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 undergoes rigorous FDA oversight and manufactures medications on a larger scale without patient-specific prescriptions, supplying these vital drugs to healthcare providers for office use.
The core function of 503B Compounding Pharmacy is the large-scale production of sterile and non-sterile compounded preparations. Our services are essential for healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779 who require a consistent and reliable supply of high-quality medications for their practice. We provide these medications for office use, ensuring that healthcare professionals have the necessary drugs on hand to administer to patients during appointments, procedures, or treatments. This model supports efficient clinical operations and enhances patient care by providing immediate access to needed therapies.
Quality and safety are the foundational principles of everything we do at our location. The 503B Compounding Pharmacy facility adheres to Current Good Manufacturing Practices (cGMP), which are enforced by the FDA. This means every step of our process, from sourcing raw ingredients to final product testing and packaging, is meticulously controlled and documented. Our sterile compounding suites are state-of-the-art, with advanced environmental monitoring to ensure the integrity of injectables, ophthalmics, and other sterile preparations. This unwavering commitment to cGMP standards provides healthcare providers and their patients with the utmost confidence in the medications we produce.
Healthcare professionals seeking a trusted partner for compounded medications can rely on 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779. We serve as a critical link in the healthcare chain, providing a vital service that ensures the availability of essential drugs that may be commercially unavailable or in short supply. By choosing an FDA-registered 503B outsourcing facility, practitioners are choosing a higher level of safety, quality, and regulatory compliance for their patients.
To learn more about our services or to speak with our team, please contact 503B Compounding Pharmacy directly. You can reach us by phone at (407)993-1381 or visit our website for comprehensive information 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, which requires us to comply with stringent Current Good Manufacturing Practices (cGMP) for the large-scale production of compounded medications for office use by healthcare practitioners.
2. Can I, as a patient, get a prescription filled directly at 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy does not accept individual patient prescriptions. We supply compounded medications in bulk to healthcare providers and practices. Your healthcare provider at their office would then use these medications for treatments, procedures, or to dispense to you directly during your visit.
3. What types of medications does 503B Compounding Pharmacy at 2160 W State Road 434 produce?
Our FDA-registered outsourcing facility produces a range of sterile and non-sterile compounded medications. This includes injectables, ophthalmics, nasal sprays, and topical preparations. These are manufactured for healthcare providers to have on hand for patient care at their practice locations.
4. How does using a 503B outsourcing facility benefit my healthcare provider?
It provides your healthcare provider at 2160 W State Road 434, Longwood, FL 32779 with access to consistently high-quality, reliable medications that are produced under the strictest quality controls. This ensures the medications they use for your care meet rigorous federal safety and potency standards, which is especially critical for sterile injectable compounds.
5. How can a healthcare provider at this location place an order with 503B Compounding Pharmacy?
Healthcare providers can initiate an order or inquire about our services by contacting our facility directly. The phone number for 503B Compounding Pharmacy is (407)993-1381. Additional information and resources are also available on our website at https://503bcompoundingpharmacy.com/.