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 compounding of sterile and non-sterile medications. As a 503B outsourcing facility, we adhere to the highest standards of pharmaceutical quality, producing medications in bulk for healthcare providers to administer to their patients within their practice settings.
The core function of 503B Compounding Pharmacy is to provide healthcare practitioners with access to medications that are not commercially available or are in shortage. Our operations at 2160 W State Road 434, Longwood, FL 32779 are strictly regulated and subject to current Good Manufacturing Practices (cGMP), ensuring every preparation meets rigorous standards for potency, purity, and sterility. This level of quality control and regulatory oversight is a defining characteristic of a 503B outsourcing facility and distinguishes our operations from other compounding models.
Our services are exclusively tailored for healthcare providers, including physicians, surgeons, hospitals, and clinics. We compound a significant volume of medications, including injectables, infusions, ophthalmics, and topicals, which are then distributed to these practitioners for office use. The medications prepared at our facility on W State Road 434 are essential for a wide range of treatments, from hormone replacement therapy and pain management to ophthalmic surgery and dermatological applications.
Patients seeking compounded medications from 503B Compounding Pharmacy will receive them directly from their prescribing healthcare provider at the provider's practice. Our facility does not dispense medication directly to individual patients at 2160 W State Road 434, Longwood, FL 32779. Instead, we serve as a critical partner to the local medical community, ensuring they have a reliable and compliant source for high-quality medications that are essential for patient care.
For more information about our services for healthcare providers, you can visit our website at or contact us by phone at (407)993-1381. 503B Compounding Pharmacy is committed to supporting the medical professionals in our community from our location 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 facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and complies with stringent current Good Manufacturing Practices (cGMP). This ensures the medications we compound for healthcare providers meet the highest federal standards for safety, quality, and sterility.
2. Can I, as a patient, pick up my medication directly from your location?
No. 503B Compounding Pharmacy provides medications exclusively to healthcare providers for office use. You will receive any medication we compound directly from your doctor or healthcare provider during your appointment at their practice, not from our address on W State Road 434.
3. What types of medications do you compound at your Longwood facility?
At our location, we specialize in compounding a large volume of sterile injectables, IV infusions, ophthalmics, and other preparations that are often on national shortage or are not available from traditional pharmaceutical manufacturers. These are supplied to local healthcare practices.
4. How do I know if my doctor uses 503B Compounding Pharmacy?
You can ask your healthcare provider or the clinical staff at their practice about the source of their compounded medications. Many providers in the area rely on our facility at 2160 W State Road 434, Longwood, FL 32779 for compliant, high-quality medications.
5. Who should I contact for more information about your services?
Healthcare providers and medical practice administrators can contact 503B Compounding Pharmacy directly for more information. You can reach us at our facility's phone number, (407)993-1381, or visit our website at .