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 at 2160 W State Road 434, Longwood, FL 32779. This designation under Section 503B of the Federal Food, Drug, and Cosmetic Act establishes a distinct category of compounding pharmacy. The 503B outsourcing facility provides medications for office use by healthcare practitioners and is subject to rigorous federal quality standards, including current Good Manufacturing Practices (cGMP). This operational framework at the Longwood location ensures that healthcare providers in the area have reliable access to high-quality, compounded medications for their patients without individual patient-specific prescriptions.
The core function of 503B Compounding Pharmacy is the large-scale compounding of medications. This process involves the combining, mixing, or altering of ingredients to create medications tailored to meet needs that are not adequately addressed by commercially available, FDA-approved drugs. The 503B outsourcing facility model at 2160 W State Road 434 allows for the anticipatory production of these medications, which are then available for healthcare practitioners to keep in stock for immediate patient need. This is a critical service for medical practices, hospitals, and clinics, enabling them to provide timely and effective treatment options.
Operating from its facility in Longwood, 503B Compounding Pharmacy adheres to the strictest protocols for sterility and potency. The environment at 2160 W State Road 434 is meticulously controlled, with compounding performed by highly trained personnel using state-of-the-art equipment. Every batch of medication produced is tested to verify its identity, strength, quality, and purity. This unwavering commitment to quality control and regulatory compliance is the foundation of the service provided by this 503B outsourcing facility, offering assurance to the medical community.
The services of 503B Compounding Pharmacy are integral to supporting local healthcare delivery. By providing office-use medications, the facility at 2160 W State Road 434 enables practitioners to treat patients with specialized needs efficiently. This includes providing access to medications that may be in shortage or discontinued by commercial manufacturers, thereby helping to prevent treatment delays. The role of this 503B outsourcing facility is to be a dependable partner to healthcare providers, ensuring a consistent supply of critical compounded medications from its Longwood location.
For healthcare practitioners seeking a trusted source for office-use compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 represents a resource built on compliance and quality. To learn more about the specific medications available or to inquire about services, you can contact the facility directly at (407)993-1381 or visit their website at https://503bcompoundingpharmacy.com/ for comprehensive information.
FAQ
1. What does it mean that 503B Compounding Pharmacy is an outsourcing facility?
It means this facility is registered with the FDA under Section 503B and is permitted to compound large volumes of medications for office use by healthcare practitioners. The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 operates under federal current Good Manufacturing Practices (cGMP) for heightened quality control.
2. Who can order medications from 503B Compounding Pharmacy?
Medications from this 503B outsourcing facility are intended for office use by healthcare practitioners with prescribing authority. Patients cannot order directly from the 503B Compounding Pharmacy; instead, their healthcare provider orders and administers or dispenses the medication from their practice.
3. What is the primary service offered at the Longwood location?
The primary service at 2160 W State Road 434, Longwood, FL 32779 is the non-patient-specific, large-scale compounding of medications. This 503B outsourcing facility produces batches of medications for healthcare practitioners to have on hand for immediate patient needs.
4. How does the 503B model ensure medication quality?
As a 503B outsourcing facility, this pharmacy is subject to strict federal standards, including rigorous testing for sterility, potency, and purity. The 503B Compounding Pharmacy follows cGMP guidelines to ensure every batch produced at its Longwood facility meets exacting quality specifications.
5. How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare practitioners can contact 503B Compounding Pharmacy directly at (407)993-1381 to discuss their needs and place an order. More information about the services of this 503B outsourcing facility is also available on their website at https://503bcompoundingpharmacy.com/.