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 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 is dedicated to the large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, it adheres to rigorous federal standards for quality control, testing, and production, distinct from traditional compounding pharmacies. The primary mission of 503B Compounding Pharmacy is to provide healthcare providers at 2160 W State Road 434, Longwood, FL 32779 with access to high-quality, compounded medications that are essential for patient care but may be commercially unavailable or in short supply.
The operations at 2160 W State Road 434, Longwood, FL 32779 are conducted within a controlled environment that meets current Good Manufacturing Practices (cGMP). This ensures that every preparation, whether an injectable, infusion, or topical formulation, is produced with the highest level of sterility assurance and potency accuracy. The team at 503B Compounding Pharmacy consists of highly trained pharmacists and technicians who specialize in the complex science of pharmaceutical compounding. They work directly with healthcare professionals to support specific patient needs, providing medications that are free from non-essential allergens or tailored to specific dosage requirements.
503B Compounding Pharmacy serves an important role for the medical community at 2160 W State Road 434, Longwood, FL 32779 by compounding medications for office use. This allows physicians and clinicians to have vital drugs on hand for immediate administration to patients during procedures, treatments, or office visits. The facility's compliance with Section 503B provides an additional layer of trust and reliability for its partners, ensuring the medications are produced under the oversight of the FDA. For more information or to initiate an order, you can contact 503B Compounding Pharmacy via their website at or by phone 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 compounds medications in accordance with Section 503B of the FD&C Act. This requires us to comply with stringent current Good Manufacturing Practices (cGMP) for quality, purity, and sterility, which are more comprehensive than the standards applied to traditional 503A pharmacies.
2. Can I, as a patient, walk into 2160 W State Road 434, Longwood, FL 32779 to get a prescription filled?
No. 503B Compounding Pharmacy operates as an outsourcing facility that supplies compounded medications for "office use" by healthcare providers. We do not accept prescriptions directly from patients. Your healthcare provider at 2160 W State Road 434, Longwood, FL 32779 can order medications from us to have on hand for treatments in their practice.
3. What types of medications does 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 produce?
Our facility specializes in compounding a wide range of sterile and non-sterile medications that are often used in clinical settings. This includes injectables, IV infusions, ophthalmics, and topical preparations. We focus on drugs that are on the FDA's drug shortage list or are not available from commercial manufacturers.
4. How does a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 place an order?
Healthcare providers can place orders directly with our facility by calling (407)993-1381. Our team will work with the provider to process the order and arrange for delivery or pickup at 2160 W State Road 434, Longwood, FL 32779.
5. Why would a provider at 2160 W State Road 434, Longwood, FL 32779 choose a 503B outsourcing facility over other sources?
Providers choose a 503B outsourcing facility like ours for the assurance of FDA oversight and cGMP compliance. This ensures the medications they use for their patients are produced under the highest standards of quality control, sterility testing, and potency verification, which is critical for patient safety and effective treatment outcomes.