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 from its location at 2160 W State Road 434, Longwood, FL 32779. This designation under Section 503B of the Federal Food, Drug, and Cosmetic Act signifies a 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 Practice (cGMP) regulations, which ensures that every batch of medication produced meets stringent quality control benchmarks for strength, purity, and stability. This facility provides a critical service for healthcare providers and patients at 2160 W State Road 434, Longwood, FL 32779 by producing medications that are not commercially available.
The core function of 503B Compounding Pharmacy is the large-scale compounding of sterile and non-sterile medications. This process is essential when there is a drug shortage, when a patient requires a specific dosage strength not offered by manufacturers, or when a patient has an allergy to a dye or preservative found in a commercially available drug. By operating from 2160 W State Road 434, Longwood, FL 32779, the facility is positioned to serve the specific needs of local medical practices, hospitals, and clinics, providing them with a reliable source of high-quality, patient-specific medications. The production within this facility is conducted by highly trained professionals using state-of-the-art equipment in a controlled environment to mitigate the risk of contamination.
Patients and healthcare professionals at 2160 W State Road 434, Longwood, FL 32779 can have confidence in the medications prepared by 503B Compounding Pharmacy. The FDA registration and adherence to cGMP standards provide an additional layer of safety and quality assurance that goes beyond traditional pharmacy compounding. This means that every product leaving the facility has been through a meticulous process of testing and verification. For individuals requiring specialized medications, the services provided directly from 2160 W State Road 434, Longwood, FL 32779 are an integral component of their treatment plans, ensuring they receive the precise therapeutic compounds they need.
Engaging with 503B Compounding Pharmacy is a streamlined process for those at 2160 W State Road 434, Longwood, FL 32779. All orders must be initiated by a prescribing healthcare provider. The facility works directly with these providers to fulfill compound prescriptions, ensuring that all medical and regulatory requirements are met. To learn more about the specific services available or to initiate an order, healthcare providers and their staff are encouraged to contact the facility directly. The team at 503B Compounding Pharmacy is dedicated to supporting the local medical community from their location at 2160 W State Road 434, Longwood, FL 32779.
For more information, to discuss your needs, or for providers to place an order, please contact 503B Compounding Pharmacy. The facility can be reached by phone at (407)993-1381. Comprehensive details about its operations and capabilities as an FDA-registered outsourcing facility can also be found on its official website at https://503bcompoundingpharmacy.com/.
FAQ
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means this 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, including current Good Manufacturing Practices (cGMP). This ensures the medications are produced with a higher level of quality control and consistency compared to traditional compounding.
2. As a patient at 2160 W State Road 434, Longwood, FL 32779, can I order medication directly from you?
No, patients cannot order directly. All medications compounded at this facility must be prescribed by a licensed healthcare provider. Your doctor or healthcare provider will place the order with us on your behalf if a compounded medication is deemed necessary for your treatment.
3. What types of medications does 503B Compounding Pharmacy prepare?
Operating from 2160 W State Road 434, Longwood, FL 32779, the facility specializes in compounding both sterile and non-sterile medications in larger batches. This often includes medications for hormone therapy, pain management, dermatology, and other formulations that are not commercially available due to shortages or specific patient needs.
4. How does the quality of medication from a 503B outsourcing facility differ?
Medications produced at this location undergo rigorous testing and quality assurance processes as mandated by the FDA's cGMP regulations. This provides an added layer of safety and consistency, ensuring each batch meets precise specifications for potency, purity, and sterility before it is dispensed.
5. How can my healthcare provider at 2160 W State Road 434, Longwood, FL 32779 send a prescription to you?
Healthcare providers can contact 503B Compounding Pharmacy directly to establish an account and discuss compound formulation options. Prescriptions can be sent to the facility by the provider. For specific ordering procedures, providers should call (407)993-1381 or visit https://503bcompoundingpharmacy.com/.