Compounded Medication – Prescription Only

Regulatory Limitation Notice

Due to current federal and state restrictions, this compounded HCG formulation is not available for women and may be prescribed only to men undergoing hormone-related therapy, when clinically appropriate and determined by a licensed healthcare provider.

This product is a compounded preparation containing human chorionic gonadotropin (HCG) supplied as a lyophilized (freeze-dried) powder vial and dispensed only pursuant to a valid prescription issued by a licensed healthcare provider. HCG is a peptide hormone naturally produced in the human body. In compounding practice, HCG formulations may be prescribed when a provider determines that individualized dosing, concentration, or formulation considerations are clinically appropriate for a specific patient. This product is not available for self-selection and may only be dispensed following provider authorization.

The lyophilized powder must be reconstituted according to prescriber instructions prior to use.

Compounded medications are not approved by the U.S. Food and Drug Administration (FDA). The FDA does not evaluate compounded formulations for safety, effectiveness, or quality. Compounding is performed by a state-licensed pharmacy pursuant to a patient-specific prescription.

This page provides general, non-therapeutic information for educational and compliance purposes only. It does not describe intended use, therapeutic benefit, hormonal effects, fertility outcomes, or expected clinical results.

General Scientific Information (Non-Therapeutic)

Human chorionic gonadotropin (HCG) is a peptide hormone referenced in scientific literature for its molecular structure and its interaction with hormone receptors involved in endocrine signaling pathways. Scientific investigation has focused on its biochemical characteristics and receptor-binding properties. Descriptions of molecular or biochemical characteristics are provided solely for general scientific context. No claims are made regarding safety, effectiveness, hormonal outcomes, fertility effects, or suitability for any particular condition.

Contraindications

HCG should not be used in individuals who have a known hypersensitivity or allergy to human chorionic gonadotropin or any component of the compounded formulation; have experienced prior adverse reactions to injectable hormone preparations; have hormone-sensitive conditions where HCG use is contraindicated as determined by the prescribing healthcare provider; or are unable to tolerate injectable therapies. This formulation is not available for women.

Warnings and Precautions

Hormonal effects may occur. Caution is advised in individuals with cardiovascular disease, prostate-related conditions, endocrine disorders, or those receiving concurrent hormone therapies. Injectable administration should be performed only as prescribed and supervised by a licensed medical provider. Patients should inform their healthcare provider of all medical conditions, medications, and hormone therapies prior to receiving this compounded formulation.

Potential Side Effects

Reported side effects associated with injectable HCG formulations may include injection site reactions such as pain, redness, swelling, or irritation; headache; fatigue; mood changes; nausea; or fluid retention. Serious adverse reactions are uncommon but may occur. Patients should seek immediate medical attention if they experience signs of a severe allergic reaction, significant hormonal effects, or unexpected systemic symptoms.