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. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the preparation of compounded medications in accordance with the highest standards of quality and safety. As a 503B Compounding Pharmacy, we produce medications on a larger scale for healthcare providers, focusing on sterile and non-sterile preparations that are not commercially available.
The operations at our Longwood location are distinct from traditional compounding. The 503B Compounding Pharmacy model ensures that all processes, from ingredient sourcing to final product testing, adhere to rigorous Current Good Manufacturing Practices (cGMP). This provides an additional layer of assurance for the healthcare providers we serve at 2160 W State Road 434, Longwood, FL 32779. Our facility is designed to support the needs of hospitals, clinics, and other healthcare entities by providing bulk quantities of essential medications, including sterile injectables, ophthalmic solutions, and other critical dosage forms that are often in short supply.
Patients who receive medications prepared by our 503B Compounding Pharmacy benefit from our commitment to quality. While patients do not order directly from our facility, they can be confident that the medications prescribed by their local healthcare providers are produced under the strict oversight mandated for an FDA-registered outsourcing facility. The team at our Longwood location comprises skilled pharmacists and technicians who utilize advanced technology and stringent protocols to ensure every preparation meets precise specifications.
For healthcare providers at 2160 W State Road 434, Longwood, FL 32779, partnering with our 503B Compounding Pharmacy means access to a reliable source for compounded medications. We provide essential support for patient care by addressing drug shortages and creating patient-specific formulations when standard options are unsuitable. Our focus is exclusively on the services rendered from our facility at this address, ensuring dedicated support for the local medical community.
To learn more about the services of our 503B Compounding Pharmacy or to inquire about partnering with us, please contact our facility. We are located at 2160 W State Road 434, Longwood, FL 32779. You can reach us by phone at (407)993-1381 or visit our website for more information at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
1. What does it mean that this is a 503B Compounding Pharmacy?
Being a 503B Compounding Pharmacy means our facility at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered outsourcing facility. We compound medications in larger batches for healthcare providers under strict federal quality standards, which differ from the regulations for traditional pharmacies.
2. Can I, as a patient, order medications directly from the 503B Compounding Pharmacy?
No, 503B Compounding Pharmacies do not typically dispense medications directly to individual patients. Medications produced at our Longwood facility are distributed to healthcare providers, such as hospitals and clinics, who then administer them to patients under their care.
3. What types of medications does the 503B Compounding Pharmacy in Longwood prepare?
Our 503B Compounding Pharmacy at 2160 W State Road 434 specializes in preparing sterile and non-sterile medications that are often unavailable from commercial manufacturers. This includes sterile injectables, intravenous (IV) bags, and ophthalmic solutions, primarily for use by local healthcare providers.
4. How does the 503B Compounding Pharmacy ensure medication safety?
Safety is paramount at our facility. As an FDA-registered 503B Compounding Pharmacy, we adhere to Current Good Manufacturing Practices (cGMP). This involves rigorous testing of ingredients, environmental monitoring of our cleanrooms, and quality control testing on finished products prepared at 2160 W State Road 434, Longwood, FL 32779.
5. How can a healthcare provider at this location work with your 503B Compounding Pharmacy?
Healthcare providers interested in the services of our 503B Compounding Pharmacy can contact us directly to discuss their needs. We encourage providers at 2160 W State Road 434, Longwood, FL 32779 to call us at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/ to initiate a partnership.