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
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 compounding pharmacy specializes in the preparation of sterile and non-sterile compounded medications. As a 503B outsourcing facility, the pharmacy adheres to rigorous federal standards for quality, safety, and production consistency, providing medications primarily for office use by healthcare practitioners.
The services at 503B Compounding Pharmacy are distinct from traditional retail pharmacy services. The facility's core function is the large-scale compounding of medications that are not commercially available, ensuring healthcare providers in Longwood have access to essential preparations. This includes producing specific dosages, formulations, or combinations of drugs that are necessary for patient care but are not mass-produced by pharmaceutical manufacturers. The operations at 2160 W State Road 434 are focused on maintaining the highest level of sterility and precision for every batch compounded.
By operating under the 503B designation, this compounding pharmacy is subject to current Good Manufacturing Practices (cGMP) and regular FDA inspections. This provides an additional layer of assurance for the healthcare professionals it serves. The team at 503B Compounding Pharmacy is dedicated to supporting the local medical community with reliable, high-quality compounded pharmaceutical products.
For more information about the services provided by this FDA-registered outsourcing facility, please contact 503B Compounding Pharmacy directly. You can reach them by phone at (407) 993-1381 or visit their website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an "outsourcing facility"?
An outsourcing facility registered under Section 503B is a facility that compounds sterile human drugs and is registered with the FDA. 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 operates under this federal framework, which requires compliance with strict production and quality standards beyond those of a traditional pharmacy.
Who can receive medications from 503B Compounding Pharmacy?
Medications compounded at this facility are typically intended for "office use" or "office stock" by healthcare practitioners. This means that licensed healthcare professionals in Longwood can order these medications for administration to patients within their practice setting, rather than for individual patient prescriptions dispensed directly to the public.
What kinds of medications does 503B Compounding Pharmacy produce?
503B Compounding Pharmacy specializes in compounding medications that are not commercially available. This can include creating specific strengths, altering dosage forms for easier administration, or preparing formulations free of certain allergens or dyes, all produced under stringent sterile or non-sterile compounding protocols at their location on W State Road 434.
How does the 503B designation ensure quality?
The 503B designation subjects the pharmacy to the FDA's current Good Manufacturing Practices (cGMP). This means the facility at 2160 W State Road 434, Longwood, FL 32779 undergoes regular FDA inspections and must meet rigorous standards for testing, cleanliness, documentation, and quality control for every batch of medication produced.
How can a healthcare provider place an order?
Healthcare providers interested in the services of 503B Compounding Pharmacy should contact the facility directly to discuss their needs. You can reach the pharmacy by calling (407) 993-1381. More information about their specific capabilities is also available on their website at https://503bcompoundingpharmacy.com/.