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 is dedicated to 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 elevated level of quality, consistency, and safety assurance for the medications it produces.
The core function of 503B Compounding Pharmacy at its Longwood facility is to provide healthcare professionals with access to a reliable supply of high-quality compounded medications. This is essential for medical practices, hospitals, and clinics that require specific formulations not readily available from traditional pharmaceutical manufacturers. By operating from its location on W State Road 434, 503B Compounding Pharmacy serves the specific needs of local practitioners, ensuring they have timely access to the necessary medications for their patient care protocols.
The operations at 2160 W State Road 434 are distinct from a traditional retail pharmacy. This facility does not serve individual walk-in patients seeking prescriptions. Instead, it functions as a wholesale-level operation, compounding medications in larger batches based on the orders received from licensed healthcare providers. This model ensures that practitioners in the area can confidently source medications that are prepared under strict sterile and non-sterile compounding guidelines, with comprehensive quality control testing, including sterility and endotoxin testing for injectables.
For healthcare providers at 2160 W State Road 434, Longwood, FL 32779, engaging with 503B Compounding Pharmacy means partnering with a facility committed to regulatory excellence and patient safety. The medications produced are essential for a wide range of treatments, including hormone replacement therapy, ophthalmics, dermatological preparations, and other customized formulations required for specific clinical applications. The team at 503B Compounding Pharmacy works diligently to maintain the highest standards of pharmaceutical science to support the local medical community.
To learn more about the services and products available from this specific outsourcing facility, healthcare providers and their staff are encouraged to contact 503B Compounding Pharmacy directly. The team can provide detailed information on formulary, ordering processes, and compliance documentation. You can reach them via their website at https://503bcompoundingpharmacy.com/ or by phone at (407)993-1381 for professional inquiries.
Frequently Asked Questions
1. What does it mean that this facility is a 503B outsourcing facility?
It means 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and complies with strict federal current good manufacturing practices (cGMP). This ensures the medications are compounded in a highly controlled environment with rigorous quality testing for strength, purity, and sterility.
2. Can I walk into the facility at 2160 W State Road 434 to pick up a prescription?
No. This location operates as a wholesale outsourcing facility for healthcare practitioners. It does not dispense medications directly to individual patients. All orders must be placed by a licensed healthcare provider for office use.
3. What types of medications does this Longwood facility compound?
The 503B Compounding Pharmacy compounds a wide array of sterile and non-sterile medications, including but not limited to injectables, topical creams, ophthalmics, and other formulations that are not commercially available, all produced under cGMP standards at its location on W State Road 434.
4. How can a healthcare provider at this location place an order?
Healthcare providers can initiate the ordering process by contacting the facility directly. For ordering information and to establish an account, please call (407)993-1381 or visit the website at https://503bcompoundingpharmacy.com/.
5. Why should a practitioner source from this specific 503B facility?
Sourcing from this FDA-registered 503B outsourcing facility at 2160 W State Road 434 provides assurance of cGMP compliance, which includes extensive quality control testing. This offers a higher level of safety and reliability for medications used in clinical practice compared to those from pharmacies operating under different standards.