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 at 2160 W State Road 434, Longwood, FL 32779
503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under 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 preparation of sterile and non-sterile compounded medications in large volumes for healthcare providers. As a 503B outsourcing facility, we adhere to the highest standards of quality and safety, which are rigorously enforced by the FDA. This designation distinguishes our operations from traditional compounding pharmacies and ensures that healthcare practitioners at our location can access medications with the assurance of consistent quality and reliability.
The core function of 503B Compounding Pharmacy is to provide bulk compounded medications for office use. This means that physicians, surgeons, hospitals, and clinics in the vicinity of 2160 W State Road 434, Longwood, FL 32779 can obtain essential medications without the need for individual patient-specific prescriptions for our stock. Our facility prepares these medications in advance, allowing for immediate availability and dispensing to healthcare providers for administration within their practice settings. This model is critical for supporting efficient medical procedures and treatments in the local area.
Our services at 2160 W State Road 434, Longwood, FL 32779 are centered on the production of a wide array of compounded pharmaceutical preparations. This includes the compounding of sterile injectables, such as hormone injections, ophthalmics, and other solutions required for various therapeutic applications. All our processes are conducted under strict controlled environments with validated procedures to ensure sterility, potency, and purity. The team at 503B Compounding Pharmacy consists of highly trained pharmacists and technicians who utilize state-of-the-art technology to meet the specific needs of the medical community we serve directly from our Longwood facility.
Compliance and quality control are the cornerstones of our operation at 2160 W State Road 434, Longwood, FL 32779. We operate under current Good Manufacturing Practices (cGMP), which mandate stringent testing of components, in-process materials, and finished drug products. This commitment to excellence ensures that every medication leaving our facility meets precise specifications and is free from contamination. For healthcare providers at our location, this translates to unwavering confidence in the medications they use to treat their patients.
503B Compounding Pharmacy is a vital resource for the medical community at 2160 W State Road 434, Longwood, FL 32779. We provide a reliable source of high-quality compounded medications that are essential for a wide range of medical treatments and procedures. Our dedicated team is committed to supporting local healthcare providers by ensuring they have access to the necessary pharmaceutical products they need, when they need them.
For more information, please visit our website at or contact us directly at (407)993-1381.
Frequently Asked Questions for 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779
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 consistent quality, strength, and purity.
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 primarily supplies medications for office use by healthcare providers. We provide compounded medications to physicians, clinics, and hospitals at our location so they can administer them to their patients during procedures or treatments. Patients should obtain their medications through their healthcare provider.
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 range of sterile preparations, including injectable hormones, ophthalmics, and other solutions needed by local healthcare providers. All products are compounded in bulk quantities under stringent sterile conditions.
4. How does a healthcare provider at this location order from 503B Compounding Pharmacy?
Healthcare providers and institutions can place orders for office-use medications directly with our facility. You can initiate an order or inquire about our available products by calling us at (407)993-1381. Our team will provide information on ordering protocols and product availability.
5. Why should a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 choose a 503B outsourcing facility?
Choosing a 503B outsourcing facility like ours provides assurance of FDA oversight and compliance with cGMP standards. This ensures the medications you receive for your practice are of the highest quality, safety, and consistency, which is critical for patient care and practice liability.