HPS Pharmacies wish to advise that multiple suppliers are experiencing a supply interruption for cefaclor products, as follows.

Product ARTG Estimated return date

Tablets

Ceclor® CD 375mg 58264 End-August 2023
Keflor® CD 375mg 58655 Early May 2023

Suspension

Ceclor® 125mg/5mL 347594 Limited availability*
Keflor® 125mg/5mL 58651 End-September 2023
Ceclor® 250mg/5mL 347593 End-July 2023
Keflor® 250mg/5mL 58653 End-July 2023

*Ceclor® 125mg/5mL suspension is currently available in most states and territories.

An internationally registered brand of cefaclor suspension 250mg/5mL has been approved for supply under Section 19A of the Therapeutic Goods Act 1989.

The Therapeutic Goods Administration (TGA) has also made a Serious Scarcity Substitution Instrument (SSSI) to help manage this situation. The SSSI declares both 125mg/5mL and 250mg/5mL cefaclor oral liquid strengths as scarce medicines. This allows pharmacists to supply another strength of cefaclor oral liquid when the prescribed strength is unavailable, providing the following conditions are met:

  • The patient, or person acting on behalf of the patient, is advised of the number of dose units of substitutable medicine that must be taken in substitution for the prescribed dose of scarce medicine;
  • The correct number of dose units of substitutable medicine that must be taken by the patient in substitution for the prescribed dose of scarce medicine must be written on the dispensing label in millilitres;
  • If multiple bottles of substitutable medicine are dispensed, the patient’s treatment course must be completed prior to the expiry of each bottle; and
  • The patient, or person acting on behalf of the patient, has access to information to support them in administering the substitutable medicine appropriately.

This SSSI is in force until 30 September 2023 unless revoked earlier by the TGA.

Retain this notice in a prominent position, including in other related business units until supplies return to normal. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact your pharmacist at HPS Pharmacies.

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