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 a commitment to the highest standards of quality, safety, and compliance in pharmaceutical compounding. Unlike a traditional 503A pharmacy, this 503B outsourcing facility prepares medications in larger batches for office use by healthcare practitioners, without requiring patient-specific prescriptions. The medications produced are intended for dispensing by physicians, surgeons, and other qualified healthcare providers directly to their patients within a clinical setting.
The core function of 503B Compounding Pharmacy is the large-scale production of sterile and non-sterile compounded medications. This operation is conducted under stringent quality control measures that are rigorously monitored and enforced by the U.S. Food and Drug Administration. The facility at 2160 W State Road 434, Longwood, FL 32779 adheres to Current Good Manufacturing Practices (cGMP), which are the same standards required of major pharmaceutical manufacturers. This ensures that every batch of medication is consistent in potency, purity, and quality, providing healthcare professionals with a reliable and trusted source for their compounding needs.
Healthcare providers in need of compounded medications for their practice can rely on 503B Compounding Pharmacy. The facility provides a critical service by manufacturing preparations that may be commercially unavailable, such as specific dosage forms or strengths, or medications that are currently on the FDA’s drug shortage list. By supplying these essential preparations, 503B Compounding Pharmacy supports local medical practices, surgical centers, and clinics, enabling them to offer comprehensive and personalized patient care with confidence in the integrity of the medications they use.
The operations at 2160 W State Road 434, Longwood, FL 32779 are focused on serving the professional medical community. The facility does not dispense medications directly to the public. Instead, it functions as a vital partner to healthcare providers, supplying them with high-quality, office-use compounded preparations. This model allows physicians to maintain an inventory of necessary medications for immediate use during procedures, treatments, or consultations, enhancing the efficiency and effectiveness of patient care delivered from their own practice locations.
For healthcare providers seeking a dependable source for compounded pharmaceuticals, 503B Compounding Pharmacy represents a pinnacle of quality and regulatory compliance. The team of skilled pharmacists and technicians at the Longwood facility is dedicated to upholding the strict protocols required of an FDA-registered 503B outsourcing facility. Providers interested in learning more about the available formulations or initiating an order are encouraged to contact the facility directly for professional consultation.
Website: | Phone: (407)993-1381
Frequently Asked Questions
1. What does it mean that this is a 503B compounding pharmacy? This means our facility at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered outsourcing facility that compounds medications in larger batches for office use by healthcare practitioners. We operate under stricter federal regulations, specifically cGMP, compared to a traditional compounding pharmacy.
2. Can I, as a patient, pick up a prescription directly from this location? No. 503B Compounding Pharmacy supplies medications exclusively to licensed healthcare providers for office use. Patients must receive their compounded medications directly from their doctor, surgeon, or other qualified healthcare professional who has sourced the preparation from our facility.
3. What types of medications does this 503B facility compound? We compound a range of sterile and non-sterile preparations, including formulations that are not commercially available or are on the FDA drug shortage list. Healthcare providers can contact us at (407)993-1381 to discuss specific formulations and availability for their practice.
4. How does a healthcare provider at a local practice order from you? Healthcare providers can initiate the process by contacting our facility directly at (407)993-1381. Our team will provide a professional consultation to discuss compound formulations, ordering procedures, and any specific requirements for their practice located at 2160 W State Road 434, Longwood, FL 32779.
5. Why would a healthcare provider choose a 503B outsourcing facility? Healthcare providers choose a 503B outsourcing facility like ours for the assurance of FDA oversight and cGMP-level quality control. This ensures the medications they use in their practice are consistently produced to the highest standards of safety, potency, and purity.