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, adhering to the stringent regulations outlined in 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 large-scale compounding of sterile and non-sterile medications. This designation signifies a commitment to the highest standards of quality, safety, and consistency, providing healthcare providers and patients with medications that are not commercially available.
The core function of 503B Compounding Pharmacy is the production of compounded medications in bulk for office use by healthcare practitioners. Physicians, surgeons, veterinarians, and other medical professionals serving patients from our local community can access a reliable supply of essential medications. This includes sterile injectables, ophthalmics, and other preparations that are critical for various treatments and procedures. By operating under Section 503B, our pharmacy is subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations, ensuring every preparation meets exacting standards for purity, potency, and sterility.
For practitioners at 2160 W State Road 434, Longwood, FL 32779, this means access to a trusted source for medications that may be in short supply or discontinued by major manufacturers. Our facility provides an alternative during drug shortages, helping to ensure patient care continues without interruption. The medications produced are intended for administration within a healthcare setting, offering practitioners the assurance of quality and compliance that comes with FDA-registered sourcing.
Engaging with 503B Compounding Pharmacy is a streamlined process for local medical offices. Healthcare providers can place orders directly for office stock, facilitating efficient patient care. The team at our Longwood facility is dedicated to supporting the medical community with consistent, high-quality pharmaceutical compounding services. We encourage local practitioners to explore how our services can integrate into their practice to enhance patient treatment options.
To learn more about our available formulations or to discuss your specific needs, please contact 503B Compounding Pharmacy directly. Our team is ready to provide detailed information and support. You can reach us by phone at (407)993-1381 or visit our website for comprehensive details at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
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 and inspected by the U.S. Food and Drug Administration. We compound medications in large volumes under Section 503B of the FD&C Act and must comply with strict current Good Manufacturing Practice (cGMP) regulations, which are more rigorous than traditional pharmacy standards.
Who can order medications from 503B Compounding Pharmacy at this location?
Our services are designed for healthcare practitioners, including physicians, surgeons, and veterinarians, who require compounded medications for office use in treating their patients. Medications are supplied to practitioners for administration within their practice at 2160 W State Road 434, Longwood, FL 32779, not directly to individual patients.
What types of medications does 503B Compounding Pharmacy provide?
We specialize in compounding a range of sterile and non-sterile medications that are often on shortage or are not available from commercial manufacturers. This includes various injectables, ophthalmics, and other preparations essential for clinical and surgical procedures performed by local healthcare providers.
How do I place an order for my practice at this location?
Healthcare practitioners can place orders for compounded medications by contacting 503B Compounding Pharmacy directly. You can initiate an order or speak with a representative about your needs by calling (407)993-1381.
Where can I find more information about your available formulations?
For a comprehensive list of our current offerings and detailed information about our compounding capabilities, please visit our website at https://503bcompoundingpharmacy.com/.