Compounded & Off-Label Medications Policy

1. Compounded (Extemporaneous) Medications

A compounded medication is a customized treatment prepared by a qualified pharmacist to meet specific patient needs when a standard, mass-produced product is unavailable or unsuitable.

This includes:

• Formulation Alteration: Changing an NMRA-registered drug into a different form (e.g., crushing a tablet into a liquid or adjusting its strength).
• Custom Formulas: Combining active ingredients into a unique preparation specifically for one patient's prescription.
• Non-Commercial Combinations: Creating a blend of clinically effective ingredients that is not sold as a pre-packaged product in Sri Lanka.

2. Off-Label Medications

"Off-label" refers to the use of an NMRA-registered medication in a way that differs from its officially approved instructions. This is a common and legal medical practice when supported by evidence.

This includes prescribing for:

• New Indications: Using a drug for a medical condition not listed on its official label, based on peer-reviewed clinical evidence.
• Different Demographics: Prescribing to an age group (e.g., children or the elderly) outside the original licensing.
• Modified Regimens: Utilizing a dosage or administration route that varies from standard registered guidelines.

3. Clinical Oversight & Safety

To ensure patient safety and NMRA compliance, every request undergoes a strict Clinical Review Protocol:

• Independent Evaluation: Licensed clinicians review each patient's specific health profile.
• Evidence-Based Authorization: Prescriptions are only issued if the treatment is medically necessary, supported by clinical data, and tailored to the individual's unique circumstances.