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 is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. Located at 2160 W State Road 434, Longwood, FL 32779, this facility specializes in the large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, it adheres to rigorous federal quality standards, including current Good Manufacturing Practices (cGMP), which are more stringent than the standards applied to traditional compounding pharmacies. This ensures that every preparation leaving the facility is of the highest quality, purity, and consistency. The primary mission of 503B Compounding Pharmacy is to provide healthcare providers with access to bulk quantities of essential medications that are often in short supply or unavailable from conventional manufacturers.
The services provided at the 2160 W State Road 434 location are exclusively for healthcare facilities and prescribers. 503B Compounding Pharmacy does not dispense medication directly to individual patients but instead serves as a critical partner to hospitals, clinics, surgical centers, and physician practices. By outsourcing their compounding needs to this FDA-registered facility, healthcare providers can be confident they are receiving medications produced under the highest level of regulatory oversight. This partnership allows providers to focus on patient care while ensuring their medication supply is reliable, safe, and effective. The facility's operations are dedicated to alleviating drug shortages and providing vital medications that are essential for patient treatments and procedures.
503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779, maintains a state-of-the-art laboratory environment. This includes advanced cleanrooms for sterile compounding, which are meticulously controlled for particulate matter and microbial contamination. The facility utilizes sophisticated equipment and validated processes to ensure dosage accuracy and sterility assurance for every batch of medication produced. The team consists of highly trained pharmacists, pharmacy technicians, and quality assurance professionals who are experts in cGMP compliance and sterile compounding techniques. This dedicated team works diligently to fulfill the specific needs of the healthcare providers they serve, ensuring timely delivery and unwavering quality.
For healthcare providers at 2160 W State Road 434, Longwood, FL 32779, and the medical community it serves, 503B Compounding Pharmacy represents a trusted source for compounded medications. The facility is committed to excellence, safety, and compliance in every aspect of its operation. Healthcare providers can learn more about the specific formulations available and initiate orders by visiting the official website at https://503bcompoundingpharmacy.com/ or by calling the facility directly at (407)993-1381.
Frequently Asked Questions
1. 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. We compound medications in large batches for office use and are required to comply with strict current Good Manufacturing Practices (cGMP) for quality and safety.
2. Can I, as an individual patient, pick up a prescription at your location?
No. 503B Compounding Pharmacy provides medications exclusively to healthcare facilities and practitioners for office use. We do not dispense prescriptions directly to individual patients at our 2160 W State Road 434 location. Your healthcare provider will administer the medication we compound to you during your appointment or procedure.
3. What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434, Longwood, FL 32779, compounds a wide range of sterile and non-sterile medications, including injectables, ophthalmics, and other preparations that are often on drug shortage lists. We provide these in bulk quantities to support the needs of local healthcare providers.
4. How does a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers and facilities can place orders directly through our website at https://503bcompoundingpharmacy.com/ or by contacting our facility by phone at (407)993-1381. Our team will assist with setting up an account and processing orders.
5. Why should a healthcare provider choose a 503B outsourcing facility?
Choosing our 503B outsourcing facility ensures the medications you use are produced under the highest federal quality standards (cGMP). This provides an added layer of safety, consistency, and reliability compared to medications compounded under traditional pharmacy standards, which is crucial for patient care.