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 under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation is central to the mission and operational standards upheld at the facility located at 2160 W State Road 434, Longwood, FL 32779. As a 503B outsourcing facility, this pharmacy adheres to rigorous federal standards for quality control, sterility assurance, and reporting, which distinguishes its services from those of a traditional 503A compounding pharmacy. The focus is on the large-scale compounding of medications for office use, which are then distributed to healthcare providers for patient administration within clinical settings.
The services provided by 503B Compounding Pharmacy are defined by its regulatory framework. The facility specializes in the non-patient-specific, bulk compounding of sterile injectable medications. This means healthcare professionals in the vicinity of 2160 W State Road 434, Longwood, FL 32779 can access a reliable supply of high-quality compounded medications for their practice needs. These medications are essential for a wide range of treatments, including but not limited to hormone replacement therapy, ophthalmologic treatments, and other injectable preparations that may be subject to national drug shortages. By operating under strict current good manufacturing practices (cGMP), 503B Compounding Pharmacy ensures a level of consistency, purity, and safety that is critical for patient care.
For healthcare providers seeking a trusted source for compounded medications, the location at 2160 W State Road 434, Longwood, FL 32779 serves as a pivotal resource. The pharmacy’s commitment to compliance with FDA regulations provides an added layer of assurance regarding the quality of its products. The team at 503B Compounding Pharmacy is dedicated to supporting the local medical community by providing essential medications that are compounded with precision and integrity. To learn more about the specific formulations available or to discuss your practice's needs, you are encouraged to contact the facility directly.
To connect with 503B Compounding Pharmacy, please use the following contact information. Website: https://503bcompoundingpharmacy.com/ | Phone: (407)993-1381. The team is available to assist healthcare providers with inquiries and orders.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means this facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and compounds medications in accordance with Section 503B of the FD&C Act. This requires compliance with stringent current good manufacturing practices (cGMP) for sterility, quality control, and adverse event reporting.
Who can order medications from 503B Compounding Pharmacy?
Medications compounded at 2160 W State Road 434, Longwood, FL 32779 are intended for office use and are distributed to healthcare providers, such as physicians, clinics, and hospitals. These are not patient-specific prescriptions for individual pickup.
What types of medications does 503B Compounding Pharmacy provide?
As an outsourcing facility, 503B Compounding Pharmacy focuses on the sterile compounding of injectable medications. This includes medications that are often on shortage or are needed in bulk quantities by healthcare providers for administration to patients at their practice locations.
How does the quality assurance at 503B Compounding Pharmacy differ from a traditional pharmacy?
The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 operates under federal cGMP standards, which are more rigorous than the USP standards applied to traditional 503A pharmacies. This includes extensive testing of components, in-process testing, and sterility testing of finished products.
How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers can contact 503B Compounding Pharmacy directly to discuss their needs and place an order. The contact details are Website: https://503bcompoundingpharmacy.com/ and Phone: (407)993-1381.