Compounded Medication Policy

Updated: 07/01/2024

At HydraMed, your health and safety are our highest priorities. Our commitment to transparency and quality ensures you have all the information necessary to make informed decisions regarding your health. This page details the nature of compounded medications, our commitment to quality, and our partnerships with FDA-registered pharmacies.

Our Commitment to Quality

At HydraMed, we are dedicated to maintaining the highest standards of medical care and treatment for our patients. Our commitment to quality is driven by our six core values:

1. Safety: We ensure patient safety by adhering strictly to medical protocols, guidelines, and industry best practices.

2. Excellence: We strive to provide the highest level of medical care and safety to our patients, ensuring their well-being and satisfaction.

3. Compassion: We treat our patients with kindness, empathy, and understanding, recognizing their unique needs.

4. Integrity: We operate with honesty and transparency in all our business practices, building trust with our patients.

5. Transparency: We maintain clear and timely communication to ensure quality service for patients and staff.

6. Innovation: We continuously innovate our services and treatments to deliver better outcomes and stay at the forefront of medical advancements.

Quality Standards of Our Partnered Pharmacies

We only partner with FDA-registered pharmacies that adhere to the highest quality standards in the industry. These standards include:

• Sterility Testing: Ensuring all products are consistently safe and reliable.

• Highest Standards in Quality Control: Continuous monitoring and cleaning to ensure zero compromise in quality.

• Up-to-Date Processes: Rx e-Notifications, dedicated customer service, and expedited Rx turnaround to keep you informed about your medication’s progress.

Commitment to Excellence

Providing quality medication for all is driven by our team of dedicated experts, a robust quality management system, and a focus on innovation. Our partnered pharmacies are:

• PCAB Accredited: Demonstrating our commitment to meeting the highest standards in pharmacy compounding.

• cGMP Compliant: Ensuring that our manufacturing processes adhere to current good manufacturing practices.

• 503A and 503B Certified: Our partnered pharmacies meet the necessary requirements for both 503A and 503B compounding, allowing for both patient-specific and large-scale medication production.

Quality Assurance Processes

Our partnered pharmacies utilize advanced technology and rigorous quality control processes to ensure the highest level of safety and efficacy. This includes:

• Environmental Monitoring: Continuous monitoring of cleanrooms and compounding areas to maintain sterile conditions.

• Independent Testing: Third-party testing for sterility, endotoxins, and potency of all compounded batches.

• Compliance with USP 800: Ensuring safe handling of hazardous drugs to protect both patients and pharmacy staff.

Understanding Compounded Medications

Compounding involves creating personalized medications tailored to individual patient needs. Licensed pharmacists formulate these medications using approved ingredients in appropriate dosages. Compounded medications can be particularly beneficial when:

• Commercially available medications do not meet a patient’s specific needs.

• A patient has allergies to certain ingredients in standard medications.

• Medications are discontinued or in short supply.

However, it’s essential to understand that compounded medications may not undergo the same rigorous testing as FDA-approved medications. Always consult with your physician before starting any treatment or therapy program.

FDA Approval and Evaluation

Our compounded versions of medications, such as Tirzepatide and Semaglutide, are not FDA-approved. The services provided by HydraMed, including our mobile IV therapy and wellness products, have not been evaluated by the FDA. We believe in complete transparency and honesty regarding our offerings and strive to provide the highest quality through our partnered FDA-registered pharmacies. Please note that compounded medications are not FDA-approved and are prepared specifically to meet the unique needs of individual patients.

Transparency and Honesty

We believe in complete transparency and honesty regarding our offerings. Our customer testimonials reflect personal experiences and are not intended to claim that our products can diagnose, treat, cure, mitigate, or prevent any disease. The information provided on our website is for informational purposes only and should not be construed as medical advice. Always seek professional medical advice from your physician or a qualified healthcare provider regarding any medical condition or treatment.