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, an outsourcing facility like 503B Compounding Pharmacy prepares medications in large batches for office use, allowing healthcare providers at local medical practices to have essential medications readily available for their patients without the delay of patient-specific compounding. This model is integral to supporting the local healthcare infrastructure at 2160 W State Road 434, Longwood, FL 32779.
The core function of 503B Compounding Pharmacy is the large-scale production of sterile and non-sterile compounded preparations. These medications are produced for healthcare practitioners to stock and administer within their own practice settings. The services provided by 503B Compounding Pharmacy are defined by rigorous quality control protocols that are a hallmark of the 503B outsourcing facility status. This includes undergoing regular FDA inspections, adhering to Current Good Manufacturing Practices (cGMP), and conducting stringent sterility and potency testing on finished products. For medical professionals at 2160 W State Road 434, Longwood, FL 32779, this provides a critical level of assurance regarding the medications they use.
Patients in the local community benefit indirectly from the services of 503B Compounding Pharmacy. When a healthcare provider utilizes medications from this outsourcing facility, their patients receive treatments that are held to an elevated standard of pharmaceutical quality. The availability of these reliably compounded medications means that local practitioners can offer a broader range of treatment options, including hormone replacement therapy (HRT), dermatological preparations, pain management solutions, and other injectable medications, with confidence in their safety and efficacy. The operations at 2160 W State Road 434, Longwood, FL 32779 are dedicated to this supportive role within the local medical ecosystem.
Engaging with 503B Compounding Pharmacy is designed for healthcare providers. The process typically involves a medical practice establishing an account, after which they can place orders for the specific compounded medications they require for their office. The team at 2160 W State Road 434, Longwood, FL 32779 works directly with physicians and their staff to fulfill these orders efficiently. For any inquiries regarding establishing an account, placing an order, or learning more about the available formulations, healthcare providers are encouraged to contact 503B Compounding Pharmacy directly. The facility can be reached by phone at (407)993-1381 or through their website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an outsourcing facility?
It means 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA under Section 503B. This registration requires compliance with stricter production standards, including Current Good Manufacturing Practices (cGMP), and subjects the facility to regular FDA inspections to ensure the quality and safety of its compounded medications.
Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications exclusively to healthcare providers for office use. Orders are placed by medical practices and healthcare professionals, not directly by patients. The medications produced at 2160 W State Road 434, Longwood, FL 32779 are intended for administration to patients within a clinical setting.
What types of medications does 503B Compounding Pharmacy prepare?
As an outsourcing facility, 503B Compounding Pharmacy specializes in the large-scale compounding of both sterile and non-sterile preparations. This includes a wide array of formulations such as injectables, hormones, topical creams, and other medications that are commonly used by healthcare providers in their practices at 2160 W State Road 434, Longwood, FL 32779.
How does the quality control at a 503B outsourcing facility differ?
The quality control at 503B Compounding Pharmacy involves rigorous testing and documentation mandated by federal law. This includes testing for sterility, potency, and endotoxins for applicable preparations, all conducted under the strict cGMP guidelines that govern major pharmaceutical manufacturers, ensuring a superior level of quality for medications supplied from 2160 W State Road 434, Longwood, FL 32779.
How can a local healthcare provider start ordering?
Healthcare providers interested in the services of 503B Compounding Pharmacy can initiate the process by contacting the facility directly. The team at 2160 W State Road 434, Longwood, FL 32779 will guide you through setting up an account and discuss your specific medication needs. You can reach them by calling (407)993-1381 or visiting their website at https://503bcompoundingpharmacy.com/.