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.
503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under 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 safe and compliant production of compounded medications for office use by healthcare practitioners. As a 503B outsourcing facility, we adhere to the highest standards of current Good Manufacturing Practices (cGMP), ensuring every preparation meets stringent quality control and testing protocols before it is dispensed.
The core function of our 503B Compounding Pharmacy is to provide physicians, surgeons, veterinarians, and other healthcare providers with access to high-quality, sterile and non-sterile compounded medications for their patients. Our location at 2160 W State Road 434, Longwood, FL 32779 is a manufacturing facility, not a retail pharmacy, and we work directly with practitioners to supply medications for office administration. This model allows healthcare professionals to maintain a vital inventory of essential drugs, including those that may be in short supply or discontinued by major manufacturers.
Our services at 2160 W State Road 434, Longwood, FL 32779 include the compounding of a wide array of preparations. We specialize in sterile injectables, ophthalmic solutions, and other medications required for clinical settings. The 503B Compounding Pharmacy team is comprised of skilled pharmacists and technicians who utilize state-of-the-art equipment within our controlled environment to ensure product integrity, potency, and sterility. We provide healthcare practitioners with a reliable and trusted source for their compounding needs, supporting the local medical community with consistent, high-volume production.
Choosing a 503B outsourcing facility like ours provides significant advantages. All medications produced are made under a comprehensive quality system with rigorous environmental monitoring, ingredient verification, and final product testing. This level of oversight provides an additional layer of safety and assurance for both the prescribing practitioner and the patient. Our commitment is to uphold the regulations and responsibilities that come with our 503B registration, providing peace of mind to the healthcare providers we serve from our facility at 2160 W State Road 434, Longwood, FL 32779.
For more information on how our 503B Compounding Pharmacy can support your practice, please contact us. We welcome inquiries from healthcare professionals interested in our services.
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Frequently Asked Questions
1. What does it mean that this is a 503B Compounding Pharmacy?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered outsourcing facility. We operate under Section 503B of the FD&C Act, which requires us to comply with strict current Good Manufacturing Practices (cGMP) for the production of compounded drugs for office use by healthcare practitioners.
2. Can I walk in as a patient to get a prescription filled at this location?
No. Our facility at 2160 W State Road 434, Longwood, FL 32779 is not a retail pharmacy. We do not dispense medications directly to patients. We compound medications in larger batches for healthcare providers who then administer them to their patients within their practice or clinic.
3. What types of medications does this 503B facility compound?
Our 503B Compounding Pharmacy specializes in producing sterile injectable medications, ophthalmic solutions, and other preparations that are commonly used in clinical and surgical settings. This includes medications that are often on drug shortage lists or are not commercially available from large pharmaceutical manufacturers.
4. How does a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 order from you?
Healthcare providers can establish an account with our 503B Compounding Pharmacy by contacting our facility directly. Orders are placed by authorized medical staff, and we provide information on ordering protocols, available formulations, and delivery options specific to our location.
5. Why should a practitioner choose a 503B outsourcing facility over other compounders?
Choosing a 503B outsourcing facility like ours ensures the medications you use in your practice are produced under the highest federal quality and safety standards, including rigorous testing and environmental controls. This provides a significant layer of patient safety and reduces liability for the practitioner.