Drug

Gain market share with your OTC drug products while meeting FDA regulations

Getting drug products approved is a complex process. In many cases, OTC drugs need to be approved by the FDA before they are marketed. However, there are some exceptions.

If your products comply with the FDA’s OTC monograph regulations, you don’t need any FDA approval before marketing your products. However, they do need to be registered and listed with the FDA. 

The OTC monograph is a “recipe book” outlining which ingredients can be used and how. If you meet these requirements, then the drugs are classified as GRASE, which stands for “generally recognized as safe and effective.”

If you sell homeopathic drugs, keep in mind that if they meet the new Compliance Policy Guide regulations, you don’t need FDA approval before marketing. However, the products will still need to be registered and listed with the FDA.

At FDA Atty, we have extensive experience helping our global clients navigate the complicated FDA regulations around OTC and homeopathic drugs. Here’s how we can help:

Label and advertising review: We offer regulatory counseling to determine whether your product needs prior approval before marketing. Plus, we review labels and product packaging, in addition to marketing materials like ads, websites, and point-of-sale material, to ensure it’s all in compliance with FDA regulations.

Classification review: Confused on whether a product is a cosmetic, drug, or both? Wondering if an FDA monograph applies? FDA Atty can guide you to the right answers through a classification review.

Adverse event reporting and record keeping: If there have been any adverse events related to your drug products, you’re required to report them to the FDA. We help clients develop standard operating procedures so you can easily identify and report the events, train your staff, and maintain compliance.

Export certificates: With all of the different export forms you need, how do you know you’ve got the right ones? As specialists in FDA regulation, we can help you identify the right forms, fill them out correctly, and ensure that your drug products don’t cause any issues at the border.

Feel confident knowing you’ve got an FDA expert on your side, looking out for your business. Click the button below to contact FDA Atty and start the process. 

How We Help

Services

Are you in trouble with the FDA?

Don’t panic — you’ve got backup. Download 5 Tips to Help You Navigate FDA Enforcement and learn how to resolve the situation now.

Expert knowledge of FDA regulations that helps you strategically grow your business