When considering dispensing medications from their offices, physicians often ask about the origin of the pharmaceuticals we distribute. What they are really asking is “how do I know that you are selling safe and effective pharmaceuticals?”
The first source to validate pharmaceuticals is the FDA. Their Orange Book 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.
What is therapeutic equivalence?
- They are approved as safe and effective
- They are pharmaceutical equivalents in that they
(a) Contain identical amounts of the same active drug ingredient in the same dosage form and route of administration
(b) Meet compendia or other applicable standards of strength, quality, purity, and identity
- They are bioequivalent in that
(a) They do not present a known or potential bioequivalence problem and they meet an acceptable in vitro standard
(b) If they do present such a known or potential problem, they are shown to meet an appropriate bioequivalence standard
- They are adequately labeled
- They are manufactured in compliance with Current Good Manufacturing Practice regulations.
Northwind Pharmaceuticals only distributes products rated in the Orange Book in the categories above. When you partner with us, you can be sure you are getting the best, both in products and in service.Contact us today to learn how our solutions can work for you.
