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 in strict compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility is located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies our commitment to the highest standards of quality, safety, and compliance in the preparation of compounded medications. As a 503B outsourcing facility, we produce large batches of compounded sterile and non-sterile preparations for healthcare providers without patient-specific prescriptions. These medications are then distributed to healthcare facilities for office use, ensuring practitioners have the necessary supplies to treat their patients effectively and without delay.
The operations at our Longwood location are distinct from traditional compounding pharmacies. Our 503B status means we are subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations. This involves extensive testing of components, in-process materials, and finished drug products, alongside stringent environmental monitoring and validation of all our processes. For medical professionals and clinics, this provides an unparalleled level of confidence in the medications they utilize. By sourcing from our 503B Compounding Pharmacy at 2160 W State Road 434, healthcare providers can be assured they are receiving medications produced in a facility that prioritizes patient safety above all else.
Our service is dedicated to supporting the local medical community. We provide healthcare practitioners with access to a reliable supply of high-quality compounded medications, which are essential for various treatments and procedures. The team at our Longwood facility is comprised of skilled pharmacists and technicians who utilize advanced technology and meticulous procedures to ensure every preparation meets exacting specifications. We understand the critical role these medications play in patient care, and our entire operation is designed to be a trusted partner to physicians, surgeons, and other healthcare providers.
Engaging with our 503B Compounding Pharmacy is a straightforward process for medical practices. Orders are placed directly with our facility for non-patient-specific, office-use medications. Our team is ready to assist with your needs and answer any questions regarding our available formulations and ordering procedures. We invite you to experience the difference that an FDA-registered outsourcing facility can make for your practice. For more detailed information about our services or to initiate an order, please contact us directly. Reach our facility at (407)993-1381 or visit our website to learn more: https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
1. What does it mean that this facility is a 503B outsourcing facility?
It means our pharmacy at 2160 W State Road 434 is registered with the FDA under Section 503B. We adhere to current Good Manufacturing Practices (cGMP) and produce compounded medications in batches for office use by healthcare practitioners without individual patient prescriptions.
2. Who can order medications from your Longwood location?
Our services are designed for healthcare providers and facilities. Orders are accepted from licensed medical professionals for office-use medications to be administered or dispensed within their practice located at 2160 W State Road 434, Longwood, FL 32779.
3. Can I as an individual patient pick up a prescription at your facility?
No. As a 503B outsourcing facility, we do not compound patient-specific medications based on an individual prescription. We supply medications in bulk to healthcare providers. Patients should contact their physician who orders from us for their care.
4. How do I place an order for my practice?
Healthcare providers can place orders by contacting our facility directly at (407)993-1381. Our team will guide you through the process, discuss your specific needs, and provide information on our available compounded preparations.
5. Why should a provider choose your 503B facility over other sources?
Choosing our FDA-registered outsourcing facility ensures you receive medications produced under the highest standards of pharmaceutical quality and safety, including rigorous testing and compliance with federal cGMP regulations, providing maximum safety for your patients.