Compounding changes


TGA seeks feedback on proposed changes to compounded medicines guidelines

The Therapeutic Goods Administration is seeking submissions from interested parties on its proposed changes to compounded medicine manufacturing practices and procedures.

The current guidance for compound medicine manufacturers was published in 2017.

Now, following updates to pharmaceutical manufacturing principles in July 2020, and the receipt of feedback regarding opportunities for improvement, the TGA’s Manufacturing Quality Branch (MQB) has produced a draft of updated guidance for compounders and has issued a consultation paper to “seek input from stakeholders”.

The current document Compounded medicines and good manufacturing practice (GMP) provides guidance on the interpretation of the PIC/S Guide to Good Manufacturing Practice for manufacturers licenced by the TGA to manufacture compounded and dispensed therapeutic goods.

The TGA says “this guidance document is being updated to align with contemporary expectations”.

The update includes additional guidance in relation to: 

  • the product expiry of compounded medicinal products
  • compounding of radiopharmaceutical products
  • information for manufacturers of dose administration aids (DAAs).

“The public consultation will facilitate input from all relevant stakeholders including TGA licensed manufacturers of compounded medicines, product sponsors, pharmacy & compounding professionals and relevant authorities,” the regulator says.  

“Submissions must be relevant to the proposed revision. In addition, submissions may include information on:

  • Suggested improvements
  • Whether or not you support the changes, including suggestions for alternatives
  • An assessment of how any of the changes might impact on you

The consultation closes on 18 December 2020.

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NOTICE: It can sometimes take awhile for comment submissions to go through, please be patient.