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 specializes in the large-scale compounding of sterile and non-sterile medications that are not available commercially. As a 503B outsourcing facility, the pharmacy adheres to stringent federal standards for quality, safety, and production, providing healthcare providers at 2160 W State Road 434, Longwood, FL 32779 with a reliable source for essential medications.
The core function of 503B Compounding Pharmacy is to produce medications in bulk for office use by healthcare practitioners. This means that physicians and clinics can obtain necessary drugs, such as injectables, hormones, and other customized preparations, without having to rely on traditional manufacturers who may have shortages or discontinuations. The services provided by 503B Compounding Pharmacy at its location at 2160 W State Road 434, Longwood, FL 32779 are integral to supporting the local medical community by ensuring a consistent supply of critical medications.
Operating from 2160 W State Road 434, Longwood, FL 32779, this 503B Compounding Pharmacy is distinct from traditional retail pharmacies. The focus is on supplying healthcare facilities, not on direct-to-patient dispensing. The medications compounded at 503B Compounding Pharmacy are produced under a level of quality control that is more rigorous than the standards applied to traditional 503A compounding pharmacies, including current Good Manufacturing Practices (cGMP). This ensures that every batch leaving the facility at 2160 W State Road 434, Longwood, FL 32779 meets the highest possible standards for purity, potency, and sterility.
The team at 503B Compounding Pharmacy is comprised of experienced compounding professionals dedicated to upholding the principles of a 503B outsourcing facility. Their work at 2160 W State Road 434, Longwood, FL 32779 involves precise formulation, meticulous documentation, and rigorous testing protocols. For healthcare providers, partnering with 503B Compounding Pharmacy means accessing a trusted resource for medications that are essential for patient care, all sourced from a local, FDA-registered facility.
To learn more about the services available from 503B Compounding Pharmacy, you can visit their website at https://503bcompoundingpharmacy.com/ or contact them directly by phone at (407)993-1381. The facility is situated 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 FDA-registered outsourcing facility?
It means that 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 operates under Section 503B of the FD&C Act. This registration signifies that the facility complies with federal current Good Manufacturing Practices (cGMP) and is subject to regular FDA inspections, ensuring a higher level of quality control for compounded medications compared to traditional pharmacies.
Who can receive medications from 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779?
503B Compounding Pharmacy supplies medications primarily for "office use" to healthcare practitioners and facilities. The medications are intended for administration to patients within a clinical setting at 2160 W State Road 434, Longwood, FL 32779 and are not typically dispensed directly to individual patients.
What types of medications does 503B Compounding Pharmacy produce?
503B Compounding Pharmacy specializes in compounding sterile injectables and other medications that are often in short supply or discontinued by large-scale manufacturers. The specific formulations available from the facility at 2160 W State Road 434, Longwood, FL 32779 can be discussed with healthcare providers.
How does a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 order from 503B Compounding Pharmacy?
Healthcare providers can initiate orders by contacting 503B Compounding Pharmacy directly at (407)993-1381. The team will provide information on available medications, ordering procedures, and compliance requirements specific to the 503B outsourcing facility model.
Why should a clinic at 2160 W State Road 434, Longwood, FL 32779 choose 503B Compounding Pharmacy?
Choosing 503B Compounding Pharmacy provides assurance of quality and reliability. The facility at 2160 W State Road 434, Longwood, FL 32779 offers medications produced under strict cGMP standards, helping to mitigate risks associated with drug shortages and ensuring a consistent supply of essential drugs for patient treatment.