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 at 2160 W State Road 434, Longwood, FL 32779
503B Compounding Pharmacy operates as an FDA-registered outsourcing facility under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation is a critical distinction that sets this facility apart from traditional compounding pharmacies. Located at 2160 W State Road 434, Longwood, FL 32779, the facility adheres to the most rigorous federal standards for quality, safety, and production. This means all medications are produced in a controlled environment following Current Good Manufacturing Practices (cGMP), which are the same standards required of major pharmaceutical manufacturers. The primary function of this 503B outsourcing facility is to compound large quantities of sterile and non-sterile medications for office use, which are then distributed to healthcare practitioners for patient administration within their clinical practices.
The services provided at 2160 W State Road 434, Longwood, FL 32779 are specifically designed for healthcare providers. Physicians, surgeons, veterinarians, and other medical professionals can source high-quality, compounded medications for their practice needs. This includes a wide array of preparations such as sterile injectables, ophthalmics, hormone replacement therapy (HRT) medications, and other customized formulations that may be in short supply or unavailable from standard commercial sources. By providing these bulk, office-use medications, the 503B Compounding Pharmacy supports local practitioners by ensuring they have reliable access to essential drugs, enabling them to provide continuous and effective patient care.
Patients receiving treatments that originate from this 503B outsourcing facility can have heightened confidence in the integrity of their medications. Every batch produced undergoes stringent testing and quality control checks to verify potency, sterility, and purity. The team at 2160 W State Road 434, Longwood, FL 32779 is comprised of highly skilled pharmacists and technicians who are experts in advanced compounding techniques. Their work is dedicated to upholding the highest pharmaceutical standards and supporting the local medical community with a dependable source of critical medications. For more information, please contact 503B Compounding Pharmacy at (407)993-1381 or visit their website at .
Frequently Asked Questions
1. What does it mean that this is a 503B outsourcing facility?
Being a 503B outsourcing facility means our pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and complies with stringent federal manufacturing standards known as Current Good Manufacturing Practices (cGMP). This ensures the medications we compound for office use meet the highest levels of quality, sterility, and potency.
2. Can I, as a patient, directly pick up a prescription from your location?
No. 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 operates as a bulk manufacturer for office use. We supply compounded medications directly to healthcare providers and practices. Patients receive their treatments from their physician or veterinarian within a clinical setting.
3. What types of medications do you compound at your Longwood facility?
Our FDA-registered facility at 2160 W State Road 434 specializes in compounding a wide range of sterile and non-sterile medications for office use. This includes, but is not limited to, sterile injectables, hormonal preparations, ophthalmics, and other formulations that are prescribed by healthcare providers for their patients.
4. How does a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers can place orders for compounded medications by contacting our facility directly at (407)993-1381. Our team will assist with setting up an account, discussing specific formulation needs, and managing the order and delivery process to support your practice.
5. Why should a practitioner source medications from your 503B facility?
Sourcing from our 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779 guarantees that the medications you use in your practice are produced under the highest federally regulated quality controls. This provides assurance of product consistency, reliability, and safety for patient care, especially for medications that are commercially unavailable or in shortage.