June is National Men’s Health Month, and a growing trend in personalized care deserves attention: compounded medications for men’s health. These individualized treatments can offer options when commercially available medications are unavailable or, in a prescriber's professional judgment, unsuitable for a patient.
Alex M. is a 57-year-old man with type 2 diabetes, a history of two heart attacks, and was 50 pounds overweight. Initially prescribed a commercially available GLP-1 medication by both his cardiologist and endocrinologist, he couldn't find the medication due to it being on shortage.
One of his doctors suggested a compounded medication as an alternative. Through a compounding pharmacy, Alex received a customized injectable GLP-1, finally making treatment accessible.
This wasn’t Alex’s first experience with compounded therapies. He had long struggled to find a testosterone replacement therapy (TRT) that didn’t trigger ingredient sensitivities. After switching to a provider who worked with a compounding pharmacy, he received a customized TRT formulation without problematic excipients.
“Moving to the compounding pharmacy allowed me to have my prescription customized so I could actually take it... game changing!” Alex reports.
Today, Alex manages his health conditions with the help of personalized treatments, solutions that weren’t available from traditional, one-size-fits-all medications. He lost weight and even completed the New York Marathon.
Pharmacy compounding involves preparing medications tailored to an individual patient’s specific needs. Unlike mass-produced pharmaceuticals, compounded medications can be customized in dosage, formulation, or combination with other ingredients to meet clinical goals when standard treatments are not appropriate.
These personalized solutions may:
Correct, they are not FDA-approved like mass-produced medications. FDA approval applies to standardized, manufactured drug products that undergo large-scale clinical trials. Compounded medications are custom-made and tailored for individual patients, which makes such trials impractical and not required.
However, that does not mean they are inherently unsafe. Compounded medications must be prepared by state-licensed compounding pharmacies or FDA-registered outsourcing facilities.
These pharmacies and facilities must follow all federal and state pharmacy regulations. State-licensed compounding pharmacies must also follow U.S. Pharmacopeia (USP) compounding standards, and outsourcing facilities must follow current Good Manufacturing Practices (cGMP).
Ingredients used in compounded medications come from FDA-registered facilities, and their identity, potency, and purity are supported by certificates of analysis and often third-party testing. Compounding pharmacies are regularly inspected by state boards of pharmacy, and in some cases, the FDA.
Hormone Changes
As hormone levels change as we age, that can impact mood, energy, libido, and overall vitality. Compounded testosterone therapies allow for individualized dosing and delivery (e.g., creams, gels, injections, troches) for men who cannot tolerate commercial testosterone products.
Sexual Health
Medications can help manage erectile dysfunction, premature ejaculation, and other concerns. When standard options aren’t effective or well-tolerated, compounded formulations can include sildenafil, tadalafil, oxytocin, or combinations thereof, delivered via troches, sublinguals, creams, or even injectables.
Hair Loss Solutions
Compounding allows multiple active ingredients to be combined at custom strengths in topical preparations. Formulas may include minoxidil, finasteride, and additional ingredients aimed at improving absorption or minimizing systemic side effects.
The future of healthcare is personalized. Men have distinct biological, hormonal, and lifestyle factors that influence their health. When standardized treatments fall short, your prescriber may determine that compounded medications can help fill the gap with individualized solutions.
As precision medicine gains ground, compounding will continue to play an essential role in optimizing patient care. This National Men’s Health Month, talk to your healthcare provider about ways to improve your health.
By Linda Williams, Chief Growth Officer for Belmar Pharma Solutions