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 503B Compounding Pharmacy provides a critical service by producing large batches of compounded sterile preparations for healthcare practitioners. The operations at 2160 W State Road 434 are distinct from traditional compounding, as this 503B Compounding Pharmacy adheres to stringent current good manufacturing practices (cGMP) mandated by the FDA.
The primary function of the 503B Compounding Pharmacy at 2160 W State Road 434 is to supply medications to healthcare facilities, such as hospitals, clinics, and surgical centers, without the need for patient-specific prescriptions for each unit. This model allows the 503B Compounding Pharmacy to enhance patient safety and medication access by providing sterile preparations that are not readily available from conventional manufacturers. The facility at 2160 W State Road 434 is equipped with advanced environmental controls and utilizes rigorous testing protocols to ensure the sterility, potency, and purity of every preparation that leaves the pharmacy.
By operating as a 503B outsourcing facility, this 503B Compounding Pharmacy can provide medications during drug shortages, which is a vital service for the medical community. The team at the Longwood location is comprised of highly trained pharmacists, technicians, and quality assurance professionals dedicated to upholding the highest standards. The 503B Compounding Pharmacy’s commitment to compliance and quality makes it a reliable partner for healthcare providers seeking compounded medications.
For healthcare entities that require compounded sterile preparations, the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779, offers a dependable source. The facility’s registration with the FDA as a 503B outsourcing facility signifies a commitment to a level of quality and oversight that goes beyond traditional pharmacy compounding. To learn more about the services provided by this 503B Compounding Pharmacy or to initiate an order, healthcare professionals are encouraged to contact the facility directly. The website, https://503bcompoundingpharmacy.com/, provides detailed information, and the pharmacy can be reached by phone at (407)993-1381.
Frequently Asked Questions for 503B Compounding Pharmacy
1. What does it mean that this is a 503B Compounding Pharmacy?
It means this facility at 2160 W State Road 434 is an FDA-registered outsourcing facility that compounds large batches of sterile medications in accordance with strict federal manufacturing standards, unlike a traditional pharmacy that compounds based on individual prescriptions.
2. Who can order medications from the 503B Compounding Pharmacy in Longwood?
Medications are supplied to healthcare practitioners and facilities, such as hospitals, clinics, and surgery centers. The 503B Compounding Pharmacy does not typically dispense medications directly to individual patients without a healthcare provider's involvement.
3. What types of medications does the 503B Compounding Pharmacy produce?
The 503B Compounding Pharmacy at 2160 W State Road 434 specializes in compounded sterile preparations, which can include injectables, IV bags, and other medications required in a clinical setting, particularly those that may be in short supply from standard manufacturers.
4. How does the 503B Compounding Pharmacy ensure medication safety?
As an FDA-registered 503B outsourcing facility, the pharmacy follows current good manufacturing practices (cGMP), which involve rigorous environmental monitoring, sterility testing, and quality control procedures for every batch produced at the Longwood location.
5. How can a healthcare facility place an order with this 503B Compounding Pharmacy?
Healthcare facilities can contact the 503B Compounding Pharmacy directly to discuss their needs. The phone number is (407)993-1381, and more information about services and ordering can be found on the website at https://503bcompoundingpharmacy.com/.