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 FDA oversight, including current Good Manufacturing Practice (cGMP) regulations, which ensures that our processes and products meet an elevated level of consistency and reliability for the healthcare providers and patients we serve at our Longwood location.
The core function of 503B Compounding Pharmacy is the large-scale compounding of sterile and non-sterile medications that are distributed for office use by healthcare practitioners. Our state-of-the-art facility at 2160 W State Road 434 is designed to produce these medications in bulk, providing a critical supply of drugs that may be experiencing a shortage or are not commercially available. By operating under Section 503B, we provide physicians, surgeons, veterinarians, and other medical professionals in Longwood with access to essential medications that are vital for patient care, all while adhering to the strictest sterility and quality assurance testing protocols.
Patients and healthcare providers who utilize the services of 503B Compounding Pharmacy can have full confidence in the integrity of every preparation. Our processes are meticulously controlled, from the sourcing of pure, high-quality active pharmaceutical ingredients (APIs) to the final packaging and labeling. Every batch undergoes stringent testing to verify potency, sterility, and stability. This unwavering dedication to quality at our facility on W State Road 434 ensures that the medications provided are of the utmost safety and efficacy, supporting positive health outcomes for the local community.
For healthcare providers seeking a reliable partner for their office-use medication needs, 503B Compounding Pharmacy stands as a trusted resource. We encourage you to learn more about our capabilities and compliance standards. You can reach us by phone at (407)993-1381 to speak with a representative, or visit our website at https://503bcompoundingpharmacy.com/ for more detailed information. Our team is dedicated to supporting the medical community at 2160 W State Road 434, Longwood, FL 32779 with consistent, high-quality compounded pharmaceuticals.
Frequently Asked Questions
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 the U.S. Food and Drug Administration and operates under Section 503B of the FD&C Act. This subjects us to federal oversight and mandatory compliance with current Good Manufacturing Practices (cGMP), ensuring a higher level of quality control and consistency for our compounded medications compared to traditional pharmacies.
Who can order medications from 503B Compounding Pharmacy at this location?
Our services are primarily designed for healthcare providers. Physicians, surgeons, clinics, hospitals, and veterinarians can order compounded medications for office use from our facility at 2160 W State Road 434. These medications are administered to patients within the professional practice setting rather than being dispensed directly to patients for home use.
What types of medications does 503B Compounding Pharmacy prepare?
As a 503B outsourcing facility, we specialize in compounding sterile injectables, ophthalmics, and other medications in larger batches. We often produce medications that are on drug shortage lists or are not available from commercial manufacturers, providing a critical supply to healthcare professionals serving the Longwood community.
How does the quality assurance process work at your Longwood facility?
Quality is paramount at our location. We implement a robust quality assurance program that includes rigorous testing of components, in-process checks, and finished product testing for sterility, potency, and endotoxins. This comprehensive testing protocol is a mandatory requirement of our 503B status to ensure every batch meets strict safety standards.
How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers can contact 503B Compounding Pharmacy directly to discuss their needs and place an order. The primary point of contact for our services at this location is our phone number, (407)993-1381. You can also find more information on our website at https://503bcompoundingpharmacy.com/.