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, this facility is dedicated to the large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, it adheres to more rigorous federal standards than a traditional compounding pharmacy, providing healthcare providers and patients with medications that meet specific quality and safety protocols. The core mission of 503B Compounding Pharmacy is to supply high-quality, compounded pharmaceutical products to healthcare practitioners for office use and to patients with prescriptions, directly from its facility in Longwood.
The services provided by 503B Compounding Pharmacy at its 2160 W State Road 434 location are defined by its regulatory designation. This includes the compounding of medications that are often in short supply or unavailable from conventional manufacturers. The pharmacy's operations are strictly confined to its registered outsourcing facility, ensuring all production is controlled and monitored under current Good Manufacturing Practices (cGMP). Patients and prescribers who utilize the services of 503B Compounding Pharmacy can be assured that the medications are prepared in a state-of-the-art environment with a focus on sterility, potency, and purity. The team at the Longwood facility works directly with healthcare providers to support patient care with reliable access to essential medications.
For healthcare professionals and patients at 2160 W State Road 434, Longwood, FL 32779, engaging with 503B Compounding Pharmacy means accessing a critical component of the pharmaceutical supply chain. The facility does not provide over-the-counter retail services but focuses on the production of compounded preparations for office-administered medications and individual patient prescriptions. This specific focus allows 503B Compounding Pharmacy to excel in its niche, providing a vital service to the local medical community from its established location. To learn more about its capabilities or to inquire about specific compounded medications, contact 503B Compounding Pharmacy directly via their website at https://503bcompoundingpharmacy.com/ or by phone at (407)993-1381.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an outsourcing facility?
It means this facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA under Section 503B and complies with stricter federal standards, including current Good Manufacturing Practices (cGMP), for the large-scale compounding of medications intended for office use or distribution to healthcare providers.
Can I walk into the 2160 W State Road 434 location to pick up a prescription?
503B Compounding Pharmacy operates as an outsourcing facility, not a retail pharmacy. Medications are typically dispensed pursuant to a prescription from a healthcare provider. You should contact the facility directly at (407)993-1381 to confirm specific pickup or delivery arrangements for your compounded medication.
What types of medications does 503B Compounding Pharmacy prepare?
Operating from its facility in Longwood, 503B Compounding Pharmacy compounds a range of sterile and non-sterile medications that are often on drug shortage lists or are not commercially available, providing them for office use by healthcare practitioners and for individual patient needs.
How do I know the medications from this location are safe?
As an FDA-registered 503B outsourcing facility at 2160 W State Road 434, the pharmacy is subject to federal oversight and must adhere to rigorous cGMP standards, which include extensive testing and quality control procedures to ensure medication safety, sterility, and potency.
How can a healthcare provider at 2160 W State Road 434 order medications for office use?
Healthcare providers can contact 503B Compounding Pharmacy directly through their website at https://503bcompoundingpharmacy.com/ or by calling (407)993-1381 to discuss their specific needs and the process for ordering compounded medications for use in their practice.