The Problems With Buying API From Foreign Sources

The Problems With Buying API From Foreign Sources

More than 80 percent of API is imported into the United States. The problem with buying API from foreign sources is that you do not know what you are getting.  For example, a pharmacetuical representative in Arizona may actually obtain its API from countries such as those in Asia or South America.  In some of these places, quality standards are very lax and counterfeit medications are more widespread and common. The identity, purity, potency and safety of drugs purchased from foreign sources is not guaranteed. It is essential that pharmacists know where the API orginated from even if they are purchasing the API from a company in the United States. Using sources of API whether the API comes from a foreign country or the United States without knowing the identity, purity, potency and safety of drugs simply to save money is not worth the exposure in liability, both civil and criminal, if a patient--human or animal--is injuried or dies from the use of these type of API.  All drugs and API distributed in the United States must comply with the Federal Food Drug and Cosmetic Act, regardless of where they are made. Note that it is illegal (with very few exceptions) to ship prescription drugs that are not approved by FDA into the US, regardless of whether the drug is legal to sell in another country. 

For more information click here.  
To see notes from an FDA seminar on imported API click here.
To review a FDA slide presentation on imported API click here.
To read prior testimony about API, click here.
To read news articles click here,  here,  here and  here
To read a 2012 report on India, click here.
To read an article published April 2012, that suggest better safeguards for imported drugs are needed, click here.
To read the FDA's report entitled Pathway to Global Product Safety and Quality, click here