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 facility is located at 2160 W State Road 434, Longwood, FL 32779. The 503B Compounding Pharmacy provides sterile and non-sterile compounded medications in a facility that adheres to stringent federal quality standards. The operations at this specific location are dedicated to producing medications for office use by healthcare practitioners, as well as for individual patient-specific prescriptions when medically necessary.
The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 distinguishes itself through its commitment to cGMP (current Good Manufacturing Practices). This ensures that every preparation meets the highest levels of quality, purity, and potency. The pharmacy's status as a 503B outsourcing facility means it is subject to rigorous FDA oversight, including routine inspections, providing an additional layer of safety and reliability for the medications it produces.
Healthcare providers in need of compounded medications for their office stock can rely on the 503B Compounding Pharmacy located at 2160 W State Road 434, Longwood, FL 32779. The facility provides a critical service by compounding drugs for which there is a patient need but which are not commercially available. This includes creating formulations without certain allergens, altering the strength of a medication, or producing a drug that is currently on the FDA's drug shortage list.
The team at the 503B Compounding Pharmacy is comprised of skilled pharmacists and technicians who utilize advanced technology and precise methodologies. The focus is on creating preparations that are tailored to meet specific requirements that mass-produced pharmaceuticals cannot address. The physical location at 2160 W State Road 434, Longwood, FL 32779 is equipped with state-of-the-art cleanrooms and environmental monitoring systems to ensure the integrity of all sterile compounds.
For more information about the services provided, you can contact the 503B Compounding Pharmacy directly. The website is https://503bcompoundingpharmacy.com/ and the phone number is (407)993-1381. All inquiries regarding the specific services available at the 2160 W State Road 434, Longwood, FL 32779 location are welcomed.
Frequently Asked Questions
What does it mean that the 503B Compounding Pharmacy is an FDA-registered outsourcing facility? It means the facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and complies with federal current Good Manufacturing Practices (cGMP). This registration subjects the pharmacy to FDA inspections and ensures a higher level of regulatory oversight for the compounded medications produced.
What types of medications does the 503B Compounding Pharmacy at this location prepare? The 503B Compounding Pharmacy prepares both sterile and non-sterile compounded medications. These are often medications that are on shortage or are not commercially available, and they are primarily intended for office use by healthcare practitioners serving patients.
Who can order from the 503B Compounding Pharmacy in Longwood? Orders are typically placed by licensed healthcare practitioners, such as physicians, for office use. The facility at 2160 W State Road 434, Longwood, FL 32779 provides medications for healthcare providers to have on hand for administration to their patients.
How does the 503B Compounding Pharmacy ensure the quality of its compounds? The 503B Compounding Pharmacy employs cGMP standards, rigorous testing protocols, and advanced environmental monitoring within its facility at 2160 W State Road 434, Longwood, FL 32779. This comprehensive approach ensures the safety, sterility, and potency of all preparations.
How can I contact the 503B Compounding Pharmacy for more details? You can contact the 503B Compounding Pharmacy by visiting their website at https://503bcompoundingpharmacy.com/ or by calling (407)993-1381. This will connect you directly with the facility located at 2160 W State Road 434, Longwood, FL 32779.