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 at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the large-scale compounding of sterile and non-sterile medications. This designation signifies our commitment to the highest standards of quality, safety, and regulatory oversight, exceeding the requirements of a traditional compounding pharmacy. We provide these critical medications for office use by healthcare practitioners, ensuring they have access to the necessary preparations to treat their patients effectively.
The core function of 503B Compounding Pharmacy is the production of medications that are not commercially available. This includes creating formulations without certain allergens like dyes or preservatives, altering the strength or dosage form of a medication to meet specific patient needs, or compounding a drug that is currently on the FDA’s drug shortage list. All processes at our 2160 W State Road 434, Longwood, FL 32779 location are conducted under a rigorous quality control system. This system encompasses stringent environmental monitoring, validated sterilization techniques, and thorough testing of components and finished preparations to ensure potency, purity, and stability.
Healthcare providers in need of compounded medications for their practice can rely on 503B Compounding Pharmacy as a trusted outsourcing partner. Our facility provides a vital service by compounding preparations for office use, meaning physicians can obtain these medications directly from us to administer to patients within their practice. This eliminates the need for individual patient-specific prescriptions for certain scenarios, streamlining the process for practitioners and improving patient access to essential treatments. Our operations are designed to support the local medical community with a consistent and reliable supply of high-quality compounded medications.
As an FDA-registered 503B outsourcing facility, our operations are subject to regular inspections by the FDA, ensuring ongoing compliance with Current Good Manufacturing Practices (cGMP). This provides an additional layer of assurance for healthcare providers regarding the quality and safety of the medications they utilize. The team at our Longwood location is comprised of skilled pharmacists and technicians who are experts in the art and science of pharmaceutical compounding. We are dedicated to upholding the highest ethical and professional standards in every preparation that leaves our facility.
For more information about the services provided by 503B Compounding Pharmacy, or to learn how we can support your practice, please contact us directly. We are located at 2160 W State Road 434, Longwood, FL 32779. You can also reach us by phone at (407)993-1381 or visit our website for further details at https://503bcompoundingpharmacy.com/.
FAQ
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 stricter federal standards, including Current Good Manufacturing Practices (cGMP), for the large-scale compounding of medications intended for office use by healthcare practitioners.
Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications for office use to healthcare practitioners and physicians. These medications are supplied to practices for administration to patients within that clinical setting, rather than being dispensed directly to individual patients based on a prescription.
What types of medications does 503B Compounding Pharmacy prepare?
As a 503B outsourcing facility, we compound a wide range of sterile and non-sterile medications that are not available commercially, including drugs on shortage, allergen-free formulations, and specific strengths or dosage forms required by healthcare providers at their practice.
How does the quality control at a 503B outsourcing facility differ?
Our facility at 2160 W State Road 434, Longwood, FL 32779 operates under a comprehensive cGMP quality system. This includes rigorous environmental monitoring, validated processes, and extensive testing of ingredients and finished products to ensure every preparation meets exacting standards for potency, sterility, and stability.
How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers can contact 503B Compounding Pharmacy directly to discuss their needs and place an order. We can be reached by phone at (407)993-1381. Additional information and resources are also available on our website at https://503bcompoundingpharmacy.com/.