Contact Information
Address:
2160 W State Road 434, Longwood, FL 32779
Phone:
Website
https://503bcompoundingpharmacy.com/
503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act, providing large-scale, sterile compounded medications to healthcare systems across the United States. The pharmacy is built to serve hospitals, surgery centers, clinics, and licensed healthcare providers that require consistent, compliant, and scalable access to compounded pharmaceuticals without patient-specific prescriptions. Operating from its facility at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy follows current Good Manufacturing Practice (cGMP) standards and is subject to routine FDA inspection. This places it in a fundamentally different category than traditional 503A pharmacies. The focus is not retail compounding or one-off prescriptions. The focus is controlled production, batch consistency, sterility assurance, and regulatory discipline. The facility specializes in sterile injectable and non-sterile compounded medications designed to address drug shortages, support procedural efficiency, and improve supply chain reliability for healthcare providers. All production is performed in ISO-classified cleanroom environments using validated processes, documented quality systems, and lot-level traceability. Each batch undergoes appropriate sterility, endotoxin, and potency testing based on risk level and formulation requirements. 503B Compounding Pharmacy prioritizes transparency and compliance over speed or marketing claims. Products are compounded using USP-grade ingredients sourced from vetted suppliers, with full documentation available for healthcare partners. Beyond production, the pharmacy supports client institutions with regulatory documentation, recall readiness, adverse event reporting protocols, and consistent supply planning. The company exists to solve real operational problems for healthcare organizations. Drug shortages, inconsistent manufacturers, and unreliable distributors create risk for patient care. A properly run 503B facility reduces that risk by acting as a compliant, predictable manufacturing partner rather than a reactive supplier.
2160 W State Road 434, Longwood, FL 32779
https://503bcompoundingpharmacy.com/
>
503B Compounding Pharmacy operates as an FDA-registered outsourcing facility in strict compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. This 503B Compounding Pharmacy is located at 2160 W State Road 434, Longwood, FL 32779. The 503B Compounding Pharmacy model represents a significant advancement in the compounding field, adhering to the highest standards of pharmaceutical quality and safety. As a 503B outsourcing facility, this 503B Compounding Pharmacy is subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations and regular inspections. This ensures that every preparation leaving the facility at 2160 W State Road 434, Longwood, FL 32779 meets stringent standards for potency, purity, and sterility.
The core function of this 503B Compounding Pharmacy is the large-scale production of compounded medications that are distributed to healthcare providers for office use. The 503B Compounding Pharmacy provides physicians, surgeons, hospitals, and clinics with access to essential medications that may be in short supply or unavailable from conventional manufacturers. By operating as a 503B outsourcing facility, this 503B Compounding Pharmacy can proactively compound and stock certain medications, helping to mitigate drug shortages and ensure that medical professionals at 2160 W State Road 434, Longwood, FL 32779 have the necessary supplies for patient care. The 503B Compounding Pharmacy's operations are distinct from traditional compounding, focusing on broader distribution under a specific regulatory framework.
Patients and medical professionals seeking the services of this 503B Compounding Pharmacy can be assured of its commitment to excellence. The team at the 503B Compounding Pharmacy location at 2160 W State Road 434, Longwood, FL 32779 consists of highly trained pharmacists and technicians who specialize in the complex processes required for 503B compounding. The 503B Compounding Pharmacy utilizes state-of-the-art equipment and technology within its facility to ensure precision and consistency in every batch. For more information on the specific services offered by this 503B Compounding Pharmacy, please visit the official website at https://503bcompoundingpharmacy.com/ or contact the facility directly at (407)993-1381.
Frequently Asked Questions for 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779
What does it mean that this is a 503B Compounding Pharmacy?
It means this facility is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. This 503B Compounding Pharmacy is subject to stricter production standards, including compliance with current Good Manufacturing Practices (cGMP), and undergoes regular FDA inspections to ensure the quality, safety, and sterility of its medications.
Who can order medications from this 503B Compounding Pharmacy?
This 503B Compounding Pharmacy primarily provides compounded medications for office use by healthcare professionals. Physicians, surgeons, hospitals, and clinics can order from this 503B Compounding Pharmacy located at 2160 W State Road 434, Longwood, FL 32779 to stock their practices with necessary medications, including those that may be on shortage.
Can I as a patient walk into the 503B Compounding Pharmacy to get a prescription filled?
No. As a 503B outsourcing facility, this 503B Compounding Pharmacy does not typically fulfill individual patient-specific prescriptions. This 503B Compounding Pharmacy compounds large batches of medications for distribution to healthcare providers. Patients should contact their healthcare provider, who may utilize medications compounded by this 503B Compounding Pharmacy.
How do I contact this specific 503B Compounding Pharmacy?
You can contact the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 by calling (407)993-1381. Additional information about this 503B Compounding Pharmacy can be found on its website at https://503bcompoundingpharmacy.com/.
What is the main advantage of using a 503B Compounding Pharmacy?
The primary advantage is the assurance of quality and consistency. This 503B Compounding Pharmacy operates under a heightened level of FDA oversight and cGMP standards, which are comparable to those of traditional drug manufacturers. This provides healthcare providers at 2160 W State Road 434, Longwood, FL 32779 with confidence in the medications they use.