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 a critical distinction that sets this facility apart from traditional compounding pharmacies. Located at 2160 W State Road 434, Longwood, FL 32779, this 503B outsourcing facility adheres to the most rigorous current good manufacturing practices (cGMP) mandated by the FDA. This ensures that every preparation leaving the facility meets the highest standards of quality, purity, and potency for the patients and healthcare providers it serves.
The core function of 503B Compounding Pharmacy is the large-scale compounding of medications that are patient-specific but are not intended for office stock. This facility compounds medications in advance of receiving a prescription, based on a history of receiving valid prescriptions for these medication compounds. The medications produced at the 2160 W State Road 434 facility are distributed to healthcare providers for office use and administration to their patients, ensuring a reliable and consistent supply of essential drugs that may be in shortage or are not commercially available. The operations at this location are integral to supporting the local medical community by providing access to vital medications.
By operating under Section 503B, this facility is subject to federal oversight and must comply with stringent testing, quality control, and reporting standards. This provides an additional layer of safety and assurance for healthcare providers at 2160 W State Road 434, Longwood, FL 32779, who utilize these compounded medications. The team at 503B Compounding Pharmacy is comprised of skilled pharmacists and technicians who are dedicated to the precise science of compounding, utilizing state-of-the-art equipment and validated processes to ensure every batch meets exacting specifications.
Healthcare providers seeking a trusted source for high-quality, compounded medications for office use can rely on the services provided at this specific location. The facility is dedicated to maintaining the highest levels of professional service and regulatory compliance. For more information on available formulations or to discuss specific needs, healthcare providers are encouraged to contact the facility directly.
To learn more about the services provided by this FDA-registered outsourcing facility or to initiate an order, please use the following contact information for the location at 2160 W State Road 434, Longwood, FL 32779. Website: https://503bcompoundingpharmacy.com/ | Phone: (407)993-1381
FAQ
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means this facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and compounds medications in accordance with Section 503B of the Federal Food, Drug, and Cosmetic Act. This requires compliance with strict current good manufacturing practices (cGMP) for heightened quality, testing, and safety standards beyond traditional pharmacy compounding.
2. Who can receive medications from 503B Compounding Pharmacy at 2160 W State Road 434?
Medications compounded at this facility are distributed to healthcare providers for office use and administration to their patients. This location provides medications to practitioners for use in their practice located at 2160 W State Road 434, Longwood, FL 32779, not directly to individual patients at the retail level.
3. What types of medications does this 503B outsourcing facility compound?
503B Compounding Pharmacy compounds a wide range of sterile and non-sterile preparations that are often on drug shortage lists or are not otherwise commercially available. These are prepared in larger batches for healthcare providers to have on hand for patient needs at 2160 W State Road 434, Longwood, FL 32779.
4. How does the 503B model benefit healthcare providers at this location?
The 503B model provides healthcare providers at 2160 W State Road 434, Longwood, FL 32779 with access to a reliable supply of high-quality compounded medications that have been produced under rigorous FDA-enforced cGMP standards. This offers assurance of product quality, consistency, and safety for office use.
5. How can a healthcare provider place an order with this specific facility?
Healthcare providers can contact 503B Compounding Pharmacy directly at (407)993-1381 or visit the website at https://503bcompoundingpharmacy.com/ to inquire about available medications and initiate the ordering process for services at 2160 W State Road 434, Longwood, FL 32779.