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 precisely located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies our commitment to producing compounded medications under the highest standards of quality and safety, surpassing those required of traditional compounding pharmacies. As a 503B outsourcing facility, we are subject to current Good Manufacturing Practices (cGMP), which ensures that every preparation leaving our facility is consistent, sterile, and reliable for the patients and healthcare providers we serve at our Longwood location.
The core function of 503B Compounding Pharmacy is the large-scale compounding of medications that are intended for office use by healthcare practitioners. Our services are designed to support the medical community at 2160 W State Road 434, Longwood, FL 32779 by providing essential medications that may be in shortage or are not commercially available. We compound sterile preparations, including injectables, infusions, and ophthalmic solutions, which are vital for procedures and treatments administered in clinical settings. By providing these critical medications, we enable local healthcare providers to focus on patient care with the assurance that their pharmaceutical needs are met with uncompromising quality.
Our operational model at 503B Compounding Pharmacy is built on a foundation of rigorous quality control. Every step of the compounding process, from ingredient sourcing to final packaging, is meticulously documented and validated. This level of scrutiny is a direct requirement of our 503B status and is fundamental to our mission. Healthcare professionals who utilize our services at 2160 W State Road 434, Longwood, FL 32779 can be confident in the integrity of every vial, syringe, and bag we produce. We serve as a trusted partner in the local healthcare ecosystem, ensuring that practitioners have access to the necessary medications without compromising on safety or efficacy.
Engaging with 503B Compounding Pharmacy is a streamlined process for medical practices. Orders are managed through our dedicated channels, and our team is committed to responsive service to meet the demands of clinical schedules. We encourage local healthcare providers to explore how our 503B compounding services can enhance their practice's capabilities and patient offerings. For detailed information on our available formulations and ordering procedures, we invite you to contact us directly or visit our online resource.
To connect with 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779, please use the following contact information. Our website is an essential tool for understanding our compliance and services: https://503bcompoundingpharmacy.com/. For direct communication regarding orders or inquiries, our phone number is (407)993-1381.
Frequently Asked Questions for 503B Compounding Pharmacy
1. 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 FDA and complies with Section 503B of the FD&C Act. This requires us to adhere to stringent current Good Manufacturing Practices (cGMP), ensuring the highest level of quality, sterility, and safety for the compounded medications we produce for office use.
2. Who can purchase medications from 503B Compounding Pharmacy?
Our medications are compounded for office use and are supplied exclusively to healthcare practitioners and facilities. We provide these medications to support the treatments and procedures performed by medical professionals serving patients from our location at 2160 W State Road 434, Longwood, FL 32779.
3. What types of medications does 503B Compounding Pharmacy specialize in?
503B Compounding Pharmacy specializes in compounding sterile preparations, including injectable medications, intravenous (IV) bags, and ophthalmic solutions. These are often medications that are on shortage or not available from large-scale commercial manufacturers, providing a critical supply for local healthcare practices.
4. How does 503B Compounding Pharmacy ensure the quality of its compounds?
Quality is assured through a rigorous system aligned with cGMP standards. This involves validated processes, extensive testing of components and finished preparations, and meticulous environmental monitoring within our facility at 2160 W State Road 434, Longwood, FL 32779 to ensure sterility and potency.
5. How can a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 place an order?
Healthcare providers can initiate orders or make inquiries by contacting 503B Compounding Pharmacy directly at (407)993-1381. Additional information about our services and compliance standards is available on our website at https://503bcompoundingpharmacy.com/.