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 means we adhere to the highest federal standards for quality control, testing, and production, providing healthcare providers with medications they can trust for their patients. We serve an essential role in the healthcare ecosystem by preparing medications that are not commercially available, addressing specific patient needs as prescribed by physicians.
The core function of 503B Compounding Pharmacy is the production of compounded medications in bulk for office use by healthcare practitioners. Physicians, surgeons, dermatologists, and other medical professionals located at and around 2160 W State Road 434, Longwood, FL 32779 can utilize our services to obtain essential medications for their practice. This includes a wide range of preparations such as sterile injectables, ophthalmics, topicals, and other dosage forms that are critical for patient care but may be on shortage or discontinued by large pharmaceutical manufacturers.
By operating as a 503B outsourcing facility, we implement a level of rigor that goes beyond traditional compounding. Our processes at the Longwood location are governed by Current Good Manufacturing Practices (cGMP), which mandates stringent environmental controls, validated processes, and rigorous testing of components and finished drug products. This ensures every preparation that leaves our facility meets precise sterility, potency, and purity specifications. For healthcare providers at 2160 W State Road 434, Longwood, FL 32779, this translates to a reliable and consistent source of high-quality medications.
503B Compounding Pharmacy provides a vital service in mitigating drug shortages. When critical drugs become unavailable from conventional manufacturers, our facility can step in to compound these essential medications, helping to ensure patient care continues without interruption. This capability is a cornerstone of our operation at 2160 W State Road 434, Longwood, FL 32779, supporting the local medical community and, by extension, the patients they serve.
Engaging with 503B Compounding Pharmacy is a streamlined process for medical practices. Healthcare providers can contact us to discuss their specific needs, place orders, and arrange for delivery or pickup. We are committed to being a dependable partner for the medical community operating from 2160 W State Road 434, Longwood, FL 32779.
For more information or to inquire about our services, please contact 503B Compounding Pharmacy directly. Website: https://503bcompoundingpharmacy.com/ | Phone: (407)993-1381
FAQ
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 FDA and complies with stringent federal standards outlined in Section 503B of the FD&C Act. This includes adhering to Current Good Manufacturing Practices (cGMP) for quality control, testing, and large-scale production of compounded medications for office use.
2. Who can order medications from 503B Compounding Pharmacy at this location?
Our services are designed for licensed healthcare practitioners with prescribing authority. We provide compounded medications for office use to doctors, clinics, and other healthcare entities that serve patients from our specific location at 2160 W State Road 434, Longwood, FL 32779.
3. Can patients directly purchase medications from 503B Compounding Pharmacy?
No. As a 503B outsourcing facility, we compound medications in bulk for office use by healthcare providers. Patients must receive their medications directly from their prescribing physician or clinic at the time of treatment and cannot order directly from our facility.
4. What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding a wide array of sterile and non-sterile preparations, including injectables, ophthalmics, and topical formulations. These are medications that are often on shortage or are not available from commercial manufacturers.
5. How does a healthcare provider at this location place an order?
Healthcare providers serving patients from 2160 W State Road 434, Longwood, FL 32779 can initiate an order by contacting our facility directly. You can discuss your specific needs and place orders by calling us at (407)993-1381 or by visiting our website at https://503bcompoundingpharmacy.com/ for more information.