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 means we adhere to the highest federal standards for quality control, testing, and production, providing a critical service for healthcare providers and patients who require medications that are not commercially available.
The core function of 503B Compounding Pharmacy is the production of compounded medications in bulk for office use by healthcare practitioners. Physicians, surgeons, dermatologists, and other medical professionals practicing at or near 2160 W State Road 434, Longwood, FL 32779 can source high-quality, ready-to-administer medications directly from our outsourcing facility. This allows clinics and practices to maintain an inventory of essential drugs, such as injectables, ophthalmics, and topical preparations, without the burden of in-house compounding, ensuring both convenience and unparalleled patient safety.
Our operations at 2160 W State Road 434, Longwood, FL 32779 are fundamentally different from a traditional retail pharmacy. We do not compound patient-specific prescriptions on an individual basis. Instead, our focus is on supplying healthcare facilities with medications they need to treat their patients. Every batch produced within our facility undergoes rigorous testing and quality assurance procedures as mandated by the FDA, providing practitioners with confidence in the potency, purity, and sterility of the medications they use in their practice.
By choosing 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779, healthcare providers are partnering with a facility that prioritizes regulatory compliance and patient safety above all else. Our team of highly trained pharmacists and technicians utilizes state-of-the-art equipment and follows current good manufacturing practices (cGMP) to ensure every product meets exacting specifications. We are committed to being a reliable and trusted source for compounded medications for the medical community serving our local area.
For more information about our services or to inquire about becoming a client, we encourage healthcare providers to contact 503B Compounding Pharmacy directly. You can reach us by phone at (407)993-1381 or visit our website to learn more about our capabilities and compliance standards at https://503bcompoundingpharmacy.com/.
FAQ
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 quality control, sterility testing, and beyond-use dating.
2. Can I, as an individual patient, get a prescription filled at 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy provides medications for office use by healthcare practitioners. We supply compounded medications in bulk to physicians and healthcare facilities located near 2160 W State Road 434, Longwood, FL 32779. Individual patients should have their prescriptions filled at a traditional retail or 503A compounding pharmacy.
3. What types of medications does 503B Compounding Pharmacy produce?
Our FDA-registered outsourcing facility at 2160 W State Road 434, Longwood, FL 32779 compounds a wide range of sterile and non-sterile medications for office use. This includes injectable medications, ophthalmic solutions, nasal sprays, and topical creams and gels that are supplied to local healthcare practices.
4. How can a healthcare practice at 2160 W State Road 434, Longwood, FL 32779 order from you?
Healthcare providers and practices can establish an account with 503B Compounding Pharmacy by contacting us directly. We encourage local medical professionals to call us at (407)993-1381 to speak with a representative about our ordering process, product availability, and compliance documentation.
5. Why should a local clinic choose 503B Compounding Pharmacy as a supplier?
Clinics and practices choosing 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 benefit from working with an FDA-registered outsourcing facility that guarantees a higher level of quality control and regulatory oversight than is required for traditional compounding. This provides assurance of medication safety, sterility, and potency for their patients.