Compounded testosterone in Canada: what it is and the rules
Compounded testosterone is a preparation made by a pharmacy for an individual patient, with no Drug Identification Number and no Notice of Compliance. Health Canada’s policy POL-0051 leaves oversight to each province’s pharmacy regulator. No randomized or controlled outcome evidence in men was found; a voluntary quality series, Wiley 2014, reported a 91 percent passing rating.
Key takeaways
- A compounded preparation carries no Drug Identification Number and no Notice of Compliance, which are the two federal markers of a manufactured product that has been through Health Canada review.
- Health Canada’s policy POL-0051 states that compounding of drugs “is practised primarily by pharmacists as an integral part of their profession and is regulated by the respective regulatory authorities in each province/territory.”
- No randomized or controlled outcome evidence on compounded testosterone potency or patient outcomes in men was found in the literature reviewed on 14 September 2026.
- The three published items that exist are a single patient case with cadaver skin permeation testing (Banov 2024), a voluntary quality control series reporting “a 91% passing rating” (Wiley 2014), and a single patient scrotal cream case (Needham 2018).
- Health Canada’s Drug Product Database, checked 14 September 2026, shows no testosterone cream at any status, no patch since the last Androderm DIN was cancelled on 14 April 2022, no long-acting undecanoate injection, no pellets and no subcutaneous auto-injector.
- The United States, the United Kingdom and Australia each place compounded medicines outside their approval systems, under FD&C Act sections 503A and 503B, MHRA Guidance Note 14, and the Therapeutic Goods Administration’s unapproved goods classification respectively.
Everything on this page concerns men with confirmed low testosterone. It does not apply to men whose testosterone is normal. No regulator described here has approved testosterone, compounded or manufactured, for that purpose. What testing your own case needs is a decision for your doctor or nurse practitioner.
What is compounded testosterone?
Compounding is the preparation of a medicine by a pharmacy for an individual patient, rather than the manufacture of a standard product in batches for the market at large. The compounded item is made to the prescription in front of the pharmacist. It is not a listed product with its own approval file.
The difference is documentary. A manufactured drug sold in Canada carries a Drug Identification Number assigned by Health Canada, and its sponsor holds a Notice of Compliance confirming that the submission met the regulatory requirements. A compounded preparation has neither. There is no product monograph for it and no approved indication attached to it.
What does the absence of a DIN mean in practice?
It means the federal approval pathway was never applied to that preparation. A DIN records that a specific product, at a specific strength and dosage form, was reviewed and authorized. Health Canada’s Drug Product Database lists every one of them and their current status, which is how a reader can check which testosterone products are actually available in Canada on any given day.
A compounded preparation does not appear in that database, because the database is a register of authorized products. The absence of a DIN is a statement about the regulatory route taken, not a finding about the preparation itself. This article does not claim that compounded and DIN products are equivalent, and it does not claim that they differ. Neither claim has published evidence behind it.
How is compounded testosterone regulated in Canada?
By the provincial and territorial pharmacy regulators, not by Health Canada. Health Canada’s policy POL-0051 sets out the federal position directly: compounding of drugs “is practised primarily by pharmacists as an integral part of their profession and is regulated by the respective regulatory authorities in each province/territory.”
That single sentence explains the whole Canadian arrangement. No Notice of Compliance is issued for a compounded preparation, and no federal drug establishment licence is required for it. Oversight sits with the provincial college of pharmacists that licenses the pharmacy and the pharmacist. A question about how a specific preparation was made, tested or documented is a question for that college and for the pharmacy itself.
This sits alongside, rather than replaces, the rules that apply to testosterone as a substance. Those are set out separately in how testosterone is regulated in Canada, the US, Europe and Australia.
Why does this question come up in Canada specifically?
Because Canada’s marketed range is narrow, and several forms a reader may have heard about are not sold here at all. Health Canada’s Drug Product Database, checked 14 September 2026, shows no testosterone cream dosage form at any status, now or ever. There is no patch: the two Androderm DINs, 02239653 and 02245972, were cancelled post market on 14 April 2022 and 13 December 2021. There is no long-acting testosterone undecanoate injection, because Nebido and Aveed have never been authorized in Canada and every testosterone undecanoate DIN here is an oral capsule. There are no implantable pellets, no subcutaneous auto-injector, no mixed-ester injection and no 2 percent topical solution.
That is the link. A form that is absent from the Canadian market exists in Canada, if at all, only as a compounded preparation, because there is no manufactured version of it to dispense. Testosterone cream is the clearest example: it is registered in Australia as AndroForte 5, testosterone 5 percent w/v, ARTG 123764, active since 11 July 2014, and it has never been a DIN product in Canada. The same applies to pellets, which are US only among the four countries compared, described further in nasal, buccal and pellet testosterone.
Readers of international articles will therefore meet descriptions of forms that have no Canadian manufactured equivalent. The gap between what is described elsewhere and what is registered here is set out in how testosterone products compare across four countries, and the transdermal forms specifically in testosterone gels and creams.
How do the United States, the United Kingdom and Australia handle compounding?
Each places compounded medicines outside its approval system, by a different legal mechanism.
United States
Compounded preparations are not FDA approved. They are exempt from premarket approval under one of two sections of the Federal Food, Drug, and Cosmetic Act. Section 503A covers a preparation made against a patient-specific prescription, which is also exempt from current good manufacturing practice and from adequate-directions labelling. Section 503B covers a registered outsourcing facility, which must meet current good manufacturing practice, register with the FDA, report adverse events and label the product “This is a compounded drug.” Neither section constitutes approval.
United Kingdom
A compounded preparation is an unlicensed medicinal product. It is supplied either as a “special” under an MHRA Manufacturer’s Specials licence, or extemporaneously under the Human Medicines Regulations 2012. Under MHRA Guidance Note 14, supply is permitted only against a bona fide unsolicited order for an individual patient, and the product cannot be advertised. The advertising prohibition is a defining feature of that framework.
Australia
Compounded medicines are not in the Australian Register of Therapeutic Goods. The Therapeutic Goods Administration classifies them as unapproved therapeutic goods, and extemporaneous compounding for an individual patient is exempt from ARTG inclusion, with the compounder answerable to the Pharmacy Board of Australia and to state or territory law.
One note on Australia. The TGA’s compounding guidance pages blocked automated retrieval on 14 September 2026, so the Australian description above is a summary of the agency’s classification rather than quoted text from the agency’s own page. It should be verified against the TGA directly.
| Country | Status of a compounded preparation | Who oversees it | Named source |
|---|---|---|---|
| Canada | No DIN, no Notice of Compliance, no federal drug establishment licence required for it | Provincial and territorial regulatory authorities | Health Canada policy POL-0051 |
| United States | Not FDA approved; exempt from premarket approval under FD&C Act section 503A or section 503B | FDA registration required for 503B outsourcing facilities | FDA, FD&C Act Provisions that Apply to Human Drug Compounding |
| United Kingdom | Unlicensed medicinal product: a “special” or an extemporaneous preparation | MHRA, under Guidance Note 14 and the Human Medicines Regulations 2012 | MHRA Guidance Note 14 |
| Australia | Not in the ARTG; classified as an unapproved therapeutic good | Pharmacy Board of Australia and state or territory law | TGA, Compounded medicines (pages could not be retrieved for direct verification) |
What published evidence exists on compounded testosterone?
Very little, and that is the finding. No randomized or controlled outcome evidence on compounded testosterone potency or patient outcomes in men was found in the literature reviewed on 14 September 2026. Three items exist, and each is small or indirect.
| Study | Design and population | Finding | Source |
|---|---|---|---|
| Banov 2024, Pharmaceutics | One patient case, plus in-vitro Franz-cell cadaver skin permeation testing of compounded topical gels at 0.5 to 20 percent | Case description with laboratory permeation data; the authors are employees of a compounding company | PMID 38794283 |
| Wiley 2014, International Journal of Pharmaceutical Compounding | Voluntary quality control samples from participating pharmacies, 2008 to 2012, covering compounded products generally | Participating pharmacies had “a 91% passing rating with a percent of target of 98.6% +/- 8.4%”; results were not reported separately for testosterone | PMID 24881121 |
| Needham 2018, International Journal of Pharmaceutical Compounding | One patient, scrotal application of a compounded testosterone cream | Levels of 1204.7 ng/dL within two hours and 1320.6 ng/dL beyond six hours | PMID 30384346 |
How should each of those three be read?
Banov 2024, published in Pharmaceutics, pairs one case with bench permeation testing on cadaver skin, which is a laboratory measurement rather than a clinical outcome. Its authors are employees of a compounding company, which is disclosed and is relevant context.
Wiley 2014, in the International Journal of Pharmaceutical Compounding, is the least specific of the three. Submission was voluntary, a single protocol was used, and results were not reported separately for testosterone, so it describes a self-selected group of pharmacies across all compounded products.
Needham 2018, in the same journal, reports one patient using a compounded cream on the scrotum. One patient is one patient.
Is there better evidence for a registered cream?
There is, and the distinction matters. Wittert 2016, published in Andrology, was an open-label, phase 2, randomized, crossover bioequivalence study of the registered Australian cream against a 1 percent gel in 16 androgen-deficient men aged 29 to 73 over two 30-day periods. Day 30 cream to gel ratios were 0.99 for area under the curve (90 percent confidence interval 0.86 to 1.14), 1.02 for maximum concentration (0.84 to 1.24) and 0.99 for average concentration (0.86 to 1.14), all inside the 80 to 125 percent window.
That study tested a registered product with an ARTG entry. It says nothing about any compounded preparation and should not be read across to one.
What the evidence does not show
- It does not show that compounded testosterone achieves, or fails to achieve, the levels or outcomes of a DIN product. No randomized or controlled outcome trial in men was found in either direction.
- The Wiley 2014 figures, “a 91% passing rating” and a percent of target of 98.6 percent plus or minus 8.4 percent, do not apply to testosterone specifically. The report did not break results out by drug, and pharmacies submitted samples voluntarily.
- Banov 2024 rests on one patient plus in-vitro cadaver skin testing, which cannot establish clinical effect, and its authors are employees of a compounding company.
- Needham 2018 reports a single patient. Two measurements in one man, 1204.7 ng/dL and 1320.6 ng/dL, describe that man on that day and nothing more.
- The Wittert 2016 bioequivalence result, with ratios of 0.99, 1.02 and 0.99 in 16 men, belongs to a registered Australian product, ARTG 123764, and does not transfer to a compounded preparation.
- No public reason is on record for why no testosterone cream for men exists outside Australia, or why long-acting testosterone undecanoate injection has never been authorized in Canada. Both absences are documented; neither is explained.
- The Australian regulatory description on this page is a summary, because the TGA compounding pages could not be retrieved on 14 September 2026.
Frequently asked questions
Does compounded testosterone have a DIN?
No. A compounded preparation is made by a pharmacy for an individual patient and does not carry a Drug Identification Number or a Notice of Compliance. Those are issued by Health Canada to manufactured products that have been through review. Health Canada’s policy POL-0051 states that compounding is regulated by the provincial and territorial regulatory authorities rather than federally.
Who regulates compounding pharmacies in Canada?
The provincial and territorial pharmacy regulators. Health Canada’s policy POL-0051 states that compounding of drugs “is practised primarily by pharmacists as an integral part of their profession and is regulated by the respective regulatory authorities in each province/territory.” No federal drug establishment licence is required for it, and no Notice of Compliance is issued. Oversight sits with the provincial college rather than with Health Canada.
Is there evidence that compounded testosterone works?
No randomized or controlled outcome evidence on compounded testosterone potency or patient outcomes in men was found in the literature reviewed on 14 September 2026. What exists is a single patient case with in-vitro cadaver skin permeation testing (Banov 2024), a voluntary quality control series (Wiley 2014) and a single patient scrotal cream case (Needham 2018). Absence of evidence is not evidence of inferiority.
Why does compounded testosterone come up more often in Canada?
Canada’s marketed range is narrow. Health Canada’s Drug Product Database, checked 14 September 2026, lists no testosterone cream at any status, no patch since the last Androderm DIN was cancelled on 14 April 2022, no long-acting testosterone undecanoate injection, no implantable pellets and no subcutaneous auto-injector. Several forms described in international material therefore exist in Canada, if at all, only as a compounded preparation.
How does the United States regulate compounded testosterone?
Under two sections of the Federal Food, Drug, and Cosmetic Act. Section 503A exempts a preparation made against a patient-specific prescription from premarket approval, from current good manufacturing practice and from adequate-directions labelling. Section 503B covers registered outsourcing facilities, which must meet current good manufacturing practice, register with the FDA, report adverse events and label the product “This is a compounded drug.” Neither route is FDA approval.
Can a compounded medicine be advertised in the United Kingdom?
No. Under MHRA Guidance Note 14, a compounded preparation is an unlicensed medicinal product, supplied either as a “special” under a Manufacturer’s Specials licence or extemporaneously under the Human Medicines Regulations 2012. Supply is permitted only against a bona fide unsolicited order for an individual patient, and the product cannot be advertised.
What is the position in Australia?
Compounded medicines are not in the Australian Register of Therapeutic Goods. The Therapeutic Goods Administration classifies them as unapproved therapeutic goods, and extemporaneous compounding for an individual patient is exempt from ARTG inclusion, with the compounder answerable to the Pharmacy Board of Australia and to state or territory law. The TGA compounding pages could not be retrieved for direct verification on 14 September 2026.
References
- Banov 2024. Testosterone Therapy for Late-Onset Hypogonadism … Compounded Testosterone 0.5-20% Topical Gels. Pharmaceutics. PMID 38794283. DOI: https://doi.org/10.3390/pharmaceutics16050621
- Wiley 2014. The standardization of nonsterile compounding. International Journal of Pharmaceutical Compounding. PMID 24881121. DOI: unknown, no DOI in the PubMed record.
- Needham 2018. Case Study: Absorption of Testosterone Cream via Scrotal Delivery. International Journal of Pharmaceutical Compounding. PMID 30384346. DOI: unknown, no DOI in the PubMed record.
- Wittert 2016. An open-label, phase 2, single centre, randomized, crossover design bioequivalence study of AndroForte 5 testosterone cream and Testogel 1% testosterone gel in hypogonadal men: study LP101. Andrology. PMID 26754331. DOI: https://doi.org/10.1111/andr.12129
- Health Canada. Policy POL-0051, on the compounding of drugs. Document date: unknown. URL: unknown.
- Health Canada. Drug Product Database. Queried 14 September 2026. https://health-products.canada.ca/dpd-bdpp/search/
- US Food and Drug Administration. FD&C Act Provisions that Apply to Human Drug Compounding. Retrieved 14 September 2026. URL: unknown.
- Medicines and Healthcare products Regulatory Agency. Guidance Note 14, on the supply of unlicensed medicinal products (specials). Retrieved 14 September 2026. URL: unknown.
- Therapeutic Goods Administration. Compounded medicines. Retrieved 14 September 2026. https://www.tga.gov.au/resources/artg (the compounding guidance pages themselves blocked automated retrieval on that date).
This page is educational information, not medical advice. Testosterone is a prescription medication and a controlled substance in Canada. Talk to your doctor or pharmacist about your own situation.