International Drug Companies Must Comply With US Law

Drugs, Regulation, and Crossing Borders

Have you ever wondered if International Drug Companies fall under the same regulations as US-based drug manufacturing companies do when selling those products inside the US border? For anyone who lives in the US and depends on the drugs that are available here, it is an important question. While there are some controversies over the FDA and how it approves new drugs, the average American does want to know that both over-the-counter and prescription drugs do meet FDA approval.

How Does The FDA Regulate Foreign And International Based Drug Companies?

Where a drug is made has no bearing on if that drug can be sold within US borders. Anytime a company wants to sell over-the-counter and prescription based drugs in the US they must go through the approval process set forth by the Federal Food and Drug Administration. The FDA sets forth a number of stringent rules that the manufacturers of drugs must meet to guarantee its quality as well as the product label requirements.

In order for a company to be approved for the production and sale of drugs in America, they must allow the FDA to give regular inspections of the manufacturing process and of course all ingredients to make sure that they meet all applicable laws and are in complete compliance with them. The Food and Drug Administration will test drugs that are sold in retail stores and manufacturing sites as well as distribution centers. If a complaint comes in from a consumer or from health care professionals about any concerns, then the FDA and will investigate the matter.

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Foreign-Made Drugs Are Rapidly Increasing In The United States

A very large amount of the drugs being sold inside the US are either fully and completely manufactured overseas or are manufactured here in the US but the process uses foreign-made ingredients in the drugs. In the last several years the amount of foreign made drugs and drugs with foreign ingredients has more than doubled and the estimates are that it is going to continue to increase in coming years. According to the FDA, its globalization initiative is designed to meet the difficult challenges of testing and processing imported drugs and products that are used in the drugs to ensure that they meet American Standards.

The FDA is working with foreign government agencies in the effort toward improving the relationships there and to better ensure that the FDA is able to inspect foreign-based drug companies and the products and drugs that are being produced there. As anyone would expect, it’s a complex and complicated matter and it’s one that is likely to always demand the utmost care. The FDA is hoping that this initiative will not only help them but also the government agencies they work with as these agencies all work together in reporting any drug situations that are found to be unsafe.

Obviously, the FDA is an organization that regulates the legal sale of drugs to Americans. For that reason, they do not regulate any type of illegal manufacturing of drugs. The sale of illegally manufactured drugs that are imported into America through the Canadian border or that are sold online are some of the drugs that do make their way into the US without being approved by the FDA.