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. Located at 2160 W State Road 434, Longwood, FL 32779, this facility specializes in the large-scale compounding of sterile and non-sterile medications that are distributed for office use by healthcare practitioners. As a 503B outsourcing facility, it adheres to rigorous federal standards for current good manufacturing practices (cGMP), providing an additional layer of safety and quality assurance for the medications it produces.
The core function of 503B Compounding Pharmacy at its Longwood location is to support local healthcare providers by supplying them with high-quality, compounded medications that are not readily available from commercial manufacturers. This includes a range of preparations such as hormone replacement therapy (HRT) medications, sterile injectables, ophthalmics, and other customized dosage forms. By operating under Section 503B, the pharmacy can compound medications in advance of receiving a patient-specific prescription, allowing physicians and clinicians at local practices to have essential medications on hand for immediate administration to their patients during office visits.
Patients in Longwood benefit indirectly from the services of 503B Compounding Pharmacy through their trusted healthcare providers. The facility enables local doctors, dermatologists, ophthalmologists, and other medical professionals to offer tailored treatments without the delays associated with traditional compounding. The stringent cGMP protocols followed at the 2160 W State Road 434 facility ensure that every batch of medication is consistently produced and tested for potency, purity, and sterility, providing peace of mind to both practitioners and their patients.
For healthcare providers seeking a reliable source for office-use compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779, represents a critical partner in patient care. To learn more about its services or to inquire about becoming a client, healthcare practices can contact the facility directly at (407)993-1381 or visit its official website at https://503bcompoundingpharmacy.com/ for comprehensive information.
Frequently Asked Questions
1. What does it mean that 503B Compounding Pharmacy is an "outsourcing facility"?
An outsourcing facility is an FDA-registered compounding pharmacy that operates under Section 503B of the FD&C Act. This means 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779, must comply with strict federal current good manufacturing practice (cGMP) regulations, which include rigorous testing and quality control standards for the medications it compounds and distributes.
2. Can I, as a patient, pick up my prescription directly from the 2160 W State Road 434 location?
No. As a 503B outsourcing facility, this location primarily compounds medications in large batches for office use by healthcare practitioners. Patients receive their medications directly from their doctor's office during their appointment. The facility does not typically dispense medications directly to individual patients based on a prescription.
3. How do the services at this location benefit me as a resident of Longwood?
The services benefit you by supplying your local healthcare providers with a consistent, high-quality supply of compounded medications. This allows your doctor to have the specific medications you might need readily available in their office, facilitating immediate and convenient treatment during your visit without waiting for a prescription to be filled elsewhere.
4. What types of medications are compounded at the Longwood facility?
The 503B Compounding Pharmacy at 2160 W State Road 434 compounds a wide array of sterile and non-sterile medications for office use. This includes, but is not limited to, sterile injectables, hormone therapy preparations, ophthalmics, and other customized solutions that are not commercially available from large pharmaceutical manufacturers.
5. How can my medical practice at 2160 W State Road 434 start ordering from 503B Compounding Pharmacy?
Healthcare practices interested in utilizing our services can initiate the process by contacting our facility directly. Please call (407)993-1381 to speak with a representative who can guide you through the onboarding process, or visit our website at https://503bcompoundingpharmacy.com/ for more information on becoming a client.