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 consistency in the preparation of compounded medications. Unlike traditional compounding pharmacies, our 503B status means we are subject to rigorous federal oversight, including current Good Manufacturing Practices (cGMP), which ensures every batch of medication we produce meets stringent quality control measures before it is released for patient use.
At our location on 2160 W State Road 434, Longwood, FL 32779, we specialize in the large-scale production of compounded sterile preparations (CSPs). Our primary mission is to provide healthcare providers with access to a reliable supply of high-quality medications that are often on shortage or unavailable from conventional manufacturers. The services provided by 503B Compounding Pharmacy are essential for hospitals, clinics, and other healthcare entities that require bulk, non-patient-specific compounded medications. We serve as a critical partner to the medical community by ensuring vital drugs are available when they are needed most.
The operational model of 503B Compounding Pharmacy is distinct. We do not compound medications based on individual patient prescriptions from the public. Instead, we manufacture medications in larger batches for healthcare facilities to administer to their patients. This allows us to achieve economies of scale and implement a robust quality assurance program that includes stringent sterility testing, stability studies, and endotoxin testing. Every product that leaves our facility at 2160 W State Road 434, Longwood, FL 32779 is backed by a Certificate of Analysis, providing full transparency and confidence in the medication's quality and purity.
Our team at 503B Compounding Pharmacy comprises highly skilled pharmacists, chemists, and quality assurance professionals dedicated to excellence. The environment at our Longwood facility is meticulously controlled, with state-of-the-art cleanrooms and advanced equipment designed to prevent contamination. We are unwavering in our commitment to patient safety and regulatory compliance, making 503B Compounding Pharmacy a trusted source for compounded medications for the healthcare providers we serve.
For more detailed information about our practices and available products, healthcare professionals are encouraged to visit our website at https://503bcompoundingpharmacy.com/ or contact us directly at (407)993-1381. 503B Compounding Pharmacy is located at 2160 W State Road 434, Longwood, FL 32779.
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 operates under Section 503B of the FD&C Act. This subjects us to federal oversight and mandatory compliance with current Good Manufacturing Practices (cGMP), ensuring the highest level of quality and safety for our compounded medications.
2. Can I, as an individual patient, get a prescription filled at 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy does not compound patient-specific medications. We provide medications in bulk to healthcare facilities and providers. Individual patients should contact a traditional 503A compounding pharmacy for their personal prescription needs.
3. Who can order products from your facility in Longwood?
Our services are exclusively for healthcare entities such as hospitals, surgery centers, clinics, and physician practices. Orders must be placed by authorized medical professionals and are for office use or administration within their practice at 2160 W State Road 434, Longwood, FL 32779.
4. How does the quality control at a 503B outsourcing facility differ?
Our quality control at 2160 W State Road 434, Longwood, FL 32779 is extensive. We perform rigorous testing on every batch, including sterility, endotoxin, potency, and stability testing, following strict cGMP guidelines. This provides a level of assurance beyond what is required for traditional compounding.
5. How can a healthcare provider place an order or get more information?
Healthcare providers can learn more about our available products and services by visiting our website at https://503bcompoundingpharmacy.com/. To discuss specific needs or to place an order, please call our facility directly at (407)993-1381. We are located at 2160 W State Road 434, Longwood, FL 32779.