What is a 503B
A 503B is an outsourcing facility that is able to manufacture large batches to be sold to healthcare facilities for office use. Since 503B facilities are made in larger batches they are able to lower their manufacturing costs, which passes the savings on to their clients.
For more information, visit https://www.fda.gov/drugs/human-drug-compounding/fdc-act-provisions-apply-human-drug-compounding
What is bioidentical hormone replacement therapy?
Bioidentical Hormone Replacement Therapy (BHRT) uses hormones derived from natural plant sources to replicate the body’s normal hormonal levels. Patients have found that BHRT with pellet implants can be extremely effective. Pellets, placed
under the skin, can consistently release small, physiologic doses of hormones that can provide optimal therapy.
Unlike typical oral and transdermal forms of therapy, which can produce “roller coaster” hormone levels, resulting in mood and energy fluctuations for the patient, Qualgen's hormone pellets typically provide consistent and sustained hormone levels throughout the day for up to three to six months.
Since the hormones used are completely natural, pellet therapy is ideal for patients who want the benefits of a natural hormone without the drawbacks of a
synthetic. Qualgen's pellets are chemically identical to the hormones your body products every day.
How are Qualgen’s hormone pellets created?
Qualgen's pellets are formed by compressing bio-identical hormone ingredients into very small cylinders a little larger than a grain of rice. Doing this process correctly is critical since it ensures that each patient receives the benefit of a steady accurate hormone dose. Qualgen is the only hormone pellet manufacturer who uses a machine press, rather than a hand press, to ensure each pellet is consistent.
What makes Qualgen’s pellets better than others?
Qualgen has worked very hard to
create the purest hormone pellets on the market. Quality is always the forefront of everything we do. Per the FDA, we can technically say our pellets are 100% pure testosterone and estradiol, because they are over 99%. However, we are very open and honest, and tell everyone our
pellets are 99.5% pure testosterone and estradiol. The other 0.5% is stearic acid, which is not used as a binder, but a lubricant to release our pellets from the machine pressed mold.
How are pellets placed in the body?
Using a local anesthetic, they are painlessly inserted under the skin of the hip, through a tiny incision, using a small insertion device called a trocar. After the pellets are inserted a small piece of tape, or a stitch or two, is placed to close the incision. The entire process only takes a few minutes and the amount of discomfort one feels is usually less than getting a blood test.
Where do the pellets go once they are inserted?
Since the hormone pellets are pure testosterone/estradiol, and do not have fillers or synthetic ingredients, they completely dissolve into the body as they are needed.
What are the hormone pellets derived from?
Qualgen's testosterone pellets are derived from soy and the estradiol pellets are derived from yam.
How can I set up an account?
To become a Qualgen provider, please fill out the new provider application here.
What is your turn around time?
Qualgen ships out all orders same day if received by 3 p.m. CST*
*Please note that at times there are situations outside of our control and shipments may not be able to go out same day.
What testing is done on qualgen's products?
Qualgen custom compounds are prepared in accordance with our customers individual needs. All Qualgen Products meet cGMP standards.
There are many advantages to custom compound pharmaceuticals:
- Preservatives and other objectionable ingredients may be removed in many formulations.
- Medicines that have been discontinued can still be formulated on demand
- Freedom to customize dosage and application to the patient’s exact need when commercially manufactured medications are limited
- Emergency response to critical National Drug Shortages.
Qualgen follows strict cGMP guidelines for environmental monitoring and control. All products are tested for potency, accuracy and sterility.