §§4.2–4.6Preparation environment, volume-based capsule selection, encapsulation and source QC requirements2026-10-13
- EMA — Guideline on quality of herbal medicinal products/traditional herbal medicinal productsEMA/HMPC/CHMP/CVMP/201116/2005 Rev.3; final 18 January 2022§§3,5,7,8; PDF pp.5–15Herbal-material identity, standardisation, contaminants, finished-product controls and stability principles; not a numerical BUD study for this capsule2026-10-13
- AEMPS — Mezclado de polvosPN/L/OF/002/00; current official standalone PDFPDF pp.3–5, §§4.2–4.4Powder mixing, dilution sequence, cross-contamination controls and drying after cleaning2026-10-13
- AEMPS — IndumentariaPN/L/PG/002/00; current official standalone PDFPDF p.3, §4Clothing, gloves and eye/respiratory protection during powder handling2026-10-13
- AEMPS — Herbal starting material Aloe barbadensis Mill., folii succus siccatusFN/2003/PAF/002PDF p.2, §§3–5; §10Starting-material definition, source assay basis and handling; historical clinical paragraphs are not used in preference to newer HMPC safety assessment2026-10-14
- AEMPS — EtiquetadoPN/L/PG/008/00; current official standalone PDFPDF pp.3–4, §4Label identifiers and patient instructions; Spanish procedural model adapted independently2026-10-13
- AEMPS — Excipiente n.º1 para cápsulasFN/2003/EX/013PDF p.2, §§3–7Microcrystalline cellulose 98.05% +colloidal anhydrous silica 1.95% powder blend; exact dependency CGR-ES-0492026-10-13
- USP compounding update — public NABP webinar handout14 September 2023; presentation by USP expertsPDF pp.10–11, slides 19–22Public explanation of aw-dependent BUD categories; not the full licensed chapter, not a Greek legal requirement and not stability evidence for this capsule2026-10-13
- AEMPS — Formulario Nacional — CÁSCARA SAGRADA, CÁPSULAS DURAS DEFN/2003/POF/002; standalone PDF in current official catalogue; NIPO 134-20-002-3 / 090-22-245-5PDF p.2, §§3–7; subsequent precautions and patient leafletExact capsule composition, process, packaging, storage and source period; historical clinical instructions reassessed against HMPC2026-10-14
- EMA/HMPC — Rhamnus purshiana DC. / Frangula purshiana (DC.) A. Gray, cortexEMA/HMPC/726270/2016; final revision 1, 6 May 2020§§2–4; §5.3Adopted clinical and safety assessment; only the herbal preparation and route specified in that document2026-10-13
- AEMPS — Herbal starting material Rhamnus purshiana DC. / Frangula purshiana (DC.) A. Gray, cortexFN/2003/PAF/003PDF p.2, §§3–5; §10Starting-material definition, source assay basis and handling; historical clinical paragraphs are not used in preference to newer HMPC safety assessment2026-10-14
- AEMPS — Formulario Nacional — CORTEZA DE FRÁNGULA, CÁPSULAS DURAS DEFN/2003/POF/003; standalone PDF in current official catalogue; NIPO 134-20-002-3 / 090-22-245-5PDF p.2, §§3–7; subsequent precautions and patient leafletExact capsule composition, process, packaging, storage and source period; historical clinical instructions reassessed against HMPC2026-10-14
- EMA/HMPC — Rhamnus frangula L. / Frangula alnus Mill., cortexEMA/HMPC/726261/2016; final revision 1, 25 September 2019§§2–4; §5.3Adopted clinical and safety assessment; only the herbal preparation and route specified in that document2026-10-13
- AEMPS — Herbal starting material Rhamnus frangula L. / Frangula alnus Mill., cortexFN/2003/PAF/004PDF p.2, §§3–5; §10Starting-material definition, source assay basis and handling; historical clinical paragraphs are not used in preference to newer HMPC safety assessment2026-10-14
- AEMPS Formulario Nacional — FN/2003/POF/004 Cutícula de ispágula, polvo para suspensión oral deSourceFN/2003; current standalone PDF reviewed 13 October 2026PDF pp.2–4; process/storage/validity; patient leaflet p.4 corroborates 60 gCurrent factual process and patient composition; current master-table quantity discrepancy is not adopted; reference 8 provides actual historical master quantity2026-10-14
- AEMPS Formulario Nacional — FN/2003/PAF/009 Ispágula, cutícula seminal deFN/2003; current official standalone PDF reviewed 13 October 2026PDF pp.2–3; plant part, identity, RFE1334 and handlingPlantago ovata seed husk, rather than whole seed; older clinical doses independently reassessed2026-10-14
- EMA/HMPC — Community herbal monograph on Plantago ovata Forssk., seminis tegumentum14 May 2013; EMA/HMPC/199774/2012PDF pp.3–8; indications, form, doses, contraindications and occupational allergyCurrent adopted husk-specific scientific reference; not authorisation or exact-blend stability evidence2026-10-13
- EMA — Guideline on quality of herbal medicinal products/traditional herbal medicinal products, revision 318 January 2022; EMA/HMPC/CHMP/CVMP/201116/2005 Rev.3PDF pp.9–10 and 12–16; sections 5.1,7,8Identity, contaminants, justified specifications, chromatographic fingerprint and multi-component stability principles; numerical shelf life not supplied2026-10-13
- USP Compounding Expert Committee — USP Compounding Webinar, NABP public handout14 September 2023; primary-author public educational handoutPDF pp.10–11, slides 19–22General aw-dependent BUD framework comparator; not full licensed USP795 text, Greek law, or measured stability/aw for this formulation2026-10-13
- AEMPS — PN/L/OF/002/00 Mezclado de polvosPN/L/OF/002/00; current official PDF reviewed 2026-10-13PDF pp.3–5; environment, mixing and cleaningPowder blending, cross-contamination prevention, equipment and complete drying2026-10-13
- EMA — Annex to European Commission excipient labelling guideline, Revision 5SANTE-2017-11668, Revision 5; published 5 December 2025English worksheet, rows 47–50: fructose declaration, exposure and hereditary fructose intoleranceCurrent fructose labelling/clinical precautions; not a product-specific BUD or efficacy approval2026-10-13
- AEMPS/BOE — Formulario Nacional,2 nd edition, October 2019 official publicationSecond edition; October 2019 updatePrinted p.609; PDF p.623; FN/2003/POF/004§§3.1–3.2Historical quantitative facts:60 g husk and correct raw-material identities. No publisher erratum or permission to reproduce the bound book is claimed. No protected prose/layout is reproduced.2026-10-14
- AEMPS — Formulario Nacional — EXTRACTO SECO DE CORTEZA DE FRÁNGULA, CÁPSULAS DURAS DEFN/2003/POF/005; standalone PDF in current official catalogue; NIPO 134-20-002-3 / 090-22-245-5PDF p.2, §§3–7; subsequent precautions and patient leafletExact capsule composition, process, packaging, storage and source period; historical clinical instructions reassessed against HMPC2026-10-14
- EMA/HMPC — Rhamnus frangula L., cortex; Frangulae corticis extractum siccum normatumEMA/HMPC/726261/2016; final revision 1, 25 September 2019§§2–4; §5.3Adopted clinical and safety assessment; only the herbal preparation and route specified in that document2026-10-13
- AEMPS — Herbal starting material Rhamnus frangula L., cortex; Frangulae corticis extractum siccum normatumFN/2003/PAF/005PDF p.2, §§3–5; §10Starting-material definition, source assay basis and handling; historical clinical paragraphs are not used in preference to newer HMPC safety assessment2026-10-14
- AEMPS — Formulario Nacional — EXTRACTO SECO DE HOJA DE SEN, CÁPSULAS DURAS DEFN/2003/POF/006; standalone PDF in current official catalogue; NIPO 134-20-002-3 / 090-22-245-5PDF p.2, §§3–7; subsequent precautions and patient leafletExact capsule composition, process, packaging, storage and source period; historical clinical instructions reassessed against HMPC2026-10-14
- EMA/HMPC — Senna alexandrina Mill. (Cassia senna L.; Cassia angustifolia Vahl), folium, dry extractEMA/HMPC/625849/2015; final, 25 September 2018, published PDF 2020§§2–4; §5.3Adopted clinical and safety assessment; only the herbal preparation and route specified in that document2026-10-13
- AEMPS — Herbal starting material Senna alexandrina Mill. (Cassia senna L.; Cassia angustifolia Vahl), folium, dry extractFN/2003/PAF/012PDF p.2, §§3–5; §10Starting-material definition, source assay basis and handling; historical clinical paragraphs are not used in preference to newer HMPC safety assessment2026-10-14
- Araujo R et al. — A comparative study of hard gelatin and hypromellose capsules containing a dry extract of sennaIndian Journal of Pharmaceutical Sciences 82(4),2020,pp.718–723; full publisher PDF retrieved through web readerMethods and Tables 1–2Different strength/excipient/shell: comparative stability evidence, not a BUD or aw measurement for POF 0062026-10-13
- Meier N et al. — Photostability of sennosides and their aglycones in solutionPhytochemical Analysis 35(3): 521–529,2024; first online 10 January 2024Publisher abstract and supporting-information description retrieved; full article not inspectedAnalytical-solution photostability, not dry-capsule storage or BUD2026-10-13
- AEMPS — Formulario Nacional — FRUTO DE HINOJO, CÁPSULAS DURAS DEFN/2003/POF/007; standalone PDF in current official catalogue; NIPO 134-20-002-3 / 090-22-245-5PDF p.2, §§3–7; subsequent precautions and patient leafletExact capsule composition, process, packaging, storage and source period; historical clinical instructions reassessed against HMPC2026-10-14
- EMA/HMPC — European Union herbal monograph on Foeniculum vulgare Miller subsp. vulgare var. dulce (Mill.) Batt. & Trab., fructus, Revision 1EMEA/HMPC/372839/2016; final revision 1, 31 January 2024§§2–4; §5.3; fennel additionally §6Adopted clinical and safety assessment; only the herbal preparation and route specified in that document2026-10-13
- AEMPS — Herbal starting material Foeniculum vulgare Mill. subsp. vulgare var. vulgare OR var. dulce, fructusFN/2003/PAF/008PDF p.2, §§3–5; §10Starting-material definition, source assay basis and handling; historical clinical paragraphs are not used in preference to newer HMPC safety assessment2026-10-14
- EMA/HMPC — Foeniculum vulgare subsp. vulgare var. vulgare, fructusEMA/HMPC/372841/2016; final revision 1,31 January 2024§§2–4,5.3,6Bitter-fennel tea scope, allergy, estragole and pregnancy/lactation precautions; not capsule efficacy or stability2026-10-13
- AEMPS Formulario Nacional — FN/2003/POF/008 HOJA DE GAYUBA, CÁPSULAS DURAS DESource code FN/2003; current standalone official PDF retrieved 13 October 2026PDF pp.2–3; sections 3–12Exact master formula, process, storage, source validity period; older clinical details reassessed using reference 32026-10-14
- AEMPS Formulario Nacional — FN/2003/PAF/006 GAYUBA, HOJA DESource code FN/2003; official standalone PDF retrieved 13 October 2026PDF p.2; identity, composition, raw-material specification and handlingBotanical raw-material identity and source-era specifications; current pharmacopoeial specification must be consulted before acceptance2026-10-14
- EMA/HMPC — European Union/Community herbal monograph on Arctostaphylos uva-ursi (L.) Spreng., folium30 January 2018; EMA/HMPC/750269/2016, revision 2PDF pp.3–7; preparation categories, sections 4.1–4.8Current adopted regulator monograph for specific plant part and preparation; not approval of this compounded product or product-specific stability evidence2026-10-13
- AEMPS — PN/L/FF/001/00 Elaboración de cápsulas durasPN/L/FF/001/00; official standalone PDF retrieved 13 October 2026PDF pp.4–5; sections 4.3–4.6Capsule preparation, measured bulk-volume approach, environment, mass uniformity, disintegration and microbiological controls2026-10-13
- AEMPS Formulario Nacional — FN/2003/POF/009 HOJA DE ORTOSIFÓN, CÁPSULAS DURAS DESource code FN/2003; current standalone official PDF retrieved 13 October 2026PDF pp.2–3; sections 3–12Exact master formula, process, storage, source validity period; older clinical details reassessed using reference 32026-10-14
- AEMPS Formulario Nacional — FN/2003/PAF/010 ORTOSIFÓN, HOJA DESource code FN/2003; official standalone PDF retrieved 13 October 2026PDF p.2; identity, composition, raw-material specification and handlingBotanical raw-material identity and source-era specifications; current pharmacopoeial specification must be consulted before acceptance2026-10-14
- EMA/HMPC — European Union/Community herbal monograph on Orthosiphon aristatus (Blume) Miq. var. aristatus, folium22 September 2021; EMA/HMPC/486551/2020, revision 1PDF pp.3–7; preparation categories, sections 4.1–4.8Current adopted regulator monograph for specific plant part and preparation; not approval of this compounded product or product-specific stability evidence2026-10-13
- AEMPS Formulario Nacional — FN/2003/POF/010 HOJA DE ROMERO, CÁPSULAS DURAS DESource code FN/2003; current standalone official PDF retrieved 13 October 2026PDF pp.2–3; sections 3–12Exact master formula, process, storage, source validity period; older clinical details reassessed using reference 32026-10-14
- AEMPS Formulario Nacional — FN/2003/PAF/011 ROMERO, HOJA DESource code FN/2003; official standalone PDF retrieved 13 October 2026PDF p.2; identity, composition, raw-material specification and handlingBotanical raw-material identity and source-era specifications; current pharmacopoeial specification must be consulted before acceptance2026-10-14
- EMA/HMPC — European Union/Community herbal monograph on Rosmarinus officinalis L., folium29 May 2024; EMA/HMPC/513940/2021, revision 1PDF pp.3–8; preparation categories, sections 4.1–4.8Current adopted regulator monograph for specific plant part and preparation; not approval of this compounded product or product-specific stability evidence2026-10-14
- AEMPS — Formulario Nacional — HOJA DE SEN, CÁPSULAS DURAS DEFN/2003/POF/011; standalone PDF in current official catalogue; NIPO 134-20-002-3 / 090-22-245-5PDF p.2, §§3–7; subsequent precautions and patient leafletExact capsule composition, process, packaging, storage and source period; historical clinical instructions reassessed against HMPC2026-10-14
- EMA/HMPC — Senna alexandrina Mill. (Cassia senna L.; Cassia angustifolia Vahl), foliumEMA/HMPC/625849/2015; final, 25 September 2018, published PDF 2020§§2–4; §5.3Adopted clinical and safety assessment; only the herbal preparation and route specified in that document2026-10-13
- AEMPS — Herbal starting material Senna alexandrina Mill. (Cassia senna L.; Cassia angustifolia Vahl), foliumFN/2003/PAF/013PDF p.2, §§3–5; §10Starting-material definition, source assay basis and handling; historical clinical paragraphs are not used in preference to newer HMPC safety assessment2026-10-14
- Goppel M, Franz G — Stability control of senna leaves and senna extractsPlanta Medica 70(5): 432–436,2004; doi: 10.1055/s-2004-818971Retrieved abstract onlyStorage/packaging and degradation differ between powdered leaf and extract; no exact capsule BUD established2026-10-13
- AEMPS Formulario Nacional — FN/2003/POF/012 POLVO DE AJO, CÁPSULAS DURAS DESource code FN/2003; current standalone official PDF retrieved 13 October 2026PDF pp.2–3; sections 3–12Exact master formula, process, storage, source validity period; older clinical details reassessed using reference 32026-10-14
- AEMPS Formulario Nacional — FN/2003/PAF/001 AJO, POLVO DESource code FN/2003; official standalone PDF retrieved 13 October 2026PDF p.2; identity, composition, raw-material specification and handlingBotanical raw-material identity and source-era specifications; current pharmacopoeial specification must be consulted before acceptance2026-10-14
- EMA/HMPC — European Union/Community herbal monograph on Allium sativum L., bulbus18 July 2017; EMA/HMPC/7685/2013, final adopted text; subsequent draft is not substitutedPDF pp.3–7; preparation categories, sections 4.1–4.8Current adopted regulator monograph for specific plant part and preparation; not approval of this compounded product or product-specific stability evidence2026-10-13
- AEMPS Formulario Nacional — FN/2003/POF/013 RAÍZ DE HARPAGOFITO, CÁPSULAS DURAS DESource code FN/2003; current standalone official PDF retrieved 13 October 2026PDF pp.2–3; sections 3–12Exact master formula, process, storage, source validity period; older clinical details reassessed using reference 32026-10-14
- AEMPS Formulario Nacional — FN/2003/PAF/007 HARPAGOFITO, RAÍZ DESource code FN/2003; official standalone PDF retrieved 13 October 2026PDF p.2; identity, composition, raw-material specification and handlingBotanical raw-material identity and source-era specifications; current pharmacopoeial specification must be consulted before acceptance2026-10-14
- EMA/HMPC — European Union/Community herbal monograph on Harpagophytum procumbens DC. and/or Harpagophytum zeyheri Decne., radix12 July 2016; EMA/HMPC/627057/2015PDF pp.3–8; preparation categories, sections 4.1–4.8Current adopted regulator monograph for specific plant part and preparation; not approval of this compounded product or product-specific stability evidence2026-10-13
- AEMPS Formulario Nacional — FN/2003/POF/014 RAÍZ DE VALERIANA, CÁPSULAS DURAS DESource code FN/2003; current standalone official PDF retrieved 13 October 2026PDF pp.2–4; sections 3–12Exact master formula, process, storage, source validity period; older clinical details reassessed using reference 32026-10-14
- AEMPS Formulario Nacional — FN/2003/PAF/014 VALERIANA, RAÍZ DESource code FN/2003; official standalone PDF retrieved 13 October 2026PDF p.2; identity, composition, raw-material specification and handlingBotanical raw-material identity and source-era specifications; current pharmacopoeial specification must be consulted before acceptance2026-10-14
- EMA/HMPC — European Union/Community herbal monograph on Valeriana officinalis L., radix2 February 2016; EMA/HMPC/150848/2015, Corr.1PDF pp.3–9; preparation categories, sections 4.1–4.8Current adopted regulator monograph for specific plant part and preparation; not approval of this compounded product or product-specific stability evidence2026-10-13
- AEMPS Formulario Nacional — FN/2003/POF/015 SEMILLA DE ZARAGATONA, POLVO PARA SUSPENSIÓN ORAL DESource code FN/2003; current standalone official PDF retrieved 13 October 2026PDF pp.2–4; sections 3–12Exact master formula, process, storage, source validity period; older clinical details reassessed using reference 32026-10-14
- AEMPS Formulario Nacional — FN/2003/PAF/015 ZARAGATONA, SEMILLA DESource code FN/2003; official standalone PDF retrieved 13 October 2026PDF p.2–3; identity, composition, raw-material specification and handlingBotanical raw-material identity and source-era specifications; current pharmacopoeial specification must be consulted before acceptance2026-10-14
- EMA/HMPC — European Union/Community herbal monograph on Plantago afra L. et Plantago indica L., semen14 May 2013; EMA/HMPC/599747/2012PDF pp.3–11; preparation categories, sections 4.1–4.8Current adopted regulator monograph for specific plant part and preparation; not approval of this compounded product or product-specific stability evidence2026-10-13
- ANSM — Amoxicilline 125 mg et 250 mg, gélules réalisées à partir d’Amoxicilline 1 g, comprimés dispersiblesDecember 2022, version 1pp 1–7 formulation, process, safety, QC/BUD;pp 8–9 assay annexExact source method and explicitly provisional 1 month shelf life; independent factual adaptation, not an official translation.2026-10-14
- ANSM — Amoxicilline: recommendations and 7 April 2025 abrogation updateUpdated 7 April 2025; checked 13 October 2026Opening update paragraphTemporary automatic substitution recommendation withdrawn; technical monograph publication is not general current substitution permission.2026-10-13
- French public medicines database — AMOXICILLINE SANDOZ 1 g dispersible tablet SmPCSmPC 21 August 2026; database 29 September 2026§§2,4.3–4.5,6.1Example of current source-product strength, excipients and clinical precautions. Other brands require their own SmPC; marketed-tablet shelf life does not transfer.2026-10-13
- ANSM — Bonnes pratiques de préparationCurrent index retrieved 13 October 2026CurrentBPP and amoxicillin preparation linksFrench professional preparation framework and source location; not a statement of Greek compounding law.2026-10-13
- AEMPS — Formulario Nacional — FN/2003/FMT/021 TRETINOÍNA, GEL DECurrent AEMPS standalone PDF; code FN/2003/FMT/021PDF p 2 §§3–7; subsequent safety and patient informationExact formulation, process, source shelf life and formulation-specific precautions; independent factual compilation, not official translation.2026-10-14
- AEMPS — Formulario Nacional — FN/2003/EX/021 GEL NEUTRO HIDROALCOHOLICOCurrent AEMPS standalone PDF; code FN/2003/EX/021PDF p 2 §§3–7; subsequent safety and patient informationExact formulation, process, source shelf life and formulation-specific precautions; independent factual compilation, not official translation.2026-10-14
- EMA — Retinoid-containing medicinal products, Article 31 referralEC decision 21 June 2018; retrieved 13 October 2026Information for healthcare professionals: topical retinoids and pregnancyCurrent precautionary contraindication in pregnancy/planning pregnancy; no transfer of the oral retinoid pregnancy-prevention programme to a topical formulation.2026-10-13
- Illinois IDFPR — Nonsterile Compounding Self-Inspection ReportPublic regulatory checklist, accessed 2026-09-12pp. 15–16; USP <795> sections 10.1–10.5Temperature conditions and requirements for supported extension; jurisdiction-specific guidance2026-10-14
- NAPRA — Model Standards for Pharmacy Compounding of Non-sterile PreparationsMarch 2018, clarification January 2022Sections 4–9Risk, personnel, facilities and QA; its historical BUD table is not used for current USP defaults2026-10-14
- NAPRA — Guidance Document for Pharmacy Compounding of Non-sterile PreparationsMarch 2018, clarification January 2022Sections 5, 6 and 7; master/batch records, delivery, qualityQuality-system implementation; historical BUD table not substituted for 2022 USP revision2026-10-14
- EMA — Guideline on Allergen Products: Production and Quality IssuesEMEA/CHMP/BWP/304831/2007; adopted 20 November 2008; effective 20 May 2009; remains current effective quality version on EMASections 2, 4.1.1, 4.2.4.4, 4.4.3–4.4.5; document pp. 4–13Industrial biological-allergen quality guidance; principles adapted explicitly, not a compounding authorisation or a food-OIT recipe2026-10-14
- Santos AF et al. EAACI guidelines on the management of IgE-mediated food allergyAllergy. 2025;80:14–36; online 2024Recommendations 8, 9, 12 and 13; desensitisation versus remission/continued treatmentSpecialist clinical recommendations; not stability evidence for local syrups or suspensions2026-10-14
- FDA — PALFORZIA prescribing informationUS prescribing information, Revised 07/2024; rechecked 2026-10-14Sections 2.3, 4, 5, 11 and 16; current FDA-linked labelSpecific authorised product only; no equivalence with pharmacy-made peanut preparations2026-10-14
- Elizur A et al. Cashew oral immunotherapy for desensitizing cashew-pistachio allergy (NUT CRACKER study)Allergy. 2022;77:1863–1872Abstract, methods and results; PMID 35000223; DOI 10.1111/all.15212Cashew OIT cohort and pistachio cross-desensitisation; no pistachio syrup or peanut suspension stability data2026-10-14
- European Parliament and Council — Directive 2001/83/ECConsolidated text displayed as current on 2026-09-12Articles 2, 3(1)–(2), 6; consolidated 1 January 2025Specific EU scope exclusions; national pharmacy conditions still require verification2026-09-12
- European Commission technical document on cosmetic claims3 July 2017Annex IV, p. 15Cosmetic claim interpretation; hypoallergenic does not mean zero allergy risk; not a medicinal-product BUD standard2026-09-12
- NIOSH — Managing Hazardous Drug Exposures: Information for Healthcare SettingsDHHS (NIOSH) 2023-130Risk assessment and activity-specific control table, printed pp. 27–33Exposure routes and hierarchy of occupational controls2026-09-12
- NIOSH List of Hazardous Drugs in Healthcare Settings, 20242024 list, publication 2025-103Drug lists and inclusion criteriaHazard identification; absence from list is not evidence that a chemical is harmless; consult the live NIOSH notices as well as this static list2026-09-12
- NIH NIDDK — Definition & Facts for Lactose IntoleranceReviewed February 2018; accessed 2026-09-12What is lactose intolerance?Lactose is milk sugar; lactose intolerance differs from immune-mediated milk allergy2026-09-12
- USP — General Chapter <795> FAQsUpdated 1 November 2023; retrieved 14 October 2026Questions 52–66, especially 52, 54–56, 58–59, 61–64Publisher interpretation: optional formula-specific aw testing, initiation-date BUD, stock-component exceptions, exact-formula stability studies and antimicrobial-effectiveness testing. Not Greek law.2026-10-14
- USP — Compounding Standards <795> and <797>, USP scientific presentation2025 USP scientific presentation; NCPA-hosted public copySlides 12–15 (nonsterile BUD table and extension)Primary USP educational presentation confirming nonsterile category ceilings and storage columns; not a substitute for the full current chapter.2026-10-14
- EMA/European Commission — Excipients in labelling and package leaflet, Annex Revision 5Revision 5, first published 5 December 2025; XLSX annexCurrent version Revision 5; row-specific route, threshold, warning and update dateAuthorised-medicine excipient labelling and safety-information source. Clinical warning review is transferable; declaration thresholds are not universal safety limits and pharmacy national obligations require separate assessment.2026-10-14
- EMA — Excipients labellingLive official page checked 14 October 2026EU guideline; excipients with known action or effect; background documentsScope and implementation of excipient warnings; official links to individual excipient assessments.2026-10-14
- NIOSH — List of Hazardous Drugs in Healthcare Settings, 2024, with subsequent noticesNIOSH Publication 2025-103, December 2024; dynamic notice tableNotice table for updates after the December 2024 listCurrent notice surveillance in addition to the static PDF and exact material SDS; does not certify absence of hazards for an unlisted substance.2026-10-14
- EMA/ICH — Q14 Analytical procedure developmentStep 5, effective 14 June 2024; 4 April 2025 error corrections; current EMA PDF checked 14 October 2026Sections 1.2, 2–3, 5–6; glossaryCommercial drug analytical development guideline, used as an explicitly scoped scientific method-design framework; does not impose a universal assay panel or pharmaceutical registration obligations on a pharmacy.2026-10-14
- FDA — Investigating Out-of-Specification Test Results for Pharmaceutical ProductionGuidance for Industry, May 2022, Revision 1Sections III–V; chemistry-based tests, investigation, retesting, resampling and reportingIndustrial chemistry-test guidance; scientific investigation principles adapted to pharmacy QC. Not biological-assay validation or automatic Greek regulatory requirements.2026-10-14
- NHS SPS — Choosing medicines for enteral tube administrationCurrent NHS Specialist Pharmacy Service professional advice, checked 14 October 2026Tube characteristics, licensed options, formulation issues and administration siteClinical/pharmaceutical assessment for actual tube and formulation; general advice cannot establish the suitability of an untested compounded preparation.2026-10-14
- NHS SPS — Administering a medicine through an enteral feeding tubePublished 18 September 2025; updated 9 February 2026Water, ENFit syringe, dead-space, separate medicines and flushingAdministration principles; fluid volumes, feed interruptions and water choice must be patient-specific, especially in children and fluid restriction.2026-10-14
- EMA — Guideline on allergen products development for immunotherapy and allergy diagnosis in moderate to low-sized study populationsEMA/161669/2025; adopted 10 June 2025; effective 1 January 2026Sections 2, 4 and 4.1 (Type I allergy quality aspects); pp. 4–6; section 8.4 for food-allergy endpointsIndustrial allergen development and quality guidance; complements 2008 guideline. Section 4.2 Type IV patch-test exceptions are not transferred to food OIT.2026-10-14
- Shwe Yee N et al. Development of Cashew and Pistachio Ladders through a Food-Processing ApproachFoods. 2024;13(21):3440Abstract and figures; DOI 10.3390/foods13213440Primary laboratory processing/extraction and antibody-binding work; no local syrup validation, clinical dose-equivalence factor or BUD.2026-10-14
- Bloom KA et al. Effect of heat treatment on milk and egg proteins allergenicityPediatr Allergy Immunol. 2014;25(8):740–746Author-institution abstract; PMID 25251921; DOI 10.1111/pai.12283Primary laboratory heat/matrix work with patient sera; not a dating study for a compounded liquid.2026-10-14
- Liu EG et al. Food Matrix Composition Affects the Allergenicity of Baked Egg ProductsJ Allergy Clin Immunol Pract. 2024;12(8):2111–2117Abstract, figures 1–3; DOI 10.1016/j.jaip.2024.04.032Primary extractable ovalbumin/ovomucoid and IgE-binding study; no generic matrix equivalence or BUD.2026-10-14
- Bermingham MD et al. Baking results in impaired detection of clinically relevant food allergensFront Allergy. 2026;7:1796342; published 21 May 2026Methods 2.1–2.2; Results 3.1–3.2; Discussion (analytical detection versus clinical reactivity); DOI 10.3389/falgy.2026.1796342Primary model-biscuit immunoassay study. Supports extraction/sampling caution; clinical reactivity differences and BUD were not established.2026-10-14
- USP <795> FAQs
- USP Compounding Standards <795> and <797>
- <795> Pharmaceutical Compounding—Nonsterile Preparations
- Stability Reference Document for Pharmaceutical Compounding
- Monographs of the European Drug Shortages Formulary — Framework
- Technical recommendations of the European Drug Shortages Formulary Working Party — Framework
- USP General Chapter <795> FAQs, November 1 2023Questions 52, 60, 61, 62, 63; printed pp.11,14Targeted prerequisite / publication decision; not batch result2026-10-14
- VVF manufacturer: Emulsifying WaxesProduct table: Vegarol EW 200; compare EW 100 and EW 300Targeted prerequisite / publication decision; not batch result2026-10-14
- Croda Pharma manufacturer: Crodex A pharmaProduct description and pharmacopoeia complianceTargeted prerequisite / publication decision; not batch result2026-10-14
- British Pharmacopoeia: Content Usage Licence for Individual UsersSections1,4 and5Targeted prerequisite / publication decision; not batch result2026-10-14
- ANSM: Collodion, Formulaire national 1994pp.1–2, content limits; ethanol test; storageTargeted prerequisite / publication decision; not batch result2026-10-14
- Addium/AQUALAB manufacturer: TDL2 volatile-sample water activity methodMeasurement principle, volatile samples, water-selective laserTargeted prerequisite / publication decision; not batch result2026-10-14
- CDC/NIOSH Pocket Guide: Ethyl etherPhysical properties, incompatibilities and reactivitiesTargeted prerequisite / publication decision; not batch result2026-10-14
- ANSM, Formulaire national 2007, Crème oléocalcaireSingle page, PREPARATIONTargeted prerequisite / publication decision; not batch result2026-10-14
- USP General Chapter <795> FAQs, updated 1 November 2023Q52, Q54–56, Q58–65, PDF pp.11–15Targeted prerequisite / publication decision; not batch result2026-10-14
- AEMPS FN/2003/PO/029, Urea, crema al 15% dePDF p.2, sections 3–7; p.3 patient leafletTargeted prerequisite / publication decision; not batch result2026-10-14
- AEMPS FN/2003/EX/010, Emulsión O/A no iónica 1PDF p.2, sections 3–4Targeted prerequisite / publication decision; not batch result2026-10-14
- AEMPS PN/L/FF/002/00, Elaboración de emulsionesPDF pp.3–5; §4.1, 4.4, 4.6Targeted prerequisite / publication decision; not batch result2026-10-14
- 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.15Targeted prerequisite / publication decision; not batch result2026-10-14
- AEMPS FN/2003/EX/006, Emulsión A/SPDF p.2, sections 3–7Targeted prerequisite / publication decision; not batch result2026-10-14
- ANVISA Formulário Nacional, 2nd edition, revision 02 (2012), historical editionPrinted pp.84–86 / PDF pp.84–86Targeted prerequisite / publication decision; not batch result2026-10-14
- EMA Questions and answers on benzoic acid and benzoates used as excipientsOfficial indexed extract: activity in acidic conditions, pH 2.5–4.5Targeted prerequisite / publication decision; not batch result2026-10-14
- ANVISA Formulário Nacional catalogueCurrent third-edition catalogue; not an exact-formula studyTargeted prerequisite / publication decision; not batch result2026-10-14
- ANSM hospital-compounding monograph: flucytosine 50 mg/mL oral suspensionpp.1–5; source date discrepancy retainedTargeted prerequisite / publication decision; not batch result2026-10-14
- USP <795> FAQs, updated 1 November 2023No universal aw testing; formula/container matching; distinction of BUD from source stability; official FAQ explanatory context. Keep combined new USP-derived prose across all project outputs within the source word budget; do not append a long FAQ paraphrase.Targeted policy source; scope and access limitations as described2026-10-14
- EDQM — Framework: Monographs of the European Drug Shortages FormularyPhysicochemical and microbial assessment linked to container, storage and in-use; risk-based evaluation. Framework, not an experimental report on Sikalias formulations.Targeted policy source; scope and access limitations as described2026-10-14
- ICH Q1D — Bracketing and Matrixing Designs for Stability TestingScientifically justified reduced designs and limits of extrapolation. Industrial stability guidance used by analogy for design, not presented as a mandatory pharmacy batch count.Targeted policy source; scope and access limitations as described2026-10-14
- USP <922> Water Activity — official public previewaw differs from total water and needs qualified/calibrated measurement; full licensed text was not accessed through the public preview.Targeted policy source; scope and access limitations as described2026-10-14
- Campbell GS, Galloway M, Campbell Z. Measurement of Water Activity in the Presence of High Volatile Concentrations Using a Tunable Diode Laser—Single Laboratory Validation, First Action 2021.04. J AOAC Int. 2022;105:649–656Primary single-laboratory validation supports selective water-vapour sensing for volatile matrices; uncertainty remains matrix dependent. Authors affiliated with instrument manufacturer; not universal validation of every finished product.Targeted policy source; scope and access limitations as described2026-10-14