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. We are located at 2160 W State Road 434, Longwood, FL 32779. As a 503B outsourcing facility, we are held to the highest standards of pharmaceutical compounding, producing large batches of sterile and non-sterile compounded medications for office use by healthcare practitioners. Our mission is to provide practitioners in our community with access to a reliable supply of high-quality, compounded medications that are essential for patient care.
Our facility at 2160 W State Road 434 is designed and maintained to meet rigorous federal quality standards. This includes adhering to Current Good Manufacturing Practices (cGMP), which ensures every medication we produce undergoes stringent quality control testing for potency, sterility, and purity. For healthcare providers at our location, this means they can confidently utilize our compounded medications, knowing they are receiving products manufactured under the most exacting regulatory framework available for compounding.
The services provided by 503B Compounding Pharmacy at our Longwood facility are specifically tailored for office-based use. We supply medications to physicians, surgeons, veterinarians, and other healthcare professionals who need these preparations on hand to administer to their patients directly within their practice. This model is distinct from traditional compounding, as it allows for the anticipatory production of medications without patient-specific prescriptions, enabling practitioners to have critical drugs ready for immediate use during procedures and treatments.
Our portfolio includes a range of compounded preparations vital for various medical specialties. We produce sterile injectables, ophthalmics, and other dosage forms that are often in high demand for clinical settings. By serving the specific needs of the medical community at 2160 W State Road 434, we help streamline the supply chain for practitioners, reducing wait times and ensuring they have the necessary medications to provide continuous, high-level care to their patients without interruption.
We invite local healthcare providers to discover the 503B difference. For more information about our available formulations and how we can support your practice, please contact us directly. You can reach 503B Compounding Pharmacy by phone at (407)993-1381 or visit our website at . Our team is dedicated to serving the medical community from our facility at 2160 W State Road 434, Longwood, FL 32779.
Frequently Asked Questions
1. What does it mean that you are a 503B outsourcing facility?
It means our pharmacy at 2160 W State Road 434 is registered with the FDA and operates under Section 503B of the FD&C Act. We comply with Current Good Manufacturing Practices (cGMP), which are rigorous federal standards for drug manufacturing that ensure the identity, strength, quality, and purity of our compounded medications.
2. Can I as an individual patient get a prescription filled at your location?
No. 503B Compounding Pharmacy provides medications for office use by healthcare practitioners. We supply medications to physicians, veterinarians, and other providers at 2160 W State Road 434 who then administer them to their patients within their practice. Individual patients should work with their prescribing doctor or a traditional 503A compounding pharmacy for personal prescriptions.
3. What types of medications do you compound for local providers?
Our facility at 2160 W State Road 434 specializes in producing a range of sterile and non-sterile compounded medications for office use. This includes sterile injectables, ophthalmic solutions, and other preparations that are commonly used by healthcare providers in clinical settings for procedures and treatments.
4. How do I, as a healthcare provider, order from your facility?
Healthcare practitioners can place orders for office-use medications by contacting our facility directly. You can reach our team at (407)993-1381 to discuss your practice's specific needs, place an order, or learn more about our available formulations and ordering process from our location.
5. Why should a practice at this location use a 503B outsourcing facility?
Utilizing a 503B outsourcing facility like ours at 2160 W State Road 434 ensures your practice receives medications produced under the highest level of federal oversight. This provides assurance of quality, consistency, and safety for the medications you administer to your patients, supporting the highest standard of care.