TGA approved vs Compounded
Key Considerations
Regulatory Approval and Quality Standards
Testosterone Enanthate (currently available under the brand name Primoteston) is a TGA-approved medicine, meaning it has been assessed for quality, safety, and efficacy by the Therapeutic Goods Administration of Australia.
This approval helps ensure consistent manufacturing standards, purity, and reliability.
By contrast, compounded testosterone preparations are individually made by pharmacists. While this allows customisation (for example, choice of carrier oil or concentration), these products are not TGA-approved and therefore can vary in potency, sterility, and shelf life depending on the compounding process.
Choosing a TGA-approved product where appropriate may help minimise risks associated with contamination or inconsistent formulation sometimes observed in compounded medicines.
Regular medical review and ongoing blood monitoring are essential when switching between Primoteston and compounded testosterone to maintain stability in hormone levels and treatment response.
Testosterone Enanthate (TGA approved)
Pros:
Pharmaceutical-grade quality: Manufactured under TGA regulation, ensuring consistent potency and high safety standards.
Regulatory assurance: Extensively tested for quality and clinical performance.
Stable and predictable release: Provides reliable testosterone levels when prescribed appropriately.
Long shelf life: Typically 3–5 years in original packaging when stored correctly.
Lower contamination risk: Produced under strict manufacturing and sterility standards.
Supported by clinical data: Long history of use with well-documented safety profile.
Widely available: Readily accessible through community pharmacies.
Cons:
Limited flexibility: Fixed dose and carrier oil (castor oil) may not suit all patients.
Injection site sensitivity: Some individuals may experience mild irritation or discomfort.
Occasional supply shortages: Availability can vary by region.
Compounded Testosterone Enanthate
Pros:
Customisable: Dose, concentration, and carrier oil can be adjusted to individual needs.
Alternative option: May suit men with sensitivities to castor oil or other excipients.
Comparable pharmacology: Uses the same ester type as Primoteston.
Cons:
Variable quality: Depends on the pharmacist’s expertise and equipment; potency and sterility may vary.
Shorter shelf life: Typically 6–12 months.
Higher contamination risk: Not subject to the same TGA manufacturing standards.
Batch variability: May lead to fluctuating testosterone levels.
Generally higher cost: Custom preparation can increase price.
Compounded Testosterone Cypionate
Pros:
Customisable: Allows tailored dosing and carrier oil options.
Longer-acting ester: Slightly longer half-life compared with enanthate.
Alternative for sensitivities: Option for men intolerant to certain ingredients.
Cons:
Variable quality and sterility: Compounded individually, with potential differences between batches.
Shorter shelf life: Usually 6–12 months.
Higher contamination risk: Less stringent oversight than TGA-approved medicines.
Possible inconsistency in potency: May cause hormone level fluctuations.
This content is provided for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
Testosterone therapy should only be initiated after comprehensive medical assessment by an AHPRA-registered doctor.
Individual results and responses vary. Always consult your healthcare provider for guidance specific to your health needs.