Compounded and Off-Label Medication Disclosure

Effective date: August 4, 2026 · Reviewed at least annually · Status: Approved.

Compounded medications

A compounded drug is prepared by a pharmacy for an identified patient or under another lawful compounding framework. Compounded drugs are not FDA-approved; FDA does not verify their safety, effectiveness, or quality before marketing. Compounding may be considered when the Provider determines that a clinically significant difference or patient-specific need makes an available approved product unsuitable or when otherwise lawful and appropriate.

Potential compounded-drug risks

• Potency, purity, sterility, stability, and consistency may differ from FDA-approved products.
• Contamination, calculation, labeling, storage, shipping, or preparation errors may cause harm.
• Published evidence, standardized labeling, insurance coverage, and long-term safety data may be limited.
• Availability, formulation, pharmacy source, and price may change.

Off-label use

Off-label use means an FDA-approved drug is prescribed for a use, dose, route, population, or other circumstance not included in FDA-approved labeling. Licensed clinicians may prescribe off label when medically appropriate and lawful. Off-label use does not mean the drug is unapproved, but the specific use may have less or different evidence and risks than labeled use.

Shared decision-making

Before prescribing, the Provider will determine medical appropriateness and discuss material expected benefits, risks, reasonable alternatives, monitoring, and the option not to use the treatment. The patient should identify pregnancy or pregnancy plans, allergies, prior reactions, other medicines, and relevant conditions.

Consent

Patients acknowledge the distinction between compounded and off-label therapy; that neither payment nor consent guarantees a prescription; that results are not guaranteed; and that they may ask questions or decline before treatment. Product-specific informed consent may also be required and is captured during intake or before treatment.

Questions and contact

Contact RCC’s Privacy Contact at Rejuvenation Care Clinic of Central Florida, LLC, 2541 S. Volusia Ave, Suite 100, Orange City, FL 32763, (386) 946-6375, or through RCC’s secure patient messaging channel. Please don’t send medical information by ordinary email.