Unparalleled Quality & Safety Through Proprietary Pellet Production & Oversight
BioTE® is renowned in the precision hormone therapy space for high-quality, scientifically-informed BHRT diagnosis and treatment. We set and monitor the standards for our proprietary development of customized hormone pellets to ensure the most precise dosage and production consistency. We regularly educate our practitioners on ethical, regulatory, privacy and billing issues and provide peer mentors to guide practitioners in appropriate diagnosis, treatment and patient counseling.
To achieve BioTE® Method Certification, all healthcare providers are required to:
- Prove good standing with their respective state licensing board
- Receive training on BioTE® procedures and protocols
- Source medications and supplements exclusively from approved vendors
- Comply with DEA’s inventory control regulations
- Use BioTE®’s proprietary technology, including the Diagnostic and Dosing Platform, training, and training videos to ensure proper procedure and protocol execution
BioTE® Works With FDA-Registered Outsourcing Facilities
Bioidentical subcutaneous pellets from our approved outsourcing facilities must be compounded pursuant to specific manufacturing processes that adhere to stringent quality control standards. We require pellets to be manufactured to potency standards stricter than the industry standards of +/- 10%.
Our outsourcing facilities have implemented proprietary methods to standardize pellet production, helping to insure consistent potency. We insist on working only with FDA-registered 503B Human Drug Compounding Outsourcing Facilities that conduct adequate regulatory oversight and consistent BHRT compounding volume. These 503B Outsourcing Facilities are held to stricter standards than a typical 503A Compounding Pharmacy and must also satisfy BioTE®s clinical, quality, and service requirements, which include:
- Compliance with 21 CFR parts 210 and 211
- Compliance with regulations promulgated by state boards of pharmacy
- The highest level of compounding precision
BioTE’s approved outsourcing facilities are required to comply with Current Good Manufacturing Practices (CGMPs) relating to sterility, endotoxin testing, environmental monitoring, quality assurance checks, and more, helping to ensure that BioTE providers receive the highest-quality compounded hormones available.