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 operates as an FDA-registered outsourcing facility under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation is a critical distinction that sets this facility apart from traditional compounding pharmacies. Located at 2160 W State Road 434, Longwood, FL 32779, this 503B outsourcing facility adheres to the most rigorous current good manufacturing practices (cGMP) mandated by the FDA. This ensures that every preparation leaving the facility meets the highest standards of quality, purity, and potency for the medical community it serves.
The core function of 503B Compounding Pharmacy is the large-scale compounding of sterile and non-sterile medications that are distributed for office use by healthcare practitioners. The medications produced at the 2160 W State Road 434 facility are not typically dispensed directly to individual patients with a prescription, but are instead provided to hospitals, clinics, surgery centers, and physician practices within the local medical ecosystem. This allows healthcare providers at these institutions to have essential, often difficult-to-find medications readily available for immediate administration to their patients, ensuring timely and effective treatment.
By operating under Section 503B, this facility provides a vital service to the healthcare providers of Longwood. It compounds medications that may be on drug shortage lists, creates formulations free of specific allergens like dyes or preservatives, or prepares specific strengths that are not commercially available from major pharmaceutical manufacturers. The team of highly trained pharmacists and technicians at the 2160 W State Road 434 location utilizes state-of-the-art technology and stringent testing protocols to guarantee the safety and efficacy of every batch produced. This commitment to excellence provides local practitioners with the confidence that the medications they use in their practice are of the utmost quality.
For healthcare facilities and practitioners seeking a reliable source for high-quality compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 stands as a pivotal partner. The facility is dedicated to supporting the local medical community by ensuring access to critical medications that are essential for patient care. To learn more about its services or to initiate an order, healthcare entities are encouraged to make direct contact.
Website: https://503bcompoundingpharmacy.com/
Phone: (407)993-1381
Frequently Asked Questions
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and complies with strict federal standards for compounding, known as current good manufacturing practices (cGMP). This ensures a higher level of quality control and consistency for the medications we produce compared to traditional pharmacy compounding.
2. Can I, as an individual patient, get a prescription filled directly at 2160 W State Road 434?
No. 503B Compounding Pharmacy primarily serves healthcare facilities and practitioners through office-use distribution. Individual patients should have their prescribing provider contact us directly. Medications are shipped to the healthcare provider's office for administration.
3. What types of medications does the Longwood facility compound?
Our 503B outsourcing facility at 2160 W State Road 434 compounds a wide range of sterile and non-sterile medications, including those on national drug shortage lists, allergen-free formulations, and specific dosages not available from standard manufacturers, all for office use by local healthcare providers.
4. How do healthcare providers at 2160 W State Road 434 place an order?
Healthcare providers and facilities can place orders by contacting 503B Compounding Pharmacy directly via the phone number provided, (407)993-1381, or through the official website at https://503bcompoundingpharmacy.com/.
5. Why would a doctor's office in Longwood use a 503B outsourcing facility?
Healthcare providers use our services to ensure they have access to reliable, high-quality medications that are not readily available from commercial sources. This allows for immediate treatment options for their patients and the assurance that all medications meet rigorous FDA-enforced quality standards.