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 quality and safety, providing healthcare providers at 2160 W State Road 434, Longwood, FL 32779 with access to critical medications that are not commercially available.
The core function of a 503B outsourcing facility is to compound medications in anticipation of receiving a prescription, which allows us to supply healthcare providers with essential drugs for office use and urgent patient needs. The team at our location on 2160 W State Road 434, Longwood, FL 32779 is comprised of skilled pharmacists and technicians who utilize advanced technology and rigorous testing protocols to ensure every preparation meets strict potency, sterility, and stability specifications. This level of quality control is a fundamental requirement of operating as a 503B outsourcing facility and is central to our mission.
Our services at 2160 W State Road 434, Longwood, FL 32779 are primarily oriented toward supplying other healthcare entities, including hospitals, clinics, and physician practices. We provide these institutions with a reliable source for compounded medications, helping to ensure they have the necessary supplies to treat their patients effectively. By operating as a 503B outsourcing facility, we help mitigate drug shortages and provide access to vital preparations that support the local medical community at 2160 W State Road 434, Longwood, FL 32779.
For healthcare providers seeking a trusted partner for compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 offers a compliant and quality-focused solution. We invite you to contact us to discuss your specific needs. You can reach us by phone at (407)993-1381 or visit our website at .
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, Longwood, FL 32779 is registered with the FDA and complies with Current Good Manufacturing Practices (cGMP). This allows us to compound medications in larger quantities for office use by healthcare providers, adhering to stricter quality control standards than traditional compounding.
2. Can I, as an individual patient, get a prescription filled at your location?
No. As a 503B outsourcing facility, our primary role is to supply compounded medications to healthcare facilities and providers for office use. Individual patients should work with their healthcare provider, who can then source medications from our facility at 2160 W State Road 434, Longwood, FL 32779 if needed.
3. What types of medications do you compound at your facility?
At our location on 2160 W State Road 434, Longwood, FL 32779, we compound a range of sterile and non-sterile preparations. This includes hormonal preparations, sterile injectables, ophthalmics, and other medications that are often on shortage or are not available from commercial manufacturers.
4. How do I, as a healthcare provider, order from your 503B outsourcing facility?
Healthcare providers can place orders for their practice by contacting our facility directly. Please call us at (407)993-1381 to speak with our team at 2160 W State Road 434, Longwood, FL 32779 about setting up an account and discussing your specific medication needs.
5. Why should a healthcare provider choose a 503B outsourcing facility?
Choosing an FDA-registered 503B outsourcing facility like ours at 2160 W State Road 434, Longwood, FL 32779 ensures the medications you use in your practice are produced under the most rigorous quality and safety standards, providing assurance and reliability for both you and your patients.