We understand that safety, transparency, and regulatory oversight are important when choosing a telehealth service. The information below explains how Direct Meds operates within applicable regulations for telemedicine, prescribing, and pharmacy compounding.
Is Direct Meds FDA Approved?
Direct Meds is a telehealth service and is not an FDA-approved entity. FDA approval applies to specific medications and medical devices—not to telemedicine platforms or service providers.
About Compounded Medications
- Compounded medications, including certain GLP-1 formulations, are not FDA-approved.
- Compounding pharmacies may prepare individualized medications when prescribed by a licensed clinician and permitted by state and federal regulations.
- Direct Meds works with U.S.-based 503A compounding pharmacies, which are licensed by state pharmacy boards and operate under federal compounding laws and applicable professional standards (such as USP <795> and USP <797>).
- Pharmacies may use ingredients sourced from FDA-registered or inspected manufacturers, as required by law.
How does Direct Meds Support Safe and Compliant Care?
Direct Meds follows a set of regulatory and compliance practices designed to support safe telehealth services:
Licensed Providers
All prescribing decisions are made by licensed healthcare providers who are authorized to practice and prescribe in your state or province. Providers independently determine whether a medication is appropriate based on your medical history and intake information.
Pharmacy Oversight
Direct Meds partners with appropriately licensed pharmacies, including 503A compounding pharmacies, to dispense medications when prescribed. These pharmacies follow state and federal compounding regulations and professional guidelines.
Internal Clinical and Compliance Review
Direct Meds maintains internal processes—overseen by a medical director—to help ensure that provider and pharmacy partners operate in alignment with applicable regulatory expectations.
LegitScript Certification
Direct Meds is LegitScript certified, meaning our business practices, platform structure, and operational controls have been reviewed for compliance with LegitScript’s certification standards for telemedicine. LegitScript certification does not imply endorsement of specific medications or guarantee safety or efficacy; rather, it reflects adherence to certain transparency and regulatory criteria.