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 at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the large-scale compounding of sterile and non-sterile medications. This designation means we adhere to the highest standards of pharmaceutical quality, undergoing rigorous FDA inspections to ensure every preparation meets exacting specifications for strength, purity, and stability. We serve the specific needs of healthcare providers and patients by providing medications that are not commercially available, thereby fulfilling a critical role in the local healthcare ecosystem centered around our Longwood location.
The core function of 503B Compounding Pharmacy is the production of compounded medications in large batches for office use by healthcare practitioners. Physicians, surgeons, dermatologists, and other medical professionals practicing in and around our facility on W State Road 434 can rely on us for a consistent, high-quality supply of essential medications. This allows these practitioners to have the necessary drugs on hand for immediate administration to their patients during procedures, appointments, or treatments, enhancing the efficiency and effectiveness of care delivered within their own practices. Our operations are designed to support the local medical community by providing a trusted source for these vital pharmaceutical compounds.
Patients in Longwood benefit indirectly from the services of 503B Compounding Pharmacy through the care they receive from their local healthcare providers. While we do not typically dispense medication directly to the public from our location at 2160 W State Road 434, the medications we compound are integral to numerous medical treatments. These can include sterile injectables for hormone therapy, ophthalmology, or pain management, as well as topical creams and other formulations. The assurance that these medications are produced under the strict quality controls of an FDA-registered 503B outsourcing facility provides peace of mind to both the prescribing doctor and the patient receiving the treatment.
Quality and safety are the foundational principles of everything we do at our Longwood facility. Our processes are governed by Current Good Manufacturing Practices (cGMP), which are enforced by the FDA. This involves stringent environmental monitoring, validated sterilization processes, and robust quality control testing. Every batch of medication is compounded by highly trained pharmacists and technicians in our state-of-the-art cleanrooms to ensure patient safety. By choosing a 503B outsourcing facility, healthcare providers at 2160 W State Road 434 can be confident they are utilizing medications produced to the highest possible standards of pharmaceutical compounding.
For healthcare providers seeking a reliable partner for office-use medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 stands as a local resource of uncompromising quality. We invite medical professionals to learn more about our capabilities and how we can support their practice. You can reach us by phone at (407)993-1381 or visit our website for more detailed 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 compound medications in large batches for office use by healthcare providers and must adhere to strict Current Good Manufacturing Practices (cGMP) for quality and safety.
2. Can I, as a patient, pick up my prescription directly from your location?
503B Compounding Pharmacy primarily supplies medications for office use to healthcare practitioners. Patients typically receive medications that we compound directly from their doctor's office during their appointment or procedure, not from our facility at 2160 W State Road 434.
3. How do I know if my doctor uses 503B Compounding Pharmacy?
You can ask your healthcare provider if they source their office-use medications from our FDA-registered outsourcing facility located at 2160 W State Road 434, Longwood, FL 32779. They can provide information on the specific medications used in your treatment.
4. What types of medications does 503B Compounding Pharmacy produce?
Our facility compounds a wide range of sterile and non-sterile medications, including injectables, ophthalmics, and topical formulations. These are provided in bulk to healthcare practices for use in treatments such as hormone therapy, pain management, and dermatology.
5. 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. We can be reached by phone at (407)993-1381. Our team will provide information on ordering procedures and our available formulations.