Legal & Compliance
FDA Disclosure
Important information about compounded medications.
Last updated: April 27, 2026
Compounded Medications Are Not FDA-Approved
The compounded medications prescribed through Haven Integrative Health are NOT FDA-approved. Compounded medications are custom-prepared by state-licensed compounding pharmacies using FDA-approved active pharmaceutical ingredients. These medications are prepared for individual patients under a valid prescription and are exempt from FDA pre-market approval requirements under Section 503A of the Federal Food, Drug, and Cosmetic Act.
What This Means
While the active ingredients in our compounded medications are FDA-approved substances or recognized pharmaceutical compounds, the specific compounded formulations we prescribe have not undergone FDA review for safety, efficacy, or quality.
Our compounded medications include:
All contain active pharmaceutical ingredients that are either FDA-approved for other medical uses or are established pharmaceutical compounds, but the compounded versions have not been evaluated by the FDA.
FDA-Approved Brand-Name Alternatives
FDA-approved brand-name versions of GLP-1 medications are available:
Semaglutide
- Ozempic® — approved for type 2 diabetes
- Wegovy® — approved for weight management
Tirzepatide
- Mounjaro® — approved for type 2 diabetes
- Zepbound® — approved for weight management
These brand-name medications have undergone rigorous FDA review for safety and efficacy. If you prefer an FDA-approved medication, discuss this with Margaret during your consultation.
Why We Prescribe Compounded Medications
Compounded medications offer several advantages:
Cost
Compounded versions are significantly more affordable than brand-name medications (typically $249–$499/month vs. $900–$1,500/month for brand-name).
Accessibility
During periods of brand-name medication shortages, compounded versions remain available.
Customization
Compounding allows for individualized dosing and formulation adjustments based on your specific needs.
Combination therapy
Our formulations include methylcobalamin (B12) at no additional cost.
Our Compounding Pharmacy
All Haven medications are compounded by a licensed Georgia compounding pharmacy, regulated by the Georgia Board of Pharmacy as a 503A facility.
Licensed Georgia Compounding Pharmacy
503A Compounding Pharmacy · Georgia Board of Pharmacy
- ✓Adheres to USP 795, 797, and 800 compounding standards
- ✓Sources active ingredients from FDA-registered, cGMP-certified manufacturers
- ✓Performs third-party laboratory testing for potency and sterility
- ✓Maintains continuous quality control and documentation
- ✓Provides certificates of analysis upon request
Quality and Safety Standards
While compounded medications are not FDA-approved, they are regulated:
State oversight: Licensed and inspected by the Georgia Board of Pharmacy
Federal standards: Must comply with USP (United States Pharmacopeia) compounding standards
Ingredient sourcing: Active pharmaceutical ingredients must come from FDA-registered facilities
Testing: Each batch undergoes sterility, potency, and endotoxin testing
Storage and shipping: Cold-chain temperature control maintained throughout distribution
Your Right to Choose
You have the right to choose between compounded and FDA-approved medications. During your consultation, Margaret will:
- ✓Explain the differences between compounded and brand-name medications
- ✓Discuss the risks and benefits of each option
- ✓Answer your questions about safety, efficacy, and cost
- ✓Help you make an informed decision based on your preferences and circumstances
If you have insurance coverage for brand-name medications (Wegovy, Zepbound, Ozempic, Mounjaro), you may prefer to use those instead of compounded versions.
Questions About FDA Status?
If you have concerns or questions about the FDA status of compounded medications, please discuss them with Margaret during your consultation. We are committed to transparency and informed consent.
Important: This information is not intended to substitute for medical advice. Always consult with a qualified healthcare provider before starting any medication.
Additional Resources
FDA Information on Compounding
www.fda.gov/compoundingGeorgia Board of Pharmacy
www.gbp.georgia.govUSP Compounding Standards
www.usp.orgReady to discuss your options?
Get started with a consultation with Margaret to discuss compounded vs. brand-name medications and find the right fit for you.