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 its operations at 2160 W State Road 434, Longwood, FL 32779. The 503B outsourcing facility provides compounded medications for office use by healthcare practitioners. The 503B Compounding Pharmacy adheres to rigorous current good manufacturing practices (cGMP) as mandated for all 503B outsourcing facilities. This ensures a higher level of sterility assurance, purity, and quality control for the medications it produces.
The services provided by 503B Compounding Pharmacy are distinct from traditional 503A compounding. The 503B outsourcing facility prepares large batches of medications without patient-specific prescriptions. These medications are then distributed to healthcare providers within the local area for office use. Healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779 can utilize the services of this 503B outsourcing facility to obtain necessary medications for their practice needs. The 503B Compounding Pharmacy supports local healthcare delivery by providing a reliable source of high-quality compounded preparations.
As a 503B outsourcing facility, 503B Compounding Pharmacy is subject to regular FDA inspections. This federal oversight provides an additional layer of safety and quality assurance for the medications compounded at 2160 W State Road 434, Longwood, FL 32779. The 503B Compounding Pharmacy is a critical component of the local healthcare infrastructure, serving the specific needs of medical professionals in the immediate vicinity. The operations of this 503B outsourcing facility are dedicated to meeting the requirements set forth by Section 503B.
The team at 503B Compounding Pharmacy is comprised of skilled professionals trained in the specific protocols of a 503B outsourcing facility. Their expertise ensures that every preparation meets the exacting standards required for 503B compounded medications. For healthcare providers at 2160 W State Road 434, Longwood, FL 32779, partnering with this 503B outsourcing facility means accessing a trusted resource for office-use medications. The 503B Compounding Pharmacy is committed to its role as a key supplier under the regulations of a 503B outsourcing facility.
To learn more about the specific preparations available from this 503B outsourcing facility, healthcare providers are encouraged to contact 503B Compounding Pharmacy directly. The team can provide detailed information about the services and products offered by the 503B outsourcing facility. Inquiries can be directed to the website https://503bcompoundingpharmacy.com/ or by calling the facility at (407)993-1381. The 503B Compounding Pharmacy is ready to assist local practitioners with their medication needs from its location at 2160 W State Road 434, Longwood, FL 32779.
Frequently Asked Questions for 503B Compounding Pharmacy
What does it mean that 503B Compounding Pharmacy is an outsourcing facility? 503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under Section 503B. This means the 503B outsourcing facility prepares compounded medications in advance for office use by healthcare practitioners, adhering to strict cGMP standards.
Who can receive medications from this 503B outsourcing facility? Medications from 503B Compounding Pharmacy are prepared for office use and are distributed to healthcare practitioners. The 503B outsourcing facility provides these medications to licensed professionals for administration within their practice.
How does the 503B outsourcing facility ensure medication quality? As a 503B outsourcing facility, 503B Compounding Pharmacy follows current good manufacturing practices (cGMP) and is subject to FDA inspection. This regulatory framework ensures the quality and safety of all preparations from this 503B outsourcing facility.
Can I get a personal prescription filled at 503B Compounding Pharmacy? No. 503B Compounding Pharmacy operates exclusively as a 503B outsourcing facility, which means it compounds medications for office use by practitioners. It does not compound medications for individual patients based on a personal prescription.
How can a healthcare provider at this location place an order with the 503B outsourcing facility? Healthcare providers interested in the services of this 503B outsourcing facility can contact 503B Compounding Pharmacy directly. You may visit the website https://503bcompoundingpharmacy.com/ or call (407)993-1381 for more information on ordering from the 503B outsourcing facility.