Drugshortage has become a serious problem. Besides problems in the distributionchain, reasons could be manufacturing and quality problems, delays, anddiscontinuations. The U.S. Food and Drug Administration (FDA) takes more andmore efforts to address and prevent drug shortages. In the case of shortage,FDA works closely with manufacturers to communicate the issue and to helprestore availability. FDA also works with other firms who manufacturer the samedrug, asking them to increase production, if possible, in order to prevent orreduce the impact of a shortage.

To doso, the FDA needs information about a potential drug shortage as soon as possibleand the majority of drug shortage information is provided to FDA by manufacturers.To ensure information is current, the FDA has now published a final rule(FDA-2011-N-0898 Permanent Discontinuance or Interruption in Manufacturing ofCertain Drug or Biological Products) that requires all drug and biologic manufacturersto notify the agency electronically of a permanent discontinuance or aninterruption in manufacturing six months in advance, or as soon as ispractical, before the disruption causes a shortage.

TheFood and Drug Administration (FDA or the Agency) is amending its regulations toimplement certain drug shortages provisions of the Federal Food, Drug, andCosmetic Act (the FD&C Act), as amended by the Food and Drug AdministrationSafety and Innovation Act (FDASIA). The rule requires all applicants of coveredapproved drugs or biological products-including certain applicants of blood orblood components for transfusion and all manufacturers of covered drugsmarketed without an approved application-to notify FDA electronically of apermanent discontinuance or an interruption in manufacturing of the productthat is likely to lead to a meaningful disruption in supply (or a significant disruptionin supply for blood or blood components) of the product in the United States.

The rule is effective from September 8,2015 .

Final Rule (PDF)

Source: Federal Register