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 of providing high-quality compounded medications for office use by healthcare practitioners. Located at 2160 W State Road 434, Longwood, FL 32779, the facility adheres to the most rigorous standards of safety and quality control, offering a critical service to the local medical community.
The operations at 2160 W State Road 434 are distinct from a traditional retail pharmacy. As a 503B outsourcing facility, the primary function is the large-scale compounding of sterile and non-sterile medications that are not available commercially. These medications are prepared for healthcare providers in the area to administer to patients within their practice settings, such as clinics, hospitals, and surgical centers. The team at 503B Compounding Pharmacy works directly with prescribers to support their patient care plans with reliable, bulk-compounded pharmaceuticals.
The facility at 2160 W State Road 434 is designed and maintained to meet the exacting requirements for an FDA-registered operation. This includes stringent environmental controls, validated processes, and robust quality assurance testing. Every batch of medication is produced under a protocol that ensures potency, purity, and sterility. For healthcare professionals in Longwood, this provides a trusted local source for essential medications that are vital for a wide range of treatments and procedures.
By focusing on the specific needs of the medical community at 2160 W State Road 434, 503B Compounding Pharmacy delivers a specialized service that enhances local patient care. The facility provides a consistent and compliant supply of medications, allowing area practitioners to focus on treatment without concerns about drug availability or quality. The dedicated professionals at this location are committed to upholding the standards expected of a 503B outsourcing facility.
To learn more about the services provided or to speak with a representative, contact 503B Compounding Pharmacy directly. The team is available to assist healthcare providers with their specific medication needs. Website: https://503bcompoundingpharmacy.com/ | Phone: (407)993-1381
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means the 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 registration signifies compliance with Current Good Manufacturing Practices (cGMP) for the large-scale compounding of medications intended for office use by healthcare practitioners.
Who can order medications from 503B Compounding Pharmacy at 2160 W State Road 434?
Medications compounded at this location are prepared for office use and are distributed to licensed healthcare practitioners. Orders are placed by physicians, clinics, hospitals, and other healthcare entities for administration to patients within their practice at 2160 W State Road 434.
Can individual patients pick up prescriptions directly from the 2160 W State Road 434 facility?
No. As a 503B outsourcing facility, the primary operation is bulk compounding for healthcare providers, not direct dispensing to individual patients. Patients should receive their medications directly from their prescribing healthcare provider at the location of their treatment.
What types of medications are compounded at the Longwood location?
The 503B Compounding Pharmacy at 2160 W State Road 434 compounds a range of sterile and non-sterile medications in larger batches. This includes, but is not limited to, sterile injectables, hormone preparations, and other formulations that are not readily available from commercial pharmaceutical manufacturers for the local medical community.
How does a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers can initiate an order or inquire about available medications by contacting the facility directly. The team will provide information on ordering procedures, product availability, and delivery options specific to the 2160 W State Road 434 location. Website: https://503bcompoundingpharmacy.com/ | Phone: (407)993-1381