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Consultation: Options for reform of the regulatory framework for pharmacy compounding

Related information

5 June 2013

This consultation closed on 26 July 2013.

The TGA sought comments from interested parties on the proposed options for reform of the regulatory framework for pharmacy compounding.

Consultation documents

How to access a pdf or Word document

Timetable

Document released for consultation on 5 June 2013.

Interested parties responded by close of business 26 July 2013.

Feedback will be released following consideration of submissions. (see 'What will happen').

About the consultation

  • The purpose of the consultation is to assist Australian Government decision making on how to address concerns that the current regulatory framework for the manufacture of extemporaneous preparations in pharmacies ('extemporaneously compounded medicines') does not provide adequate assurance that medicines manufactured in this way will meet acceptable standards of quality and safety.
  • The scope of this consultation does not extend to the traditional role of a pharmacist in preparing medicine for a known particular patient.
  • Appendix 2 of the consultation document provides references and links to previous papers and consultations.

Submissions

See: Submissions received

Submissions may address any, or all, of the proposed options for reform of the regulatory framework for pharmacy compounding.

In addition, submissions might include:

  • Suggested improvements
  • Whether or not you support the proposed options. If you do not support the proposed options, you may make suggestions for an alternative acceptable to you.
  • An assessment of how the proposed change will impact on you. That is, what do you see as the likely benefits or costs to you (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits.

What will happen

Submissions will be reviewed by the TGA and feedback on submissions will be provided through the TGA's Internet site.

Consultation feedback will be used to inform the development of advice to the Australian Government on the need for changes to the regulatory framework.

Confidentiality

All submissions will be placed on the TGA website unless marked confidential. Any confidential material contained within your submission should be provided under a separate cover and clearly marked 'IN CONFIDENCE'. Reasons for a claim to confidentiality must be included in the space provided on the TGA submission cover sheet.

For submissions made by individuals, all personal details other than your name will be removed from your submission before it is published on the TGA's website.

In addition, a list of parties making submissions will be published. If you do not wish to be identified with your submission you must specifically request this in the space provided on the submission cover sheet.

Enquiries

Any questions relating to submissions should be directed to the Management and Coordination Section, Office of Scientific Evaluation by email to pharmacy.manufacture@tga.gov.au or by telephone to 02 6232 8623.