Over The Counter Drug Lawyer | FDA Consultant

Navigate FDA Homeopathic and OTC Drugs Regulations With Expert Attorneys

Getting FDA approval for OTC drug products is a complex process. In many cases, OTC products 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. This means you don’t need FDA homeopathic drugs 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. From export certificates, to classification reviews and FDA approval for OTC drugs, at FDA Atty we offer OTC and homeopathic drugs guidance for FDA regulations.

FDA Regulations for Homeopathic and OTC Drugs We Can Help With

• Label and advertising review: We offer regulatory counseling and homeopathic drug guidance for FDA regulations to determine whether your product needs prior FDA approval before marketing. Plus, we review your drug product’s labels and 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 homeopathic and OTC drug products don’t cause any issues at the border.