Regulatory Process to Sell OTC Drugs in the U.S

The United States has some of the strictest regulations when it comes to prescription drugs, OTC medications and any type of product that can be ingested or applied to the body. The FDA is the approving organization for these items so if you to market them in the US then you will have to follow the laid down rules.

The purpose of regulatory agencies like the FDA is to ensure that all citizens and residents within the country are protected from fraudulent manufacturers who are looking to make a quick dollar. There are many reputable companies all over the world that spend millions over a span of years to get a drug ready for the market. Unfortunately, there are others who will dress a product in the right packaging but because they took shortcuts it isn’t safe for users to consume and therefore should be banned from being sold in the market.

It is important to note that not every OTC (over-the-counter) drug has to be approved by the FDA but there is still a process and a list where it must be documented for tracking and accountability reasons. The majority of companies outside the U.S. may not be aware of which category they fall into which is why there are organizations that help them walk through the process and the paperwork to ensure that everything is completed correctly. When this gets done right the first time then the business has a better chance of getting their product to the market faster which allows them to build their profit and expansion.

The FDA Drug Establishment Registration service is provided to check patents on name brands, assist in submission of a new drug application and marketing approval. This can be done online with the help of a representative who will answer all your questions and give you the required information about fees, documents, forms and timeframes. The goal is make things as easy as possible for global manufacturers who want to sell their OTC, homeopathic and supplement drugs or even open up testing laboratories in the U.S. It is best to have all the data you are going to need on hand as the form is very detailed and specific about wanting to know ingredients (active and inactive), packaging and other relevant information.

Once submitted, the FDA will review and hand down a decision on whether you are approved to proceed or not but regardless, your application will be kept on file with their decision. Since you can submit the application online through the approved vendor this helps to speed up the process and get it into the right hands faster. Time is money and when you have invested a large amount of capital then it becomes extremely important to be able to get a return on that for yourself and the investors. This process ensures the safety of the consumers but also allows countries to market new products that can help with age old problems.

If you work for a drug manufacturing company and have a desire to expand your marketing stage to the United States then check out the online resources and tools that can help you get started. The FDA Drug Establishment Registration service process takes some time but the more complete your documentation is then the easier it is for the FDA officials to make a decision in your favor. This approval ensures that you will have no problems on the regulatory side of working with industry related stores in stocking their shelves.

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