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 operates as an FDA-registered outsourcing facility 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. This designation signifies our commitment to adhering to the highest federal standards for quality, safety, and consistency, which are more rigorous than those applied to traditional compounding pharmacies. We serve healthcare providers by producing medications that are patient-specific or in bulk for office use, ensuring practitioners at local medical facilities have access to essential drugs that may be in shortage or not commercially available.
The core function of 503B Compounding Pharmacy is the preparation of medications in advance of a prescription based on the established needs of healthcare providers. Our location at 2160 W State Road 434, Longwood, FL 32779 is equipped with state-of-the-art technology and environmental controls to ensure the integrity of every preparation. Our team of highly trained pharmacists and technicians follows strict compounding protocols and undergoes regular testing to guarantee the potency, purity, and sterility of all medications that leave our facility. This process provides an additional layer of safety and reliability for both prescribers and their patients.
We specialize in providing medications for office use to healthcare professionals. This service is critical for clinics, hospitals, and surgical centers in the immediate vicinity of 2160 W State Road 434, Longwood, FL 32779, as it allows them to maintain an on-hand supply of necessary injectable medications, such as hormones, ophthalmics, and other sterile preparations. By working directly with healthcare providers, 503B Compounding Pharmacy helps ensure that patients receive the medications they need without delay, particularly when those drugs are on the FDA drug shortage list or are not produced by major pharmaceutical manufacturers.
As a 503B outsourcing facility, our operations are subject to ongoing oversight by the FDA, including routine inspections. This regulatory framework requires us to report adverse events and provides a level of transparency and accountability that is paramount for patient safety. For healthcare providers seeking a trusted partner for compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 represents a source of consistently high-quality pharmaceutical products. We encourage local medical professionals to contact us to discuss their specific compounding needs.
For more information about our services or to place an order, please reach out to our facility. Website: | Phone: (407)993-1381
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 complies with strict federal standards for current Good Manufacturing Practices (cGMP). This ensures the medications we compound meet higher requirements for sterility, stability, and strength testing compared to a traditional pharmacy.
2. Can I, as a patient, get my personal prescriptions filled at 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy does not compound patient-specific medications based on an individual prescription. We provide medications in bulk for office use to healthcare providers. Your prescribing doctor would obtain medications from our facility at 2160 W State Road 434, Longwood, FL 32779 for use in their practice.
3. What types of medications does 503B Compounding Pharmacy at 2160 W State Road 434 prepare?
Our facility specializes in compounding sterile injectable and non-sterile medications that are often on national drug shortage lists or are not available from commercial manufacturers. This includes hormones, ophthalmics, dermatological agents, and other preparations needed by local healthcare providers for their practice.
4. How can a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 order from you?
Healthcare providers and medical facilities can place orders directly with our facility by calling (407)993-1381. Our team will work with you to understand your practice's needs and provide information on our available formulations and ordering process.
5. Why should a healthcare provider choose 503B Compounding Pharmacy for office-use medications?
Choosing our facility ensures you receive medications produced under the highest federally mandated quality controls. This reduces risk and provides assurance of product consistency and safety for your patients. Our location at 2160 W State Road 434, Longwood, FL 32779 is dedicated to supporting local healthcare providers with reliable access to essential medications.