Quality Standards

Precise Dosing is Key.

Proper hormone levels are determined by simple blood tests. Based on over 30 years of knowledge and experience, precise and proper dosing is recommended for each individual patient.

Pellets deliver hormones 24 hours a day, 7 days a week for 3 to 5 months.

Our standards for approved partner 503B outsourcing facilities

  • Licensed Pharmacy in All States
  • Registered Outsourcing Facility with the FDA
  • Multiple Clean Rooms, both positive and negative pressure
  • Sterility Validation Process for Pellets, compliant with FDA standards
  • Proprietary Pellet Compounding process for repeatable and consistent quality
  • 100% Sterility, Potency and Endotoxin Testing per pellet batch
  • Environmental Monitoring per pellet batch compliant with FDA standards
  • Dedicated Quality Unit and dedicated FDA compliance Microbiologist
Become A Provider

Become A Provider

Contact us to become a Certified BioTE® Provider. Provide the following information to get started today!

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