Updated CAL advice issued in APF Digital
24 July 2025
The Pharmaceutical Society of Australia (PSA) has updated advice in the digital Australian Pharmaceutical Formulary (APF) relating to the use of Cautionary Advisory Labels (CAL) 6, CAL 13, CAL 18 and CAL I.
CAL 18, and CAL I:
- Instead of two labels that relate to avoiding certain food and juices (CAL 18 and CAL I), there is now one – an updated CAL 18. The wording of the updated CAL 18, and its explanatory notes have been updated in APF Digital. CAL I has been retired.
- The wording of CAL 18 previously only warned about the effects of grapefruit on certain medicines, due to inhibition of cytochrome P450 3A4 isoenzymes. However, the product information (PI) for new medicines that are substrates for CYP3A4 increasingly mention other fruits that also interact via this mechanism, including Seville oranges, pomelo, star fruit, bitter melon and pomegranate.
- CAL I was used to advise patients about foods and juices that interact with medicines through mechanisms other than inhibition of CYP3A4. However, due to its limited applicability, its use and uptake was low.
- The revised CAL 18 covers a broader range of situations where foods and fruit juices may interfere with a patient’s medicines and provides support for clearer and more actionable dietary advice for patients.
CAL 6:
- The wording of CAL 6 is not changing. However, its explanatory notes have been expanded to help support pharmacists in providing actionable, accurate advice as to the storage of temperature sensitive medicines.
- The updated explanatory notes advise pharmacists on how to advise on instances whereby refrigeration of temperature sensitive medicines may not be practical, for example travel days, power outages or ‘in-use’ multi-dose containers/devices.
CAL 13:
- The wording of CAL 13 previously only warned about not removing a medicine from the original packaging until a dose was required. As its wording was applicable to many medicines, its impact was diluted, and uptake was low.
- The wording of CAL 13 and its explanatory notes have been updated and refined to prompt meaningful conversations with patients about dosage forms and active ingredients truly sensitive to light, moisture or temperature excursions. It is now also recommended when complex storage instructions are applicable and other CALs relating to storage requirements (e.g CALs 6, 7a or 7b) do not adequately cover these.
- To support the change to CAL 13, the APF’s Good dispensing practice chapter has been updated with clearer and expanded guidance on providing advice to patients on how to store their medicines.
Emeritus Professor Lloyd Sansom AO, Chair of the APF editorial board said: “CALs are intended to be an adjunct to verbal counselling on medicine-related issues, not to replace this. Pharmacists should apply their expertise and clinical judgement when using these and always refer to the most up-to-date CAL recommendations including CAL explanatory notes.”
Pharmacists should familiarise themselves with the updates in the digital Australian Pharmaceutical Formulary and Handbook (APF digital).
It is anticipated printers will commence printing of the new labels (updated CAL 18 and updated CAL 13) during their next print run.
Until then, pharmacists should use the existing CAL 18, CAL I and CAL 13 – ensuring patients are equipped with the updated advice and counselling points for these CALs (and CAL 6), available now in APF Digital which always contains the latest updates.
Media contact: Georgia Clarke M: 0480 099 798 E: georgia.clarke@psa.org.au