From an unmet need to a development plan · PUB-004

From recurring need to research question

Repeated requests are a signal to investigate, not proof of market size or efficacy. Record a denominator, available solutions and why they do not meet the need. Define dosage form, concentration, device, duration and critical quality attributes. Then assess feasibility, scaling, testing and the appropriate regulatory route.

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.

Changes and process transfer

The same rpm in a different mixer does not establish equivalent mixing. Scale, impeller diameter, time, geometry and temperature affect the process. Assess packaging-material or excipient-supplier changes against the attributes they could alter. Document applicability in F-013 before reusing the previous dating decision.

Scope and professional responsibility

Article 3 of Directive 2001/83/EC provides specific scope exclusions: pharmacy preparation against a prescription for an individual patient and, separately, pharmacopoeial preparation supplied directly to that pharmacy’s patients. This is not a blanket exemption for every activity called compounding and does not remove national quality or operational requirements. Industrial product development and supply require a separate regulatory assessment.

Data and traceability

Using technical experience does not require publishing identifiable patient information. Public documents describe questions and technical findings without personal details. Full order/material/batch/recipient linkage remains in the pharmacy’s protected system. Research use of data requires appropriate separate governance.

Sources and references

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
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
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