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
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 compounding pharmacy specializes in the preparation of sterile and non-sterile compounded medications. As a 503B outsourcing facility, the pharmacy adheres to rigorous current good manufacturing practices (cGMP) to ensure the highest standards of quality, purity, and potency for its compounded preparations. The facility's primary focus is on producing medications in larger batches for healthcare providers and facilities, ensuring a consistent and reliable supply of essential drugs.
The services provided by 503B Compounding Pharmacy are distinct from traditional retail pharmacy services. The pharmacy's operations are centered on compounding medications that are not commercially available or are in shortage. This includes the preparation of injectable medications, IV solutions, ophthalmic preparations, and other sterile products. By operating under Section 503B, the pharmacy is subject to federal oversight and must comply with stringent manufacturing standards, providing an added layer of safety and assurance for the medications it produces. The team at 503B Compounding Pharmacy consists of experienced pharmacists and technicians who are dedicated to precision and quality control in every preparation.
For healthcare providers and facilities seeking a dependable source for compounded medications, 503B Compounding Pharmacy offers a critical service. The pharmacy is equipped to handle complex compounding needs and can work with providers to ensure specific formulation requirements are met. Patients benefit indirectly through the availability of these high-quality medications prescribed by their healthcare providers. The pharmacy's commitment to compliance and quality makes it a trusted resource within the healthcare supply chain.
To learn more about the services offered by 503B Compounding Pharmacy or to inquire about specific compounded preparations, please contact them directly. You can visit their website at https://503bcompoundingpharmacy.com/ or call them at (407)993-1381. 503B Compounding Pharmacy is located at 2160 W State Road 434, Longwood, FL 32779.
Frequently Asked Questions
What is a 503B compounding pharmacy?
A 503B compounding pharmacy is an FDA-registered outsourcing facility that compounds medications in accordance with Section 503B of the Federal Food, Drug, and Cosmetic Act. These facilities compound sterile medications without patient-specific prescriptions and must comply with current good manufacturing practices.
What types of medications does 503B Compounding Pharmacy prepare?
503B Compounding Pharmacy specializes in preparing sterile compounded medications, which can include injectable drugs, IV solutions, and ophthalmic preparations. These are often produced for healthcare facilities to administer to patients.
Who can order from 503B Compounding Pharmacy?
Orders are typically placed by healthcare providers, hospitals, clinics, and other healthcare facilities. The pharmacy provides medications for office use or for administration within a clinical setting, rather than directly to individual patients for home use.
How does the 503B designation ensure medication quality?
The 503B designation requires the pharmacy to register with the FDA and undergo regular inspections. They must adhere to strict cGMP standards, which involve rigorous testing, environmental monitoring, and quality control procedures to ensure the safety and sterility of all compounded preparations.
Where is 503B Compounding Pharmacy located?
503B Compounding Pharmacy is located at 2160 W State Road 434, Longwood, FL 32779. You can contact them by phone at (407)993-1381 or through their website at https://503bcompoundingpharmacy.com/.