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 in strict compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility is located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies our commitment to the highest standards of quality, safety, and compliance in the preparation of compounded medications. Unlike traditional compounding pharmacies, a 503B outsourcing facility adheres to rigorous current good manufacturing practices (cGMP), providing a significant level of assurance for the medications we produce.
At our location on 2160 W State Road 434, Longwood, FL 32779, we specialize in the large-scale compounding of sterile and non-sterile medications. Our primary mission is to support healthcare providers by supplying them with high-quality, patient-specific medications that are not commercially available. The services provided by 503B Compounding Pharmacy are essential for meeting unique clinical needs that cannot be addressed by mass-produced, FDA-approved drugs. Our state-of-the-art facility is designed to ensure every preparation meets exacting standards for purity, potency, and sterility.
The core function of 503B Compounding Pharmacy is the production of medications in larger batches for office use by healthcare practitioners. Physicians and clinicians in the area can utilize our services to obtain essential medications for their practice, ensuring they have the necessary treatments on hand for immediate patient care. This model enhances efficiency for local healthcare providers and improves patient access to vital therapies. Our operations are strictly confined to our registered address, and we encourage all local practitioners to consider us a reliable partner for their compounding needs.
To learn more about the specific medications and formulations available from our facility, healthcare providers are encouraged to contact us directly. You can reach 503B Compounding Pharmacy by phone at (407)993-1381. Detailed information about our compliance, services, and the distinctions of being a 503B outsourcing facility can also be found on our official 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 operates under Section 503B of the FD&C Act. This requires us to comply with stricter current good manufacturing practices (cGMP) than traditional compounding pharmacies, ensuring a higher level of quality control and consistency in our compounded medications.
2. Can I as an individual patient pick up my medication directly from your location?
No. 503B Compounding Pharmacy primarily supplies medications for office use by healthcare practitioners. Individual patients should receive their compounded medications directly from their prescribing physician or clinic, not from our facility at 2160 W State Road 434, Longwood, FL 32779.
3. How can a healthcare provider at a local practice order from 503B Compounding Pharmacy?
Healthcare providers serving patients in the area can place orders for compounded medications by contacting our facility directly. We can be reached at (407)993-1381 to discuss specific formulations, availability, and the ordering process for office-use medications from our location.
4. What types of medications does 503B Compounding Pharmacy at this location produce?
As a 503B outsourcing facility, we compound a wide range of sterile and non-sterile medications in batches for office use. This includes, but is not limited to, hormonal preparations, sterile injectables, ophthalmics, and other formulations that are prescribed by local healthcare providers but are not readily available from commercial manufacturers.
5. How do I get more information about the services offered at your Longwood facility?
The most accurate and detailed information regarding our services, capabilities, and compliance standards can be found on our official website at https://503bcompoundingpharmacy.com/. For specific inquiries, you are always welcome to call us at (407)993-1381.