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 is located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies our commitment to the highest standards of quality, safety, and compliance in the preparation of compounded medications. Unlike traditional compounding pharmacies, a 503B outsourcing facility is subject to rigorous federal oversight, including current Good Manufacturing Practice (cGMP) regulations, which ensures that every batch of medication we produce meets stringent quality assurance testing for potency, sterility, and purity.
The services provided by 503B Compounding Pharmacy at our Longwood location are designed to support the specific needs of healthcare providers and their patients. We specialize in the large-scale compounding of medications that are not commercially available, providing essential alternatives when a patient has an allergy to a dye or preservative, requires a different dosage strength, or needs a specific formulation that is not on the market. Our state-of-the-art facility at 2160 W State Road 434 is equipped to produce sterile and non-sterile preparations, ensuring we can meet a wide array of clinical requirements with precision and care.
Patients and practitioners who utilize the services of 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779, benefit from our unwavering dedication to safety and quality. Our processes are meticulously designed to prevent contamination and ensure accuracy. Every step, from ingredient sourcing to final packaging, is controlled and documented. For more information about our services or to speak with our team, please contact us via our website at https://503bcompoundingpharmacy.com/ or by phone at (407)993-1381.
Frequently Asked Questions
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 operates under Section 503B of the FD&C Act. This subjects us to federal cGMP standards and routine FDA inspections, ensuring a higher level of oversight for sterility, potency, and quality control compared to a traditional pharmacy.
Who can receive medications from 503B Compounding Pharmacy?
Medications compounded at our facility are typically prescribed by a healthcare provider for their patients. We work directly with practitioners to provide them with the compounded medications they need to treat their patients, who then receive the medication through their clinician or a designated distributor.
What types of medications does 503B Compounding Pharmacy prepare?
503B Compounding Pharmacy prepares a range of medications, including sterile injectables, ophthalmics, and other formulations that are not available commercially. This includes creating specific strengths, removing allergens, or compounding a medication that is currently in shortage.
How do I place an order with 503B Compounding Pharmacy?
Orders for our compounded preparations are placed by healthcare providers and healthcare facilities. Practitioners can initiate an order by contacting our facility directly at (407)993-1381 to discuss their specific patient or practice needs.
Where is 503B Compounding Pharmacy located?
503B Compounding Pharmacy is located at 2160 W State Road 434, Longwood, FL 32779. This is our only location, and all of our compounding services are performed at this specific, FDA-registered facility.