503B Outsouring Facility
office-use medications
817-282-9376 | Customer Service
940-382-6758 | Speak to a pharmacist
8400 Esters Blvd Ste 190 Irving, TX 75063
503B Outsouring Facility
office-use medications
817-282-9376 | Customer Service
940-382-6758 | Speak to a pharmacist
8400 Esters Blvd Ste 190 Irving, TX 75063
We are a state-of-the-art, FDA-registered 503B outsourcing facility focused on providing healthcare providers with unique sterile and non-sterile compounded medications.
In 2015, we became one of the first to register with the FDA as a 503B outsourcing facility. Four years later, we more than doubled the size of our facility when we moved into our present-day location. Today, we provide hospitals, urgent care facilities, clinics, and others with unique, difficult-to-source compounded medications. We are also dedicated to developing new sterile and non-sterile compounded medications for which there is a significant need but little supply.
Our goal is to provide healthcare providers with high-quality, unique 503B compounded medications.
What is a 503B Outsourcing Facility?
Outsourcing facilities like ours are often referred to as “503Bs” or “503B outsourcing facilities” because they are required to register with the FDA pursuant to Section 503B of the Federal Food, Drug, and Cosmetic Act. These facilities compound medications that are administered to patients by healthcare providers or are sold to pharmacies to dispense medications to patients. No prescriptions are needed. Instead, appropriately licensed healthcare providers and pharmacies are able to order compounded medications in bulk from outsourcing facilities. This prescription-free, bulk ordering of compounded medications has made it easier, safer, and more affordable to have important medications readily available for patients.
How is it done?
As an outsourcing facility, all of our compounding is performed pursuant to Current Good Manufacturing Practices (cGMP). These practices mandate the use of certain cleanroom classifications, manufacturing equipment, monitoring systems, quality management systems, raw material testing, and more, and they reflect the same production practices of pharmaceutical manufacturers. Unlike traditional compounding, outsourcing facilities need teams of pharmacists, scientists, and technicians to comply with cGMP.
Why is it important?
Carie Boyd Pharmaceuticals and other outsourcing facilities fill important needs within the pharmaceutical supply chain. Outsourcing facilities, for example, are able to supply the healthcare system with compounded medications when the commercially available options are on the FDA’s Drug Shortages list. In other situations, outsourcing facilities provide compounded medications when there are no commercial options, or when a meaningful portion of the patent population has a clinical need for a modified version of a commercial medication (e.g., allergies, strength, etc.), outsourcing facilities can step in to address that need. By requiring that outsourcing facilities comply with the same production standards as pharmaceutical manufacturers, and by subjecting outsourcing facilities to FDA oversight and inspections, these facilities are expected to be a safe and effective solution to many pharmaceutical supply-chain issues.
Office Use Medications
We compound office-use medications in our FDA registered 503B facility. We ship to every state except Alabama, California, New York, Vermont, and West Virginia.
How to order our 503B compounded medications?
To order our compounded office-use medications, you must have an active medical license and NPI number and complete our very brief (less than 2-minute) enrollment form. We are required by law to collect all of the information in our enrollment form. You can enroll by clicking here or on the Enroll link at the top of the page. We will process your enrollment within 24 hours in most cases (it might take up to 48 hours in rare cases). Once your account is activated, login by clicking “Login” at the top right corner of the page. You will redirected to our Customer Portal where you will need to click on the “Shop Now” tab and create a new order.
How do we ship your orders?
Orders placed before 4 p.m. CT are shipped that same day. All orders for compounded medications receive FREE 2-DAY SHIPPING. There are no minimum order quantities or amounts. We ship medications Monday through Friday and work tirelessly to make your experience seamless and cost-effective.
