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 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 large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, we adhere to rigorous federal standards for quality control, testing, and production, which are distinct from traditional compounding practices. This ensures that healthcare providers at our location receive medications that are consistently produced to the highest levels of safety, potency, and purity.
The core function of 503B Compounding Pharmacy is to provide bulk compounded medications for office use. This means we supply physicians, surgeons, hospitals, and clinics with essential medications that they can keep on hand to administer to patients immediately during office visits or procedures. By serving the medical community from our location at 2160 W State Road 434, Longwood, FL 32779, we help ensure that local healthcare providers have reliable access to critical drugs that may be in short supply, discontinued, or not commercially available in the required form or strength. Our operations are pivotal in supporting the efficient and effective delivery of care within our community.
Our state-of-the-art facility in Longwood is designed to meet the strictest compounding standards. We utilize advanced technology and controlled environments to produce a wide array of preparations. This includes sterile injectables, ophthalmics, and other dosage forms that are essential for various medical treatments and surgical applications. Every batch is meticulously crafted and undergoes stringent testing to verify sterility and potency before it is released for distribution. The team at 503B Compounding Pharmacy comprises highly skilled pharmacists and technicians who are experts in the science of compounding, ensuring that every product leaving our facility is of the utmost quality.
For healthcare professionals seeking a trusted partner for their office-use medication needs, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 stands as a pillar of reliability and excellence. We are committed to upholding the integrity of the pharmaceutical supply chain and supporting the vital work of local medical practices. To learn more about our services or to place an order, please contact us directly. We can be reached at (407)993-1381 or through our website at https://503bcompoundingpharmacy.com/.
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 complies with Current Good Manufacturing Practices (cGMP). This regulatory status requires us to meet higher federal standards for production, testing, and quality control compared to a traditional pharmacy, ensuring the medications we compound are of consistent and verifiable quality.
2. Can I, as a patient, order medications directly from 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy provides medications exclusively for office use by healthcare providers. Patients must receive their compounded medications directly from their physician, surgeon, or a healthcare clinic that sources its medications from our facility at 2160 W State Road 434, Longwood, FL 32779.
3. What types of medications does 503B Compounding Pharmacy produce?
Our facility specializes in compounding sterile injectables, ophthalmics, and other preparations in larger batches for office use. These are typically medications that are on drug shortage lists, have been discontinued by manufacturers, or are needed in a specific strength or formulation not available from commercial pharmaceutical companies.
4. How can a medical practice at this location order from 503B Compounding Pharmacy?
Healthcare providers and facilities can place orders by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will guide you through the ordering process, which is designed for medical professionals seeking bulk compounded medications for use within their practice at our location.
5. Why should a healthcare provider choose 503B Compounding Pharmacy?
Choosing our facility ensures you are receiving medications from an FDA-registered outsourcing facility that operates under strict cGMP guidelines. This provides an added layer of safety and quality assurance, guaranteeing that the medications you administer to your patients from our location are potent, pure, and sterile.