The Department of Health has been notified of the ongoing critical shortage of Australian-registered and Section 19A (S19A) benzathine benzylpenicillin products. As such, there is a need to consider implementing measures to conserve benzathine benzylpenicillin products where possible.
HealthShare Victoria, Safer Care Victoria and the Department of Health are coordinating a response to ensure safety and continuity of clinical care, including best practice in antimicrobial stewardship. The group are currently assessing the current supply of benzathine benzylpenicillin, reviewing clinical indications for benzathine benzylpenicillin with a view to provide guidance advice and recommendations.
This is an evolving situation, and further updates will be provided as they are available.
Situation
Due to manufacturing issues, there is an ongoing disruption to the supply of the following Australian-registered products:
- Benzathine benzylpenicillin (Bicillin L-A) 1,200,000 units/2.3 mL suspension for injection pre-filled syringe
- Benzathine benzylpenicillin (Bicillin L-A) 600,000 units/1.17 mL suspension for injection pre-filled syringe
The Therapeutic Goods Administration (TGA) have approved alternative S19A products. These products are also experiencing supply disruptions.
International options are available through TGA’s Special Access Scheme (SAS) but are not subsidised under the Pharmaceutical Benefits Scheme (PBS).
Additionally, the TGA has released an Urgent Product in relation to Pfizer’s benzathine benzylpenicillin (Bicillin L-A) 1,200,000 units/2.3 mL suspension for injection pre-filled syringe indicating that during visual inspection of certain lots of this product particulates have been identified.
Background
Benzathine benzylpenicillin is an antimicrobial agent indicated for the treatment and prevention of group A streptococcal infection-related conditions such as Acute Rheumatic Fever (ARF) and Rheumatic Heart Disease (RHD), as well as for the treatment of early and late-stage syphilis in adults.
Actions
Given the limited availability of Australian-registered and S19A benzathine benzylpenicillin products, action is required to ensure access for patients with priority clinical needs, particularly where suitable alternatives are not available and PBS stock may be inaccessible.
Recommendations
Priority groups
Children with ARF/RHD
Children requiring benzathine benzylpenicillin for ARF/RHD who cannot access stock at their community pharmacies may contact the Royal Children’s Hospital to obtain the medication. Administration of the antibiotic should be carried out by the patient’s usual healthcare provider.
Pregnant patients with syphilis
Primary care providers managing pregnant patients with syphilis who are unable to access stock through their routine provider, can contact Melbourne Sexual Health Centre (MSHC) doctors' information line for assistance with accessing stock or referring patients for treatment. Call 1800 009 903, available Mondays to Fridays 8.30am-12.30pm and 1.30pm-5pm.
Ensure pregnant patients are not lost to follow-up. Local Public Health Units and the Department's Partner Notification Officers can assist with patients lost to follow-up. Partner Notification Officers can be reached on (03) 9096 3367 or by email at contact.tracers@dhhs.vic.gov.au.
Non-pregnant patients with syphilis
MSHC can also be contacted for clinical advice and support regarding alternative treatment options for non-pregnant patients with early or late-stage syphilis. Call 1800 009 903, available Mondays to Fridays 8.30am-12.30pm and 1.30pm-5pm.
Particulates identified in benzathine benzylpenicillin (Bicillin L-A) 1,200,000 units/2.3 mL
Replacement stock for this Brand is currently unavailable due to the stock shortage. It is recommended that clinicians follow the TGA’s < ; regarding continued use of this product for affected batches.
Safety considerations
It is recommended for clinicians to carefully check the product information before administration due to important safety considerations with S19A and SAS products:
- There may be differences in presentation; volume of administration and storage requirements compared to Australian-registered products.
- The presence of soy lecithin in some products (including Australian-registered products) which is not suitable for use in patients with an allergy to soy or peanuts.
Conservation strategies
- Conserve benzathine benzylpenicillin use where possible, by considering the use of alternative antibiotic agents in suitable patients.
- For more information on alternative antibiotic agents, refer to the Australian Therapeutic , relevant condition-specific guidelines and/or infectious disease specialists for advice.
- Refer to the Australian Sexually Transmissible Infections (STI) Management
- Refer to 2025 Australian Guideline for Prevention, Diagnosis and Management of Acute Rheumatic Fever and Rheumatic Heart
- Where available and clinically appropriate, health services should utilise S19A and SAS alternatives to reserve supply of Australian-registered products for community patients to access via the PBS.
Further information
Refer to TGA for updates regarding further changes to supply and the TGA S19A approvals for updates on further S19A alternatives.
Further advice will be provided once available.
For health service stock issues, contact HealthShare Victoria: supplychainsurety@healthsharevic.org.au.
For primary care providers, contact your Local Public Health (LPHU).
For general inquiries regarding this critical update, contact CPLU@safercare.vic.gov.au.
Reviewed 08 August 2025