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. Our facility is located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies our commitment to the highest standards of quality, safety, and consistency in pharmaceutical compounding. We serve healthcare providers and their patients from our specific location by producing large quantities of compounded sterile preparations (CSPs) and compounded non-sterile preparations without receiving patient-specific prescriptions.
The core function of 503B Compounding Pharmacy is the anticipatory compounding of medications. This means our facility at 2160 W State Road 434, Longwood, FL 32779 manufactures medications in advance of receiving a prescription, based on the established needs of healthcare providers. These medications are then distributed to hospitals, clinics, and physician offices for administration to patients under their care. Our operations are subject to rigorous Current Good Manufacturing Practice (cGMP) regulations, which are the same standards followed by conventional drug manufacturers. This ensures every preparation that leaves our facility meets stringent identity, strength, quality, and purity standards.
Our services at 503B Compounding Pharmacy are distinct from traditional 503A compounding pharmacies. By operating as a 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779, we provide a critical supply of essential medications that may be in shortage or are not commercially available. Healthcare professionals can confidently utilize our services knowing our processes, testing protocols, and facility conditions are held to an elevated level of regulatory oversight. We provide a reliable source for high-quality medications to support the local medical community.
For more information about the services provided by 503B Compounding Pharmacy, please contact us directly. You can visit our website at https://503bcompoundingpharmacy.com/ or call our facility at (407)993-1381. Our team at 2160 W State Road 434, Longwood, FL 32779 is prepared to assist healthcare providers with their medication needs.
Frequently Asked Questions
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our specific facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and complies with Section 503B of the FD&C Act. We operate under Current Good Manufacturing Practices (cGMP), which are more rigorous than the standards applied to traditional compounding pharmacies, ensuring a higher level of quality control and consistency in our preparations.
2. Can I, as an individual patient, get a prescription filled directly at 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy does not accept prescriptions directly from patients. Our facility at 2160 W State Road 434, Longwood, FL 32779 provides medications in bulk to healthcare providers, such as hospitals, clinics, and doctors' offices. Your healthcare provider will then dispense or administer the medication to you as part of your treatment.
3. How does a healthcare provider at a local clinic order from your facility?
Healthcare providers can initiate orders by contacting 503B Compounding Pharmacy directly. They can reach our facility at 2160 W State Road 434, Longwood, FL 32779 by phone at (407)993-1381 or through the professional channels outlined on our website at https://503bcompoundingpharmacy.com/. Our team will work with them to fulfill their specific medication requirements.
4. What types of medications does 503B Compounding Pharmacy produce?
503B Compounding Pharmacy produces both sterile and non-sterile compounded preparations. This includes a wide range of medications that are often on shortage or are not available from large-scale commercial manufacturers. All production is done at our location, 2160 W State Road 434, Longwood, FL 32779, following strict cGMP protocols.
5. Why would a healthcare provider choose 503B Compounding Pharmacy?
Healthcare providers choose our services because of our commitment to quality and reliability. By sourcing from our FDA-registered outsourcing facility at 2160 W State Road 434, Longwood, FL 32779, they gain access to consistently prepared, high-quality medications that are essential for patient care, especially when facing drug shortages or needing specific formulations not available on the market.