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 at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the large-scale compounding of sterile and non-sterile medications. This designation signifies our unwavering commitment to the highest standards of quality, safety, and consistency, exceeding the requirements of traditional compounding. We serve healthcare providers by producing medications that are not commercially available, enabling them to better address the unique and specific medical needs of their patients.
The core function of 503B Compounding Pharmacy is the production of medications in bulk for office use by healthcare practitioners. Physicians, dermatologists, veterinarians, and other medical professionals located at and serving 2160 W State Road 434, Longwood, FL 32779 can rely on our facility for a consistent supply of high-quality compounded preparations. This allows these practitioners to have essential medications readily available for immediate administration during patient appointments, enhancing treatment efficiency and patient care. Our operations are strictly wholesale and we support the local medical community by being a trusted source for these critical pharmaceutical compounds.
As an FDA-registered 503B outsourcing facility, our processes are subject to rigorous federal oversight. This includes adherence to Current Good Manufacturing Practices (cGMP), which govern every aspect of our operation from ingredient sourcing and environmental monitoring to sterility testing and final product release. Every batch of medication produced at our Longwood facility undergoes stringent quality control testing to ensure potency, purity, and sterility. This level of regulatory scrutiny provides healthcare providers and their patients with a level of confidence in the medications they use.
The team at 503B Compounding Pharmacy comprises skilled pharmacists and technicians who are experts in the science of compounding. Utilizing state-of-the-art technology and equipment within our modern facility at 2160 W State Road 434, we are capable of producing a wide array of dosage forms. Our capabilities include sterile injections, ophthalmics, topicals, and other formulations that are essential for various medical treatments. We work directly with prescribers to support their practice needs and the therapeutic requirements of their patient base.
For healthcare providers at 2160 W State Road 434, Longwood, FL 32779 seeking a dependable source for compounded medications, 503B Compounding Pharmacy is the definitive choice. We invite local medical practices to partner with us to ensure their patients receive the highest quality care. To learn more about our services or to place an order, please contact us directly. You can reach us by phone at (407)993-1381 or visit our website for more detailed information at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
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 compounds medications in accordance with Section 503B of the FD&C Act. We adhere to Current Good Manufacturing Practices (cGMP) and are subject to routine FDA inspections, ensuring the highest level of quality and safety for the medications we produce.
Who can order medications from 503B Compounding Pharmacy?
Our services are designed for healthcare providers. Physicians, clinicians, and veterinarians with practices at or serving 2160 W State Road 434, Longwood, FL 32779 can order compounded medications from our facility for office use in treating their patients.
Can I as a patient directly pick up a prescription from your location?
No. 503B Compounding Pharmacy operates as a wholesale outsourcing facility. We do not compound patient-specific prescriptions or serve individual consumers directly. All medications are dispensed to and administered by licensed healthcare providers within their practice settings.
What types of medications does 503B Compounding Pharmacy produce?
Our FDA-registered facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding sterile and non-sterile medications in larger batches. This includes, but is not limited to, sterile injections, ophthalmics, dermatological topicals, and other formulations that are not commercially available for healthcare providers.
How do I place an order for my practice at this location?
Healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can place orders by contacting our facility directly. Please call our dedicated line at (407)993-1381 to speak with our team about your practice's specific compounding needs and to initiate the ordering process.