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Consultation: Seeking information from compounding pharmacies

10 June 2010

This consultation closed on 30 July 2010

The National Coordinating Committee on Therapeutic Goods (NCCTG) invited pharmacists to provide information on their current compounding practices to assist in the finalisation of the NCCTG's proposals to update regulatory arrangements around extemporaneous compounding. The NCCTG will also need to consider the regulatory impacts that could flow from those proposals.

The NCCTG's aim was to develop an appropriate regulatory response to the changes in the practice of pharmacy that have occurred over recent years. In 2008 the NCCTG published A discussion paper on regulation of extemporaneously prepared medicines in non-hospital pharmacies and called for public comment. Following from its review of submissions and the need to define the requirements for licenses for pharmacies undertaking substantial compounding (manufacturing) activity, the NCCTG sought specific information on a more refined proposal.

Invitation to provide information

Information was sought from the following businesses:

  • non-hospital pharmacies in New South Wales, Victoria and Tasmania that would compound, on average, at least 50 compounded prescriptions per month; and
  • non-hospital pharmacies in Queensland, Northern Territory, South Australia, Western Australia and Australian Capital Territory that are incorporated entities, or supply interstate, or supply compounded medicines under the PBS/RPBS, and that would compound, on average, at least 50 compounded prescriptions per month.

Information was sought on the following:

  1. Whether the pharmacy compounds, per month on average:
    1. 50 - 100 compounded prescriptions
    2. 100 - 250 compounded prescriptions
    3. 250 - 350 compounded prescriptions
    4. 350 - 500 compounded prescriptions
    5. over 500 compounded prescriptions
  2. Whether the pharmacy compounds:
    1. eye drops, eye lotions, eye ointments
    2. injections, and if so, whether multiuse or single use, and if single use, whether for immediate use
    3. sterile dosage forms other than the above, and if so, what dosage forms.

Notes

  • A 'non-hospital pharmacy' means a pharmacy operating under the relevant State or Territory laws that is open to the public, and includes Friendly Society pharmacies, and pharmacies located within hospital premises that are not subject to the oversight or clinical governance of the hospital.
  • The estimation of 'compounded prescriptions' should include medicines that are unscheduled (e.g. nutritional supplements) as well as medicines in any schedule of the SUSDP/Poisons Standard/Poisons List that applies in your jurisdiction, but should not include veterinary medicines. Both PBS and non-PBS compounding should be included.
  • The estimation of 'compounded prescriptions' should refer to dosage forms compounded in the pharmacy. If a prescription or compounded medicine moves between pharmacies, only the pharmacy making the dosage form should include that medicine in the estimation of their manufacturing output.
  • Details of proposed good manufacturing practice (GMP) requirements for pharmacies are under development.

NCCTG's response to the April 2008 consultation

The National Coordinating Committee on Therapeutic Goods (NCCTG) is a subcommittee of the Australian Health Ministers' Advisory Council (AHMAC). The NCCTG aims to develop, implement and maintain a uniform national approach to the regulation and controls over therapeutic goods and chemicals used by the public.

In 2008 the NCCTG published A discussion paper on regulation of extemporaneously prepared medicines in non-hospital pharmacies and called for public comment.

The NCCTG received submissions from 26 groups (including regulators, medical and pharmacy professional groups, health advocacy groups, and pharmaceutical manufacturers), individual pharmacists, individual medical practitioners (of which dermatologists were a significant group), and individual consumers.

The submissions took diverse positions, with both support for and opposition to the proposals relating to restrictions on the range of active ingredients and dosage forms that would be allowed to be compounded in pharmacies, and the quantitative limits or other indicators that would differentiate pharmacies into three classes. Some submissions argued against the limited scope of the proposals, particularly the exclusion of hospital pharmacies and healthcare practitioners with compounding privileges. Some proposals attracted general support, including a role for the Therapeutic Goods Administration (TGA) to license pharmacies undertaking substantial manufacturing activity, and the reporting of significant adverse events.

The NCCTG took note of comments that quantitative limits based on dosage form units such as individual capsules or grams of product would disadvantage users of topical preparations, for which normal weekly usage can exceed 500 g. While maintaining its position that a quantitative limit is needed for the effective regulation of compounding pharmacies, the NCCTG intends to express this in terms of prescriptions.

The Attachment tabulates the NCCTG's amended proposal, which takes account of the submissions received. At this time the NCCTG does not recommend proceeding with the earlier proposals that would limit the range of active ingredients used in compounding, require prior approval of compounded medicines, or differentiate 'Class 1' from 'Class 2' pharmacies.

The NCCTG confirmed that pharmacies that manufacture medicines would require a GMP (good manufacturing practice) licence from the TGA in two situations:

  1. where the pharmacy compounds sterile medicines other than topical sterile medicines and single-use injections (which may be subject to further qualification)
  2. where the pharmacy compounds in excess of a specified quantitative limit.

With rare exceptions, submissions received to date have not provided quantitative data to assist in the finalisation of the NCCTG's proposals and the consideration of regulatory impacts that could flow from those proposals. The NCCTG is now seeking information direct from potentially affected pharmacies on their current compounding practices.

The NCCTG recognises that manufacture of compounded medicines that exceeds a quantitative limit does not intrinsically identify 'high-risk' pharmacies. However, a quantitative limit is a surrogate marker to identify pharmacies for which external audit by the TGA of the quality of manufacture is warranted from a public health perspective, including pharmacies that supply few, if any, medicines manufactured by other manufacturers.

The House of Representatives Standing Committee on Health and Ageing report Treating Impotence: Roundtable forum on impotence medications in Australia (2009) states that the NCCTG proposed recommendations are a sensible approach to strengthening the regulations around compounding and the Standing Committee supported their development and speedy implementation.

Submissions

Pharmacies were invited to provide information by 30 July 2010.

Attachment: NCCTG's proposals on regulation of compounding pharmacists (June 2010)

Class Regulatory Framework Moderation of risk factors
activity non sterile products sterile products regulation ingredients dosage form advertising supply
3 extemporaneous manufacture as specified in licence conditions as specified in licence conditions manufacturer licence from TGA

no changes from current controls

(i.e. continue existing Schedule 9 and Appendix C restrictions)

as specified in licence conditions

no changes from current controls

(i.e. no consumer advertising of S4 or most S3 medicines; TGAC applies†)

no changes from current controls

(i.e. comply with State/ Territory laws)

1

and

2#

extemporaneous compounding

extemporaneous dispensing

up to total quantity limit* up to total quantity limit*, and limited to topical preparations including eye preparations, and single-use injection§ self assessment or other, as required by pharmacy regulators or professional associations Any non-sterile dosage forms; topical sterile products; single-use injections§

# Distinctions between the previously proposed "Class 1" and "Class 2" would not be pursued.

* The average monthly number of extemporaneously compounded prescriptions/supplies of products to not exceed a specified limit. Sterile and non-sterile products would contribute to a single limit.

§ "Single use injection" may be further qualified.

† Therapeutic Goods Advertising Code (TGAC) applies to advertising particular medicines and the TGAC's principles also apply to the 'generic information' that can be published about active ingredients.