Contact Information
Address:
2160 W State Road 434, Longwood, FL 32779
Phone:
Website
https://503bcompoundingpharmacy.com/
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.
2160 W State Road 434, Longwood, FL 32779
https://503bcompoundingpharmacy.com/
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 is located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies our commitment to the highest standards of quality, safety, and compliance in the preparation of compounded medications. Unlike traditional compounding pharmacies, a 503B outsourcing facility is subject to rigorous federal oversight, including current Good Manufacturing Practice (cGMP) regulations and regular FDA inspections. This ensures that every preparation leaving our facility meets stringent quality assurance testing for sterility, potency, and purity, providing healthcare providers and patients with a level of confidence and reliability that is paramount for patient care.
The core function of 503B Compounding Pharmacy at 2160 W State Road 434 is the large-scale compounding of medications that are patient-specific but not individually identifiable until the point of distribution. We provide these preparations for office use by healthcare practitioners, as well as for specific patient prescriptions. Our services are essential for situations where a commercially manufactured drug is not available, such as during a drug shortage, or when a specific dosage strength or formulation is needed that is not otherwise on the market. The team at our Longwood facility is comprised of highly skilled pharmacists and technicians who utilize state-of-the-art equipment and technology to compound sterile and non-sterile preparations with precision and accuracy.
By operating under Section 503B, our pharmacy can provide bulk quantities of compounded drugs to hospitals, clinics, and physician offices located near 2160 W State Road 434 for office stock, enabling these healthcare entities to have essential medications readily available for immediate administration to patients. This model supports the local medical community by ensuring access to critical drugs that are compounded under the most rigorous quality controls. Patients and practitioners who utilize the services of 503B Compounding Pharmacy can be assured that they are receiving medications produced in a facility that prioritizes patient safety above all else, adhering to a level of regulatory scrutiny that is unmatched in traditional pharmacy compounding.
For more information about our compounding services or to speak with our team, we encourage you to visit our website at https://503bcompoundingpharmacy.com/ or contact us directly by phone at (407)993-1381. The professionals at 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 are dedicated to supporting the healthcare needs of the community through reliable, high-quality pharmaceutical compounding.
Frequently Asked Questions
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 subjects us to federal cGMP regulations and routine FDA inspections, ensuring a higher level of quality control and testing for the compounded preparations we produce compared to a traditional pharmacy.
Can I, as a patient, pick up a prescription directly from your location?
Our primary operation at 2160 W State Road 434 involves compounding medications for office use by healthcare providers and for specific patient prescriptions that are distributed through partnering clinics and physicians. Please contact your healthcare provider or our facility at (407)993-1381 to understand the specific process for receiving your medication.
What kinds of medications does 503B Compounding Pharmacy prepare?
As a 503B outsourcing facility, we compound a wide range of sterile and non-sterile preparations that are often used in clinical settings. This includes medications for hormone replacement therapy, pain management, ophthalmology, and other specialized needs, particularly those that are on shortage or are not available from commercial manufacturers.
How does a healthcare provider at a local clinic order from your facility?
Healthcare providers and institutions can establish an account with our facility at 2160 W State Road 434, Longwood, FL 32779. Orders can be placed directly by phone at (407)993-1381 or through processes outlined on our website at https://503bcompoundingpharmacy.com/. We provide compounded medications for office stock to be administered within their practice.
Why should a healthcare provider choose a 503B outsourcing facility over other compounders?
Choosing our 503B Compounding Pharmacy ensures that the medications you administer to your patients are produced under the most stringent federal quality and safety standards. This mitigates risk and provides assurance regarding the sterility, potency, and purity of the compounded drug, which is critical for patient safety and positive health outcomes.