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 large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, we adhere to the highest standards of quality and safety, providing healthcare providers with access to essential medications that are not commercially available. Our operations are strictly regulated and subject to current good manufacturing practices (cGMP), ensuring every preparation meets rigorous quality control standards before it is dispensed.
The core function of 503B Compounding Pharmacy is to support the local medical community by producing medications in larger batches for office use. Healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779 and throughout the local area can utilize our services to obtain necessary medications for their practice needs. We compound a significant volume of injectable medications, including hormones, vitamins, and other therapeutic solutions, which are vital for various treatment protocols. Our status as a 503B outsourcing facility means we can provide these medications without requiring patient-specific prescriptions for office stock, streamlining the process for medical offices and clinics.
Quality and safety are the cornerstones of our operation at 2160 W State Road 434, Longwood, FL 32779. Our facility undergoes regular and rigorous FDA inspections to maintain our registered status. Every batch of medication we produce is tested for potency, sterility, and endotoxins to ensure it is safe for patient use. This level of oversight provides healthcare providers and their patients with the confidence that the medications they are receiving are of the highest quality and purity. Our commitment to compliance and excellence defines the 503B Compounding Pharmacy service model.
While we operate on a larger scale, our presence at 2160 W State Road 434, Longwood, FL 32779 is a dedicated resource for the local healthcare infrastructure. We work directly with physicians, dermatologists, oncologists, and other medical professionals to supply them with the compounded medications they require to treat their patients effectively. By focusing on the specific needs of practitioners, 503B Compounding Pharmacy plays a crucial role in the local medical ecosystem, ensuring that healthcare providers have reliable access to high-quality medications.
For more information about our services or to place an order, healthcare providers can contact 503B Compounding Pharmacy directly. Reach us by phone at (407)993-1381 or visit our website at . Our team is ready to assist the medical community at 2160 W State Road 434, Longwood, FL 32779 with their compounding needs.
Frequently Asked Questions for 503B Compounding Pharmacy
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 operates under Section 503B of the FD&C Act. This registration requires us to comply with stringent current good manufacturing practices (cGMP) and undergo regular FDA inspections, ensuring the medications we compound meet the highest standards for quality, sterility, and strength.
2. Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications for office use to licensed healthcare practitioners. Our services are designed for medical practices, clinics, and hospitals that require bulk compounded medications for their patient treatments. We serve healthcare providers at 2160 W State Road 434, Longwood, FL 32779 and the surrounding local community.
3. Do you compound medications for individual patients with a prescription?
No, 503B Compounding Pharmacy operates as an outsourcing facility that compounds medications in larger batches for office use by healthcare providers. We do not compound patient-specific medications based on an individual prescription. Patients should contact their healthcare provider, who can then order the necessary compounded medications from our facility for their use.
4. What types of medications does 503B Compounding Pharmacy produce?
Our FDA-registered outsourcing facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding a wide array of sterile injectable medications. This includes, but is not limited to, hormone replacement therapies, vitamin injections, and other sterile solutions that are commonly used in clinical settings by healthcare professionals.
5. How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers can place an order by contacting 503B Compounding Pharmacy directly. Please call us at (407)993-1381 to speak with a representative about your practice's specific needs. You can also find more information and order details on our website at .