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 unwavering commitment to the highest standards of quality, safety, and consistency, exceeding the requirements of a traditional compounding pharmacy. We serve healthcare providers and patients at our Longwood location by providing access to essential medications that are often unavailable or in short supply from conventional manufacturers.
The core function of 503B Compounding Pharmacy is the production of medications in bulk for office use by healthcare practitioners. Physicians, surgeons, dermatologists, and other medical professionals practicing at or near 2160 W State Road 434, Longwood, FL 32779 can rely on our outsourcing facility for a consistent supply of high-quality, ready-to-administer medications. This allows these providers to enhance patient care by having the necessary drugs on hand for immediate use during procedures, treatments, and office visits, ensuring efficiency and convenience for both the practitioner and their patients.
As a 503B outsourcing facility, our operations are subject to rigorous FDA oversight, which includes adherence to Current Good Manufacturing Practices (cGMP). This ensures every preparation that leaves our location at 2160 W State Road 434, Longwood, FL 32779 meets stringent standards for potency, purity, and sterility. Our processes involve extensive testing, environmental monitoring, and validated procedures to guarantee the integrity of every compounded medication. This level of quality control provides healthcare providers and their patients with the utmost confidence in the medications they receive from our pharmacy.
503B Compounding Pharmacy provides a critical service by compounding medications that are currently on the FDA’s drug shortage list. When commercial manufacturers are unable to supply essential drugs, our facility at 2160 W State Road 434, Longwood, FL 32779 can step in to help mitigate the impact of these shortages for the local medical community. By compounding these vital medications, we support continuity of care for patients in Longwood, ensuring that treatments are not delayed or interrupted due to supply chain issues beyond a provider's control.
Healthcare providers looking for a trusted partner in medication supply can connect with 503B Compounding Pharmacy directly. We encourage local practitioners to visit our website at https://503bcompoundingpharmacy.com/ or call us at (407)993-1381 to learn more about our current product offerings, discuss specific needs, or inquire about becoming a client. Our team is dedicated to supporting the medical community at our location on State Road 434 with reliable service and uncompromising quality in every preparation.
FAQ
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 and inspected by the FDA. We operate under Section 503B of the FD&C Act and must comply with stricter Current Good Manufacturing Practices (cGMP), which ensures a higher level of quality control, testing, and consistency compared to traditional compounding pharmacies.
Can I, as a patient, order medications directly from 503B Compounding Pharmacy?
No. As a 503B outsourcing facility, we compound medications in large volumes for "office use" by healthcare providers. Patients must receive their medications through their physician, surgeon, or other authorized healthcare professional who has sourced the medication from our location at 2160 W State Road 434, Longwood, FL 32779 for use in their practice.
What types of medications does 503B Compounding Pharmacy at this location provide?
Our facility compounds a wide range of sterile and non-sterile medications, including those used for office-based procedures, pain management, dermatology, hormone therapy, and ophthalmic treatments. A significant focus is also on producing medications that are currently on the FDA's drug shortage list to ensure local providers have consistent access.
How can a healthcare provider at this location order from 503B Compounding Pharmacy?
Healthcare providers practicing at or near 2160 W State Road 434, Longwood, FL 32779 can place orders by contacting our facility directly. We encourage providers to call us at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/ to establish an account, view our available products, and place orders for their practice.
Why should a local provider choose 503B Compounding Pharmacy over other suppliers?
Choosing our facility ensures you are receiving medications produced under the highest federal standards of quality and safety. Our FDA oversight and cGMP compliance provide an extra layer of assurance regarding sterility, potency, and purity. This commitment to quality, combined with our focus on mitigating drug shortages, makes us a reliable partner for healthcare providers in Longwood.