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 located at 2160 W State Road 434, Longwood, FL 32779. We specialize in the non-sterile and sterile compounding of medications, adhering to the highest standards of quality and safety as mandated by federal law. As a 503B outsourcing facility, our primary focus is on producing large batches of compounded medications for office use, which are then distributed to healthcare practitioners for patient administration within their clinical settings.
The operations at 2160 W State Road 434, Longwood, FL 32779 are distinct from a traditional retail pharmacy. Our core service is the large-scale production of medications that are not commercially available or are in shortage. This includes compounding sterile preparations such as injections, ophthalmic drops, and irrigation solutions, as well as non-sterile preparations like topical creams and oral suspensions. All processes at our facility are conducted under stringent quality control measures, including rigorous testing and environmental monitoring, to ensure the potency, purity, and sterility of every preparation that leaves our location.
Healthcare providers in need of reliable, high-quality compounded medications for their practice can rely on the services provided at 2160 W State Road 434, Longwood, FL 32779. We work directly with physicians, veterinarians, hospitals, and clinics to provide the essential medications they require. Our status as a 503B outsourcing facility means we are subject to FDA oversight and current Good Manufacturing Practice (cGMP) regulations, providing an additional layer of assurance for the medical community we serve.
For more information about the specific services available from our facility, please visit our website at or contact us directly by phone at (407)993-1381. The team at 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is dedicated to supporting the healthcare community with compliant and critical medications.
Frequently Asked Questions
1. What does it mean that you are a 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779?
It means our facility is registered with the FDA under Section 503B of the FD&C Act. This registration requires us to comply with more stringent federal standards, including current Good Manufacturing Practices (cGMP), for the large-scale compounding of sterile and non-sterile medications intended for office use by healthcare practitioners.
2. Can I, as an individual patient, pick up a prescription at 2160 W State Road 434?
No. 503B Compounding Pharmacy operates as an outsourcing facility that supplies medications in bulk to healthcare providers for office use. Individual patient prescriptions are typically dispensed by a traditional retail pharmacy. Our location at 2160 W State Road 434, Longwood, FL 32779 is a manufacturing facility, not a retail storefront for the public.
3. What types of medications do you compound at your Longwood facility?
At our facility at 2160 W State Road 434, Longwood, FL 32779, we compound a wide range of sterile and non-sterile preparations. This includes injectables, ophthalmic solutions, nasal sprays, topical creams, and oral suspensions. These are produced for healthcare settings to administer to patients.
4. How can a healthcare provider order from your 503B facility?
Healthcare providers interested in ordering compounded medications from our facility at 2160 W State Road 434, Longwood, FL 32779 can initiate the process by contacting our office directly at (407)993-1381. Our team will provide information on our available formulations, ordering procedures, and compliance requirements.
5. Why should a clinic use a 503B outsourcing facility like yours instead of a 503A pharmacy?
Utilizing a 503B outsourcing facility like ours at 2160 W State Road 434, Longwood, FL 32779 provides clinics with medications produced under federal cGMP standards, which are the same standards required of large drug manufacturers. This offers a higher level of quality assurance, including strict environmental monitoring, testing for sterility and potency, and full FDA oversight, which is ideal for office-use medications.