5 March 2021

Pharmacy Compounding Partnership Programs

Be aware of the legal requirements

Dear Pharmacists,

It has come to our attention that NSW pharmacies have been approached by interstate pharmacies offering ‘partnership’ programs in order to access their compounding services.

Many of the proposals are NOT LEGAL! We strongly urge all pharmacists to refresh their knowledge on the legal requirements.

TGA Exemption

Schedule 8 of the Commonwealth Therapeutic Goods Regulations 1990 outlines the persons who are exempt from the operation of Part 3-3 of the Therapeutic Goods Act 1989 - manufacturing of therapeutic goods.

Pharmacists are only exempt from the requirements of Part 3-3 - manufacturing of therapeutic goods, if:

(a) the goods are not biologicals; and

(b) the goods are produced by the pharmacist:

(i) in a pharmacy where the pharmacist practices and the pharmacy is open to the public; or
(ii) on the premises of a dispensary conducted by a Friendly Society; or
(iii) on the premises of a private hospital; and

(c) the goods are for supply (other than by wholesale) on or from those premises

Pharmacists entering such partnership arrangements may be:

in breach of the Therapeutic Goods legislation
in breach of the Pharmacy Board’s of Australia’s Codes and Guidelines
practicing in a manner that does not accord with the National Competency Standards and Professional Practice Standards for Pharmacists.

The above circumstances may also be grounds for a complaint of unsatisfactory professional conduct.

If you are considering entering into an arrangement with another pharmacy for the compounding of medicines, either in NSW or outside of the State, we recommend you seek independent legal advice to ensure you do not inadvertently jeopardise your practise.

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