“FDA Approved Medications” - what does this mean?
Many writers in many forums warn against buying medication over the Internet. Some warnings are quite reasonable with counterfeiting and expired stock being genuine concerns held about products supplied by unverified online pharmacies. However when consumers are warned against buying products because they are “not FDA approved”, what does this mean and why is it an issue?
The FDA must to approve any product before it is able to be sold in the USA. However this approval is not just related to product safety and efficacy, it also relates to the product packaging and batch number.
This means that some batches of many major brand name products may not be FDA approved while others are. A good example is found with Lipitor tablets. Lipitor has been the biggest selling pharmaceutical product in the world. Because of the volume required internationally all Lipitor tablets were manufactured at the same manufacturing facility located in Ireland. Some of these tablets were also packaged in Ireland while others were shipped to other parts of the world to be packed.
Unless a specific batch and pack of Lipitor was submitted to the FDA for approval it would therefore never be “FDA approved”. So if half of a batch was packed for the US market and the other half (of exactly the same batch) was sent to Australia and packaged there for the Australian market. The Australian Lipitor would not be “FDA approved”.
But (I hear you ask) won’t all of the tablets from this ’state of the art’ manufacturing facility in Ireland be of the same high quality? ANSWER - Of course!! Consumers should therefore be a little cynical about some of the warnings given about buying medication online. While it is often true that the products offered “are not FDA approved”, the safety implications associated with this statement can be ZERO!