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 traditional compounding. We serve healthcare providers by producing medications that are patient-specific or in bulk for office use, ensuring that practitioners at 2160 W State Road 434, Longwood, FL 32779 have access to reliable and essential pharmaceutical preparations.
The core function of 503B Compounding Pharmacy is the preparation of medications that are not commercially available or are in shortage. Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 utilizes advanced technology and rigorous testing protocols to ensure every preparation meets stringent potency, sterility, and purity standards. This process is critical for patient populations with unique medical needs that cannot be met by mass-produced, commercially available drugs. By operating under the 503B framework, we provide an additional layer of safety and oversight, offering healthcare professionals a trusted source for compounded medications.
Our operations at 2160 W State Road 434, Longwood, FL 32779 are integral to the local healthcare ecosystem. We work directly with physicians, clinics, and hospitals, providing them with the necessary pharmaceutical tools to treat their patients effectively. The medications prepared at our facility are essential for a wide range of therapeutic areas, including but not limited to hormone replacement therapy, pain management, ophthalmology, and dermatology. The staff at 503B Compounding Pharmacy are highly trained professionals dedicated to upholding the integrity of the pharmaceutical compounding process from our location at 2160 W State Road 434, Longwood, FL 32779.
Quality control is the foundation of everything we do at 503B Compounding Pharmacy. Every batch of medication produced at our facility undergoes extensive testing in our in-house laboratory. This includes testing for sterility, endotoxins, potency, and stability. Our adherence to Current Good Manufacturing Practices (cGMP) ensures a level of quality and consistency that is paramount for patient safety. Healthcare providers who utilize our services from 2160 W State Road 434, Longwood, FL 32779 can be confident that the medications they administer are of the highest possible quality.
For more information about the services provided by 503B Compounding Pharmacy or to speak with a representative, please contact us directly. We are located at 2160 W State Road 434, Longwood, FL 32779. You can reach us by phone at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/ to learn more about our compliance and quality assurance measures.
Frequently Asked Questions for 503B Compounding Pharmacy
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 complies with stricter regulations under Section 503B of the FD&C Act, including adherence to Current Good Manufacturing Practices (cGMP) for heightened quality control and patient safety.
Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications exclusively to licensed healthcare providers and facilities. We do not dispense medications directly to individual patients from our location at 2160 W State Road 434, Longwood, FL 32779. Your healthcare provider must place an order on your behalf.
What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding sterile injectable and non-sterile medications, particularly those that are on drug shortage lists or are not commercially available from traditional pharmaceutical manufacturers.
How does the quality assurance process work at your facility?
Every batch of medication compounded at 2160 W State Road 434, Longwood, FL 32779 undergoes rigorous testing in our on-site laboratory. This includes testing for sterility, potency, and endotoxin levels to ensure the medication meets all specifications before it is released for distribution.
How can a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 place an order?
Healthcare providers can initiate the ordering process by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will provide information on our formulary, ordering procedures, and how to establish an account for your practice.