Quiet Waters Health 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.
Quiet Waters Health Certification Program Requirements
To achieve Quiet Waters Health Method Certification, all healthcare providers are required to:
Prove good standing with their respective state licensing board
Receive training on Quiet Waters Health procedures and protocols
Source medications and supplements exclusively from approved vendors
Comply with DEA’s inventory control regulations
Use Quiet Waters Health’s proprietary technology, including the Diagnostic and Dosing Platform, training, and educational videos to ensure proper procedure and protocol execution
Quiet Waters Health 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 ensure 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 Quiet Waters Health’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
Quiet Waters Health’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 Quiet Waters Health providers receive the highest-quality compounded hormones available.
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