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. Located at 2160 W State Road 434, Longwood, FL 32779, this facility specializes in the large-scale, non-patient-specific compounding of sterile and non-sterile medications. As a 503B outsourcing facility, the pharmacy adheres to rigorous federal standards for quality, safety, and production, providing healthcare providers at 2160 W State Road 434, Longwood, FL 32779 with a reliable source for high-quality compounded medications.
The operations at 2160 W State Road 434, Longwood, FL 32779 are distinct from traditional compounding pharmacies. 503B Compounding Pharmacy prepares medications in bulk for office use by healthcare practitioners, meaning medications are available for immediate administration to patients within the practitioner's care. This model is essential for clinics, hospitals, and surgical centers at 2160 W State Road 434, Longwood, FL 32779, ensuring they have vital medications on hand without delay. The facility's commitment to compliance with Current Good Manufacturing Practices (cGMP) ensures every product meets stringent purity, potency, and sterility testing requirements.
Services provided from the location at 2160 W State Road 434, Longwood, FL 32779 include the compounding of a wide array of sterile injectables, ophthalmics, and other dosage forms that are often in short supply from conventional manufacturers. By focusing on bulk compounding, 503B Compounding Pharmacy helps mitigate drug shortages and provides healthcare professionals at 2160 W State Road 434, Longwood, FL 32779 with critical therapeutic options for their patients. The team of highly trained pharmacists and technicians utilizes state-of-the-art technology and cleanroom environments to ensure the integrity of every preparation.
503B Compounding Pharmacy serves the specific needs of the medical community operating at 2160 W State Road 434, Longwood, FL 32779. Healthcare providers can confidently source their office-use medications from this FDA-registered facility, knowing they are receiving products that have undergone extensive quality control testing. For more information on available formulations or to place an order, contact 503B Compounding Pharmacy directly. 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 and inspected by the U.S. Food and Drug Administration (FDA) under Section 503B of the FD&C Act. We operate under stricter Current Good Manufacturing Practice (cGMP) standards compared to traditional pharmacies, which includes rigorous testing for sterility, potency, and purity on all our compounded medications.
2. Can I, as an individual patient, get a prescription filled directly at 2160 W State Road 434, Longwood, FL 32779?
No. 503B Compounding Pharmacy is an outsourcing facility that compounds medications in bulk for office use by healthcare practitioners. Individual patients must receive these medications through their prescribing healthcare provider, who can order and stock our products from our location at 2160 W State Road 434, Longwood, FL 32779 for administration in their practice.
3. What types of medications does 503B Compounding Pharmacy prepare at its Longwood facility?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding a wide range of sterile injectable medications, including IV bags, ophthalmics, and other formulations that are often subject to national drug shortages. We produce these medications for healthcare providers to have on hand for patient care.
4. How does a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 order from your pharmacy?
Healthcare providers and medical facilities can place orders for office-use compounded medications by contacting our facility directly. You can reach our team at (407)993-1381 to discuss your needs, place an order, or learn more about our available formulations. Ordering information is also available on our website at https://503bcompoundingpharmacy.com/.
5. Why should a healthcare provider choose 503B Compounding Pharmacy at 2160 W State Road 434?
Healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can choose our facility for a reliable supply of high-quality, compounded medications that undergo extensive quality control. Our FDA-registered status and adherence to cGMP standards provide an added layer of safety and assurance, helping to ensure patient safety and practice efficiency.