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 at 2160 W State Road 434, Longwood, FL 32779
503B Compounding Pharmacy operates as an FDA-registered outsourcing facility under 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 preparation of sterile and non-sterile compounded medications in a large-scale environment for healthcare providers. This designation signifies our adherence to the most rigorous federal standards for quality, safety, and production, which are distinct from the standards applied to traditional 503A compounding pharmacies. Our primary mission is to provide healthcare practitioners with access to high-quality compounded pharmaceutical products that are essential for patient care.
The operations at our Longwood location are defined by a commitment to cGMP (current Good Manufacturing Practices). This framework ensures every batch of medication produced is consistently prepared and controlled according to the highest quality standards. Our state-of-the-art facility features advanced environmental controls, including ISO-classified cleanrooms for sterile compounding, which are meticulously monitored for particulate and microbial contamination. This controlled environment is critical for producing medications like injectables, ophthalmics, and other sterile preparations that are free from contaminants. The entire process, from sourcing raw ingredients to final product testing and release, is governed by stringent protocols to ensure patient safety and therapeutic efficacy.
503B Compounding Pharmacy serves an important role in the healthcare supply chain by providing medications that are often on shortage or otherwise unavailable from conventional manufacturers. Physicians, hospitals, clinics, and other healthcare providers can rely on our Longwood facility for a consistent supply of essential drugs. By outsourcing their compounding needs to our 503B outsourcing facility, healthcare providers can be assured they are receiving products that have undergone rigorous quality testing, including sterility testing, endotoxin testing, and potency assays. This allows medical professionals to focus on patient care with confidence in the medications they administer.
Our team at 2160 W State Road 434 comprises highly trained pharmacists, pharmacy technicians, and quality assurance professionals. Each staff member is extensively trained in the principles of cGMP and the specific, precise procedures required for large-scale compounding. Continuous training and a culture of quality are paramount to our operation. We invest in advanced technology and analytical equipment to support our quality control laboratory, ensuring that every product leaving our facility meets its labeled strength, purity, and quality specifications. For healthcare providers seeking a dependable source for compounded medications, 503B Compounding Pharmacy in Longwood represents a partnership built on quality, reliability, and regulatory compliance.
To learn more about our services or to speak with our team, please contact us via our website at or by phone at (407)993-1381. Our facility at 2160 W State Road 434, Longwood, FL 32779 is focused on supporting the local medical community with federally compliant compounded pharmaceutical solutions.
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 Federal Food, Drug, and Cosmetic Act. We operate under current Good Manufacturing Practices (cGMP), which are the strict federal standards for drug manufacturing that ensure consistent quality, strength, and purity in every batch we produce.
2. Who can order medications from the 503B Compounding Pharmacy in Longwood?
Our services are provided to healthcare professionals and entities. We supply compounded medications to physicians, hospitals, clinics, and other healthcare providers for office use and administration to their patients. Patients should consult their healthcare provider to determine if a medication compounded at our facility is appropriate for their treatment.
3. What types of medications does the 503B Compounding Pharmacy prepare?
As a 503B outsourcing facility, we specialize in the large-scale compounding of both sterile and non-sterile medications that are often on drug shortage lists or are not commercially available. This includes a range of preparations such as sterile injectables, ophthalmics, and other dosage forms required by healthcare providers for patient treatment.
4. How does the quality control process work at your facility?
Our quality control process at 2160 W State Road 434 is comprehensive. It begins with the rigorous testing of all incoming active pharmaceutical ingredients and components. During production, our processes are strictly controlled within ISO-classified cleanrooms. Finished products undergo analytical testing, including sterility, endotoxin, potency, and identity testing, to ensure they meet all specifications before being released for distribution.
5. How can a healthcare provider place an order with your pharmacy?
Healthcare providers can initiate an order by contacting our facility directly. We encourage you to visit our website at for more information or to call our dedicated line at (407)993-1381 to speak with a representative who can assist with your specific compounding needs and requirements.