Drug Quality and Dispensing – Part I

Physicians evaluating medication dispensing from their office often ask about the origin of the pharmaceuticals we distribute.  What they are really asking is “how do I know that you are selling me safe and effective pharmaceuticals?”  The first source to validate pharmaceuticals is the FDA.  The Orange Book is published annually by the FDA and is essentially a list of all pharmaceuticals evaluated by the FDA for safety and effectiveness.  For generics, the products should be rated AA, AB, AN, AO, AP or AT.  This indicates that they are considered therapeutically equivalent to the original brand product; therapeutic equivalence means the following:

1. They are approved as safe and effective;
2. They are pharmaceutical equivalents in that they
   1. (a) contain identical amounts of the same active drug ingredient in the same dosage form and route of administration, and
   2. (b) meet compendial or other applicable standards of strength, quality, purity, and identity;
3. They are bioequivalent in that
   1. (a) they do not present a known or potential bioequivalence problem, and they meet an acceptable in vitro standard, or
   2. (b) if they do present such a known or potential problem, they are shown to meet an appropriate bioequivalence standard;
4. They are adequately labeled;
5. They are manufactured in compliance with Current Good Manufacturing Practice regulations.

PCA Pharmaceuticals only distributes products rated in the Orange Book in the categories above.  Providers of medication dispensing solutions should be held accountable to distributing FDA approved products.  My next post will talk about some other things to look for when confirming quality and safety of pharmaceuticals.