TGA Maintains Restrictions on GP Prescribing of Isotretinoin
06 Nov 2026
The interim decision keeps prescribing restricted to specialist physicians and dermatologists, with safety concerns and the need for specialist monitoring among the main reasons.
The TGA highlighted the medicine's risk of causing serious birth defects, known as teratogenicity. It also raised concerns about the clinical knowledge needed to start treatment and monitor patients safely.
The decision has been met with disappointment from the Royal Australian College of General Practitioners (RACGP), which described it as a missed opportunity to improve access to treatment.
RACGP President Dr Michael Wright said GPs have the skills to manage patients taking isotretinoin, including providing contraception, managing cholesterol concerns and supporting patients with mental health needs.
The RACGP also argued that allowing appropriately trained GPs to prescribe the medicine could improve access, particularly for people living in rural and remote areas.
However, the TGA said the evidence provided did not show that the proposed changes would maintain the same level of safety as the current restrictions. It also found insufficient evidence that existing prescribing rules created a significant barrier to patient access.
Concerns raised during the assessment included the risk of incorrect diagnosis, inappropriate prescribing for mild acne and difficulties with safe treatment initiation and monitoring.
The TGA also raised concerns about online and cosmetic services that may prescribe isotretinoin without consistently following recommended clinical care standards.
While acknowledging that isotretinoin is an effective treatment for severe acne, the regulator said its benefits must be carefully weighed against its risks.
The decision is still interim, and the current prescribing restrictions remain in place while consultation continues. The TGA is inviting feedback on its findings until 4 December.
The RACGP plans to respond to the decision and is encouraging GPs to share their experiences of difficulties accessing isotretinoin. It also intends to meet with senior TGA representatives to discuss the concerns and continue advocating for appropriately trained GPs to prescribe the medicine.
TGA Maintains Restrictions on GP Prescribing of Isotretinoin
Source: Therapeutic Goods Administration (TGA) and newsGP (RACGP).