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 operates as an FDA-registered outsourcing facility under Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility is precisely located at 2160 W State Road 434, Longwood, FL 32779. This designation is a critical distinction, signifying our adherence to the highest federal standards for quality, safety, and production. Unlike a traditional 503A compounding pharmacy, our 503B outsourcing facility prepares large volumes of compounded sterile preparations (CSPs) for office use by healthcare practitioners. We serve as a vital component of the local healthcare infrastructure, providing practitioners in Longwood with access to essential medications that are not commercially available.
The core function of 503B Compounding Pharmacy is the anticipatory compounding of medications. This means we produce batches of sterile medications before a patient-specific prescription is received. This model allows healthcare providers at practices and clinics near our 2160 W State Road 434 location to maintain an inventory of critical drugs for immediate administration to patients during office visits. Our services are essential for medications that are on drug shortage lists or for those that have been discontinued by large-scale manufacturers. By providing these necessary preparations, we help ensure continuity of care for patients within our community.
Quality and safety are the foundational principles of our operation at 2160 W State Road 434. As an FDA-registered 503B outsourcing facility, we are subject to rigorous cGMP (current Good Manufacturing Practice) standards. Our processes include extensive environmental monitoring, stringent testing of components and finished preparations, and comprehensive sterility testing. Every step, from ingredient sourcing to final packaging, is meticulously controlled and documented. This unwavering commitment to quality provides healthcare professionals in Longwood with the confidence that the medications they administer meet the most exacting safety and potency specifications.
Healthcare practitioners rely on 503B Compounding Pharmacy for a consistent and reliable supply of sterile compounded medications. Our portfolio includes a wide array of preparations vital for various medical specialties, including office-based surgeries, pain management, ophthalmology, dermatology, and hormone replacement therapy. By outsourcing their compounding needs to our facility at 2160 W State Road 434, practitioners can focus their resources on direct patient care, assured that their medication supply is managed by a trusted, compliant, and professional partner dedicated to upholding the highest standards of pharmaceutical compounding.
For more information about our services or to speak with our team, please contact 503B Compounding Pharmacy. You can reach us by phone at (407)993-1381 or visit our website at . Our facility is located 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 strict federal regulations known as cGMP. This ensures the medications we compound meet the highest standards for sterility, quality, and safety for office use by healthcare practitioners.
2. Can I, as a patient, get a prescription filled directly at your location?
No. 503B Compounding Pharmacy provides medications for office use by healthcare providers. Your practitioner at their local office can order and administer our preparations to you during your appointment, but we do not dispense directly to individual patients from our facility at 2160 W State Road 434.
3. What kinds of medications do you compound for local healthcare providers?
We compound a wide range of sterile preparations, including medications for pain management, ophthalmology, dermatology, and hormone therapy. These are often drugs that are on shortage or are not available from commercial manufacturers, providing essential options for practitioners serving the Longwood community.
4. How do I, as a healthcare provider, order from your facility?
Healthcare providers with practices near our 2160 W State Road 434 location can establish an account by contacting us directly. You can place orders and speak with our team by calling (407)993-1381.
5. Why should a provider choose a 503B outsourcing facility over other compounders?
Choosing our 503B facility ensures you are sourcing medications from a provider that is subject to FDA oversight and mandatory compliance with cGMP. This offers a significantly higher level of assurance regarding the quality, consistency, and sterility of the medications you use in your practice at 2160 W State Road 434.