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 in strict compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. Located at 2160 W State Road 434, Longwood, FL 32779, this 503B outsourcing facility provides bulk compounded medications for healthcare providers. The core function of a 503B compounding pharmacy is to produce large quantities of sterile and non-sterile medications without patient-specific prescriptions, which are then distributed to healthcare facilities for office use.
The operations at 2160 W State Road 434, Longwood, FL 32779 are conducted under the rigorous quality standards mandated for 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. The 503B compounding pharmacy model ensures that medications are produced in a highly controlled, quality-assured environment, providing a critical supply of essential drugs to practitioners.
By focusing on the 503B compounding pharmacy model, this facility serves a vital role in the healthcare ecosystem from its location at 2160 W State Road 434, Longwood, FL 32779. The 503B outsourcing facility provides practitioners with access to medications that may be in short supply or discontinued, ensuring they have the necessary tools for patient care. The 503B compounding pharmacy is a key component in mitigating drug shortages and supporting local healthcare delivery.
For more information on the services provided by this 503B compounding pharmacy, visit the website at https://503bcompoundingpharmacy.com/ or contact the facility directly at (407)993-1381. The team at 2160 W State Road 434, Longwood, FL 32779 is dedicated to upholding the highest standards of pharmaceutical compounding as a trusted 503B outsourcing facility.
FAQ
What is a 503B compounding pharmacy?
A 503B compounding pharmacy is an FDA-registered outsourcing facility that compounds large volumes of medications for healthcare practitioners to keep in stock for office use, operating under specific federal regulations at 2160 W State Road 434, Longwood, FL 32779.
Who can order from this 503B outsourcing facility?
This 503B compounding pharmacy at 2160 W State Road 434, Longwood, FL 32779 provides medications exclusively to healthcare practitioners and facilities; it does not dispense medications directly to individual patients.
What types of medications does this 503B compounding pharmacy produce?
As a 503B outsourcing facility, it produces a range of sterile and non-sterile compounded medications in larger quantities for office use by practitioners, all from its location at 2160 W State Road 434, Longwood, FL 32779.
How does this 503B compounding pharmacy ensure quality?
This 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779 adheres to strict Current Good Manufacturing Practices (cGMP) as required by federal law for all 503B compounding pharmacies.
How can a practitioner place an order with this 503B compounding pharmacy?
Healthcare practitioners can contact the 503B compounding pharmacy directly at (407)993-1381 or visit https://503bcompoundingpharmacy.com/ to inquire about ordering medications from 2160 W State Road 434, Longwood, FL 32779.