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 at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the large-scale compounding of sterile and non-sterile medications. This designation signifies our commitment to the highest standards of quality, safety, and regulatory oversight, exceeding the requirements of a traditional compounding pharmacy. We serve healthcare providers and facilities by providing bulk quantities of compounded medications that are not commercially available, thereby fulfilling specific patient needs.
The core function of 503B Compounding Pharmacy is the production of medications for office use. This means healthcare practitioners at our local address can obtain essential medications for immediate administration to patients within their practice, without the need for patient-specific prescriptions in advance. Our operations at 2160 W State Road 434 are integral to supporting the local medical community by ensuring a reliable supply of critical drugs, including sterile injectables, ophthalmics, and other formulations that may be in short supply or discontinued by major manufacturers.
As an outsourcing facility, our processes are governed by Current Good Manufacturing Practices (cGMP). This involves rigorous testing of components, stringent environmental controls, and validated processes to ensure every batch of medication we compound meets precise sterility, potency, and purity specifications. The team at 503B Compounding Pharmacy comprises skilled pharmacists and technicians who utilize advanced technology within our state-of-the-art cleanrooms to achieve these uncompromising quality standards for every preparation that leaves our facility.
Our location at 2160 W State Road 434, Longwood, FL 32779 is a hub for providing healthcare professionals with access to a consistent supply of high-quality compounded medications. We focus on building strong, collaborative relationships with local providers, understanding their specific needs, and acting as a dependable partner in patient care. The services provided by 503B Compounding Pharmacy are designed to be seamlessly integrated into the practices of our local healthcare partners.
For detailed information on our available formulations and to understand how our services can support your practice, we encourage you to contact us directly. You can reach our team at (407)993-1381 or visit our website to learn more: https://503bcompoundingpharmacy.com/. 503B Compounding Pharmacy is your trusted, local FDA-registered outsourcing facility dedicated to excellence in compounding.
Frequently Asked Questions
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It 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. This requires us to comply with more rigorous standards, including Current Good Manufacturing Practices (cGMP), for the large-scale compounding of medications intended for office use by healthcare providers.
2. Can I as an individual patient pick up a prescription directly from your location?
No. 503B Compounding Pharmacy provides medications primarily for office use by healthcare providers. While we compound medications, they are supplied in bulk to physicians, clinics, and hospitals for administration within their practice. Patients should work directly with their healthcare provider who sources medications from our facility.
3. What types of medications does 503B Compounding Pharmacy produce?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding sterile injectables, ophthalmics, and other non-sterile preparations in larger batch quantities. These are often medications that are on shortage or not available from commercial manufacturers, providing a critical supply for local healthcare providers.
4. How do I, as a healthcare provider, order from your facility?
Healthcare providers can establish an account with 503B Compounding Pharmacy by contacting our team directly. You can reach us at (407)993-1381 to discuss your practice's specific needs, place orders, and arrange for delivery or pickup from our location at 2160 W State Road 434, Longwood, FL 32779.
5. Why should a provider choose a 503B outsourcing facility over other compounders?
Choosing 503B Compounding Pharmacy ensures you are receiving medications from a facility subject to federal oversight and cGMP standards. This provides an added layer of safety, quality, and consistency for the medications you use in your practice, mitigating risk and ensuring the best possible patient outcomes.