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 in strict compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility is located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies our commitment to the highest standards of quality, safety, and compliance in the preparation of compounded medications. Unlike traditional compounding pharmacies, a 503B outsourcing facility is subject to rigorous federal oversight, including current Good Manufacturing Practices (cGMP), which ensures that every preparation leaving our facility meets stringent, reproducible quality standards.
At our location on 2160 W State Road 434, Longwood, FL 32779, we specialize in the large-scale compounding of medications that are distributed for office use by healthcare practitioners. Our primary mission is to provide physicians, surgeons, dermatologists, veterinarians, and other medical professionals with access to a reliable supply of high-quality, sterile and non-sterile compounded preparations. This allows these practitioners to better serve their patients by having essential medications readily available for administration during procedures, treatments, or for dispensing directly from their offices.
The services provided by 503B Compounding Pharmacy are defined by our operational model as an outsourcing facility. We produce compounded medications in larger batches, which are then distributed to healthcare providers. This model is distinct from patient-specific compounding. Our work at 2160 W State Road 434, Longwood, FL 32779 is focused on supporting the local medical community by ensuring a consistent and compliant source for critical medications, including sterile injectables, ophthalmics, topicals, and other dosage forms that are essential for modern medical practice.
Quality and safety are the cornerstones of our operation at 2160 W State Road 434, Longwood, FL 32779. Our state-of-the-art facility employs advanced environmental controls, and our processes are validated to ensure sterility and potency. Every batch of medication is rigorously tested to confirm its identity, strength, quality, and purity. By adhering to these exacting cGMP standards, 503B Compounding Pharmacy provides healthcare professionals with the confidence that the medications they use in their practice are of the highest possible quality and reliability.
Healthcare providers seeking a trusted partner for their office-use medication needs are invited to connect with 503B Compounding Pharmacy. To learn more about our services or to place an order, please contact us directly. You can reach our facility at 2160 W State Road 434, Longwood, FL 32779 by phone at (407)993-1381 or visit our website for more detailed information at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
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 operates under Section 503B of the FD&C Act. This subjects us to federal oversight and mandatory compliance with current Good Manufacturing Practices (cGMP), ensuring the highest standards of quality, safety, and consistency in our compounded preparations.
Who can receive medications from 503B Compounding Pharmacy at 2160 W State Road 434?
Our medications are distributed for office use to healthcare practitioners with prescribing authority, such as physicians, surgeons, and veterinarians. These practitioners can then administer or dispense these medications to their patients from their own practice locations.
What types of medications does 503B Compounding Pharmacy prepare?
As an outsourcing facility, we prepare a range of sterile and non-sterile compounded medications in batches. This includes but is not limited to sterile injectables, ophthalmic solutions, topical creams and ointments, and other formulations required by healthcare providers for use in their practices located near our facility.
How does the quality control process work at your Longwood location?
Our quality control at 2160 W State Road 434, Longwood, FL 32779 is comprehensive. It involves stringent environmental monitoring, validated sterilization processes, and rigorous testing of raw materials and finished preparations. We conduct assays to verify the identity, strength, purity, and quality of every batch we produce to ensure it meets all cGMP requirements.
How can a healthcare provider place an order with your facility?
Healthcare providers can place an order by contacting 503B Compounding Pharmacy directly. Please call our facility at (407)993-1381 to speak with a representative. You can also find more information and contact details on our website at https://503bcompoundingpharmacy.com/.