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 signifies our commitment to the highest standards of quality, safety, and regulatory oversight, exceeding the requirements of a traditional compounding pharmacy. We serve healthcare providers and facilities by providing bulk quantities of essential medications that are often in short supply or unavailable from conventional manufacturers.
The core function of 503B Compounding Pharmacy is the production of medications for office use. This means physicians and clinicians at local medical practices can obtain vital, pre-made medications directly from our facility at 2160 W State Road 434, Longwood, FL 32779 for immediate administration to patients within their care settings. Our operations are pivotal in supporting the local healthcare infrastructure by ensuring a reliable source for critical drugs, thereby helping to prevent treatment delays and contributing to positive patient outcomes. The medications produced are not for individual patient-specific prescriptions but are instead distributed to authorized medical professionals for professional use.
Our state-of-the-art facility on W State Road 434 is designed to uphold a pristine environment necessary for sterile compounding. This includes advanced air filtration systems, ISO-classified cleanrooms, and rigorous environmental monitoring to ensure every preparation meets stringent sterility assurance levels. Our processes are governed by current Good Manufacturing Practices (cGMP), which enforce consistency, purity, and identity in every batch we produce. The team at 503B Compounding Pharmacy comprises highly trained pharmacists and technicians who are experts in aseptic technique and quality control, ensuring that every product leaving our facility is of the highest integrity.
For healthcare providers at 2160 W State Road 434, Longwood, FL 32779, partnering with our 503B outsourcing facility offers significant advantages. It mitigates the risks associated with in-office compounding, reduces the administrative burden on clinical staff, and guarantees that the medications used are produced under the most rigorous quality controls mandated by the FDA. We provide a dependable solution for obtaining essential medications, allowing healthcare professionals to focus their expertise on patient care. To learn more about our available formulations or to discuss your facility's needs, please contact us directly.
To inquire about our services or to place an order, you can reach 503B Compounding Pharmacy at (407)993-1381. For comprehensive information about our compliance, available drug products, and the specifics of operating as a 503B outsourcing facility, please visit our website at https://503bcompoundingpharmacy.com/. Our team is ready to assist the medical community at our location.
FAQ
1. What does it mean that this facility is a 503B outsourcing facility?
It means our pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and complies with stricter production standards under Section 503B of the FD&C Act. We follow current Good Manufacturing Practices (cGMP) for large-scale compounding, which involves enhanced quality control, testing, and reporting compared to a traditional 503A pharmacy.
2. Can I, as an individual patient, get a prescription filled at 503B Compounding Pharmacy?
No. As an FDA-registered 503B outsourcing facility, we compound medications in large batches for "office use" by healthcare providers. Individual patient-specific prescriptions are handled by traditional compounding pharmacies. We supply medications to physicians and clinics at 2160 W State Road 434, Longwood, FL 32779 for them to administer to patients within their practice.
3. What types of medications does 503B Compounding Pharmacy produce?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding both sterile injectable and non-sterile medications that are often on drug shortage lists or are not commercially available from large pharmaceutical manufacturers. This includes a range of preparations needed by local clinics and healthcare providers.
4. How does a medical practice at this location order from you?
Authorized healthcare providers and facilities can place orders for office-use medications by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will guide you through the process, which includes verifying your eligibility to order from a 503B outsourcing facility.
5. Why should a clinic at 2160 W State Road 434 use a 503B outsourcing facility?
Sourcing medications from our 503B outsourcing facility ensures the drugs are produced under the highest level of quality regulation, reducing risk and liability for the practice. It provides a reliable supply of essential medications, often alleviating shortages, and saves clinical staff the time and resources required for in-office compounding.