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.
503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. Located at 2160 W State Road 434, Longwood, FL 32779, our facility is dedicated to the large-scale, non-patient-specific compounding of sterile and non-sterile medications. We adhere to the most rigorous federal quality and safety standards, providing healthcare providers at 2160 W State Road 434, Longwood, FL 32779 with access to high-quality compounded pharmaceutical preparations.
The core function of a 503B compounding pharmacy is to produce medications in bulk for office use by healthcare practitioners. This means physicians and clinicians at 2160 W State Road 434, Longwood, FL 32779 can obtain essential medications for their practice without the need to compound them in-house. Our services are vital for supporting the medical community at 2160 W State Road 434, Longwood, FL 32779, ensuring they have a reliable and compliant source for critical drugs, including those that may be in shortage. By operating under strict cGMP (current Good Manufacturing Practice) regulations, we provide an additional layer of safety and quality assurance for the patients treated at this location.
Our facility at 2160 W State Road 434, Longwood, FL 32779 is equipped to handle a wide array of compounding needs. This includes the preparation of sterile injectables, ophthalmics, and other dosage forms that are essential for various medical procedures and treatments administered on-site. The 503B compounding pharmacy model ensures that every batch of medication is produced with meticulous attention to detail, from ingredient sourcing and testing to environmental monitoring and final product sterility testing. For healthcare professionals practicing at 2160 W State Road 434, Longwood, FL 32779, this translates to confidence and trust in the medications they use to care for their patients.
We are committed to serving the specific needs of the medical community at 2160 W State Road 434, Longwood, FL 32779. Our team of highly trained pharmacists and technicians is dedicated to upholding the principles of a 503B outsourcing facility: quality, consistency, and safety. For more information or to discuss your office-use pharmaceutical needs, please contact 503B Compounding Pharmacy at our location: 2160 W State Road 434, Longwood, FL 32779. Reach us via our website at or by phone at (407)993-1381.
FAQ
1. What does it mean that you are a 503B compounding pharmacy?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA as an outsourcing facility under Section 503B of the FD&C Act. We compound sterile and non-sterile medications in larger batches for office use by healthcare practitioners, adhering to strict federal manufacturing standards (cGMP) instead of traditional pharmacy compounding rules.
2. As a patient at 2160 W State Road 434, Longwood, FL 32779, can I order medications directly from you?
No. A 503B compounding pharmacy provides medications directly to healthcare providers and practices for office use. Your physician or clinician at 2160 W State Road 434, Longwood, FL 32779 will administer or dispense to you the medications they procure from our facility as part of your treatment.
3. How does your location benefit my healthcare provider at 2160 W State Road 434, Longwood, FL 32779?
We provide a local, reliable, and FDA-regulated source for essential medications, including those that may be on shortage. This allows healthcare providers at 2160 W State Road 434, Longwood, FL 32779 to focus on patient care without the burden and liability of in-office compounding, ensuring you receive medications that meet the highest safety and quality standards.
4. What kind of quality controls are in place at your facility?
As a 503B outsourcing facility, we operate under current Good Manufacturing Practices (cGMP). This involves rigorous testing of ingredients, validated sterility testing, stringent environmental monitoring of our cleanrooms, and comprehensive record-keeping for every batch produced at our location on W State Road 434.
5. How can a medical practice at this location place an order?
Healthcare providers and practices located at 2160 W State Road 434, Longwood, FL 32779 can contact our facility directly to establish an account and discuss their specific pharmaceutical needs. You can reach our team for more information by calling (407)993-1381 or visiting our website at .