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 facility meets precise specifications for strength, purity, and stability.
The core function of 503B Compounding Pharmacy is to provide healthcare providers with access to medications that are not commercially available. This includes producing large-scale batches of compounded preparations for office use by physicians, surgeons, veterinarians, and other practitioners. Our location at 2160 W State Road 434, Longwood, FL 32779 is equipped with state-of-the-art technology and staffed by highly trained pharmacists and technicians who specialize in complex compounding. We serve a critical role in the local healthcare ecosystem by mitigating drug shortages and creating essential medications that are vital for patient care.
Our services at 2160 W State Road 434, Longwood, FL 32779 are distinct from traditional retail compounding. We operate on a larger scale, supplying healthcare facilities and practices with the medications they need to treat their patients effectively. The 503B designation signifies our commitment to a level of oversight and quality assurance that goes beyond traditional pharmacy compounding. Patients and practitioners at 2160 W State Road 434, Longwood, FL 32779 can have full confidence in the safety and integrity of the medications we produce.
For more information about the services provided by 503B Compounding Pharmacy, please visit our website at or contact us directly by phone at (407)993-1381. Our team at 2160 W State Road 434, Longwood, FL 32779 is prepared to answer your questions and support the medication needs of the local medical community.
Frequently Asked Questions
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and complies with strict federal standards for compounding. We operate under Section 503B of the FD&C Act, which requires us to follow current good manufacturing practices (cGMP), undergo regular FDA inspections, and provide medications for office use by healthcare providers.
2. Can I, as a patient, pick up my prescription directly from 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy primarily supplies medications in bulk to healthcare providers and facilities for office use. Patients should receive their compounded medications directly from their doctor, veterinarian, or clinic. Our location at 2160 W State Road 434, Longwood, FL 32779 is a manufacturing facility, not a retail pharmacy.
3. How does 503B Compounding Pharmacy help with drug shortages?
When commercially manufactured drugs are in short supply, healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can rely on our 503B outsourcing facility to compound those essential medications. We have the capability to produce large batches of critical drugs, helping to ensure local patients continue to receive the treatments they need without interruption.
4. What kind of quality controls are in place at your facility?
As a 503B outsourcing facility, we implement rigorous quality control measures at 2160 W State Road 434, Longwood, FL 32779. This includes environmental monitoring, validated sterility testing, endotoxin testing, stability studies, and stringent standard operating procedures. All processes are designed to meet or exceed FDA cGMP requirements to guarantee product safety and efficacy.
5. How can a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 place an order?
Healthcare providers can place an order by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will provide information on our available preparations, ordering process, and delivery options specifically for the 2160 W State Road 434, Longwood, FL 32779 location.