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 in strict compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the preparation of sterile and non-sterile compounded medications. As a 503B outsourcing facility, we adhere to the highest standards of quality control, current good manufacturing practices (cGMP), and rigorous testing protocols as mandated by federal law. This ensures that every preparation leaving our pharmacy meets exacting standards for potency, purity, and sterility.
The core function of 503B Compounding Pharmacy is to provide bulk quantities of compounded medications for office use by healthcare practitioners. We serve the medical community at 2160 W State Road 434, Longwood, FL 32779 by supplying medications that are often on shortage or unavailable from traditional manufacturers. Our services enable physicians, surgeons, dermatologists, and other healthcare providers to have immediate access to the critical medications they need for their patients without the delays associated with traditional patient-specific compounding. This model supports efficient clinic and surgical center operations by ensuring vital drugs are in stock and ready for administration.
Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 is designed to prevent microbial contamination and ensure product integrity. Environmental controls, including ISO-classified cleanrooms, are continuously monitored. Our highly trained compounding personnel follow validated processes for every formulation. All finished products undergo stringent quality assurance testing, which may include sterility testing, endotoxin testing, and potency assay, providing an additional layer of safety and reliability for the practitioners we serve.
503B Compounding Pharmacy provides a vital link in the healthcare chain for the local medical community. By focusing on the specific needs of practitioners at our location, we contribute to enhanced patient care and treatment outcomes. We are committed to reliability, safety, and excellence in every preparation. For more information on how our 503B outsourcing facility can support your practice, please contact us.
Website: | Phone: (407)993-1381
Frequently Asked Questions
1. What does it mean that this is a 503B outsourcing facility?
It means our pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and operates under Section 503B of the FD&C Act. We compound medications in bulk for office use by healthcare practitioners and must comply with federal cGMP standards, which include rigorous testing and quality control procedures not always required of traditional pharmacies.
2. Can I, as a patient, walk into 503B Compounding Pharmacy to get a prescription filled?
No. 503B Compounding Pharmacy does not dispense medications directly to patients. We supply compounded medications in bulk to licensed healthcare practitioners for "office use" in their practices, clinics, or surgical centers located at 2160 W State Road 434, Longwood, FL 32779. Your healthcare provider would then administer or dispense the medication to you as part of your treatment.
3. What types of medications does this facility typically compound?
Our FDA-registered outsourcing facility at 2160 W State Road 434, Longwood, FL 32779 specializes in preparing a wide range of sterile and non-sterile medications that are often on backorder or unavailable from commercial manufacturers. This includes injectables, ophthalmics, topicals, and other formulations needed by local healthcare providers to treat their patients effectively.
4. How does a healthcare practitioner at this location order from 503B Compounding Pharmacy?
Healthcare practitioners can place orders for office-use compounded medications by contacting our facility directly. Orders can be initiated by calling our main phone line at (407)993-1381. Our team will guide you through the process, which is designed for efficiency to meet the urgent needs of practices at 2160 W State Road 434, Longwood, FL 32779.
5. Why should a practitioner choose a 503B outsourcing facility over other compounders?
Choosing our 503B outsourcing facility provides an added layer of safety and quality assurance. Because we are regulated by the FDA and must adhere to strict cGMP standards, practitioners at 2160 W State Road 434, Longwood, FL 32779 can have greater confidence in the sterility, potency, and purity of the medications they use to treat patients, compared to products from pharmacies operating under different regulatory standards.