Advertising: extemporaneously compounded medicines
Information for compounding pharmacies on the legislative requirements on advertising extemporaneously compounded medicines to consumers
In Australia, advertisements for extemporaneously compounded medicines must comply with the Therapeutic Goods Act 1989 (the Act) and other relevant laws, including the Health Practitioner Regulation National Law (and applicable advertising and dispensing guidelines), the Australian Consumer Law, and State and Territory Laws. Extemporaneously compounded medicines, although exempt from some parts of the Act, are not exempt from the advertising provisions of the Act.
Generally, it is unlawful to publish or broadcast an advertisement to the general public for an extemporaneously compounded medicine, that:
- refers to a substance (any ingredient of a medicine) or a good containing a substance classified in the Standard for the Uniform Scheduling of Medicines and Poisons (the Poisons Standard1) as a "Pharmacist Only Medicine" (Schedule 3), "Prescription Only Medicine" (Schedule 4) or "Controlled Drug" (Schedule 8) (some exceptions apply); or
- has not been pre-approved by the Secretary of the Department of Health, if that advertisement is for a 'designated therapeutic good'2 published or broadcast in 'specified media'3.
Exemptions from the Act applying to extemporaneously compounded medicines
Medicines extemporaneously compounded by a pharmacist for individual patient use are exempted from the registration, listing and manufacturing requirements in Parts 3-2, 3-2A and 3-3 of the Act (there are certain requirements that must be met for these exemptions to apply4 ). As a result, pharmacists that supply these medicines do not require prior approval of the medicine for safety and efficacy from the Therapeutic Goods Administration (TGA), and do not require a manufacturing licence from the TGA for their preparation, provided that certain conditions are met5.
These exemptions for extemporaneously compounded medicines do not extend to the advertising provisions of the Act.
Applying the advertising provisions to extemporaneously compounded medicines
The advertising requirements in Part 5-1 of the Act apply to advertisements that are:
- directed to the general public; and
- for therapeutic goods, even where an advertisement also promotes other goods or services that are not therapeutic goods.
Both a medicine and an ingredient used in the manufacture of a medicine is a therapeutic good.
The advertising provisions in Part 5-1 of the Act do not apply to advertisements:
- for services6, for example an advertisement that only promotes the service of extemporaneously compounding medicines, without promoting or impliedly promoting any therapeutic goods, is not covered by the advertising provisions of the Act7; or
- that are directed exclusively to health professionals (however, not all health practitioners are included in this exemption)8.
Advertisements must not refer to restricted scheduled substances
Under section 42DL(1)(f) of the Act it is an offence to publish or broadcast an advertisement about therapeutic goods to the general public where the advertisement refers to a good or a substance contained in a good that is listed in an entry in Schedule 3, 4 or 8 of the Poisons Standard (a 'restricted scheduled substance'). However, there is an exception to the offence for those Schedule 3 substances listed in Appendix H to the current Poisons Standard. Please note that there are certain exemptions from the scheduling requirements which may also apply.
Advertisements for extemporaneously compounded medicines therefore must not refer to any medicine that contains a restricted scheduled substance, even where:
- the restricted scheduled substance is one of several ingredients, including substances that are not restricted scheduled substances; or
- the advertisement does not refer to the restricted scheduled substance by name.
Some advertisements for non-scheduled medicines require pre-approval
Under section 42C of the Act it is an offence to publish or broadcast in 'specified media'3 an advertisement about 'designated therapeutic goods' to the general public unless the advertisement has been pre-approved by the Secretary of the Department of Health. Generally, 'designated therapeutic goods' will include any extemporaneously compounded medicines that do not contain a restricted scheduled substance.
The Price Information Code of Practice (the Price Code)9 sets out the requirements under which pharmacies may publish price information about medicines containing a restricted scheduled substance. However, as compounded medicines are not included on the Australian Register of Therapeutic Goods, they do not meet the requirements of the Price Code and therefore price information about compounded medicines cannot be lawfully published.
- Section 42DL(1)(f) of the Act provides that an advertisement for therapeutic goods that does not require pre-approval must not contain a statement referring to goods, or a substance or preparation containing goods, included in Schedule 3, 4, or 8 to the current Poisons Standard, other than a statement authorised or required by a government or government authority.
- Section 42C(1) of the Act provides that it is an offence to publish or broadcast in specified media, without approval from the Secretary of the Department of Health, an advertisement for therapeutic goods that is required under the Therapeutic Goods Regulations 1990 to be approved.
- visit ComLaw for:
- the Therapeutic Goods Act 1989
- the Therapeutic Goods Regulations 1990
- the Therapeutic Goods Advertising Code 2007
- the Standard for the Uniform Scheduling of Medicines and Poisons
Penalties for non-compliance
When non-compliant advertising comes to the TGA's attention, the advertiser is notified (see how to make an advertising complaint).
In the first instance, the TGA seeks to inform, educate and assist advertisers to comply with the rules relating to advertising. However, if this approach fails, the TGA may take further action to achieve compliance. The Act provides for financial penalties for advertising breaches. Fines for such offences can be up to $10,800 for individuals and up to $54,000 for corporations10.
This fact sheet considers the circumstances when it may be lawful to advertise extemporaneously compounded medicines. Advertisers must note that further provisions in the Act govern the content of advertisements. For information relating to the content of advertisements, see Advertising therapeutic goods or consult a regulatory affairs consultant.
For further information about advertising therapeutic goods:
- visit the TGA website
- email TGA.Advertising@tga.gov.au
- contact AHPRA (the Pharmacy Board), the ACCC and your State/Territory Health department.
Consumers and health professionals are encouraged to report problems with medicines, vaccines or medical devices. Reports can be made online at Reporting problems.
- The Poisons Standard is a legislative instrument prepared by the Secretary (or delegate) under Part 6-3 of the Act.
- Therapeutic goods other than therapeutic devices, biologicals and goods included in Schedules 3 (except those listed in Appendix H), 4 and 8 of the Poison Standard.
- Includes advertisements broadcast on free-to-air TV, published in mainstream print media such as newspapers and magazines, cinema advertising and displayed on billboards and posters or on public transport and in public places such as shopping malls (other than in-store displays).
- See item 6, Schedule 5 and item 2, Schedule 8 of the Therapeutic Goods Regulations 1990 which set out the exemptions.
- The conditions are specified under item 2 of Schedule 8 of the Therapeutic Goods Regulations 1990.
- A service may include the compounding of specific dose forms or compounding under specific conditions.
- However, an implied reference to a therapeutic good in an advertisement, even where it is not specifically named, will mean the advertising provisions of the Act do apply to the advertisement.
- For a full list of the professions considered to be 'health professionals', see section 42AA of the Act.
- See Price information code of practice.
- These amounts are current as at the date of publication of this fact sheet.