Non-FDA Approved Compounded Products Disclaimer

Effective Date: July 3, 2025

Last Updated: July 3, 2025

Important Notice Regarding Compounded Medications

Virtual Concierge MD may prescribe compounded products that have not been approved by the FDA.

What Are Compounded Medications?

Compounded medications are:

1. Customized medications prepared by licensed pharmacists
2. Created to meet specific patient needs
3. Not mass-produced like FDA-approved drugs
4. Prepared when commercially available medications are not suitable

FDA Position on Compounded Drugs

Critical Disclosure

The FDA does not verify the safety or effectiveness of compounded drugs.

Regulatory Framework

Compounded medications are regulated under:

1. Section 503A: Traditional compounding pharmacies (patient-specific prescriptions)
2. Section 503B: Outsourcing facilities (larger batch compounding)

Why We May Prescribe Compounded Medications

Virtual Concierge MD specialists may prescribe compounded medications when:

1. FDA-approved medications contain allergens or unsuitable ingredients
2. Specific dosage strengths are not commercially available
3. Alternative delivery methods are medically necessary
4. Combination therapies provide better patient outcomes
5. Pediatric or geriatric formulations are needed

Types of Compounded Medications We May Prescribe

Hormone Replacement Therapy

1. Bioidentical hormones
2. Custom hormone combinations
3. Specific delivery methods (creams, troches, pellets)

Weight Management

1. Custom dosage adjustments
2. Combination therapies
3. Note: Compounded GLP-1 agonists are no longer available as of 2025

Other Specialties

1. Dermatological preparations
2. Pain management compounds
3. Nutritional supplements

Important Safety Information

Quality Assurance

While compounded medications are prepared by licensed pharmacies:

1. They lack FDA's pre-market review
2. Manufacturing standards may vary
3. Batch-to-batch consistency is not FDA-verified
4. Adverse event reporting is limited

Your Rights and Responsibilities

You have the right to:

1. Ask questions about your compounded medication
2. Request information about the compounding pharmacy
3. Report any adverse effects immediately
4. Choose FDA-approved alternatives when available

Off-Label Prescribing Disclosure

Medical Practice Standards

Virtual Concierge MD specialists may prescribe:

1. FDA-approved medications for non-FDA approved uses
2. Medications at different doses than FDA-approved
3. Combinations not specifically FDA-approved

This is called "off-label" prescribing and is:

1. Legal and ethical
2. Based on medical literature and clinical experience
3. Common in medical practice (up to 20% of prescriptions)
4. Subject to physician's professional judgment

Informed Consent Requirements

Before receiving compounded medications, you will:

1. Receive detailed information about the medication
2. Discuss risks and benefits with your provider
3. Have opportunity to ask questions
4. Provide written consent when required

Reporting and Monitoring

Your Responsibilities

Please immediately report:

1. Any adverse reactions
2. Unexpected side effects
3. Changes in your condition
4. Concerns about medication quality

How to Report

Contact us immediately at:

1. Emergency: Call 911
2. Urgent: (310) 275-8377
3. Non-urgent: support@virtualconciergemd.com

Cost and Insurance Information

Insurance Coverage

1. Most insurance plans do not cover compounded medications
2. Coverage verification is your responsibility
3. Payment is typically required at time of order
4. HSA/FSA funds may be eligible (verify with your plan)

Alternative Options

You always have the right to:

1. Request FDA-approved alternatives
2. Seek a second opinion
3. Decline compounded medications
4. Transfer prescriptions to another provider

Legal Compliance

Virtual Concierge MD works only with:

1. Licensed compounding pharmacies
2. Facilities compliant with state regulations
3. Pharmacies maintaining proper quality standards
4. USP 795/797 compliant facilities when applicable

State-Specific Requirements

Compounding regulations vary by state. We comply with requirements in:

1. California
2. Illinois
3. Indiana
4. Montana
5. New York
6. Nevada

Questions About Compounded Medications

For more information about compounded medications:

Virtual Concierge MD

Theressia L. Washington, MD, P.C.

9663 Santa Monica Blvd, Suite 957

Beverly Hills, CA 90210

Phone: (310) 275-8377

Email: support@virtualconciergemd.com

Additional Resources

1. FDA Compounding Information: www.fda.gov/drugs/human-drug-compounding
2. USP Compounding Standards: www.usp.org
3. State Board of Pharmacy (varies by state)

By accepting a prescription for compounded medication, you acknowledge understanding that these products have not been evaluated by the FDA for safety or effectiveness.