Updated: 18 June 2025
The Therapeutic Goods Administration has updated information about long acting methylphenidate shortages. Short acting methylphenidate is available and can be used as a short-term solution. We have just launched some clinical guidance which can be found here. Read on for a better understanding about some of the factors at play during these shortages.
There has been no change to the timeline for the resolution of the current methylphenidate shortages – they will continue until December 2025. Here is a useful table in the TGA update here.
As we field various queries about alternatives, emergency PBS listings and prescribing alternatives we feel it’s important to explain, as best we can, what’s happening.
Australia is facing an escalating shortage of ADHD medications, and while emergency alternatives like a Swiss-registered Concerta are technically available under Section 19A, the lack of PBS listing and long import delays make them inaccessible for most families.
In short, we’re in the midst of a perfect storm but what these current problems bring into sharp focus is the critical role non-pharmacological interventions play in the treatment of ADHD symptoms and how important these strategies will be not just for the rest of 2025 but into the future.
In this context we are working hard to think through the different options available for prescribers and people with ADHD to ensure that they continue to receive high quality treatment that is resulting in positive outcomes.
Section 19A option
Section 19A of the Therapeutic Goods Act 1989 allows the Therapeutic Goods Administration (TGA) to temporarily approve the supply of overseas-registered medications not currently registered in Australia, when an equivalent registered medicine is in short supply. It’s a regulatory workaround—designed to maintain supply continuity during critical shortages.
How Fast Is Approval?
In urgent cases, a Section 19A approval can be processed in a matter of days to weeks. The sponsor (usually a pharmaceutical supplier) must:
- Identify an overseas-registered equivalent;
- Submit a formal application to the TGA;
- Provide evidence of quality, safety, and appropriate packaging and labelling.
If the product is already well-known (e.g., FDA or EMA approved) and the TGA is satisfied it’s a suitable substitute, approval can be expedited—especially when the shortage is nationally significant.
Fore example: the TGA has approved a Section 19A supply of Concerta from Switzerland (this approval has been given to Medsurge Healthcare), which technically offers a lifeline. However, it’s not listed on the PBS, meaning patients are facing costs exceeding $200 for 30 tablets.
That’s assuming it can even be sourced—pharmacies are reporting 2-month delivery delays, minimum order quantities, and little financial viability to carry this stock.
In short: it’s not a practical alternative for most Australians right now.
The Myth of “PBS by default”
Understandably, many ask: if the TGA has approved it, why isn’t it on the PBS?
The crux of the dilemma is that approval for use by the TGA does not mean a medication is automatically subsidised. PBS listing is an entirely separate, multi-step process involving:
- A formal submission by the sponsor (the company importing the medication) to the Pharmaceutical Benefits Advisory Committee (PBAC)
- Evidence that the product is cost-effective compared to existing options;
- Pricing negotiations between the sponsor and the Department of Health;
- And, for any product with an expected PBS spend of over $20 million/year, Cabinet-level approval.
We don’t currently know how much individual medications cost the PBS. That is all commercial-in-confidence information. Sometimes a costing is announced by the Health Minister but the commercial arrangements between a company and the Government is never disclosed.
The PBAC only meets three times per year. Even with a fast-track, the full process post-recommendation can take 6–12 months or more.
The Federal Health Minister cannot override PBAC decisions or approve an “emergency” listing without the steps above. If a company has applied for a listing it might be possible to allocate money immediately, which in theory can fast-track the process but the steps above still need to be followed.
Pharmac & Medsafe in NZ
For our kiwi cousins, Pharmac is aware of the shortages and often posts updates from the TGA and the UK’s NHS.
ADHD medication is regulated by Medsafe under the Medicines Act 1981. One key option for Medsafe to respond to shortages is allowing the supply of unapproved medicines under Section 29 of the Act, where a doctor can prescribe an unregistered medicine to a specific patient.
Pharmacists may also provide limited emergency supplies without a new prescription, though this is only possible under certain conditions. In extreme cases, Medsafe can approve temporary supply of medicines that don’t fully meet usual standards, or fast-track access to overseas products.
Global supply lines and American DEA quotas: A fragile balancing act
The supply of ADHD medications like Concerta, Ritalin, Teva XR, and other methylphenidate formulations, relies on a complex, often brittle global supply chain.
The active pharmaceutical ingredient (API) — methylphenidate hydrochloride — is manufactured in several countries including China, India, and also within the United States. But having multiple sources doesn’t mean resilience.
In the U.S., the Drug Enforcement Administration (DEA) imposes strict annual production quotas for controlled substances like methylphenidate. This is related to longstanding concerns about diversion and abuse that predate the current administration.
This means that even if demand increases legitimately or shortages loom, more API can not be produced without a green light from the DEA — a process that’s often slow, bureaucratic, and misaligned with real-world prescribing patterns.
So even when U.S. companies could theoretically make more API, they’re typically prevented from doing so at the scale required. Meanwhile, generic products and international alternatives rely mainly on India and China — but global manufacturing delays, raw material shortages, and freight bottlenecks continue to choke supply.
We made a submission to the DEA to increase supply, as did others from Australia, but no increase was granted.
And then, there’s politics!
MAHA and RFK: When policy meets the pharmacy shelf
Enter the Make America Healthy Again (MAHA) Commission, launched in early 2025 and chaired by Robert F. Kennedy Jr. The Commission’s stated goal is to investigate chronic health issues and medication use in children — but the language is loaded. The official line?
“Overmedication, particularly among children, is a growing concern. More than 3.4 million children are currently taking medication for ADD/ADHD and diagnoses continue to rise.”
It’s a clear shot across the bow at stimulant prescribing in the US. While MAHA doesn’t set quotas, its influence has already been felt. Since March 2025, there has been over $20b cut from organisations including the National Institute of Health and 20 000 jobs were cut from the Food and Drugs Administration (FDA) and the Centre for Disease Control (CDC). These decisions have raised legitimate concerns about the future of ADHD drug regulation, approval processes, and supply stability.
Add in trade tensions, and you’ve got a perfect storm!
Let’s not forget the Trump tariff yo-yo. The tariffs that are a bit like quicksilver would drive up the cost of importing APIs and finished medications. This particularly impacts low-margin generic medications. For medications like methylphenidate, which depend on efficient international coordination, it’s yet another strain on a system already under pressure.
So yes, APIs are being made. But between DEA ceilings, manufacturing bottlenecks, policy headwinds, and trade war leftovers, the finished product is not landing on Australian pharmacy shelves in the required quantities.
And that’s the reality we’re dealing with.
What can prescribers do now?
If considering a switch of medication to manage the current medication shortages, we urge prescribers to consult AADPA’s ADHD Prescribing Guide, which includes detailed information about optimising treatment, and switching between different preparations and medications. It also includes a very helpful dose equivalence table to help safely transition between the different methylphenidate formulations.
NSW Health temporary measures
NSW Health has updated and expanded the temporary measure introduced in January 2025 to support patients in accessing methylphenidate products. Under the new measure, pharmacists are exempted from the requirement to retain paper prescriptions and repeats for all methylphenidate products when dispensed.
This means pharmacists who are unable to supply these medicines due to the shortage can provide patients with their prescription and any repeat authorisations, to assist them in sourcing ongoing medicine supply from another pharmacy. This applies to paper prescriptions as electronic prescriptions, by virtue of their nature, cannot be physically retained at any one pharmacy.
Note: The pharmacist requesting the medicine must provide a written and signed order to the other pharmacist. See NSW Health for more information.
Non-medication treatment paths
We also need to think carefully about the non-medication treatments and strategies that we are providing. While non-pharmacological approaches for ADHD do not address the core symptoms they are effective at reducing the impact of these symptoms on day to day activities.
AADPA’s ADHD Guideline covers many non-medication treatment options. Download AADPA’s free information sheet covering Non-Medication Interventions Types and read on for more quality non-pharmacological interventions:
Psychoeducation
Psychoeducation is the bedrock from which all other interventions can be offered. Providing high quality psychoeducation takes time and is a skilled enterprise. We need to arm ourselves with good quality evidence based literature that we can recommend to our patients. A good starting place is AADPA’s free Non-Medication Interventions Overview.
Parental Training Approaches
For younger children, parent training approaches can help parents effectively manage their child’s ADHD. These have been shown to be effective in increasing positive parenting, reducing negative parenting and oppositional behaviours.
Behaviour Therapy
For young people and adults with ADHD, psychotherapies based around cognitive or dialectical behaviour approaches can also improve self esteem, mood and self efficacy.
ADHD Coaching
Our Australian Guideline For ADHD acknowledges that while we don’t yet have high quality evidence about the effectiveness of ADHD coaching, there are benefits, including the opportunity to develop lifelong skills in reducing the impact of ADHD symptoms, and the opportunity to improve self-esteem, mental health and broader wellbeing.
Looking for more professional training?
Register now for our upcoming ADHD Medication Workshop: Friday 25 July 2025
For more comprehensive training on ADHD Medication, register now for the Optimising Medication Outcomes for ADHD Workshop this July. Part of our 8th Annual Conference Pre-Conference Program, this Full Day Workshop aims to provide more intensive training where attendees can develop new skills and refine existing ones under expert guidance.
Optimising Medication Outcomes for ADHD
This comprehensive full-day workshop provides healthcare professionals with practical expertise to navigate the entire ADHD treatment journey. Based on AADPA’s Prescribing Guide, you’ll learn to optimise medication selection, titration, monitoring and management of complex presentations.
Perfect for prescribers, pharmacists and nurse practitioners seeking to enhance their ADHD medication management skills. You’ll gain confidence in selecting appropriate medications, implementing effective monitoring systems, managing adverse effects and creating collaborative care plans that improve adherence.
Facilitated by academic child psychiatrist and AADPA President, Professor David Coghill, alongside AADPA Prescribing Guide Co-Lead Author and experienced community pharmacist Kate Tognarini.
Whether you join us in person at Hilton Sydney ($399+gst) or virtually from the comfort of your home ($299+gst), you’ll also receive a recording of the workshop to watch on demand at your convenience.
