Last Updated: 3 Sep 2026

Compounded Medications Disclaimer

Practice: Dr Tess of Beverly Hills/Virtual Concierge MD

Effective Date: September 2, 2026

Supersedes: Version dated July 3, 2025

Core Disclosure

Compounded medications are not approved by the FDA. The FDA does not review compounded drugs to evaluate their safety, effectiveness, or quality before they reach patients.

If we prescribe a compounded medication for you, you are entitled to know this, to ask questions about it, and to request an FDA-approved alternative.

What Compounded Medications Are

Compounded medications are prepared by a licensed pharmacist to meet the needs of an individual patient. They are not mass-produced, and they do not go through FDA pre-market review.

Regulatory Framework
  1. 503A pharmacies compound pursuant to patient-specific prescriptions and are regulated primarily by state boards of pharmacy
  2. 503B outsourcing facilities may compound in larger quantities, register with the FDA, and must follow Current Good Manufacturing Practice requirements

Neither category produces FDA-approved drugs.

When We May Prescribe a Compounded Medication

We may prescribe compounded medications when an FDA-approved product contains an ingredient you cannot tolerate, when a needed strength is not commercially available, when a different delivery form is medically necessary, or when a combination preparation is clinically appropriate for you.

A pharmacy may not lawfully compound a product that is essentially a copy of a commercially available FDA-approved drug.

GLP-1 and Weight Management Medications

The shortages of semaglutide and tirzepatide that previously supported broad compounding have been resolved, and the FDA has proposed removing semaglutide, tirzepatide, and liraglutide from the bulk substances list available to outsourcing facilities.

We prescribe FDA-approved GLP-1 medications. We do not market compounded GLP-1 products as equivalent to brand-name products, and we do not use practice-branded labeling that obscures the identity of a compounding pharmacy.

Compounded Hormone Therapy

Compounded bioidentical hormone therapy warrants particular caution:

  1. The National Academies of Sciences, Engineering, and Medicine concluded that evidence is insufficient to support the safety and effectiveness of compounded bioidentical hormone therapy for general use, and recommended restricting it to patients with a documented allergy to an ingredient in an FDA-approved product or a need for a dosage form not commercially available
  2. The FDA has been considering adding several compounded hormones to its "demonstrably difficult to compound" list, which would restrict or eliminate their compounding
  3. Major menopause societies do not recommend compounded bioidentical hormone therapy where an FDA-approved alternative exists

Where an FDA-approved hormone product is appropriate for you, we will prescribe it. Where compounded hormone therapy is clinically indicated, we will document the reason and obtain your informed consent.

Your Rights

You may ask which pharmacy is preparing your medication, ask about that pharmacy's licensure and accreditation, request an FDA-approved alternative, decline compounded medication, seek a second opinion, and transfer your prescription elsewhere at any time.

Risks

Because compounded drugs do not undergo FDA pre-market review, potency and consistency may vary between batches and between pharmacies, sterility assurance depends on the compounding facility's practices, stability and shelf-life data may be limited, and adverse event reporting is less systematic than for approved drugs.

Reporting Problems

Report any adverse reaction, unexpected side effect, change in your condition, or concern about medication appearance or quality immediately.

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

You may also report adverse events directly to the FDA through MedWatch.

Cost and Insurance

Most insurance plans do not cover compounded medications. Verification of coverage is your responsibility. Payment is generally required at the time of order. HSA and FSA eligibility varies by plan.

Pharmacy Standards

We work only with licensed compounding pharmacies that are compliant with the regulations of the state in which they operate and with applicable USP standards for non-sterile and sterile compounding.

States Where We Practice

We comply with compounding-related requirements in California, Illinois, Indiana, Montana, New York, and Nevada. Requirements vary by state, and some products available in one state may not be available in another.

Contact

Dr Tess of Beverly Hills/Virtual Concierge MD

9663 Santa Monica Blvd, Suite 957, Beverly Hills, CA 90210

Phone: (310) 275-8377 | Email: support@virtualconciergemd.com


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

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