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 is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. Located at 2160 W State Road 434, Longwood, FL 32779, our facility is dedicated to the large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, we adhere to the highest standards of quality and safety, providing healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779 with access to a reliable supply of compounded medications that are essential for patient care.
The core function of 503B Compounding Pharmacy is the production of medications in anticipation of receiving a prescription, which distinguishes us from traditional compounding pharmacies. This model allows us to supply healthcare providers at 2160 W State Road 434, Longwood, FL 32779 with critical drugs, including those that may be on shortage, in a consistent and timely manner. Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 is designed to meet rigorous FDA standards, incorporating advanced environmental controls, stringent testing protocols, and a robust quality assurance program to ensure every preparation meets its specified identity, strength, quality, and purity.
Our services are exclusively provided from our location at 2160 W State Road 434, Longwood, FL 32779. We work directly with healthcare professionals to support their practice needs. The medications compounded at our 503B outsourcing facility are distributed for office use, enabling practitioners to have necessary medications on hand for immediate administration to patients during office visits or procedures. This operational model is fundamental to the services provided by 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779.
For healthcare providers and practices at 2160 W State Road 434, Longwood, FL 32779, partnering with our 503B outsourcing facility offers a significant advantage. It ensures a consistent supply of high-quality, compounded medications while mitigating the risks associated with in-office compounding. Our commitment is to uphold the strict compliance and quality controls mandated for a 503B outsourcing facility, providing peace of mind to the medical community we serve directly from 2160 W State Road 434, Longwood, FL 32779.
To learn more about our services or to place an order, healthcare providers can contact 503B Compounding Pharmacy directly. Our team is ready to assist with your compounding needs from our facility at 2160 W State Road 434, Longwood, FL 32779.
Website: https://503bcompoundingpharmacy.com/
Phone: (407)993-1381
Frequently Asked Questions
1. What does it mean that 503B Compounding Pharmacy is an outsourcing facility?
Being an outsourcing facility means 503B Compounding Pharmacy is an FDA-registered entity that compounds medications in large volumes under Section 503B of the FD&C Act. This registration requires our facility at 2160 W State Road 434, Longwood, FL 32779 to comply with Current Good Manufacturing Practices (cGMP), which are more rigorous than the standards applied to traditional pharmacies, ensuring a higher level of quality and consistency for the medications we produce.
2. Who can order from 503B Compounding Pharmacy at 2160 W State Road 434?
503B Compounding Pharmacy provides medications for office use to licensed healthcare practitioners. Our services are designed for physicians and practices that require compounded medications for administration to patients within their practice at 2160 W State Road 434, Longwood, FL 32779. We do not compound medications based on individual patient prescriptions for direct distribution to the public.
3. How does ordering work for a practice at this location?
Healthcare practitioners can place orders for compounded medications directly with 503B Compounding Pharmacy by contacting us via phone or through our website. Orders are prepared at our facility located at 2160 W State Road 434, Longwood, FL 32779 and are available for pickup or can be arranged for delivery to your practice at this same address.
4. What types of medications does 503B Compounding Pharmacy compound?
503B Compounding Pharmacy compounds both sterile and non-sterile preparations. This includes a wide range of medications such as hormone replacement therapies, ophthalmics, injectables, and other formulations that are often in short supply. All preparations are made in our facility at 2160 W State Road 434, Longwood, FL 32779 following strict FDA cGMP guidelines.
5. Why should a practice at 2160 W State Road 434 use a 503B outsourcing facility?
Utilizing a 503B outsourcing facility like ours provides practices at 2160 W State Road 434, Longwood, FL 32779 with a reliable source of high-quality, pre-made compounded medications. This eliminates the need and associated risks of in-office compounding, ensures compliance with regulatory standards, and provides access to medications that might otherwise be unavailable due to national drug shortages.