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.
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 commitment to the highest standards of quality, safety, and consistency, exceeding the requirements of a traditional compounding pharmacy. We serve healthcare providers and facilities by providing them with essential medications that are not commercially available or are in shortage.
The core function of 503B Compounding Pharmacy is the anticipatory compounding of medications. This proactive approach allows us to maintain an inventory of critical drugs, ensuring a reliable supply for our partners at 2160 W State Road 434, Longwood, FL 32779. All our processes are conducted under rigorous quality control measures, including stringent environmental monitoring, validated sterilization techniques, and thorough analytical testing. Every batch of medication is compounded according to current Good Manufacturing Practices (cGMP), providing an additional layer of safety and assurance for patient care.
Our services are exclusively tailored for administration by licensed practitioners. The medications produced at our 503B outsourcing facility are distributed to hospitals, clinics, surgery centers, and other healthcare providers for office use. This model supports the local medical community by mitigating drug shortages and providing access to vital, patient-specific formulations. We are a pivotal resource for healthcare professionals seeking a trusted and compliant source for compounded medications.
For more information on our available formulations and services, please visit our website at or contact us directly at (407)993-1381. The team at 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is dedicated to supporting the healthcare community with the highest quality compounded pharmaceuticals.
Frequently Asked Questions
1. What does it mean that this is a 503B compounding pharmacy?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA as an outsourcing facility under Section 503B. We compound medications on a larger scale without patient-specific prescriptions and adhere to stricter federal standards, including current Good Manufacturing Practices (cGMP), for enhanced quality and safety.
2. Who can order medications from this 503B compounding pharmacy?
Medications are provided for office use by licensed healthcare practitioners and facilities. This includes hospitals, clinics, and surgical centers that administer medications on-site. We do not dispense medications directly to individual patients at our location on 2160 W State Road 434, Longwood, FL 32779.
3. What types of medications does this 503B outsourcing facility compound?
Our 503B compounding pharmacy specializes in compounding sterile injectables, ophthalmics, and other formulations that are often on national shortage or are not available from commercial manufacturers. Our inventory is designed to meet the anticipatory needs of the local healthcare community.
4. How does the quality control at a 503B facility differ?
As a 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779, we operate under cGMP. This involves rigorous environmental monitoring, validated sterility testing, stability studies, and thorough documentation for every batch, providing a level of quality control that is more comprehensive than traditional pharmacy compounding.
5. How can a healthcare facility place an order?
Healthcare facilities and practitioners can inquire about our current product list and place orders by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will provide all necessary information for establishing an account and fulfilling your medication needs.