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 designation is central to the operations and services provided at our specific location: 2160 W State Road 434, Longwood, FL 32779. As a 503B outsourcing facility, we adhere to rigorous federal standards for quality control, sterility assurance, and beyond-use dating that distinguish our practice from traditional 503A compounding pharmacies. Our facility in Longwood is designed and maintained to meet these stringent FDA requirements, ensuring that every preparation leaving our premises is of the highest possible quality and consistency.
The core function of 503B Compounding Pharmacy at 2160 W State Road 434 is the large-scale compounding of medications that are intended for office use by healthcare practitioners. This means we provide physicians, surgeons, ophthalmologists, dermatologists, veterinarians, and other medical professionals with bulk quantities of sterile and non-sterile compounded preparations. These medications are not dispensed directly to patients at our location but are instead supplied to the practices and clinics that serve them. Our role is to support the local medical community by providing them with reliable, high-quality compounded medications they can trust for their procedures and treatments.
Our services at the Longwood facility are defined by the regulatory framework of a 503B outsourcing facility. We compound medications that are patient-specific, but our primary focus is on producing batches of medications for office-use. This includes a wide range of preparations such as sterile injectables, ophthalmic solutions, topical creams and gels, and other dosage forms that are in demand by healthcare providers. Every step of the compounding process at 2160 W State Road 434 is performed under the direct supervision of licensed pharmacists and trained technicians within controlled environments that meet current Good Manufacturing Practices (cGMP).
Quality and safety are the foundational principles of everything we do at 503B Compounding Pharmacy. Our location at 2160 W State Road 434, Longwood, FL 32779, is equipped with state-of-the-art technology for compounding, testing, and environmental monitoring. We conduct rigorous stability testing to assign accurate beyond-use dates and perform extensive sterility testing on all applicable preparations. This unwavering commitment to quality ensures that the healthcare providers we serve receive products that are safe, effective, and consistent from batch to batch, allowing them to focus on patient care with confidence.
Engaging with 503B Compounding Pharmacy is a streamlined process for medical practices. Healthcare providers located near our facility can coordinate directly with our team to discuss their specific compounding needs, place orders, and arrange for pickup or delivery. We are dedicated to being a responsive and reliable partner to the medical community in the immediate area of our Longwood location.
For more detailed information about our services or to initiate a professional relationship, please contact us directly. You can reach 503B Compounding Pharmacy at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/ to learn more about our capabilities as an FDA-registered 503B outsourcing facility.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our specific operation 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 for compounding, including current Good Manufacturing Practices (cGMP), which govern quality control, testing, and production standards on a larger scale.
Can individual patients pick up their prescriptions at your Longwood location?
No. As a 503B outsourcing facility, our primary function is to supply compounded medications in bulk for office-use to healthcare practitioners. Patients should receive their medications directly from their doctor, clinic, or veterinarian, who sources from us.
What types of compounded medications do you provide from your facility on State Road 434?
We compound a wide array of sterile and non-sterile preparations, including but not limited to injectables, ophthalmic drops, topical creams, and oral solutions. These are provided in larger quantities for healthcare providers to use within their practice for procedures and treatments.
How do local healthcare providers place an order with your pharmacy?
Healthcare providers and their staff can contact us directly at (407)993-1381 to discuss their compounding needs, place orders, and coordinate logistics for obtaining medications from our Longwood location.
Why should a practice choose a 503B outsourcing facility like yours over other compounding options?
Choosing our 503B Compounding Pharmacy ensures the medications you use in your practice are produced under the most rigorous quality and sterility standards mandated by the FDA. This provides an added layer of safety and consistency for both the practitioner and the patient.