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 is dedicated to the large-scale compounding of sterile and non-sterile medications that are not available commercially. As a 503B outsourcing facility, it adheres to rigorous federal standards for quality control, testing, and production, providing a critical service for healthcare providers and their patients.
The core function of 503B Compounding Pharmacy is the production of compounded medications in bulk for office use by healthcare practitioners. This means physicians, surgeons, veterinarians, and other medical professionals serving the community can obtain essential, high-quality medications for their practice located at 2160 W State Road 434, Longwood, FL 32779. The pharmacy compounds a significant volume of medications, ensuring that local practitioners have reliable access to the specific drugs they need to treat their patients effectively.
Operating from its facility at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy follows current Good Manufacturing Practices (cGMP). This commitment to the highest manufacturing standards includes stringent environmental controls, validated processes, and robust quality assurance testing. Every batch of medication is produced with precision and undergoes thorough testing to ensure potency, purity, and sterility, providing practitioners with confidence in the medications they administer.
The services provided by 503B Compounding Pharmacy are distinct from traditional retail pharmacy services. This facility does not typically dispense medications directly to individual patients for home use. Instead, it serves as a wholesale-level manufacturer, supplying healthcare practices with medications intended for administration within a clinical setting. This model supports the local medical community by ensuring a consistent and compliant supply of vital drugs.
For healthcare providers seeking a trusted source for compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 represents a commitment to safety, quality, and reliability. To learn more about its services or to place an order, healthcare entities can contact the facility directly via its website at https://503bcompoundingpharmacy.com/ or by phone at (407)993-1381.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our 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. We operate under current Good Manufacturing Practices (cGMP), which are the strict federal standards for drug manufacturing that ensure product quality, safety, and sterility.
Can I, as an individual patient, pick up my prescription at 2160 W State Road 434, Longwood, FL 32779?
No. 503B Compounding Pharmacy operates as an outsourcing facility that supplies compounded medications in bulk for office use to healthcare practitioners. We do not typically dispense medications directly to individual patients. Your healthcare provider will administer medications compounded at our facility within their practice setting.
What types of medications does 503B Compounding Pharmacy produce?
Our facility at 2160 W State Road 434, Longwood, FL 32779 compounds a wide array of sterile and non-sterile medications that are not readily available from commercial manufacturers. This includes various injectables, ophthalmics, and other preparations that are essential for healthcare providers to have on hand for procedures and treatments in their practices.
How does a healthcare practice order from 503B Compounding Pharmacy?
Healthcare practices and providers can place orders for compounded medications by contacting our facility directly. Orders can be initiated through our website at https://503bcompoundingpharmacy.com/ or by calling our main line at (407)993-1381. Our team will provide information on ordering protocols and account setup.
Why should a healthcare provider choose 503B Compounding Pharmacy at 2160 W State Road 434?
Healthcare providers choosing our facility benefit from our commitment to cGMP standards and FDA oversight. This ensures that the medications they use in their practice are produced with the highest level of quality control, sterility assurance, and batch consistency, which is critical for patient safety and effective treatment outcomes.