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 503B Compounding Pharmacy provides medications to healthcare practitioners for office use and for dispensing to patients under their care. The 503B Compounding Pharmacy model is distinct, focusing on producing larger batches of compounded sterile preparations (CSPs) and non-sterile preparations without patient-specific prescriptions, serving the needs of hospitals, clinics, and healthcare providers.
The operations at 2160 W State Road 434, Longwood, FL 32779 are conducted under the rigorous standards required of a 503B outsourcing facility. This includes adherence to Current Good Manufacturing Practices (cGMP), which are more stringent than the standards applied to traditional 503A compounding pharmacies. For healthcare providers at 2160 W State Road 434, Longwood, FL 32779, this means access to medications that have been produced in an environment of heightened quality control, sterility assurance, and regulatory oversight. The 503B Compounding Pharmacy is a critical partner for ensuring medication supply for office-based procedures and immediate patient needs.
Services provided by this 503B Compounding Pharmacy are tailored for the medical community. The facility at 2160 W State Road 434, Longwood, FL 32779 specializes in the compounding of medications that are often in short supply or are needed in specific formulations not readily available from large-scale manufacturers. By operating as a 503B Compounding Pharmacy, the facility can proactively compound these essential drugs, helping to mitigate drug shortages and provide healthcare practitioners with reliable access to necessary medications for their practice at 2160 W State Road 434, Longwood, FL 32779.
The commitment of this 503B Compounding Pharmacy is to uphold the highest levels of safety and quality. Every batch produced at the Longwood facility undergoes rigorous testing and quality assurance processes. For healthcare professionals relying on the 503B Compounding Pharmacy, this translates to confidence in the medications they administer and dispense. The team at 2160 W State Road 434, Longwood, FL 32779 is dedicated to supporting the local healthcare ecosystem through reliable service and consistent product quality, embodying the standards expected of an FDA-registered 503B outsourcing facility.
To learn more about the services available from this 503B Compounding Pharmacy or to inquire about becoming a client, healthcare providers can contact the facility directly. The 503B Compounding Pharmacy is available to discuss specific medication needs and how their services can support medical practices at 2160 W State Road 434, Longwood, FL 32779.
Contact 503B Compounding Pharmacy:
Website: https://503bcompoundingpharmacy.com/
Phone: (407)993-1381
Address: 2160 W State Road 434, Longwood, FL 32779
Frequently Asked Questions for 503B Compounding Pharmacy
What does it mean that this is a 503B Compounding Pharmacy?
Being a 503B Compounding Pharmacy means this facility at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered outsourcing facility. It compounds medications in larger batches for healthcare practitioners to have on hand for office use or for dispensing to their patients, operating under stricter Current Good Manufacturing Practice (cGMP) regulations compared to traditional pharmacies.
Who can purchase medications from the 503B Compounding Pharmacy at 2160 W State Road 434?
The 503B Compounding Pharmacy provides medications exclusively to healthcare practitioners and facilities, such as doctors, surgeons, clinics, and hospitals. Medications are not dispensed directly to individual patients without a prescription from their provider. The services are focused on supporting the medical community at 2160 W State Road 434, Longwood, FL 32779.
What types of medications does this 503B Compounding Pharmacy produce?
This 503B Compounding Pharmacy specializes in producing compounded sterile preparations (CSPs), which are injectable medications, as well as certain non-sterile preparations. These are often drugs that are on shortage or require specific formulations not commercially available, providing a vital resource for practitioners at 2160 W State Road 434, Longwood, FL 32779.
How does the 503B Compounding Pharmacy ensure medication safety?
Safety is paramount at this 503B Compounding Pharmacy. The facility at 2160 W State Road 434, Longwood, FL 32779 adheres to cGMP standards, which involve rigorous environmental monitoring, sterility testing, and quality control checks on every batch of medication produced. This ensures the highest level of safety and quality for healthcare providers.
How can a healthcare provider at 2160 W State Road 434 place an order with the 503B Compounding Pharmacy?
Healthcare providers interested in the services of the 503B Compounding Pharmacy can initiate contact through the official website at https://503bcompoundingpharmacy.com/ or by calling the facility directly at (407)993-1381. The team will provide information on setting up an account and the ordering process tailored for practitioners at this location.