How We Source Your Medications

Where your medications come from

Kesbury Health partners with licensed U.S. compounding pharmacies. Some of your medications are dispensed pursuant to a patient-specific prescription by a pharmacy operating under Section 503A of the federal Food, Drug, and Cosmetic Act. Others may be prepared by a licensed 503B outsourcing facility — a compounder registered with and inspected by the FDA that prepares medications under federal current good manufacturing practice (CGMP) standards — and dispensed to you pursuant to your prescription. Each pharmacy we work with is state-licensed and operates under applicable pharmacy regulations.

Medications are prescribed only by a board-certified, U.S.-licensed physician on the Kesbury Health Clinical Team after reviewing your health information. A pharmacy cannot dispense a compounded medication for you without that valid prescription.

What compounding is

Compounding is the process by which a licensed pharmacist or pharmacy prepares a medication — for example, in a strength, form, or formulation that is not commercially available as an FDA-approved product. Compounding serves an important role when an individualized or non-commercially-available preparation is clinically appropriate.

A 503A pharmacy compounds a medication for an individual patient based on that patient’s prescription. A 503B outsourcing facility may compound medications in larger batches under FDA registration and CGMP oversight; when one of those medications is dispensed to you, it is dispensed pursuant to your prescription. In either case, a compounded medication is different from a mass-marketed, FDA-approved, off-the-shelf drug product.

Important: compounded medications are not FDA-approved

Compounded medications — whether prepared by a 503A pharmacy or a 503B outsourcing facility — are not FDA-approved. This means the specific compounded product has not gone through the U.S. Food and Drug Administration's premarket review process for safety, effectiveness, and manufacturing quality that applies to FDA-approved drug products.

Compounded medications can serve important clinical needs, but because they are not FDA-approved, it is important that they be prescribed by a licensed physician, prepared by a licensed pharmacy, and used as directed. We will provide information about any medication prescribed to you, and you should ask your Kesbury Health physician any questions before starting it.

A note on labeling

Some compounded products — particularly those prepared by a 503B outsourcing facility — may carry a manufacturer label such as “For Office Use Only.” That labeling reflects how the facility manufactures and labels its inventory; it does not change the fact that your medication is dispensed to you pursuant to your own valid prescription. If you have any question about a label on a product you receive, contact us before using it.

Prescribed only when clinically appropriate

Medication is never automatic. A physician reviews your intake and health information and prescribes only when they determine it is appropriate for you. There is no guarantee that you will be prescribed any particular medication, and the physician may recommend an alternative or decline to prescribe.

Quality and oversight

We work to source from licensed U.S. compounding pharmacies that operate under state pharmacy licensure and applicable federal and state requirements — Section 503A for patient-specific compounding pharmacies, and Section 503B (FDA registration and CGMP) for outsourcing facilities. Like all medications, compounded preparations carry risks, and individual results vary; no specific outcome is guaranteed.

Our LegitScript certification

Kesbury Health is LegitScript-certified (certification #51875982). LegitScript certification is an independent monitoring program that evaluates healthcare merchants for compliance with applicable laws, regulations, and program standards. Certification reflects our commitment to operating transparently and responsibly; it is not an endorsement of any specific medication and does not mean a compounded medication is FDA-approved.