Compounding of Medicines

Flashcards covering key concepts related to the compounding of medicines, including definitions and distinctions between compounding and manufacturing, as well as guidelines for pharmacists.

Compounding

The extemporaneous preparation and supply of a therapeutic product for a specific patient in response to an identified need.

Manufacturing

A commercial activity that includes production, processing, assembling, packaging, labelling, storage, sterilizing, testing, and release of therapeutic goods.

Simple Compounding

Preparation and supply of a single unit of issue for a specific patient usually from published formulations.

Complex Compounding

Involves special competencies, equipment, processes, and/or facilities, such as sterile preparations or cytotoxic preparations.

Risk Assessment

A clinical justification must be completed for each request for a compounded medicine, assessing the need to compound.

Single Unit of Issue

The quantity of a medicine that meets the required quality standards for the treatment period as determined by the prescriber.

Reconstitution

The process of adding one or more ingredients to a commercial product to make it suitable for a specific patient.

Patient Consent

Patients must agree to receive a compounded medicine, ensuring informed consent is obtained.

PBA Guidelines

Guidelines that outline the protocols and ethical practices for pharmacists in relation to compounding.

Therapeutic Goods Act 1989

Legislation that requires manufacturers of therapeutic goods to hold licenses or conformity assessment certificates.