Contact Information
Address:
2160 W State Road 434, Longwood, FL 32779
Phone:
Website
https://503bcompoundingpharmacy.com/
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.
2160 W State Road 434, Longwood, FL 32779
https://503bcompoundingpharmacy.com/
503B Compounding Pharmacy operates as an FDA-registered outsourcing facility, adhering to the stringent regulations outlined in 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 the highest standards of quality, safety, and compliance, providing healthcare providers and patients with medications that are not commercially available.
The core function of 503B Compounding Pharmacy is the production of compounded medications in bulk for office use by healthcare practitioners. Physicians and clinics in Longwood can utilize our services to obtain essential medications for their practice needs. By operating under Section 503B, our outsourcing facility is subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) standards. This ensures that every preparation leaving our facility at 2160 W State Road 434, Longwood, FL 32779 meets consistent and reproducible quality benchmarks, offering practitioners a reliable and trusted source for their patient care requirements.
Our portfolio includes a wide array of sterile preparations, such as injections, ophthalmic drops, and intravenous bags, as well as non-sterile compounds like topical creams, capsules, and oral suspensions. The 503B Compounding Pharmacy process is designed for efficiency and scale, allowing us to support the specific demands of local medical practices. Healthcare providers can confidently source medications from our Longwood location, knowing they are produced in an environment that prioritizes precision, purity, and patient safety above all else.
Engaging with 503B Compounding Pharmacy is a streamlined process for medical professionals. Orders are managed through our dedicated channels, and our team is available to discuss specific formulation needs. We encourage healthcare providers at 2160 W State Road 434, Longwood, FL 32779 to connect with us to learn how our 503B compounding services can integrate into their practice, ensuring their patients have access to necessary medications. For more detailed information or to initiate an order, please contact us directly.
Website: https://503bcompoundingpharmacy.com/
Phone: (407)993-1381
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 U.S. Food and Drug Administration and complies with strict federal standards, including current Good Manufacturing Practices (cGMP). This regulatory oversight differentiates us from traditional 503A pharmacies and ensures a higher level of quality control and consistency for the compounded medications we produce.
2. Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications for office use by healthcare practitioners. Physicians, clinics, and other healthcare providers can order compounded medications from our facility at 2160 W State Road 434, Longwood, FL 32779 to have on hand for administering to their patients during treatments and procedures.
3. Can I as a patient directly purchase medications from your Longwood facility?
No. As a 503B outsourcing facility, we compound medications in larger batches for distribution to licensed healthcare providers for office use. Patients must receive these medications through their physician or clinic, who sources them from our facility at 2160 W State Road 434, Longwood, FL 32779.
4. What types of medications does 503B Compounding Pharmacy produce?
Our FDA-registered outsourcing facility at 2160 W State Road 434, Longwood, FL 32779 compounds a broad range of both sterile and non-sterile medications. This includes injectables, IV solutions, ophthalmics, as well as topical creams, gels, and oral formulations that are not otherwise available from commercial manufacturers.
5. How do I place an order as a healthcare provider?
Healthcare providers can place orders by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will guide you through the process. You can also find more information and resources on our website at https://503bcompoundingpharmacy.com/.