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.
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 signifies a commitment to the highest standards of quality, safety, and compliance in pharmaceutical compounding. Unlike a traditional 503A pharmacy, this 503B outsourcing facility prepares medications in larger batches for office use by healthcare practitioners, without patient-specific prescriptions, and is subject to rigorous FDA oversight, current Good Manufacturing Practices (cGMP), and stringent testing protocols.
The core function of 503B Compounding Pharmacy is to provide healthcare professionals with access to a reliable supply of high-quality compounded sterile preparations. The medications produced at the 2160 W State Road 434 facility are essential for various clinical settings, including hospitals, surgical centers, ophthalmology clinics, dermatology practices, and veterinary offices. By outsourcing their non-patient-specific compounding needs to this 503B outsourcing facility, practitioners can be assured they are utilizing products that meet exacting federal standards for sterility, potency, and purity, thereby enhancing patient safety and streamlining their own operational efficiency.
Operating from its location at 2160 W State Road 434, Longwood, FL 32779, this 503B Compounding Pharmacy utilizes state-of-the-art technology and cleanroom environments to compound a range of preparations. The facility's processes are designed to mitigate the risk of contamination and ensure consistency in every batch. Healthcare providers who source their medications from this 503B outsourcing facility can confidently integrate these preparations into their treatment protocols, knowing they are produced under the strict regulatory framework that governs all FDA-registered 503B outsourcing facilities.
The team at 503B Compounding Pharmacy comprises skilled pharmacists, technicians, and quality assurance professionals dedicated to upholding the principles of cGMP. Every batch produced is meticulously documented and tested to verify its integrity before it is made available for distribution. For healthcare practitioners seeking a dependable source for office-use compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 represents a partnership grounded in quality, reliability, and regulatory compliance.
To learn more about the services provided by this 503B outsourcing facility or to inquire about becoming a client, healthcare providers are encouraged to make direct contact. The facility can be reached via its website at or by telephone at (407)993-1381. All operations and distributions are conducted from the FDA-registered location at 2160 W State Road 434, Longwood, FL 32779.
Frequently Asked Questions
1. What does it mean that this is a 503B Compounding Pharmacy?
It means this facility at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered outsourcing facility operating under Section 503B. This designation subjects it to federal oversight, including compliance with current Good Manufacturing Practices (cGMP), for the production of compounded drugs for office use by healthcare practitioners.
2. Can I as an individual patient get a prescription filled at this location?
No. 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 prepares medications in batches for office use by healthcare providers. Individual patients with prescriptions should contact a traditional 503A compounding pharmacy for their patient-specific medication needs.
3. What types of medications does this 503B outsourcing facility compound?
This 503B outsourcing facility compounds sterile preparations, which may include injectables, infusions, ophthalmologic drops, and other sterile products. These are supplied in bulk to healthcare practices and institutions for use within their clinical operations at 2160 W State Road 434, Longwood, FL 32779.
4. How does a healthcare practice order from this 503B Compounding Pharmacy?
Healthcare practices and providers can establish an account by contacting 503B Compounding Pharmacy directly. Orders are placed by authorized medical personnel for office-use stock and are shipped from the facility located at 2160 W State Road 434, Longwood, FL 32779. Inquiries can be made at or (407)993-1381.
5. Why should a healthcare provider choose a 503B outsourcing facility?
Choosing an FDA-registered 503B outsourcing facility like this one ensures that the compounded medications meet federally mandated quality standards for sterility, potency, and purity. This provides an added layer of safety and compliance for healthcare providers utilizing these medications in their practice.