FDA Sets Policy on Scoring of Generic Drug Tablets

The CDER Office of Generic Drugs has issued a Manual of Policies and Procedures (MAPP) on scoring configuration of generic drug products. The document says that consistent scoring assures that patients are able to adjust the drug’s dose by breaking a generic drug in the same manner as the branded product. Consistent scoring also assures that neither the generic product nor the listed drug may have a marketplace advantage due to the score.

The MAPP says that the scoring configuration of a generic tablet should be the same as that of the listed drug and should be evident in the exhibit batch when the application is submitted to the agency.

If the scoring configuration of the exhibit batch does not match that of the listed drug, it says, the generic firm will be requested to provide a commitment not to market the product until it is correctly scored.

The MAPP also includes special considerations such as changes in listed drug scoring and patented scoring configuration.