Compounded medication consent
Certain medications offered through LEV18 may be compounded medications prepared by licensed pharmacies based on a provider's clinical judgment and patient specific needs.
- FDA status: compounded medications are not FDA approved
- Your right: transfer your prescription at any time
- Pharmacy: licensed 503A compounding pharmacy
Key point: Clinical services are provided by independent licensed providers of Arora Health.
1. What compounded means
If your provider prescribes medication as part of your program, it may be a compounded medication prepared specifically for you by a licensed 503A compounding pharmacy, based on your provider's individual prescription. A 503A pharmacy is a state licensed compounding pharmacy that prepares customized medications for an individual patient prescription and is regulated by state boards of pharmacy.
2. FDA disclosure
Compounded products are not approved nor evaluated for safety, effectiveness, or quality by the FDA. Compounded medications have not been evaluated by the FDA in the same manner as commercially manufactured FDA approved drugs. Their use is based entirely on your provider's independent clinical judgment.
3. Risks and benefits
Compounding allows a provider to tailor a medication's dose, form, or ingredients to an individual patient when that is clinically appropriate. Risks to understand before consenting:
- Variability in potency, purity, and sterility compared to FDA approved products, though licensed 503A pharmacies must comply with USP standards and state pharmacy regulations
- The specific formulation prescribed has not been evaluated in clinical trials for safety or efficacy in the way FDA approved medications have been
- Compounded medications may produce side effects, allergic reactions, or adverse events. Report any unexpected symptoms to your provider immediately.
- Long term safety data for specific compounded formulations may be limited
4. Pharmacy partners
Your medication is dispensed by a licensed U.S. compounding pharmacy and shipped directly to you. Our pharmacy partners are licensed and may vary based on your location and treatment plan; for privacy, compliance, and partnership protection reasons, we do not publicly disclose their names. You have the right to request your prescription be transferred to any licensed pharmacy of your choice at any time; contact support@lev18.com to initiate a transfer.
The pharmaceutical component of your program fee is collected on behalf of the dispensing pharmacy and remitted to it separately. The pharmacy is solely responsible for all pharmaceutical services.