How Big are Biote Pellets?
How big are Biote pellets? It’s amazing that something so small, can make such a HUGE difference!
There are 2 different types of pellets used in Biote hormone replacement therapy. Estrogen pellets are made from soy and are about the size of a grain of rice. Testosterone pellets are made from wild yam and are slightly larger, about the size of a tic-tac.
BioTE Pellet Manufacturing
The technology behind the bio-identical pellets has been around since 1939. Pellet therapy was developed to help the growing number of women having hysterectomies. These women began suffering the effects of menopause (hot flashes, night sweats, brain fog, weight gain, etc.) while still in their 20’s and 30’s.
While all pellets used for BHRT are either Estrogen or Testosterone, the rules about their manufacture can vary a lot. The pellets made for use in Biote Certified offices are all made in “503B facilities”.
503A vs. 503B Compounding Pharmacies
The Food and Drug Administration (FDA) divides compounding pharmacies into two groups: 503A and 503B facilities.
- 503A facilities are considered “traditional” compounding pharmacies. This means the medications they make are limited to home use and you must take your prescription to a pharmacy to have it fulfilled. This means an extra trip to the pharmacy so that you can pick up the pellets that your provider will then insert.
- A 503B pharmacy is considered an “outsourcing facility” and can send their products directly to your doctor’s office. Besides saving you a trip to the pharmacy, a 503B facility must also meet these additional standards:
- 503B facilities must follow Current Good Manufacturing Practice (CGMP) which is not required by a 503A compounding pharmacy.
- Before releasing a new product, 503B facilities have to make several batches of their new product and each must be individually tested before being released. This ensures new products meet the high standards set by CGMP and the FDA, resulting in a consistent, reliable quality product.
- 503B testing methods and products are also required to follow USP standards. The 503B supplier must pass on-site testing and inspections. 503A pharmacies are tested every six months while 503B pharmacies are tested on a daily and weekly basis.
- 503A and 503B pharmacies must register with their state pharmacy board. However, 503B facilities must also register with the FDA and complete special reports about their products.
When choosing a provider to perform your BHRT, make sure they use the highest quality products, made to the highest standards. If you have any questions, please contact us or call Integrative Health and Rehabilitation at (303) 424-7171 to speak to one of our Biote Certified Providers!