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 Drug Quality and Security Act. Located at 2160 W State Road 434, Longwood, FL 32779, this facility is dedicated to the large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, it adheres to rigorous federal standards for quality, safety, and production, providing healthcare providers with a reliable source for patient-specific medications that are not commercially available.
The core function of 503B Compounding Pharmacy is the production of compounded medications in bulk for office use by healthcare practitioners. This enables physicians, surgeons, dermatologists, and other medical professionals at clinics and practices to have essential medications readily on hand for immediate administration to patients during procedures and treatments. The facility's operations are strictly regulated, requiring compliance with Current Good Manufacturing Practices (cGMP), which ensures every product meets exacting standards for potency, purity, and sterility. This level of oversight provides an additional layer of safety and assurance for both prescribers and their patients at 2160 W State Road 434, Longwood, FL 32779.
Services provided by 503B Compounding Pharmacy include the compounding of sterile injectables, ophthalmics, topicals, and other dosage forms. By focusing on non-patient-specific, office-use compounding, the pharmacy acts as a critical support system for the local medical community, ensuring that practitioners have access to the necessary medications to provide continuous and effective care. The team at 503B Compounding Pharmacy is comprised of skilled pharmacists and technicians who utilize advanced technology and stringent protocols to fulfill the needs of healthcare providers.
For more information about the services available from this specific outsourcing facility, you can visit their website at https://503bcompoundingpharmacy.com/ or contact them directly by phone at (407)993-1381. 503B Compounding Pharmacy is committed to upholding the highest levels of pharmaceutical compounding from its location at 2160 W State Road 434, Longwood, FL 32779.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an "outsourcing facility"?
An outsourcing facility is an FDA-registered compounding pharmacy that operates under Section 503B of the Federal Food, Drug, and Cosmetic Act. This means 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 complies with stricter federal quality standards, including Current Good Manufacturing Practices (cGMP), and compounds medications for office use by healthcare practitioners without requiring patient-specific prescriptions.
Can I, as a patient, directly order medications from 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy provides medications exclusively for office use by licensed healthcare providers. Patients cannot order directly. Your healthcare provider at their practice will administer medications compounded at this facility during your appointment or procedure.
What types of medications does 503B Compounding Pharmacy at 2160 W State Road 434 produce?
The facility compounds a range of sterile and non-sterile medications, including injectables, ophthalmics, and topical preparations. These are produced in larger batches for healthcare providers to have on hand for treatments at their practices located near 2160 W State Road 434, Longwood, FL 32779.
How does the 503B designation ensure the quality of the compounded medications?
The 503B designation requires compliance with rigorous federal cGMP standards. This ensures that every medication produced at 2160 W State Road 434, Longwood, FL 32779 meets specific benchmarks for sterility, potency, and purity, providing an elevated level of safety and consistency compared to traditional compounding.
How can a local healthcare provider order from 503B Compounding Pharmacy?
Healthcare providers interested in utilizing the services of this outsourcing facility can initiate the process by contacting 503B Compounding Pharmacy directly. You can discuss your practice's needs and place orders by calling (407)993-1381 or by visiting their website at https://503bcompoundingpharmacy.com/ for more information.