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. Our facility is located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies our commitment to the highest standards of quality, safety, and compliance in the preparation of compounded medications. Unlike traditional compounding pharmacies, a 503B outsourcing facility is subject to rigorous federal oversight, including current Good Manufacturing Practice (cGMP) regulations and regular FDA inspections. This ensures that every preparation leaving our facility meets stringent quality control benchmarks for potency, purity, and sterility.
The services provided by 503B Compounding Pharmacy at our Longwood location are distinct and specialized. We focus on the large-scale production of compounded sterile preparations (CSPs) that are distributed to healthcare providers for office use. This model allows physicians, surgeons, dermatologists, and other medical professionals practicing at 2160 W State Road 434, Longwood, FL 32779 to have immediate access to critical medications without the need for patient-specific prescriptions in advance. Our core offerings include a range of sterile injectables, ophthalmics, and other preparations that are essential for clinics, surgical centers, and medical practices operating within our facility's vicinity.
Our operational model is designed to support the local medical community at 2160 W State Road 434, Longwood, FL 32779 by providing a reliable, compliant source for medications that are often on shortage or are not commercially available. By adhering to cGMP standards, we implement a robust quality assurance program that encompasses environmental monitoring, validated sterilization processes, and meticulous documentation for full traceability. This level of quality control is a fundamental aspect of our service, providing healthcare practitioners with the confidence that the medications they administer are prepared under the most stringent conditions.
Engaging with 503B Compounding Pharmacy is a streamlined process for medical offices. Healthcare providers can place orders directly for their office stock, enabling them to efficiently treat patients with necessary medications that are ready for immediate use. Our team is dedicated to facilitating this process, ensuring that orders are handled with precision and professionalism. We invite local practitioners to learn more about how our services can integrate into their practice to enhance patient care.
For detailed information on our available preparations and to discuss your specific needs, we encourage you to contact us directly. You can reach our team by phone at (407)993-1381 or visit our website to discover more about our compliance and quality standards at https://503bcompoundingpharmacy.com/.
FAQ
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with and inspected by the U.S. Food and Drug Administration. We operate under Section 503B of the FD&C Act and must comply with current Good Manufacturing Practices (cGMP), which are more rigorous standards than those applied to traditional compounding pharmacies.
2. Can I as an individual patient pick up a prescription from your location?
No. 503B Compounding Pharmacy provides medications for office use by healthcare practitioners. We distribute compounded preparations directly to physicians and medical practices, who then administer them to patients within their care. Patients do not pick up medications directly from our facility at 2160 W State Road 434, Longwood, FL 32779.
3. What types of medications does 503B Compounding Pharmacy prepare?
Our focus at our Longwood location is on the production of compounded sterile preparations (CSPs). This includes a variety of sterile injectables, such as hormone injections, ophthalmics, and other solutions that are essential for clinical and surgical settings serving the 2160 W State Road 434 area.
4. How can a medical practice at this location order from you?
Healthcare providers and medical practices operating at 2160 W State Road 434, Longwood, FL 32779 can place orders for office-use medications by contacting our facility directly. Our team will provide all necessary information regarding ordering procedures, available preparations, and compliance documentation.
5. Why should a local clinic choose 503B Compounding Pharmacy over other suppliers?
Choosing our facility ensures you are receiving medications produced under the highest federally regulated quality standards. Our cGMP compliance, FDA oversight, and commitment to safety provide assurance that the preparations you use in your practice at 2160 W State Road 434 are of consistent quality, potency, and sterility.