Required disclosure: If your physician prescribes a compounded medication, this disclosure applies to you. Please read it carefully.
Compounded medications are custom-prepared drug formulations created by licensed compounding pharmacies for individual patients based on a valid prescription from a licensed physician. Compounding allows for precise dosing, alternative delivery methods, and formulations not available in commercially manufactured forms.
Compounded medications are not FDA-approved finished drug products. The FDA has not evaluated the safety, efficacy, or quality of specific compounded formulations. This is distinct from FDA-approved medications, which have undergone clinical trials and manufacturing inspections required for market approval.
This does not mean compounded medications are unsafe or ineffective. Compounding has a long history in medicine and fills important clinical needs. However, you should understand the regulatory distinction and discuss it with your physician.
PepLab does not compound, manufacture, or dispense medications. All compounded medications prescribed through our physician network are prepared by licensed, independent compounding pharmacies that:
PepLab coordinates the relationship between you and the pharmacy but does not inspect, control, or guarantee the quality of pharmacy operations beyond verifying licensure status.
The regulatory framework governing compounded medications — particularly compounded hormones and GLP-1 medications — is subject to ongoing change. Federal and state regulatory requirements may shift in ways that affect the availability of certain compounded formulations. Your physician will advise you of any changes that affect your protocol.
Certain compounded formulations, including oral forms of some medications, may have limited evidence of equivalent bioavailability compared to injectable or other delivery forms. Your physician will discuss the evidence base for any specific formulation prescribed to you.
The decision to prescribe any compounded medication is made exclusively by your treating physician based on your individual clinical picture, lab results, and medical history. PepLab does not influence or direct prescribing decisions. If your physician determines that a compounded medication is clinically appropriate for you, they will discuss the specific formulation, expected effects, risks, and alternatives with you.
If you experience an unexpected or concerning reaction to any medication, contact your physician immediately. For emergencies, call 911. You may also report adverse events directly to the FDA at MedWatch (1-800-FDA-1088).
Questions about this disclosure: