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.
503B Compounding Pharmacy operates as an FDA-registered outsourcing facility under Section 503B of the Federal Food, Drug, and Cosmetic Act. This facility is located at 2160 W State Road 434, Longwood, FL 32779. The 503B designation signifies a commitment to the highest standards of quality, safety, and compliance in pharmaceutical compounding. As a 503B outsourcing facility, this pharmacy adheres to rigorous current good manufacturing practices (cGMP) and is subject to regular FDA inspections. The primary function of this 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) for office use by healthcare practitioners.
The services provided by this 503B Compounding Pharmacy are distinct from traditional retail compounding. The 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779 prepares medications, including intravenous (IV) bags, injections, and ophthalmic preparations, in bulk quantities without receiving patient-specific prescriptions. These preparations are then distributed to hospitals, clinics, surgery centers, and other healthcare providers for administration to patients within their care. This model ensures that healthcare facilities have immediate access to critical medications that may be in short supply or not commercially available. The 503B Compounding Pharmacy plays a vital role in the local healthcare infrastructure by providing these essential pharmaceutical products.
Quality control is a foundational principle for this 503B Compounding Pharmacy. Every process, from ingredient sourcing to final product sterilization and testing, is meticulously controlled and documented. The facility at 2160 W State Road 434, Longwood, FL 32779 utilizes advanced environmental monitoring, state-of-the-art equipment, and validated processes to ensure every preparation meets stringent sterility, potency, and purity standards. This unwavering commitment to cGMP compliance differentiates a 503B outsourcing facility and provides healthcare professionals with the confidence that the medications they administer are of the highest quality and safety.
Healthcare providers seeking a reliable source for compounded sterile medications can partner with the 503B Compounding Pharmacy located at 2160 W State Road 434, Longwood, FL 32779. The team of experienced pharmacists and technicians is dedicated to supporting the local medical community with consistent, high-quality pharmaceutical solutions. For more information on available formulations or to discuss your facility's needs, please contact the 503B Compounding Pharmacy directly. You can reach this facility by phone at (407)993-1381 or visit the website at .
Frequently Asked Questions for 503B Compounding Pharmacy
1. What does it mean that this is a 503B Compounding Pharmacy?
This 503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation means our facility at 2160 W State Road 434, Longwood, FL 32779 adheres to current good manufacturing practices (cGMP) and is subject to federal oversight, ensuring the highest standards of quality and safety for our compounded sterile preparations.
2. Can I, as an individual patient, get a prescription filled at this 503B Compounding Pharmacy?
No. This 503B Compounding Pharmacy operates as an outsourcing facility that produces medications for office use by healthcare providers. We do not accept or compound prescriptions for individual patients. Medications are supplied in bulk to hospitals, clinics, and other healthcare facilities located near 2160 W State Road 434, Longwood, FL 32779.
3. What types of medications does this 503B Compounding Pharmacy prepare?
This 503B Compounding Pharmacy specializes in compounded sterile preparations (CSPs), such as intravenous (IV) fluids, injectable medications, and ophthalmic solutions. These are produced for healthcare facilities to have on hand for procedures, emergency use, or to address drug shortages.
4. How does a healthcare facility order from this 503B Compounding Pharmacy?
Healthcare facilities interested in ordering compounded medications from our 503B outsourcing facility should contact us directly to establish an account. You can reach the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 by phone at (407)993-1381 to speak with a representative.
5. Why should a healthcare facility choose this specific 503B Compounding Pharmacy?
Choosing this 503B Compounding Pharmacy means partnering with a local, FDA-registered outsourcing facility committed to cGMP compliance. Our location at 2160 W State Road 434, Longwood, FL 32779 allows us to provide reliable service and high-quality sterile compounds to the medical community with a focus on safety and consistency.