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. 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 patients who require medications that are not commercially available.
The core function of 503B Compounding Pharmacy is the preparation of compounded medications in bulk for office use by healthcare practitioners. This means that physicians, surgeons, veterinarians, and other medical professionals at practices and clinics can order essential medications directly from the facility at 2160 W State Road 434, Longwood, FL 32779. These medications are not made for individual patient prescriptions in the traditional compounding sense but are instead produced for healthcare providers to have on hand for immediate administration to patients during procedures, treatments, or office visits.
Operating from its location on State Road 434, 503B Compounding Pharmacy provides healthcare practitioners with access to a reliable supply of high-quality medications that meet strict sterility and potency assurances. The facility's compliance with Current Good Manufacturing Practices (cGMP) ensures that every product is consistently produced and controlled according to quality standards. For medical professionals seeking a trusted source for office-use medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 serves as a vital partner in patient care.
To learn more about the services available or to place an order, you can contact 503B Compounding Pharmacy directly. The facility can be reached by phone at (407)993-1381. Detailed information about its operations and compliance is available on its official website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
1. What does it mean that 503B Compounding Pharmacy is an "outsourcing facility"?
An outsourcing facility is an FDA-registered entity, like 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779, that compounds drugs in accordance with Section 503B of the FD&C Act. It must comply with Current Good Manufacturing Practices (cGMP) and is subject to FDA inspection, providing a higher level of regulatory oversight for compounded medications intended for office use by healthcare practitioners.
2. Can I as an individual patient pick up a prescription at 2160 W State Road 434?
No. 503B Compounding Pharmacy operates as a bulk manufacturer for office use. It does not compound medications based on individual patient prescriptions. Medications are distributed to licensed healthcare practitioners for use within their practice. Patients should contact their healthcare provider directly for their medication needs.
3. What types of medications does 503B Compounding Pharmacy prepare?
503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 compounds a wide range of sterile and non-sterile medications in bulk quantities. This includes, but is not limited to, injectable medications, ophthalmics, and other preparations that are routinely used by healthcare providers in a clinical setting for procedures and treatments.
4. How can a healthcare practice place an order with 503B Compounding Pharmacy?
Healthcare practices and licensed practitioners can place orders for office-use medications by contacting 503B Compounding Pharmacy directly. You can initiate the process by calling (407)993-1381. The facility will provide information on ordering protocols, available products, and account setup for qualified healthcare providers.
5. Why should a healthcare provider choose 503B Compounding Pharmacy for office-use medications?
Choosing 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 ensures that the medications you use in your practice are produced under the strict quality controls of an FDA-registered outsourcing facility. This provides assurance of sterility, potency, and purity, which is critical for patient safety and effective treatment outcomes.