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 precisely located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies our commitment to the highest standards of quality, safety, and compliance in the preparation of compounded medications. We serve a critical role in the healthcare ecosystem by providing bulk quantities of sterile and non-sterile compounded preparations to healthcare providers for office use and to hospitals within our operational framework.
The core function of 503B Compounding Pharmacy is the large-scale production of medications that are not commercially available. This includes medications that may be on a drug shortage list or those that require specific formulations not offered by traditional pharmaceutical manufacturers. By operating under Section 503B, our facility at 2160 W State Road 434, Longwood, FL 32779 adheres to Current Good Manufacturing Practices (cGMP), which are the stringent quality standards enforced by the FDA for all drug manufacturers. This ensures that every preparation leaving our facility meets rigorous testing and quality assurance protocols for potency, sterility, and purity.
Our services are designed to support physicians and healthcare institutions by providing them with reliable access to essential medications. The offerings from our location at 2160 W State Road 434, Longwood, FL 32779 include the compounding of various pharmaceutical dosage forms. This encompasses sterile preparations such as injections, ophthalmics, and irrigations, as well as non-sterile preparations. All processes are conducted within our controlled environment by our team of highly trained pharmacists and technicians, utilizing state-of-the-art equipment to guarantee precision and safety in every batch.
Engaging with 503B Compounding Pharmacy means partnering with a facility that prioritizes patient safety and regulatory excellence above all else. We understand the critical nature of the medications we produce and the trust that healthcare providers place in us. Our team at 2160 W State Road 434, Longwood, FL 32779 is dedicated to upholding the integrity of the pharmaceutical supply chain by delivering high-quality, compounded preparations that healthcare professionals can administer with confidence.
For more detailed information about our compliance, services, or to initiate an order, we invite you to contact us directly. You can reach our facility by phone at (407)993-1381 or visit our official website to learn more: https://503bcompoundingpharmacy.com/. Our team is prepared to assist with your specific needs and provide the support required for your practice.
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 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 comply with Current Good Manufacturing Practices (cGMP) for the large-scale production of compounded drugs for office use by healthcare practitioners.
2. Who can receive medications from 503B Compounding Pharmacy?
Medications compounded at our facility at 2160 W State Road 434, Longwood, FL 32779 are provided to healthcare practitioners and institutions for office use. We do not compound medications for individual patient prescriptions that are to be dispensed directly to the patient; that is the role of a traditional 503A pharmacy.
3. What types of medications does 503B Compounding Pharmacy produce?
Our facility at 2160 W State Road 434, Longwood, FL 32779 produces both sterile and non-sterile compounded preparations in larger batches. This often includes medications that are on a drug shortage list or that require a specific formulation not available from a commercial manufacturer, providing a vital resource for local healthcare providers.
4. How does the quality assurance process work at your facility?
As a 503B outsourcing facility located at 2160 W State Road 434, Longwood, FL 32779, we are mandated to follow strict cGMP standards. This involves rigorous testing of components, in-process materials, and finished preparations for sterility, potency, and purity to ensure every batch meets the highest quality and safety standards before it is released.
5. How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers interested in our services can contact our facility directly at 2160 W State Road 434, Longwood, FL 32779 by calling (407)993-1381. Our team will provide information on our available preparations and guide you through the ordering process. You can also learn more about our capabilities on our website at https://503bcompoundingpharmacy.com/.