Services

503-A Pharmacies

Traditional Compounding Pharmacies: 503A pharmacies are traditional compounding pharmacies. They compound medications according to a healthcare provider's prescription, tailored for individual patients.
State Regulation: These pharmacies are primarily regulated by state boards of pharmacy.
Compounding Limitations: They must compound medications based on specific patient prescriptions and cannot produce large batches without patient-specific prescriptions.
Quality Standards: They must comply with the United States Pharmacopeia (USP) standards for compounding.
Prohibition on Distribution: 503A pharmacies are not permitted to distribute compounded medications for "office use" (i.e., bulk supply to healthcare practitioners for use in their offices).

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We are also licensed in Guam and Puerto Rico!

Outsourcing Facilities

Outsourcing Facilities: Are a newer category known as outsourcing facilities. They can produce larger batches of compounded drugs and supply them to healthcare facilities.
FDA Regulation: In addition to being subject to state regulations, 503B facilities are also overseen by the U.S. Food and Drug Administration (FDA).
Batch Production: They are allowed to compound medications in bulk without individual patient prescriptions, primarily for use in hospitals, clinics, and healthcare centers.
Quality and Compliance: 503B facilities must comply with Current Good Manufacturing Practices (CGMP) as required by the FDA, ensuring a higher level of quality control and consistency.
Reporting Requirements: They have to adhere to more stringent reporting and labeling requirements compared to 503A pharmacies.

map locations of where we can and cannot ship to for 503B

Vendors

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