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 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 regulatory oversight, exceeding the requirements of a traditional compounding pharmacy. We serve healthcare providers by producing medications that are patient-specific or in bulk for office use, ensuring practitioners at 2160 W State Road 434, Longwood, FL 32779 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 an environment that adheres to rigorous FDA current Good Manufacturing Practices (cGMP). This involves a meticulous process from sourcing high-quality active pharmaceutical ingredients (APIs) to final product testing and release. Our location at 2160 W State Road 434, Longwood, FL 32779 is equipped with state-of-the-art technology and staffed by a team of highly skilled pharmacists and technicians. We provide healthcare professionals with a reliable source for compounded medications, supporting the specific needs of their patients and practice operations directly from our facility.
Our services are exclusively tailored for healthcare providers. The medications produced at our 503B Compounding Pharmacy location are intended for office use and are distributed to licensed practitioners. We do not dispense medications directly to individual patients from our facility at 2160 W State Road 434, Longwood, FL 32779. Instead, we empower physicians and clinicians by supplying them with the necessary pharmaceutical tools, allowing them to administer treatments efficiently within their practice settings. This model ensures a seamless and professional workflow for medical providers.
For healthcare professionals seeking a dependable partner for their pharmaceutical needs, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 stands as a trusted resource. We encourage you to learn more about our specific compounding capabilities and how we can support your practice. You can reach us directly at (407)993-1381 or visit our website for comprehensive information at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
1. What does it mean that this facility is a 503B outsourcing facility?
It means our pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA as an outsourcing facility under Section 503B. This requires us to comply with stricter federal standards, including current Good Manufacturing Practices (cGMP), which involve rigorous testing, quality control, and reporting for all medications we compound.
2. Can I, as a patient, pick up my prescription directly from your location?
No. 503B Compounding Pharmacy provides medications exclusively to healthcare providers for office use. Individual patients do not receive prescriptions directly from our facility at 2160 W State Road 434, Longwood, FL 32779. Your healthcare provider will administer any medication we compound for them during your office visit.
3. How do I place an order as a healthcare provider?
Healthcare providers can place orders for compounded medications by contacting 503B Compounding Pharmacy directly. Please call our facility at 2160 W State Road 434, Longwood, FL 32779 at (407)993-1381 to speak with our team about your specific needs and to initiate the ordering process.
4. What types of medications do you compound at your facility?
As a 503B outsourcing facility, we compound a wide range of sterile and non-sterile medications in larger volumes. This often includes medications that are currently in drug shortage or are not available from commercial manufacturers, providing a critical supply for healthcare practices at 2160 W State Road 434, Longwood, FL 32779.
5. How can I verify the quality and safety of your compounded products?
Our registration as a 503B outsourcing facility means we are subject to FDA inspection and must adhere to cGMP standards. This ensures strict quality control, including stability testing, sterility testing, and endotoxin testing for applicable products. You can request information about our quality assurance processes by contacting us at (407)993-1381.