Alexander Gaffney of raps.org posted an interesting article regarding the current standing of the drug import system. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA may prohibit the import of any drug that has not been approved in the United States. Consequently, FDA is often required to either deny the product or detain it for further processing. This requirement presents a loophole to exporters: in the event that their product has been refused by FDA, its sponsor may request to have the drug returned (even misbranded or counterfeit drugs) and essentially gain the opportunity to resend it with a greater chance of passing inspection.
FDA’s major concern regarding these imports is the negative impact on consumer health because of misbranded dietary supplements and counterfeit drugs. In fact, FDA estimates that anywhere between 20 and 100 million packages containing drugs are imported into the U.S. each year, many from questionable online pharmaceutical sources.
In an effort to solve this issue of imported drugs, a proposition has been created granting FDA authority to destroy any refused drug without providing its sponsor an opportunity for return as long as the value of the drug is less than $2,500. In this case, the owner of the drug would then receive a notice of intent to destroy from FDA.
To read the full article, click here.