Benzathine Benzylpenicillin Shortage

19 August 2025

There continues to be a global shortage of Bicillin® L-A (benzathine benzylpenicillin pre-filled syringes of 600,000 units/1.17 mL AND 1,200,000 units/2.3 mL suspension for injection) due to manufacturing issues and increases in consumer demand.

The shortage is predicted to continue through to October 2025. Efforts are being made to maintain supply and ensure access for critical indications where no suitable alternative exists.

Temporary supply of alternatives to Bicillin® L-A pre-filled syringes have been approved by the Therapeutic Goods Administration (TGA) under Section 19A (s19A) of the Therapeutic Goods Act 1989.

These s19A alternatives are limited to overseas-registered 1,200,000-unit products and are not suitable in all clinical scenarios. They have specific safety and suitability considerations including:

  • The need for reconstitution with a diluent and immediate administration (which may make them less suitable in some patient cohorts and settings, e.g. rural/remote)
  • Larger volume of administration, making them unsuitable for infants and children

There are also supply issues affecting s19A alternatives to Bicillin® L-A. Therefore, it is important to carefully consider whether treatment with benzathine benzylpenicillin is necessary, and, if so, which formulation is appropriate. Not all s19A products are currently listed on the Pharmaceutical Benefits Scheme (PBS); refer to the PBS website for up-to-date information.

Health professionals are recommended to:

  • Only prescribe products containing benzathine benzylpenicillin for the following priority indications:
    • Treatment and secondary prophylaxis of acute rheumatic fever (ARF), and secondary prophylaxis of rheumatic heart disease (RHD). Refer to www.sahealth.sa.gov.au/rhd
    • Treatment of syphilis for proven or suspected infection and their recent sexual contacts. Refer to the Australian STI Management Guidelines (https://sti.guidelines.org.au/) Note: doxycycline is not considered first-line treatment for syphilis due to efficacy concerns, but may be used in non-pregnant people when no alternative is available; close follow-up is required.
    • Treatment of group A streptococcal infections (sore throats and skin sores) for people at high risk of ARF and post-streptococcal glomerulonephritis, where oral therapy is not acceptable, or the likelihood of non-adherence is high.
  • See the Therapeutic Guidelines and Australian Medicines Handbook for treatment of other infections.
  • Conserve the pre-filled syringe product of Bicillin® L A for use in:
    • Neonatal and paediatric patients (due to large volume of alternative products).
    • Healthcare settings where use of alternative product is not appropriate due to need for reconstitution and immediate administration, for example some rural and remote settings.
    • Patients with ARF and RHD, to maintain continuity of Bicillin® L-A treatment and reduce risk of medication errors.
  • Consider use of s19A products for other patients requiring treatment with benzathine benzylpenicillin. For details on ordering, supply and administration of s19A products, refer to the s19A approvals database and Product Information. Different suppliers may need to be contacted to access stock.
  • Consider referring patients to Priority Care Centres and SA Health Urgent Care Hubs (BRIGHT) if you are not able to access or source benzathine benzylpenicillin for priority indications.
  • Consider referring patients requiring syphilis treatment to Adelaide Sexual Health Centre (7117 2800).
  • Restrict ordering of Bicillin® L A for prescriber bag supplies, unless there is a reasonable expectation that a high number of patients with the priority indications listed above will be encountered.
  • Order alternative antibiotics for prescriber bags where it is unlikely that a high number of patients with priority indications for Bicillin® L A will be encountered.
  • Contact CDCB for advice if you are unable to access BOTH Bicillin® L A AND the s19A-approved alternative products, OR have a patient with ARF/RHD OR untreated syphilis who is lost to follow up.

For all enquires please contact the CDCB on 1300 232 272 (24 hours/7 days)

Dr Louise Flood – Medical Lead, Communicable Disease Control Branch