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Review of the need for further regulation of extemporaneous compounding

21 September 2005

In late 2004, the Therapeutic Goods Administration (TGA) commissioned a review by Oceania Health Consulting on the growth in the practice of extemporaneous compounding and the concerns that this had caused the National Co-ordinating Committee on Therapeutic Goods (NCCTG). The report has been reviewed by the NCCTG and by the Australian Health Ministers' Advisory Council (AHMAC). The AHMAC acknowledged that public health concerns existed and endorsed continued development by the NCCTG, in consultation with stakeholders, of an appropriate regulatory response for managing health and safety risks of extemporaneously compounded therapeutic goods.

A copy of the report has been circulated to organisations that contributed to the review. Further work is progressing, including a meeting with key stakeholders in September.

How to access a pdf document

Review of the need for further regulation of extemporaneous compounding (pdf,169kb)

Contents

  1. Introduction
  2. The present legislative framework in Australia
  3. Findings from the consultations
  4. A risk based approach to legislative exemptions for extemporaneous compounding
  5. The exemptions for hospital pharmacies
  6. Advertising
  7. The application of any new controls beyond pharmacists
  8. Veterinary products
  9. Appendices
    1. Organisations consulted during the project
    2. Exemptions provided in the Schedules to the regulations relevant to this project
    3. A scheme for limiting the overall level of production at a compounding pharmacy before full compliance with Part 3-3 of the Therapeutic Goods Act is required
    4. Key sections of the Trans-Tasman Advertising Code relevant to compounded preparations