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 unwavering commitment to the highest standards of quality, safety, and consistency, 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 production of medications in an environment of unparalleled quality control. Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 adheres to Current Good Manufacturing Practices (cGMP), which are the same rigorous standards followed by conventional pharmaceutical manufacturers. This involves stringent testing of all incoming components, meticulous environmental monitoring of our cleanrooms, and rigorous sterility testing of finished products. Every batch compounded at 2160 W State Road 434, Longwood, FL 32779 is created under these exacting protocols to ensure the integrity, potency, and safety of every medication that leaves our facility.
Healthcare professionals relying on our services at 2160 W State Road 434, Longwood, FL 32779 benefit from our focus on mitigating drug shortages. 503B Compounding Pharmacy plays a critical role in the healthcare supply chain by compounding preparations that are currently on the FDA’s drug shortage list or are otherwise unavailable from standard manufacturers. This vital service helps ensure continuity of care for patients by providing practitioners with a reliable and regulated source for these critical medications, all produced and shipped from our location at 2160 W State Road 434, Longwood, FL 32779.
Our operational model at 503B Compounding Pharmacy is specifically designed to support other healthcare entities. We provide medications for office use, allowing practitioners to have necessary drugs on hand for immediate administration to patients during office visits, procedures, or treatments. The medications produced at our facility at 2160 W State Road 434, Longwood, FL 32779 are distributed to healthcare providers; they are not dispensed directly to individual patients without a prescription. This focused approach ensures we maintain the highest level of regulatory compliance and product integrity for our professional clients.
Choosing 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 means partnering with a facility that prioritizes safety and compliance above all else. Our status as a 503B outsourcing facility provides an additional layer of assurance, as we are subject to regular and rigorous FDA inspections. For healthcare providers seeking a trusted source for compounded medications, we invite you to contact our team at 2160 W State Road 434, Longwood, FL 32779 to discuss your needs. Reach out to us via our website at https://503bcompoundingpharmacy.com/ or by phone at (407)993-1381.
Frequently Asked Questions for 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779
1. What does it mean that this is a 503B compounding pharmacy?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered outsourcing facility that compounds medications in large volumes. We operate under stricter federal regulations, including Current Good Manufacturing Practices (cGMP), which are the same standards used by major drug manufacturers, ensuring a higher level of quality control and consistency compared to traditional compounding pharmacies.
2. Can I, as an individual patient, pick up my prescription directly from your location?
No. 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 distributes compounded medications exclusively to healthcare providers and facilities for office use or administration. Patients must receive their medications through their prescribing physician or clinic, not directly from our facility.
3. What kinds of medications do you compound at your Longwood facility?
At our location at 2160 W State Road 434, Longwood, FL 32779, we compound a wide range of sterile and non-sterile medications, with a significant focus on products that are currently in shortage or are not available from commercial pharmaceutical manufacturers. This includes various injectables, hormones, ophthalmics, and other preparations needed by healthcare providers.
4. How does a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers can initiate an order by contacting our facility directly. Our team at 2160 W State Road 434, Longwood, FL 32779 will guide you through the process. You can reach us by phone at (407)993-1381 or find more information and contact forms on our website at https://503bcompoundingpharmacy.com/.
5. Why should a practice choose your 503B facility over other compounders?
Choosing our facility at 2160 W State Road 434, Longwood, FL 32779 provides the assurance of FDA oversight and cGMP compliance. This translates to enhanced patient safety, reduced risk, and consistent product quality. Our primary mission is to be a reliable source for high-quality medications, particularly during critical drug shortages.