The purpose of medicines regulation is to protect people from harm by making sure medicines are manufactured according to their licenced conditions. People are typically exposed to toxic or poisonous chemicals from pharmaceuticals, from consumer products, from the environment, in the home, and at work. Most cases or wrongdoing for which an action for damages may be brought arise either from exposure to pharmaceutical drugs or occupational exposures.

Pharmacy compounding involves the preparation of customised medications that are not commercially available for individual patients with specialised medical needs. Pharmacy compounding is the art and science of preparing personalized medications for patients. Compounded medications are made based on a practitioners prescription in which individual ingredients are mixed together in the exact strength and dosage form required by the patient. This method allows the compounding pharmacist to work with the patient and the prescriber to customize a medication to meet the patient’s specific needs.

Traditional pharmacy compounding is suitable when done on a small scale by pharmacists who prepare the medication based on an individual prescription. However, the regulatory oversight of pharmacy compounding is significantly less demanding than required for registered medicines though compounded medicines may pose added risks to patients.

Registered medicines are made and tested in line with good manufacturing practice regulations (GMPs) that govern the production and testing of medicines. In contrast, compounded medicines are free from GMPs, and testing to assess product quality is erratic. Unlike registered medicines, pharmacy-compounded medications are not clinically appraised for safety or effectiveness. Also, compounded preparations do not have standard product labelling or prescribing information with instructions for safe use.

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