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 is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. Located at 2160 W State Road 434, Longwood, FL 32779, this facility is dedicated to the large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, it adheres to rigorous federal standards for quality control, testing, and production, providing healthcare providers with a reliable source for compounded medications that are not commercially available.
The core function of 503B Compounding Pharmacy is to produce medications in bulk for office use by healthcare practitioners. This means physicians, surgeons, veterinarians, and other medical professionals in Longwood can obtain essential medications for their practice directly from this location. The pharmacy compounds a significant volume of medications, ensuring consistent quality and sterility for preparations like injectables, ophthalmics, and other dosage forms that require a high level of precision and safety. The team at 2160 W State Road 434, Longwood, FL 32779 is comprised of skilled pharmacists and technicians who utilize advanced technology and strict aseptic techniques to meet the specific needs of the local medical community.
Patients benefit indirectly from the services of 503B Compounding Pharmacy through their trusted healthcare providers. When a physician at a local clinic or hospital utilizes a medication compounded at this facility, patients receive a product that has been created under the highest applicable manufacturing standards. The pharmacy’s commitment to compliance with Current Good Manufacturing Practices (cGMP) ensures that every preparation is accurately compounded, thoroughly tested, and properly packaged. For healthcare providers and patients in Longwood, this represents a critical layer of safety and reliability for medications that are vital to treatment plans.
To learn more about the specific services available from this FDA-registered outsourcing facility, healthcare providers are encouraged to contact the team directly. The pharmacy welcomes inquiries and can provide detailed information about its compounding capabilities. You can reach 503B Compounding Pharmacy by visiting their website at https://503bcompoundingpharmacy.com/ or by calling the facility at (407)993-1381.
Frequently Asked Questions
1. What does it mean that this is a 503B outsourcing facility?
It means this pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and follows strict federal standards for compounding medications on a larger scale. This includes adhering to Current Good Manufacturing Practices (cGMP) for consistent quality, purity, and sterility.
2. Can I, as a patient, pick up my prescription directly from this location?
No. 503B Compounding Pharmacy primarily supplies compounded medications for office use by healthcare providers. Your physician or veterinarian will obtain the medication from this facility and administer it to you within their practice located in Longwood.
3. What types of medications does this Longwood facility compound?
As an outsourcing facility, this location specializes in compounding a wide array of sterile preparations, including injectables, IV bags, and ophthalmic solutions, as well as non-sterile medications, all produced in larger batches for healthcare providers to use in their practice.
4. How does a healthcare provider in Longwood order from 503B Compounding Pharmacy?
Healthcare providers can contact the pharmacy directly to establish an account and place orders. The team at (407)993-1381 can guide them through the process and provide information on available formulations and ordering protocols.
5. Why would a provider choose a 503B outsourcing facility over a traditional compounding pharmacy?
Healthcare providers choose this facility at 2160 W State Road 434 because medications from an FDA-registered 503B outsourcing facility are produced under heightened quality and safety standards, providing an added level of assurance for medications used in their practice.