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 at 2160 W State Road 434, Longwood, FL 32779
503B Compounding Pharmacy operates as an FDA-registered outsourcing facility in strict compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility at 2160 W State Road 434, Longwood, FL 32779 is specifically designed and regulated to compound large quantities of sterile and non-sterile medications for office use by healthcare practitioners. This designation signifies our commitment to the highest standards of quality, safety, and regulatory oversight, providing healthcare providers in our community with a trusted source for compounded medications.
The 503B outsourcing facility model is distinct from traditional compounding. Our operation at 2160 W State Road 434, Longwood, FL 32779 adheres to rigorous Current Good Manufacturing Practice (cGMP) regulations. This ensures that every batch of medication we produce undergoes stringent quality control testing for potency, sterility, and purity before it is released for distribution. For medical professionals, this means receiving medications that are consistent, reliable, and produced under a level of federal oversight that provides an additional layer of patient safety.
Our primary service at 2160 W State Road 434, Longwood, FL 32779 is the provision of office-use medications for physicians, surgeons, veterinarians, and other healthcare providers. We compound a significant volume of injectable medications, including sterile solutions, suspensions, and lyophilized powders. These are essential for a wide range of in-office procedures, from pain management and hormone therapy to ophthalmology and dermatology. By supplying these ready-to-use medications directly to practices, we enable healthcare providers to enhance patient care with greater efficiency and convenience.
In addition to sterile preparations, our 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779 also compounds non-sterile medications for office use. This includes topical creams, gels, ointments, and oral suspensions that are commonly used in various clinical settings. Our capacity for batch compounding allows us to support healthcare practices with their specific formulary needs, ensuring they have the necessary medications on hand to treat their patients effectively without the delays associated with traditional pharmacy dispensing.
The team at 503B Compounding Pharmacy is comprised of highly skilled pharmacists and technicians who are experts in the science of compounding. Operating from our location at 2160 W State Road 434, Longwood, FL 32779, we work closely with the local medical community to understand their needs and provide solutions. We are dedicated to being a reliable partner for healthcare providers, offering a critical service that supports the delivery of high-quality medical care. For more information or to discuss your practice's needs, please contact us via our website at or by phone at (407)993-1381.
Frequently Asked Questions for 503B Compounding Pharmacy
1. What does it mean that this is a 503B outsourcing facility?
Being a 503B outsourcing facility means our pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and operates under Section 503B of the FD&C Act. We adhere to strict cGMP standards, which include rigorous testing of our compounded medications for sterility, potency, and purity before they are distributed for office use.
2. Who can receive medications from your 503B facility?
Our 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 supplies compounded medications exclusively to healthcare practitioners for office use. These medications are administered to patients within the practitioner's facility and are not dispensed directly to the public from this location.
3. What types of medications do you compound at this location?
At our facility on 2160 W State Road 434, Longwood, FL 32779, we compound both sterile and non-sterile medications in larger batches. This includes injectables for procedures, hormone therapies, pain management solutions, topical creams, and other preparations as needed by the healthcare practices we serve.
4. How does using a 503B pharmacy benefit my practice?
Utilizing our 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 provides your practice with FDA-registered, cGMP-compliant medications. This ensures a consistent, high-quality, and reliable supply of drugs for office procedures, enhancing patient safety and streamlining your clinical operations.
5. How can I place an order for my practice?
Healthcare practitioners can place orders for compounded medications by contacting our facility directly. You can reach the team at 2160 W State Road 434, Longwood, FL 32779 by phone at (407)993-1381. Our staff will assist you with setting up an account and processing your order.