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 that are not available commercially. We serve healthcare providers by producing high-quality pharmaceutical preparations for their patients, ensuring a reliable supply of essential drugs.
The core function of 503B Compounding Pharmacy is the production of medications in bulk for office use by healthcare practitioners. This means physicians and clinicians in Longwood can obtain vital medications directly for administration to patients within their practice, without the need for individual patient-specific prescriptions. Our operations are subject to rigorous FDA standards regarding current good manufacturing practices (cGMP), which provides an added layer of safety and quality assurance beyond traditional compounding. This regulatory framework ensures every batch of medication produced at our Longwood facility meets stringent testing and quality control protocols.
By operating as a 503B outsourcing facility, we provide a critical service to the local medical community. Healthcare providers at 2160 W State Road 434, Longwood, FL 32779 and the immediate vicinity can rely on a consistent and trustworthy source for compounded medications. This includes sterile injectables, ophthalmics, and other preparations that are often in short supply from conventional manufacturers. Our presence helps mitigate drug shortages and provides practitioners with the necessary tools to deliver optimal patient care without interruption.
Patients benefit indirectly from the services of 503B Compounding Pharmacy. When a healthcare provider utilizes our medications for office-based treatments, patients receive therapies that are prepared under the highest standards of pharmaceutical safety. Our work supports the local healthcare infrastructure by enabling clinics and practices to offer a wider range of treatments and procedures with confidence in the quality of the drugs they use. The entire process is designed to be seamless for the practitioner, from ordering to delivery.
Engaging with 503B Compounding Pharmacy is a straightforward process for authorized medical professionals. Orders are placed directly through our dedicated systems, and our team ensures prompt and secure delivery to the practice location. We maintain a commitment to excellence, safety, and reliability in every aspect of our operation at 2160 W State Road 434, Longwood, FL 32779. For more information on our available formulations and ordering process, healthcare providers are encouraged to contact us directly or visit our website.
Website: https://503bcompoundingpharmacy.com/ | Phone: (407)993-1381
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 medications in large volumes. We operate under Section 503B of the FD&C Act, which requires adherence to Current Good Manufacturing Practices (cGMP) for heightened quality control and testing.
2. Can I as an individual patient get my prescriptions filled at 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy does not compound medications based on individual patient prescriptions. We are an outsourcing facility that produces large batches of medications for "office use" by healthcare providers. Patients receive these medications directly from their doctor during a clinic visit or procedure at the practitioner's office.
3. How do healthcare providers at 2160 W State Road 434, Longwood, FL 32779 order from you?
Healthcare providers and their authorized staff can place orders for compounded medications directly through our pharmacy. The ordering process is designed for medical practices and can be initiated by contacting our facility at (407)993-1381 or through the professional portal on our website, https://503bcompoundingpharmacy.com/.
4. What types of medications does 503B Compounding Pharmacy produce?
We compound a range of sterile and non-sterile medications that are often on drug shortage lists or are not commercially available. This includes, but is not limited to, sterile injectables, ophthalmologic solutions, and other preparations required by healthcare providers for administration in a clinical setting.
5. Why should a healthcare provider choose a 503B outsourcing facility over a traditional compounding pharmacy?
Choosing a 503B outsourcing facility like ours provides assurance of quality and safety. Our compliance with FDA cGMP standards means every batch of medication is rigorously tested for potency, sterility, and purity. This offers healthcare providers at 2160 W State Road 434, Longwood, FL 32779 a higher level of confidence in the medications they use for their patients.