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Compounded Testosterone Products

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Compounded Testosterone Products

Compounded Testosterone Products
Testosterone Replacement Therapy Defy Medical 04

Defy Medical carefully selects pharmacy vendors who are licensed within the patient’s resident state and who comply with FDA and DEA regulations. All preferred pharmacy vendors have passed their most recent FDA inspection.

Testosterone and compounding
lab compounded products

Advanced testosterone therapies often involve prescribing medications that cannot be patented by pharmaceutical manufacturers. Most substances involved in these treatments can be produced by dual-licensed 503B and 503A compounding pharmacies who acquire the FDA-approved active ingredients necessary to manufacture testosterone in a variety of dosage forms.

Using a compounding pharmacy allows our physicians to collaborate with the pharmacy to produce custom drug formulas not commercially available. This includes injectable testosterone esters not available at retail pharmacies, allowing for continued access to a variety of options. Through this process, Defy patients receive uniquely formulated medications that target their specific needs and goals.

We contract medications at wholesale prices, so our patients have access to a full catalog of affordable lifestyle medications while keeping the medication cost lower than many insurance co-pays.

Defy Medical has close relationships with FDA-registered compounding pharmacies, maintaining contracts that guarantee competitive wholesale pricing and cost predictability.

Why use a compounded product when brand name TRT options are often covered by insurance

Why use a product customized by a compounding pharmacy when brand name TRT options are often covered by insurance for men with diagnosed hypogonadism?

Brand name options have many limitations. Most patients report high co-pay cost, limitations on what type of brand an insurance company may be willing to cover, and other restrictions that make it impractical for physicians to prescribe or for patients to afford. 

Compounded TRT options can be manufactured with varying concentrations of testosterone and/or blends of different esters, usually at a lower cost than most insurance co-pays. This provides a more targeted treatment, typically at a lower cost.

 

Available Testosterone Dosage Form Options

Compounding allows for access to a variety of options including the ability to customize testosterone into different dosage forms, strengths, and combinations. This allows your Defy physician to deliver a truly personalized experience.

A variety of testosterone esters are available for self-administered or clinic-administered injections. Our preferred pharmacies follow USP and cGMP guidelines for the manufacturing of sterile drugs. Every batch of injectable testosterone is independently tested for sterility, potency, and endotoxins before becoming available for dispensing. Compounded testosterone injections use less viscous carriers than the standard cottonseed oil, which allows for the use of smaller gauge needles and a decreased risk of injection reaction.

Testosterone is available in a topical cream base that can be applied to the skin to deliver testosterone through diffusion. Compounded testosterone creams can be customized to adjust the strength or type of cream based used. Testosterone can also be combined with other hormones into a single cream, reducing the need to apply multiple products. Higher concentrations are available for patients who poorly absorb topical or transdermal testosterone products.   

Testosterone as an implantable pellet is available in several dose options. We only use pellets that are manufactured by an FDA-registered facility that specializes in implantable hormone pellets. Pellets must be stored in glass ampules to maintain stability and integrity for the entire shelf life. 

Compounded testosterone gel is available in a custom base designed for nasal application. Testosterone is combined with oxytocin to deliver an effective combination therapy in a novel dosage form. Testosterone nasal gel is easy to apply using the attached nasal applicator.

Testosterone can be compounded as a buccal troche.  A troche is a small lozenge that dissolves between the cheek and gum over a period of about 10-20 minutes. Once applied, the troche dissolves and delivers testosterone through the buccal mucosa, or gums.  Different strengths are available to treat both men and women. 

We often use formulas that combine 2 or more ingredients, especially when there is a known synergy or when it can reduce the number of medications a patient needs to administer. Sometimes the effects are altered or enhanced when two or more medications are combined. 

Examples:

  • Combination of multiple esters for injection – Cypionate and Propionate
  • Combination of testosterone with other hormones in a topical cream – testosterone and tamoxifen
  • Combination of testosterone and sildenafil in a single buccal troche
  • Combination of DHEA and clomiphene in a single capsule
  • Combination of testosterone and oxytocin as a nasal gel

Drug Enforcement Compliance: Any prescription medication containing testosterone is considered a federally controlled substance. Defy Medical maintains Minimum Standards for Practitioners' Handling of Controlled Substances as guided in Title 21 CFR 1300. Additional security measures are followed to further secure the handling of controlled substances. We maintain optimal product stability by using proper storage techniques with environmental controls to ensure each product is stored as recommended on the manufacturer's label.


Vendor Highlights

It is important that any medication delivered by sterile injection is manufactured by a facility that adheres to USP and Good Manufacturing Practices to meet the highest level of quality. 

These standards include:

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Superior facilities and staffing.

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USP 795 & 797 compliant.

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ISO Class 5 environment for sterile compounding.

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Independent semi-annual certification for ante-room, cleanroom, hoods, and filters.

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Weekly environment testing.

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Daily humidity and temperature monitoring.

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In-house and independent quality, sterility, endotoxin, and potency testing.

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Wide range of compounding experience.

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Active participants in local and national associations.

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Wet and dry sterilization.

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Post filtration filter testing.

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FDA quality ingredients and chemicals.

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pH testing of all injectables & liquid products.

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Quality analysis and control performed on each batch.

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