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 outsourcing facility adheres to the most rigorous federal standards for quality, safety, and production. The operations at this specific location are dedicated to the large-scale compounding of sterile and non-sterile medications that are distributed for office use by healthcare practitioners. The core mission of 503B Compounding Pharmacy is to provide practitioners with access to high-quality, compounded medications that are essential for patient care, all produced under a framework of stringent regulatory oversight.
The facility at 2160 W State Road 434 is designed and maintained to meet the exacting requirements of an FDA-registered outsourcing facility. This includes employing advanced environmental controls, state-of-the-art sterility testing, and validated processes to ensure every preparation meets its predefined specifications. The highly skilled team of pharmacists and technicians at this Longwood location are experts in their field, rigorously trained in aseptic techniques and current Good Manufacturing Practices (cGMP). This ensures that every batch of medication produced is consistent, potent, and free from contamination. For healthcare providers, partnering with 503B Compounding Pharmacy means they can confidently administer medications knowing they are sourced from a facility that prioritizes patient safety above all else.
503B Compounding Pharmacy provides healthcare professionals with a reliable source for medications that may be in short supply or not commercially available. The services rendered from the facility at 2160 W State Road 434 are exclusively for office use, supplying physicians, clinics, and other healthcare providers with the necessary medications to treat their patients. This model allows practitioners to avoid the challenges of in-office compounding, which can be resource-intensive and may not meet the same level of quality assurance. By outsourcing these needs to this FDA-registered facility, healthcare providers can enhance practice efficiency while ensuring the highest standard of care for their patients in Longwood.
Engaging with 503B Compounding Pharmacy is a streamlined process for medical practices. Healthcare providers can initiate orders and discuss specific patient needs by contacting the facility directly at (407)993-1381. The professional staff is available to provide information, support, and guidance. Comprehensive details about the facility's capabilities, regulatory status, and the process for establishing an account can be found on the official website at https://503bcompoundingpharmacy.com/. The team at 2160 W State Road 434 is committed to building strong, collaborative relationships with the local medical community, providing a vital service that supports superior patient outcomes.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
This designation 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. We comply with stringent federal current Good Manufacturing Practices (cGMP) for the large-scale production of compounded medications for office use by healthcare practitioners.
Who can receive medications from 503B Compounding Pharmacy?
Medications compounded at our facility on W State Road 434 are distributed for office use to licensed healthcare practitioners, such as physicians, surgeons, and clinics. We do not dispense medications directly to individual patients at this location.
How does a healthcare provider at a local practice place an order?
Healthcare providers serving patients in the area can place orders by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will assist with setting up an account and processing orders for compounded medications from our Longwood facility.
What types of medications does the Longwood facility compound?
As a 503B outsourcing facility, we compound a wide range of sterile and non-sterile medications that are typically used in clinical settings. This includes preparations that are on drug shortage lists or are not otherwise commercially available for healthcare providers at 2160 W State Road 434.
Why should a healthcare provider choose 503B Compounding Pharmacy?
Choosing our facility ensures that the medications you use in your practice are produced under the highest level of quality control and federal oversight. This provides an added layer of safety and reliability for your patients, backed by the standards of an FDA-registered outsourcing facility in Longwood.