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 in strict compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation is a critical distinction that sets this facility apart, ensuring the highest standards of quality, safety, and consistency for its compounded medications. Located at 2160 W State Road 434, Longwood, FL 32779, this pharmacy serves a vital role for patients and healthcare providers by preparing medications that are not commercially available. The team at 503B Compounding Pharmacy specializes in creating customized pharmaceutical preparations to meet the unique prescriptive needs of individual patients, adhering to rigorous federal quality standards.
The core mission of 503B Compounding Pharmacy is to provide healthcare practitioners and their patients with access to essential medications that are manufactured under the exacting controls required of an FDA-registered outsourcing facility. This includes large-scale compounding of medications for office use, allowing physicians at local practices to maintain an inventory of necessary, yet commercially unavailable, drugs for immediate patient administration. The facility at 2160 W State Road 434, Longwood, FL 32779 is equipped with state-of-the-art technology and staffed by experienced compounding professionals who are dedicated to precision and quality in every batch.
Patients and providers who utilize the services of 503B Compounding Pharmacy can have absolute confidence in the integrity of their medications. Every process, from sourcing active pharmaceutical ingredients (APIs) from FDA-registered suppliers to final product testing, is meticulously controlled and documented. This unwavering commitment to compliance and excellence ensures that every preparation leaving the facility meets its specified identity, strength, quality, and purity characteristics. For healthcare providers seeking a reliable partner for their compounding needs, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 represents the pinnacle of trust and professional service.
To learn more about the specific services available or to inquire about how 503B Compounding Pharmacy can assist with your compounding requirements, please contact the facility directly. The dedicated team is available to answer questions and provide support. You can reach them by phone at (407)993-1381 or visit their website for additional information at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
This designation means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with and inspected by the U.S. Food and Drug Administration (FDA). We operate under Section 503B of the FD&C Act, which requires us to adhere to stricter current Good Manufacturing Practices (cGMP) than traditional compounding pharmacies, ensuring the highest level of quality and safety for our compounded preparations.
Who can place an order with 503B Compounding Pharmacy?
503B Compounding Pharmacy primarily provides medications for office use by healthcare practitioners. Orders are accepted from licensed healthcare providers for their patients. Patients seeking compounded medications should discuss their needs with their healthcare provider, who can then place an order with our facility at 2160 W State Road 434, Longwood, FL 32779 if appropriate.
How do I know the medications from 503B Compounding Pharmacy are safe?
Safety is our paramount concern. As a 503B outsourcing facility, we are required to comply with rigorous cGMP standards. This includes testing incoming components for identity and purity, conducting stability studies, performing sterility testing on injectable products, and thoroughly validating our processes. This multi-layered quality control system ensures the medications produced at our location are safe and effective.
Can I pick up my medication directly from your location?
503B Compounding Pharmacy operates as an outsourcing facility that typically supplies medications directly to healthcare providers and clinics for office use. Patients should consult with their healthcare provider regarding the pickup or administration of any medication compounded at our facility located at 2160 W State Road 434, Longwood, FL 32779.
How can I get more information about your available preparations?
Healthcare providers interested in our services are encouraged to contact our facility directly. Our knowledgeable staff can provide detailed information about our capabilities and available preparations. Please call us at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/ for more information.