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 at 2160 W State Road 434, Longwood, FL 32779. This designation, granted under Section 503B of the Federal Food, Drug, and Cosmetic Act, signifies a commitment to the highest standards of quality, safety, and compliance in the preparation of compounded medications. Unlike a traditional pharmacy, this 503B outsourcing facility adheres to rigorous current good manufacturing practices (cGMP), ensuring that every batch of medication produced meets stringent federal quality standards for sterility, potency, and purity. The team at this Longwood location is dedicated to providing healthcare providers and their patients with access to essential medications that are not commercially available.
The services provided by 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 are specifically designed for office use by healthcare practitioners. This facility specializes in the large-scale compounding of sterile preparations, which are then distributed to hospitals, clinics, and other healthcare settings for administration to patients. The medications produced are critical in situations where there is a drug shortage, or when a specific dosage form or strength is needed that is not otherwise available on the market. By operating under Section 503B, this facility provides an essential link in the healthcare chain, ensuring that medical professionals in the area have a reliable and compliant source for these vital medications.
Quality assurance is the cornerstone of the operation at 2160 W State Road 434, Longwood, FL 32779. The processes employed by 503B Compounding Pharmacy include extensive testing, environmental monitoring, and validation to guarantee the integrity of every preparation. The highly skilled team of pharmacists and technicians utilizes advanced technology and follows meticulous protocols to compound medications in a controlled environment. For healthcare providers seeking a trusted partner for their compounding needs, 503B Compounding Pharmacy offers a dependable solution rooted in regulatory excellence and a commitment to patient safety.
To learn more about the services available or to speak with a representative, you can contact 503B Compounding Pharmacy at (407)993-1381 or visit their website at .
Frequently Asked Questions
1. What does it mean that this is a 503B Compounding Pharmacy?
It means this facility at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered outsourcing facility that compounds large volumes of sterile drugs for office use by healthcare practitioners. It operates under stricter federal regulations (cGMP) than a traditional compounding pharmacy.
2. Can I, as a patient, walk in and get a prescription filled at this location?
No. 503B Compounding Pharmacy provides medications for office use to healthcare providers and facilities. Patients should work directly with their doctor, who can order the necessary compounded medications from this facility for administration in a clinical setting.
3. What types of medications does this 503B facility compound?
This location specializes in compounding sterile injectable medications, often including IV bags, syringes, and other preparations that are in shortage or not available from commercial manufacturers, specifically for healthcare providers serving patients.
4. How does a healthcare provider at a local clinic order from your pharmacy?
Healthcare providers can initiate orders by contacting 503B Compounding Pharmacy directly at (407)993-1381. The team will provide information on ordering procedures, available medications, and compliance requirements.
5. Why should a healthcare provider choose this specific 503B facility?
Choosing this 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 ensures receipt of medications produced under the highest FDA compliance standards, offering assurance of quality, safety, and reliability for patient care.