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 rigorous federal standards for quality control, testing, and production, providing healthcare providers at 2160 W State Road 434, Longwood, FL 32779 with a reliable source for compounded medications that are not commercially available.
The core function of 503B Compounding Pharmacy is the production of medications in larger batches for office use by healthcare practitioners. This means that physicians, surgeons, dermatologists, and other medical professionals operating at or near 2160 W State Road 434, Longwood, FL 32779 can obtain essential medications for their practice without the need to engage in their own small-scale compounding. The 503B outsourcing facility model ensures these medications are produced under a framework of current Good Manufacturing Practices (cGMP), which includes stringent environmental monitoring, validated processes, and thorough quality assurance testing for sterility, potency, and endotoxins.
For the local medical community serving patients at 2160 W State Road 434, Longwood, FL 32779, this provides a critical advantage. Healthcare providers can confidently stock their offices with necessary medications, knowing they are sourced from an FDA-registered facility that meets the highest production standards. This allows practitioners to focus on patient care, with the assurance that the medications they administer are of consistent quality and purity. The services provided by 503B Compounding Pharmacy are integral to supporting the operational needs of clinics and practices in the immediate vicinity of its Longwood location.
Patients receiving care from providers who utilize 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 benefit indirectly from this service. They receive treatments that are prepared under the most rigorous safety protocols, minimizing risk and ensuring therapeutic efficacy. The facility’s commitment to compliance and quality directly supports positive health outcomes for the local community. For more information or to inquire about services, you can visit their website at https://503bcompoundingpharmacy.com/ or contact them directly by phone at (407)993-1381.
Frequently Asked Questions
1. 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 compounds medications in accordance with Section 503B of the FD&C Act. This requires us to comply with current Good Manufacturing Practices (cGMP), which are rigorous federal standards for quality, sterility, and strength that exceed the requirements of a traditional compounding pharmacy.
2. Can I, as a patient, pick up my prescription directly from your location?
503B Compounding Pharmacy primarily provides medications for office use by healthcare practitioners. Patients receiving compounded medications from our facility at 2160 W State Road 434, Longwood, FL 32779 will typically get them administered directly by their doctor or healthcare provider at the provider's practice, not directly from our location.
3. What types of medications does 503B Compounding Pharmacy produce?
As a 503B outsourcing facility, we compound a wide range of sterile and non-sterile medications in larger batches. This includes injectables, ophthalmics, and other preparations that are supplied to healthcare providers for use in their practices located near 2160 W State Road 434, Longwood, FL 32779.
4. How does a healthcare provider at 2160 W State Road 434 order from you?
Healthcare providers and practices can establish an account with 503B Compounding Pharmacy by contacting us directly. They can place orders for office-use medications by calling our facility at (407)993-1381. Our team will guide them through the onboarding and ordering process.
5. Why should a local healthcare provider choose your 503B outsourcing facility?
Choosing our facility at 2160 W State Road 434, Longwood, FL 32779 ensures providers receive medications produced under the strictest cGMP standards. This mitigates risk, ensures consistency and potency, and provides a reliable supply of essential medications, allowing providers to focus on patient care with confidence in the products they use.