503A vs. 503B Compounding Pharmacies
Patient-Specific vs. Office-Use Compounding
If you’ve heard about these two types of compounding pharmacies, you may be confused as to what each one does. These are designations used by the Food and Drug Administration (FDA) to separate pharmacies it federally regulates from those regulated primarily by state boards. The regulatory differences can be complex, but from a patient viewpoint, the distinctions are fairly simple.
503A pharmacies are traditional state-regulated compounding pharmacies that make individualized formulations, following a compounding prescription written for a specific patient. In other words, your doctor writes your prescription, sends the prescription to our 503A pharmacy where we mix it specifically for you, exactly the way your doctor wants it. Once it’s ready, we ship your prescription directly to you to use at your home.
With compounding, we can combine, remix, or change a medication’s active ingredients and additives to address your specific needs. For example, we can compound to eliminate allergens, tailor dosages, enhance absorbability, combine drugs for convenience, or change a drug’s flavor or texture. Only compounding pharmacies mix medications for an individual patient. Regular pharmacies dispense medications manufactured by major drug companies in standard dosage forms and amounts.
503B pharmacies are large-scale FDA-regulated facilities that manufacture in bulk. They compound drugs, but not for you individually. They manufacture large batches of medications to be sold to doctors’ offices, clinics, hospitals, and other health facilities for use on-site only. They do not sell products directly to you as a patient or sell medications that would be administered to you outside of a medical facility.
Contact Belmar Pharma Solutions
If you’re a patient, we’re here to help you fill prescriptions or provide you the information you need to work with your doctor to help decide if a compounded prescription might be a good treatment for you.
Prescribers, for a complete formulary or access to our clinical resources fill out the form below and one of our Solutions Engineers will be in touch shortly. If you are new to compounding, you may also find our page on How to Write a Compounding Prescription helpful.
Thank you for reaching out. A member of our team is reviewing your message and will reach out as soon as possible. In the meantime, below are a few links, including our formulary, that we think you might find helpful:Formulary