PUB-012 / v2.0
Compounding service in dermatological care
Individualisation may address a specific dosage-form or ingredient problem. It does not imply universal superiority, lower cost or absence of allergies. Development formulas need their own evidence before becoming compounding instructions.
Clinical question and dosage form
Assessment starts with the patient, route, required dose and available authorised product. Document swallowing difficulty, device use, age-related excipient restrictions and allergies. Another dosage form may meet the need, but the change requires formulation, dose-delivery and clinical-suitability evidence. Sharing an active ingredient alone does not establish therapeutic equivalence.
Compatibility of the final matrix
Mechanical mixing does not establish solubility, uniformity or chemical compatibility. Assess pH, crystallisation tendency, emulsion structure and preservative partitioning. A concentration stated for the original base may change after dilution. The two starting products’ expiry dates do not establish the mixture’s lifetime.
Patient staff and contamination
Assess clinical risk, staff exposure and residue carryover into the next task separately. Quantity, frequency, dust/vapour generation and containment influence the decision. Use the exact material’s current SDS and an appropriate active-drug source. Absence from a hazardous-drug list does not mean absence of hazard.
Tests that answer the question
Appearance identifies some failures but does not establish strength, absence of degradants or microbiological suitability. Select method and criterion for the actual dosage form and use. A suspension needs redispersibility and device-delivered-dose assessment; at low strength, uniform mass does not imply uniform API. A critical specification failure requires quarantine and investigation.
Specific ingredient and allergy claim
Removing fragrance or a preservative supports only the precise statement that this ingredient was not used, after material and contamination checks. It does not establish allergen-free status. Even a cosmetic hypoallergenic claim requires scientific support and does not guarantee zero reactions. Surfactant irritation is not the same as allergy.
Incorporating actives
Do not use generic instructions such as dissolve in a little water for vitamin D or lipoic acid, or equal ethanol for caffeine. Exact chemical form and concentrations are essential for solvent choice and proof of dissolution. Dispersion, encapsulation and dissolution are different states. Commercial complexes require their actual technical data and evaluation in the final base.
Sources and references
- 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 defaults2026-09-12
- 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
- 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
- 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