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. This designation is a critical distinction that sets this facility apart from traditional compounding pharmacies. Located at 2160 W State Road 434, Longwood, FL 32779, this 503B Compounding Pharmacy adheres to the most rigorous federal standards for quality control, sterility assurance, and production scale. The operations at this specific location are dedicated to the large-scale compounding of medications that are distributed for office use by healthcare practitioners, ensuring a reliable and compliant source of essential drugs.
The core function of the 503B Compounding Pharmacy at 2160 W State Road 434 is the production of sterile injectable medications. This includes a significant focus on hormone replacement therapy (HRT), pain management solutions, and other complex sterile preparations that are in constant demand within medical practices. By operating under Section 503B regulations, the pharmacy is exempt from the patient-specific prescription requirement, allowing it to compound medications in larger batches. This model provides physicians and clinics with immediate access to vital medications, streamlining their inventory management and enhancing patient care protocols directly from their practice locations.
Quality and safety are the foundational principles guiding every process at this Longwood facility. The 503B Compounding Pharmacy employs state-of-the-art environmental monitoring, rigorous testing protocols, and advanced analytical equipment to ensure every preparation meets or exceeds USP <797> standards for sterile compounding. The highly trained staff, including pharmacists and technicians, work within validated cleanrooms to mitigate any risk of contamination. This unwavering commitment to compliance and excellence ensures that healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can administer medications with the highest degree of confidence in their safety and efficacy.
Healthcare professionals seeking a trusted outsourcing partner will find that the 503B Compounding Pharmacy provides an essential service. The facility’s operational model is designed to alleviate the compounding burden from individual practices, allowing medical staff to focus on direct patient care. By supplying office-use medications, the 503B Compounding Pharmacy supports the local medical community with a consistent, high-quality, and reliable source of compounded sterile preparations, all produced under the strict oversight mandated for an FDA-registered 503B outsourcing facility.
For more detailed information on available formulations or to discuss your practice's specific needs, you can contact 503B Compounding Pharmacy directly. The team is available to provide comprehensive support and information to healthcare providers.
Website: https://503bcompoundingpharmacy.com/ Phone: (407)993-1381 Address: 2160 W State Road 434, Longwood, FL 32779
Frequently Asked Questions
What does it mean that this is a 503B Compounding Pharmacy at 2160 W State Road 434? It means this specific facility is an FDA-registered outsourcing facility that compounds large batches of sterile, injectable medications for office use by healthcare practitioners, operating under stricter federal regulations than a traditional pharmacy.
Who can order from the 503B Compounding Pharmacy in Longwood? This 503B Compounding Pharmacy provides medications for office use to licensed healthcare practitioners and medical facilities. Medications are not dispensed directly to individual patients from this location.
What types of medications does this 503B Compounding Pharmacy typically compound? The 503B Compounding Pharmacy at 2160 W State Road 434 specializes in sterile preparations, including hormone replacement therapy (HRT) and pain management formulations, produced for administration within a clinical setting.
How does the 503B Compounding Pharmacy ensure medication safety? This facility follows rigorous USP <797> standards and FDA regulations, which include extensive environmental monitoring, sterility testing, and endotoxin testing on all batches of compounded sterile preparations produced at this location.
How can a healthcare provider at 2160 W State Road 434 place an order? Healthcare providers can contact the 503B Compounding Pharmacy directly by calling (407)993-1381 or by visiting the website at https://503bcompoundingpharmacy.com/ to initiate the order process and establish an account.