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. This designation is a critical distinction that sets this facility apart from traditional compounding pharmacies. Located at 2160 W State Road 434, Longwood, FL 32779, this outsourcing facility adheres to the highest current good manufacturing practices (cGMP), ensuring that every preparation meets rigorous standards for sterility, potency, and purity. The primary mission of 503B Compounding Pharmacy is to provide healthcare practitioners with access to high-quality, bulk-compounded medications that are essential for patient care but may be unavailable or in short supply from conventional pharmaceutical manufacturers.
The services provided at the 2160 W State Road 434 facility are specialized and large-scale. As an outsourcing facility, 503B Compounding Pharmacy prepares medications without patient-specific prescriptions, instead supplying these preparations to healthcare facilities and practitioners for office use. This model is vital for hospitals, clinics, and surgical centers that require immediate access to critical medications, such as sterile injectables, ophthalmics, and other complex formulations. The team at the Longwood location comprises highly skilled pharmacists and technicians who utilize advanced technology and stringent quality control protocols to produce these essential medications reliably and efficiently.
Patients and healthcare providers who source medications from 503B Compounding Pharmacy at 2160 W State Road 434 can have confidence in the integrity of every product. The facility's commitment to operating under federal oversight and its adherence to cGMP standards provide an additional layer of safety and assurance. For more information on its capabilities or to inquire about its services, you can visit the official website at https://503bcompoundingpharmacy.com/ or contact the facility directly by phone at (407)993-1381.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
This means the facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and operates under Section 503B of the FD&C Act. It is subject to federal oversight and must comply with current good manufacturing practices (cGMP) for drug manufacturing, which includes rigorous testing and quality control standards beyond those required of traditional pharmacies.
Can I get a prescription filled for myself at the 2160 W State Road 434 location?
No. As an outsourcing facility, 503B Compounding Pharmacy does not typically compound medications for individual patients based on a prescription. The facility produces medications in larger quantities for healthcare providers to keep in stock for office use. You would need to contact a traditional 503A compounding pharmacy for patient-specific prescriptions.
What types of medications does the Longwood facility compound?
The 503B Compounding Pharmacy at 2160 W State Road 434 specializes in compounding sterile preparations, which can include injectables, intravenous (IV) bags, ophthalmics, and other formulations that are essential for hospitals, surgery centers, and clinical practices. All preparations are made for office use by healthcare providers.
How does a healthcare provider order from this facility?
Healthcare providers and facilities can place orders for office-use medications directly with 503B Compounding Pharmacy. To begin the process or to discuss specific needs, providers should contact the facility at (407)993-1381 or through the official website at https://503bcompoundingpharmacy.com/.
Why should a healthcare provider choose 503B Compounding Pharmacy for their office-use medications?
Choosing the 503B Compounding Pharmacy at 2160 W State Road 434 ensures that medications are produced under the strict cGMP standards required by the FDA for outsourcing facilities. This provides a higher level of assurance regarding sterility, potency, and purity, which is crucial for patient safety in clinical settings.