Serious Record-Keeping Failures in Extemporaneous Medicine Manufacturing Lead to Undertakings for Retiring Superintendent Pharmacist
Date of Decision: August 28, 2024
Registrant's Role: Pharmacist
Allegations:
- Failed to ensure the pharmacy was organised to comply with standards for unlicensed medicine preparation.
- Allowed unlicensed medicine “The Tonic” to be manufactured and supplied with inadequate manufacturing records (1,511 bottles supplied, only 120 records).
- Allowed unlicensed products (“Nappy Ointment”, “Hack Cream”, “Japanese 35% Peppermint Oil Cream”) to be made and sold without any manufacturing records.
- Failed to ensure SOP for “The Tonic” was adhered to.
- Failed to have SOPs for other unlicensed medicines listed above.
Outcome: Undertakings accepted in lieu of sanction, including voluntary removal from the register and commitment not to engage in pharmacy or healthcare services.
GPhC Standards Breached:
- Standard 4 – Sale and Supply of Medicines: Requires adherence to procedures and maintenance of manufacturing records for unlicensed medicine preparations.
Case Summary
Allegations
This case involved a Superintendent Pharmacist who faced multiple allegations concerning the improper extemporaneous preparation of unlicensed medicines over a two-year period, from 1 January 2020 to 13 January 2022. As the Director and Superintendent of Dorman Healthcare Limited, the registrant was responsible for overseeing all pharmacy activities, including compliance with the Pharmaceutical Society of Northern Ireland’s Professional Standards and Guidance for the Sale and Supply of Medicines.
A pharmacy inspection conducted on 13 January 2022 uncovered that several unlicensed medicines were being extemporaneously manufactured and sold without appropriate manufacturing records. The medicines included:
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Original Case Document
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