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:

“The Tonic”: 1,511 bottles were supplied but only 120 manufacturing records were found.
“Nappy Ointment”: 31 supplies were recorded but no manufacturing records were kept.
“Hack Cream”: 45 supplies recorded, again with no manufacturing records.
“Japanese 35% Peppermint Oil Cream”: Manufactured and offered for sale with neither sales nor manufacturing records.

In addition to these record-keeping deficiencies, the registrant failed to ensure adherence to the existing SOP for “The Tonic” and lacked any SOPs for the other three unlicensed medicines. These actions constituted serious breaches of professional standards and raised concerns regarding patient safety, regulatory compliance, and overall governance.

Findings

The registrant admitted all allegations through counsel, as well as the underlying facts presented in the Society’s statement of case. The Committee accepted these admissions, noting that the registrant acknowledged the seriousness of his misconduct.

The panel emphasized that manufacturing unlicensed extemporaneous medicines without proper documentation and oversight is a high-risk activity. The required safeguards, including written SOPs and manufacturing records, were either missing or not followed. This presented a considerable risk to public safety, although no specific harm or adverse incidents were reported.

Compounding the matter, this was not the first time concerns had been raised. Inspections in 2012 and 2014 previously highlighted deficiencies in extemporaneous preparations and record-keeping. After the 2014 inspection, the registrant had assured inspectors that proper records were in place—assurances that were ultimately not upheld, further undermining professional trust.

GPhC Determination on Impairment

The Committee concluded that the registrant’s fitness to practise was impaired. While recognising that there was no evidence of patient harm, the failings occurred over a prolonged period and were repeated despite earlier regulatory interventions. The registrant had failed to implement fundamental governance requirements for extemporaneous manufacturing—a core part of his business.

Nevertheless, the Committee also considered several mitigating factors:

The registrant fully cooperated with the investigation.
He promptly ceased all extemporaneous manufacturing within two weeks of the inspection.
He showed genuine insight and accepted full responsibility for the failings.
The registrant had sold his pharmacy and expressed a clear intent to retire at the age of 71.
He had a long, otherwise unblemished career, and no previous fitness to practise history.

The panel noted:

“The undertakings provide a protection of the reputation of the profession, they align with the public interest, and meet the regulatory objectives.”

Sanction

Instead of imposing a formal sanction, the Committee accepted a package of undertakings proposed by the registrant. These included:

Applying for voluntary removal from the register within 14 days.
Ceasing all pharmacy or healthcare-related activities until removal is formalised.
A commitment never to engage in the management or provision of such services in the future.
Notification to the Registrar of any intent to reapply for registration (with a minimum of four weeks’ notice).

The Committee viewed these undertakings as proportionate, particularly given the registrant’s retirement plans and low risk of repetition. However, it was noted that if he ever sought to rejoin the register, the Society would reassess fitness to practise in light of the historical findings.

Key Learning Points for Pharmacy Professionals

Unlicensed Medicine Manufacturing Demands Rigorous Oversight
Manufacturing extemporaneous preparations, while sometimes necessary, is inherently high-risk and must be supported by SOPs, staff training, and robust documentation. The absence of these safeguards is a serious regulatory breach.
Record-Keeping Is Not Optional
Documentation of each batch manufactured is not merely bureaucratic—it is critical for traceability, patient safety, and regulatory accountability. Pharmacists must maintain accurate and complete records for every extemporaneous product.
Historic Non-Compliance Is Relevant
Previous inspections had raised similar concerns, and failing to act on past warnings undermines professional credibility. Regulators will consider prior history when assessing current fitness to practise.
Governance Responsibilities Are Non-Delegable
As Superintendent, the registrant bore ultimate responsibility for ensuring that appropriate systems were in place. Accountability cannot be delegated to junior staff or assumed to be informally managed.
Insight and Remediation Can Influence Outcomes
The registrant’s cooperation, acceptance of responsibility, and steps to cease manufacturing were viewed favourably. Early insight and proactive remediation can lead to less severe outcomes, even in serious cases.
SOP Adherence Is Crucial
Merely having a written SOP is not enough—it must be actively implemented and monitored. SOPs for all extemporaneous preparations should be reviewed regularly and reflect current best practice.

This case serves as a stark reminder to pharmacy professionals, especially those involved in specialist compounding or extemporaneous services, of the legal and ethical obligations surrounding such work. Thorough governance, vigilant record-keeping, and an uncompromising commitment to standards are essential for maintaining public trust and professional integrity.

Original Case Document

The full determination transcript is available to logged in users.