FDA Approved Drugs: Changes to Approved Drugs

Post-approval, manufacturers may alter the new or generic product.

Such changes can include altering the active pharmaceutical ingredient, manufacturing process or site, formulation, batch size, and container closure system.

These changes must be evaluated for their impact on the drug’s identity, strength, quality, purity, potency, safety, and efficacy, before modified product distribution.

The FDA classifies these changes as major, moderate, and minor, each having varying impact on the product.

Major changes, like manufacturing site relocation, substantially impact drug safety or effectiveness and require FDA approval before drug product distribution.

Moderate changes, like a modification in the manufacturing process, moderately impact drugs. These changes require either submitting the supplement to the FDA thirty days before distribution or distribution upon the FDA’s receipt of the supplement.

Minor changes like updating existing code imprints for dosage forms have minimal influence on the drug product. However, these changes must be reported in the manufacturer's next annual report.