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 and safety, producing medications in larger batches for office use by healthcare practitioners or for patient-specific prescriptions based on a valid prescription order.
The core function of 503B Compounding Pharmacy is to provide healthcare providers with access to high-quality compounded medications that are not otherwise commercially available. Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 is designed to meet rigorous FDA standards, ensuring every preparation undergoes stringent quality control testing. This includes sterility testing, endotoxin testing, and potency verification, providing practitioners and their patients with unparalleled confidence in the medications they receive.
Our services at 2160 W State Road 434, Longwood, FL 32779 are distinct from traditional compounding. We prepare medications for office use, allowing healthcare providers to have essential treatments readily available for immediate administration to patients during office visits. This is particularly critical for medications like injectables, hormones, and other specialized formulations that require the advanced capabilities of an FDA-registered facility. We work directly with prescribers to support their practice needs.
For patients with a prescription from their healthcare provider, 503B Compounding Pharmacy can also fulfill individual prescriptions. Our capabilities include creating dosage forms that are not commercially manufactured, such as altering the strength of a medication, removing a non-essential allergen, or creating a more palatable liquid formulation for those who cannot swallow pills. Every step of this process is conducted within our facility at 2160 W State Road 434, Longwood, FL 32779 under the supervision of our expert compounding team.
The team at 503B Compounding Pharmacy is comprised of highly skilled pharmacists and technicians who are experts in the science of compounding. We are committed to supporting the local medical community by providing a reliable source for safe, effective, and high-quality compounded medications. We invite healthcare practitioners and patients to contact us to learn more about how our specific services at 2160 W State Road 434, Longwood, FL 32779 can meet their needs.
For more information, please visit our website at or contact us directly by phone at (407)993-1381.
FAQ
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our specific facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and operates under Section 503B of the FD&C Act. This requires us to comply with Current Good Manufacturing Practices (cGMP) for higher-risk compounding, which includes rigorous testing for sterility, potency, and purity on our products.
2. As a patient, how can I get a medication from 503B Compounding Pharmacy?
You must have a valid prescription from your healthcare provider. Your provider can send the prescription directly to our facility at 2160 W State Road 434, Longwood, FL 32779. We will then compound the medication specifically for you based on your provider's instructions and contact you when it is ready.
3. Can I walk into the facility at 2160 W State Road 434 to pick up a prescription?
Our operations at 2160 W State Road 434, Longwood, FL 32779 are primarily focused on production and working directly with healthcare providers. Arrangements for prescription pickup or delivery should be discussed directly with our pharmacy team by calling (407)993-1381.
4. What is the difference between "office use" and a patient-specific prescription?
"Office use" refers to medications that are compounded in advance and supplied to a healthcare provider for them to have on hand to administer to patients in their office at 2160 W State Road 434, Longwood, FL 32779. A patient-specific prescription is compounded for an individual patient based on their unique prescription from their doctor.
5. How do I know the compounded medications from this location are safe?
Because we are a 503B outsourcing facility, the medications prepared at 2160 W State Road 434, Longwood, FL 32779 are subject to strict federal quality standards. This includes testing each batch for sterility, strength, and purity, which provides a significant layer of safety and quality assurance beyond traditional compounding.