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 specializes in 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 services provided at the 2160 W State Road 434 facility are distinct from traditional compounding. This 503B Compounding Pharmacy prepares medications in bulk for office use by healthcare practitioners, ensuring a consistent and readily available supply. The medications produced at this location are essential for many medical practices, including hormone replacement therapy, ophthalmology, dermatology, and pain management. By operating under strict FDA oversight, the pharmacy provides an additional layer of safety and assurance for both practitioners and their patients.
Patients and healthcare providers visiting or utilizing the services of the 503B Compounding Pharmacy at 2160 W State Road 434 can be confident in the integrity of every preparation. The facility employs state-of-the-art technology and follows current good manufacturing practices (cGMP) to ensure sterility, potency, and purity. This commitment to excellence makes the 503B Compounding Pharmacy a critical partner for the local medical community, supporting enhanced patient care through access to high-quality, tailored medications.
For more information about the services available or to speak with a representative, please contact 503B Compounding Pharmacy directly. The team at 2160 W State Road 434, Longwood, FL 32779 is ready to assist healthcare providers with their compounding needs. Website: https://503bcompoundingpharmacy.com/ | Phone: (407)993-1381
Frequently Asked Questions
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 medications in large volumes for office use by healthcare practitioners. It operates under stricter federal regulations than a traditional 503A pharmacy, which focuses on patient-specific prescriptions.
Can I, as a patient, pick up my prescription directly from the 2160 W State Road 434 location?
No. This 503B Compounding Pharmacy primarily supplies medications in bulk to physicians and healthcare facilities for office use. Patients typically receive their compounded medications directly from their healthcare provider's office, not from this facility.
What types of medications does the 503B Compounding Pharmacy at this location prepare?
The pharmacy at 2160 W State Road 434 compounds a wide array of sterile and non-sterile medications, including but not limited to hormone therapies, sterile injectables, ophthalmologic drops, and topical creams, all prepared for healthcare provider administration.
How does the 503B status ensure the quality of the medications?
As an FDA-registered 503B outsourcing facility, this pharmacy must comply with current Good Manufacturing Practices (cGMP). This includes rigorous testing of ingredients, environmental monitoring, and stringent quality control procedures for every batch produced at the Longwood location.
How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers can contact the 503B Compounding Pharmacy directly to discuss their needs and place orders. The contact information for the facility at 2160 W State Road 434 is Website: https://503bcompoundingpharmacy.com/ | Phone: (407)993-1381.