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 primary 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 can utilize our services to obtain necessary medications for their practice, ensuring they have the right treatments on hand for patient care. Our portfolio includes a wide array of compounded preparations, which may include hormone replacement therapies, ophthalmics, injectables, and other customized formulations that address specific patient needs which cannot be met by commercially manufactured drugs.
Our location at 2160 W State Road 434, Longwood, FL 32779 is a center for quality and reliability. The 503B compounding process involves stringent environmental controls, validated processes, and extensive testing to guarantee sterility and potency. By operating under the 503B designation, we provide a critical service that enhances the capabilities of local healthcare providers, allowing them to offer more comprehensive and personalized treatment options. We are committed to upholding the trust placed in us by the medical community through our unwavering dedication to compliance, safety, and excellence in pharmaceutical compounding.
For more information about the services provided by 503B Compounding Pharmacy, please visit our website at or contact us directly at (407)993-1381. Our team at 2160 W State Road 434, Longwood, FL 32779 is prepared to assist healthcare professionals with their compounding needs.
Frequently Asked Questions
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 FDA and operates in compliance with Section 503B of the FD&C Act. This designation subjects us to federal oversight, including adherence to current Good Manufacturing Practices (cGMP) and routine 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 at 2160 W State Road 434?
503B Compounding Pharmacy provides medications for office use by healthcare providers. Licensed medical practitioners can order compounded medications from our facility at 2160 W State Road 434, Longwood, FL 32779 to have on hand for administering to patients within their practice. We do not dispense medications directly to individual patients without a prescription from their provider.
3. What types of medications does 503B Compounding Pharmacy prepare?
As a 503B outsourcing facility, we compound a variety of sterile and non-sterile medications in larger batches. This includes but is not limited to injectables, ophthalmics, and hormone therapies. All preparations made at 2160 W State Road 434, Longwood, FL 32779 are created for situations where a commercially manufactured drug is not appropriate or available for a patient's needs.
4. How does 503B Compounding Pharmacy ensure the quality of its compounded medications?
Our facility at 2160 W State Road 434, Longwood, FL 32779 follows strict cGMP guidelines. This involves rigorous testing of components, validated compounding processes, environmental monitoring, and thorough quality control checks on finished preparations. This comprehensive approach guarantees the identity, strength, quality, and purity of all medications we compound.
5. How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers interested in our services can contact 503B Compounding Pharmacy directly by phone at (407)993-1381. Our team will provide information on our available medications, ordering process, and how we can support your practice from our location at 2160 W State Road 434, Longwood, FL 32779.