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 in strict compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the preparation of sterile and non-sterile compounded medications. This designation means we adhere to the highest current good manufacturing practices (cGMP) for quality and safety, providing a critical service for patients whose clinical needs cannot be met by commercially available FDA-approved drugs. We serve healthcare providers and their patients directly from our Longwood location, ensuring access to essential, high-quality compounded preparations.
The core function of 503B Compounding Pharmacy is the large-scale compounding of medications. Unlike traditional compounding, our 503B outsourcing facility prepares medications in advance of receiving a prescription, based on orders we have received from healthcare providers. This model allows us to supply physician offices, hospitals, and clinics with vital medications that are ready for immediate administration to patients. Our operations at 2160 W State Road 434, Longwood, FL 32779 are focused on producing these medications under a robust quality framework that includes stringent environmental controls, rigorous testing, and extensive documentation to ensure every preparation meets its specified identity, strength, quality, and purity.
Our facility is equipped to handle a wide array of compounding needs. This includes the production of sterile injectables, such as hormone injections, ophthalmics, and other parenteral medications, which are prepared in ISO-classified cleanrooms to ensure sterility. We also compound non-sterile preparations, including topical creams, capsules, and oral suspensions. Every process at our Longwood facility is designed to mitigate risk and provide healthcare professionals with medications they can trust for their patients. The 503B Compounding Pharmacy is an integral partner to the local medical community, providing a reliable source for compounded medications that are essential for patient care.
Patients and healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can be assured of our commitment to excellence. Our status as a 503B outsourcing facility is a testament to our dedication to surpassing the standards required of a traditional compounding pharmacy. We invest in advanced technology and a highly trained staff to maintain our compliance and to serve the specific needs of the medical practitioners and patients we support. For more information about our services or to place an order, please contact us directly.
Website: https://503bcompoundingpharmacy.com/
Phone: (407)993-1381
FAQ
1. What does it mean that 503B Compounding Pharmacy is an "outsourcing facility"?
An outsourcing facility is an FDA-registered entity that compounds medications in accordance with Section 503B of the FD&C Act. This means our facility at 2160 W State Road 434, Longwood, FL 32779 operates under current good manufacturing practices (cGMP) and is subject to FDA oversight. We compound medications in larger volumes for healthcare providers without requiring patient-specific prescriptions in advance.
2. Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications to licensed healthcare providers, including physicians, hospitals, and clinics. Healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can order compounded medications from our facility for office use and administration to their patients.
3. Can I as a patient pick up a prescription directly from your location?
No. 503B Compounding Pharmacy operates as a bulk manufacturer for healthcare providers, not as a retail pharmacy. Patients receive their medications directly from their prescribing healthcare provider at their practice or clinic located at 2160 W State Road 434, Longwood, FL 32779.
4. What types of medications does 503B Compounding Pharmacy prepare?
Our facility specializes in compounding both sterile and non-sterile medications. This includes sterile injectables, ophthalmics, hormone therapies, and various non-sterile preparations like topical creams and oral suspensions, all produced for healthcare providers serving 2160 W State Road 434, Longwood, FL 32779.
5. How does the quality of a 503B compounded drug compare to a traditional pharmacy?
As an FDA-registered 503B outsourcing facility, we are required to comply with more rigorous cGMP standards. This involves extensive testing, environmental monitoring, and quality control processes that often exceed the standards of a traditional compounding pharmacy, ensuring a consistently high-quality product for providers at 2160 W State Road 434, Longwood, FL 32779.