The federal government has published new guidance on the requirements for compounding medicines.
Last month the TGA released additional clarification about the requirements for compounded medicines.
“The guidance explains how community and hospital pharmacists, medical practitioners and other relevant health practitioners can lawfully compound medicines under the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Regulations 1990,” the agency said in a statement. “This includes when exemptions may apply from manufacturing licensing requirements and inclusion in the [Australian Register of Therapeutic Goods].”
Compounding refers to the process of making a medicine, which involves either:
- reconstituting or manipulating commercial products that may require the addition of one or more ingredients; or
- preparing a medicine from two or more raw ingredients in fixed portions, where the end product has different properties from the original ingredients.
The manufacturing, supply, and advertising of compounded medicines fall under the scope of the Act and other legislative requirements such as the Health Practitioner Regulation National Law.
Prescription medicines that require compounding are also subject to the same prescribing, dispensing, and supply restrictions of other prescription medications.
Meeting regulatory requirements involves ensuring that the person compounding the medicine is legally allowed to manufacture it, confirming that the medicine is exempt from the ARTG and that the type of compounding is permitted, and whether there are any additional requirements specific to the medicine you are planning on compounding.
Being aware of these factors is important, as “medicines for gene therapy, biologicals, medicinal cannabis products and glucagon‑like peptide‑1 (GLP-1) receptor agonist analogues are generally not covered by [ARTG] exemptions”, and certain exemptions differ on whether anticipatory (done before a patient asks for it) or extemporaneous (done for an individual patient after receiving a prescription) compounding is allowed.
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The TGA requires individuals and organisations involved in the manufacturing of therapeutic goods to hold a manufacturing licence, although there are certain circumstances where people are exempt from manufacturing licence requirements. These include medical practitioners, dentists, pharmacists, biomedical engineers and radiochemists in public hospitals, and herbalists, nutritionists, naturopaths, practitioners of traditional Chinese medicine, or homeopathic practitioners.
Serious penalties apply for not complying with the Act, which may include infringement notices, directions or prevention notices, or pursuing civil or criminal proceedings.
“Penalties for breaches of the Act include civil penalties of up to $1.65 million per breach for individuals or $16.5 million per breach for corporations, as well as fines or imprisonment,” the agency noted.
The complete guidance is available via the TGA website.
