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 is an FDA-registered outsourcing facility operating under 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 large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, we adhere to the highest standards of pharmaceutical quality, producing medications in bulk for healthcare providers to administer to their patients within their practice settings. Our core mission is to provide healthcare practitioners with access to reliable, high-quality compounded medications that are essential for patient care.
The operations at our Longwood facility are distinct from a traditional compounding pharmacy. We operate on a larger scale under current Good Manufacturing Practices (cGMP), which are the strict standards enforced by the FDA for drug manufacturers. This commitment to cGMP ensures that every batch of medication we produce undergoes rigorous testing and quality control procedures. Healthcare providers who utilize our services at 2160 W State Road 434 can be confident that they are receiving medications produced with an unparalleled level of precision, sterility, and consistency. This reliability is crucial for medications used in offices, clinics, and hospitals.
Our service to the local medical community at 2160 W State Road 434 is focused on providing a consistent supply of essential medications. We compound a significant volume of preparations that are often on shortage or are not commercially available from large pharmaceutical companies. This includes a wide array of sterile preparations such as injectables, ophthalmics, and irrigations, as well as non-sterile formulations. By working directly with healthcare providers, 503B Compounding Pharmacy helps ensure that patients in our community have access to the necessary medications their treatments require, without interruption.
The team at our Longwood location is comprised of highly skilled pharmacists, pharmacy technicians, and quality assurance professionals. Each staff member is extensively trained in the specific and stringent protocols required of a 503B outsourcing facility. Our entire process, from sourcing high-quality active pharmaceutical ingredients (APIs) to the final packaging and labeling, is meticulously controlled and documented. This creates a fully transparent and traceable chain of custody for every product that leaves our facility at 2160 W State Road 434, providing peace of mind to the practitioners we serve.
503B Compounding Pharmacy is committed to being a vital partner to the healthcare providers in our area. We understand the critical need for dependable access to compounded medications and strive to be a reliable source. For more information about our services or to speak with our team, we encourage you to visit our website at https://503bcompoundingpharmacy.com/ or call us directly at (407)993-1381. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to upholding the highest principles of pharmaceutical compounding.
Frequently Asked Questions
1. What does it mean that 503B Compounding Pharmacy is an "outsourcing facility"?
An outsourcing facility is an FDA-registered entity that compounds medications in large volumes under Section 503B of the Federal Food, Drug, and Cosmetic Act. Unlike a traditional pharmacy, our facility at 2160 W State Road 434 operates under current Good Manufacturing Practices (cGMP), which are the strict quality standards required for pharmaceutical manufacturers.
2. Who can order medications from your facility at 2160 W State Road 434?
503B Compounding Pharmacy provides medications exclusively to healthcare practitioners and facilities. We do not dispense medications directly to individual patients. Healthcare providers can order compounded medications from our Longwood facility for office use and administration to their patients within their practice.
3. What types of medications does 503B Compounding Pharmacy produce?
Our FDA-registered outsourcing facility in Longwood specializes in compounding both sterile and non-sterile medications that are often on shortage or are not commercially available. This includes a wide range of injectables, ophthalmics, and other formulations needed by healthcare providers for patient treatment.
4. How does the quality control at your Longwood facility work?
Every batch of medication produced at 2160 W State Road 434 undergoes rigorous testing and quality control procedures as mandated by cGMP standards. This includes testing of raw materials, in-process testing, and final product sterility and potency testing to ensure the highest level of quality and safety.
5. How can a healthcare provider get started with your services?
Healthcare providers interested in utilizing our services can contact 503B Compounding Pharmacy directly to establish an account. You can reach our team at our Longwood facility by calling (407)993-1381 or by visiting our website at https://503bcompoundingpharmacy.com/ for more information.