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 traditional compounding. We serve the specific needs of healthcare providers and their patients by providing access to medications that are not commercially available or are in shortage.
The core function of 503B Compounding Pharmacy is the production of medications in bulk for office use by healthcare practitioners. Physicians, surgeons, dermatologists, and other medical professionals at practices in our community can rely on our facility for a consistent supply of critical medications. This allows them to have essential drugs readily available for immediate administration to patients during procedures, appointments, or treatments, enhancing both patient care and clinical efficiency. Our operations are pivotal in mitigating the impact of national drug shortages, ensuring that patient care at 2160 W State Road 434, Longwood, FL 32779 remains uninterrupted.
Quality assurance is the foundation of everything we do at 503B Compounding Pharmacy. Our state-of-the-art facility employs rigorous testing protocols, environmental monitoring, and validated processes to ensure every preparation meets stringent potency, sterility, and purity standards. Our highly trained pharmacists and technicians adhere to current Good Manufacturing Practices (cGMP), which are the same standards required of major pharmaceutical manufacturers. This level of oversight provides healthcare providers and their patients with the utmost confidence in the medications we produce.
Healthcare providers seeking a reliable source for office-use compounded medications are invited to partner with us. Our team is prepared to discuss specific formulation needs and how our services can support your practice. We welcome inquiries and orders from medical professionals to better serve the patient community. You can reach us directly at (407)993-1381 to speak with a representative or visit our website at https://503bcompoundingpharmacy.com/ for more detailed information about our capabilities and compliance.
Frequently Asked Questions
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and complies with strict federal standards for compounding, including current Good Manufacturing Practices (cGMP). This ensures a higher level of oversight for the medications we produce compared to a traditional compounding pharmacy.
2. Can I, as a patient, order medications directly from 503B Compounding Pharmacy?
No. As a 503B outsourcing facility, we compound medications in larger batches for "office use" by healthcare providers. Patients must receive these medications through their physician, surgeon, or other authorized healthcare professional who has ordered them for administration within their practice.
3. What types of medications does 503B Compounding Pharmacy typically produce?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding a wide range of sterile and non-sterile medications that are often on shortage or unavailable from commercial manufacturers. This includes injectables, ophthalmics, and other preparations essential for healthcare providers to have on hand for patient procedures and treatments.
4. How can a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 place an order?
Healthcare providers can initiate orders by contacting our facility directly at (407)993-1381. Our team will work with you to understand your practice's specific needs and provide information on ordering, formulary, and delivery.
5. Why should a healthcare provider choose 503B Compounding Pharmacy?
Choosing our facility ensures you are sourcing medications from an entity that adheres to the highest level of federal quality and safety standards. We provide a reliable solution to drug shortages, ensuring you have consistent access to critical medications for your patients, all produced under the rigorous cGMP framework.