Kentucky News: Authorized Generics and Substitution Laws

September 1, 2009 4:50 PM

Published in the September 2009 Kentucky Board of Pharmacy Newsletter

In recent years, drug manufacturers have been introducing a class of products to the market known as “authorized generics”; these products represent previously “brand name” medications from the original brand manufacturer that have been repackaged and sold under a generic label. These products are often released to coincide with the release of the first abbreviated new drug application-labeled generic product. These authorized generics have recently been the subject of confusion among pharmacists with regard to Kentucky’s generic substitution laws and the requirement that substituted drugs must be published as therapeutically equivalent.
Part of the confusion lies in the fact that distributors or computer systems have no uniform method for indicating that a product is an authorized generic version of a brand name medication; sometimes the products are labeled as “AB rated” by the distributor or computer system, even though no such entry will exist when a pharmacist searches the Food and Drug Administration’s (FDA) “Orange Book” by active ingredient. However, in the preface to the current edition of the “Orange Book,” FDA has the following statement: “Any drug product in
the List repackaged and/or distributed by other than the application holder is considered to be therapeutically equivalent to the application holder’s drug product even if the application holder’s drug product is single source or coded as non-equivalent (e.g., BN). Also, distributors
or repackagers of an application holder’s drug product are considered to have the same code as the application holder.” (29th edition, page vii.) Essentially, this means that regardless of what code a drug product is given, authorized generics may still be substituted for that manufacturer’s
original product, despite any rating on the manufacturer’s original drug product. Example: if a patient is started on a drug in which the product is controlled-release and generic equivalent products would normally be rated “B,” you may still consider an authorized generic to be therapeutically equivalent and substitutable.
So what does this mean to a pharmacist in Kentucky? In general, this means authorized generics are therapeutically equivalent by FDA standards, but there is no easy way to search for such products in the “Orange Book,” as the search tool does not include these types of products. However, as FDA considers authorized generics to be repackaged versions of new drug application-approved drugs, the package for the drug product must still indicate the original manufacturers’ name. This name should match the company listed in the “Orange Book” as the manufacturer of the reference listed drug. To find the manufacturer, one may visit the electronic “Orange Book” at www.accessdata.fda.gov/scripts/cder/ob/default.cfm and search by proprietary name or active ingredient; in the search results, look for the line where the RLD field is labeled “Yes.”
Please note that even though FDA publishes a list of authorized generic products (www.fda.gov/AboutFDA/CentersOffices/CDER/ucm126391.htm), it is only updated quarterly and companies only report authorized generics marketed on a yearly basis. If you have questions regarding an authorized generic, you should contact FDA or the Board of Pharmacy.