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.
503B Compounding Pharmacy operates as an FDA-registered outsourcing facility at 2160 W State Road 434, Longwood, FL 32779. This designation, granted under Section 503B of the Federal Food, Drug, and Cosmetic Act, signifies that this facility adheres to the highest current good manufacturing practice (cGMP) standards. Unlike a traditional 503A compounding pharmacy, this 503B outsourcing facility prepares medications in larger batches for office use by healthcare practitioners, without requiring patient-specific prescriptions. The core mission of this facility is to provide practitioners with access to high-quality, compounded medications for their patients, ensuring a reliable supply of essential drugs that may be in shortage or are not commercially available.
The operations at 2160 W State Road 434 are strictly regulated and routinely inspected by the FDA. This ensures that every preparation leaving the facility meets stringent standards for potency, purity, and sterility. The team at this location is comprised of skilled pharmacists and technicians who are experts in the science of compounding. They utilize state-of-the-art equipment and validated processes to produce a range of sterile and non-sterile preparations. This includes injectables, ophthalmic drops, nasal sprays, and topical formulations. The focus is on producing these medications for healthcare providers to stock and administer within their practices, supporting the local medical community with critical patient care tools.
For healthcare practitioners, utilizing a 503B outsourcing facility like this one offers significant advantages. It provides access to a trusted source for compounded medications that have been produced under a level of oversight comparable to that of large-scale pharmaceutical manufacturers. This mitigates risk and provides assurance regarding the quality and consistency of the medications being administered to patients. The facility at 2160 W State Road 434 is dedicated to supporting the local healthcare ecosystem by providing a vital service that bridges gaps in the pharmaceutical supply chain and enables practitioners to deliver comprehensive care.
Communication with the 503B Compounding Pharmacy at this location is direct and professional. Healthcare providers and their staff can contact the facility to discuss available medications, place orders, and address any specific inquiries. The team is committed to providing responsive service to meet the needs of the medical practices it serves from its facility in Longwood.
Contact 503B Compounding Pharmacy:
Location: 2160 W State Road 434, Longwood, FL 32779
Website:
Phone: (407)993-1381
Frequently Asked Questions:
1. What does it mean that this is a 503B outsourcing facility?
This means our facility at 2160 W State Road 434 is registered with the FDA under Section 503B. We operate under federal cGMP standards and are subject to regular FDA inspections. We compound medications in larger batches for office use by healthcare practitioners.
2. Who can order medications from this 503B Compounding Pharmacy?
This facility provides medications exclusively to healthcare practitioners for office use. Orders are placed by physicians, veterinarians, and other qualified healthcare providers for use in their practice at 2160 W State Road 434. We do not fulfill prescriptions for individual patients directly.
3. What types of medications does this facility compound?
As a 503B outsourcing facility, we compound a range of sterile and non-sterile preparations, including injectables, ophthalmic solutions, and topical formulations. These are often medications that are on shortage or are not commercially available from larger pharmaceutical companies.
4. How does the quality assurance at a 503B facility differ?
Our facility at 2160 W State Road 434 follows rigorous cGMP standards mandated by the FDA for outsourcing facilities. This includes extensive testing of raw materials, in-process testing, and finished product testing for potency, sterility, and endotoxins to ensure the highest quality and safety.
5. How can a healthcare provider place an order with your facility?
Healthcare providers can contact our facility directly at (407)993-1381 to speak with our team about available medications, place an order, and arrange for delivery or pickup from our location at 2160 W State Road 434.