Guidance for Registered Pharmacies Preparing Unlicensed Medicines

Introduction

This guidance provides information to registered pharmacies on the preparation of unlicensed medicines. Unlicensed medicines play an important role in meeting special patient needs when appropriate licensed alternatives are not available. Pharmacists preparing such medicines must adhere to specific regulatory requirements and quality standards to ensure patient safety.

While the preparation of unlicensed medicines is a legitimate pharmaceutical activity, it requires thorough understanding and implementation of appropriate controls and procedures. This guidance outlines key considerations for registered pharmacies engaged in these activities.

Regulatory Framework

Registered pharmacies preparing unlicensed medicines must operate within the appropriate regulatory framework established by:

• Medicines and Healthcare products Regulatory Agency (MHRA)
• General Pharmaceutical Council (GPhC)
• Human Medicines Regulations 2012
• National Health Service (NHS) contractual requirements where applicable

The preparation of unlicensed medicines typically falls under the exemptions provided in Regulation 167 of the Human Medicines Regulations 2012, which allows pharmacies to prepare medicines at the request of a prescriber for an individual patient.

Requirements for Preparing Unlicensed Medicines

When preparing unlicensed medicines, registered pharmacies must ensure:

• The preparation is only undertaken in response to a specific prescription or medical order
• Adequate facilities, equipment, and procedures are in place to ensure quality and safety
• Appropriate documentation of the preparation process is maintained
• Staff involved have received appropriate training and are competent
• There is appropriate insurance and risk management processes

Quality Assurance

Pharmacies must implement robust quality assurance systems for the preparation of unlicensed medicines, including:

• Standard operating procedures for all preparation processes
• Validation of critical processes where appropriate
• Quality control testing according to risk level of the preparation
• Regular audits of preparation facilities and processes
• Equipment maintenance and calibration schedules
• Environmental monitoring where aseptic preparation is undertaken

Documentation and Record-Keeping

Pharmacies must maintain comprehensive records for the preparation of unlicensed medicines, including:

• Original prescription or medical order
• Detailed preparation records including calculations, methods, and equipment used
• Records of ingredients used, including batch numbers where available
• Quality control results where applicable
• Records of any deviations from standard procedures
• Dispensing and supply records
• Retention of records according to regulatory requirements (typically 5 years)

Training and Competency

Staff involved in the preparation of unlicensed medicines must receive appropriate training in:

• Relevant legislation and guidance
• Specific preparation techniques
• Quality assurance procedures
• Risk assessment for different types of unlicensed medicines
• Documentation requirements

Training should be documented, and competency should be assessed and periodically reviewed.

Patient Safety and Information

Patient safety must be paramount when preparing unlicensed medicines. Pharmacies should:

• Conduct risk assessments for each unlicensed medicine prepared
• Provide appropriate information to patients about their unlicensed medicine
• Establish adverse incident reporting procedures
• Implement recall procedures for unlicensed medicines when necessary
• Maintain appropriate labelling that meets regulatory requirements

Labelling of Unlicensed Medicines

Unlicensed medicines prepared by pharmacies must be appropriately labelled to ensure safe use, including:

• Name of the patient
• Method and route of administration
• Dose and administration directions
• Date of preparation
• Expiry date
• Storage conditions
• Name and address of the pharmacy
• Batch/reference number
• Statement indicating the product is unlicensed

Special Considerations

Additional considerations may apply for specific types of unlicensed medicines:

For aseptic preparations:

• Environmental monitoring requirements
• MediaFill or process simulation testing
• Specific staff training and aseptic technique qualifications
• Garment and aseptic area qualification requirements

For radiopharmaceuticals:

• Radiation protection requirements
• Specific documentation for radioactive materials
• Quality control requirements for radioactivity

Conclusion

The preparation of unlicensed medicines is a legitimate and valuable pharmaceutical service that requires appropriate knowledge, facilities, and quality systems. Registered pharmacies must ensure they adhere to regulatory requirements and implement robust quality assurance processes to protect patient safety.

Pharmacies should regularly review their procedures for preparing unlicensed medicines to ensure continued compliance with evolving regulatory requirements and professional standards. This guidance provides a foundation but should be supplemented with detailed standard operating procedures tailored to each pharmacy's specific activities.