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 under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation is a critical distinction that sets this facility apart from traditional compounding pharmacies, signifying adherence to the highest standards of pharmaceutical production. Located at 2160 W State Road 434, Longwood, FL 32779, this facility is dedicated to the large-scale compounding of sterile and non-sterile medications that are distributed for office use by healthcare practitioners. The core mission of 503B Compounding Pharmacy is to provide healthcare providers with access to high-quality, compounded medications that are essential for patient care, all while operating under a framework of rigorous quality control and regulatory compliance.
The operations at the 2160 W State Road 434 facility are governed by Current Good Manufacturing Practices (cGMP), which are enforced by the U.S. Food and Drug Administration. This means every process, from ingredient sourcing and environmental monitoring to testing and documentation, meets stringent federal standards. For healthcare professionals, this provides a significant level of confidence and assurance. The medications produced are not made for specific individual patients but are instead created in larger batches for healthcare providers to keep in stock, allowing for immediate administration to patients when needed. This model is vital for practices requiring readily available medications for procedures, treatments, and therapies.
By focusing exclusively on its role as a 503B outsourcing facility, this location ensures that it specializes in a specific and vital segment of the pharmaceutical supply chain. The team at 2160 W State Road 434 comprises skilled pharmacists and technicians who are experts in sterile compounding techniques, working within controlled environments to prevent contamination. The commitment to quality is paramount, with rigorous testing protocols in place to ensure the potency, purity, and sterility of every product that leaves the facility. For local healthcare providers, 503B Compounding Pharmacy serves as a reliable partner, supplying essential medications that support a wide range of medical treatments and procedures.
Engaging with 503B Compounding Pharmacy is a streamlined process for medical practices. Healthcare providers can place orders for the compounded medications they require to serve their patient base. The facility at 2160 W State Road 434, Longwood, FL 32779, is equipped to handle these orders with efficiency and precision, ensuring that practitioners receive the products they need. To learn more about the specific formulations available or to initiate an account, healthcare providers are encouraged to contact the facility directly. The dedicated team is available to provide information and support, upholding the professional standards expected from an FDA-registered 503B outsourcing facility.
Frequently Asked Questions
What does it mean that this is a 503B compounding pharmacy?
It means this facility is an FDA-registered outsourcing facility that compounds medications in accordance with Section 503B of the Federal Food, Drug, and Cosmetic Act. This registration requires adherence to Current Good Manufacturing Practices (cGMP) for higher-volume production of sterile and non-sterile medications intended for office use by healthcare practitioners.
Who can order medications from this 503B compounding pharmacy?
Medications compounded at our 2160 W State Road 434 location are distributed to healthcare practitioners and facilities for office use. These products are not dispensed directly to individual patients without a prescription but are supplied to licensed medical professionals for administration within their practice.
How does the quality assurance process work at this facility?
As an FDA-registered 503B outsourcing facility, we operate under strict cGMP standards. This involves rigorous testing of ingredients, validation of compounding processes, extensive environmental monitoring of our cleanrooms, and thorough sterility testing on finished products to ensure the highest levels of safety, potency, and purity.
What types of medications does this 503B facility compound?
Our facility at 2160 W State Road 434 compounds a range of sterile and non-sterile medications for office use. This includes but is not limited to injectables, ophthalmics, and other preparations that are commonly utilized by healthcare providers in clinical settings. Specific available formulations can be discussed by contacting our team.
How can a healthcare provider place an order with your pharmacy?
Healthcare providers interested in our services can contact us directly to establish an account. You can reach our team at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/ for more information on our processes and to initiate the ordering procedure.