Expertise. Understanding. Integrity. Period.



Over-the-Counter Drug Approvals: A Routine Matter That Requires Attention to Detail*

OTC drug approvals and compliance should be simple, right? After all, we are talking about over-the-counter drugs, nothing more complex than that. But in fact, there are a few key factors of which manufacturers and distributors should be aware when it comes to OTC drug approval and compliance by the US Food and Drug Administration (FDA):

1. OTC Drugs Are Not Always What You Might Think.

OTC drugs including products that we usually don’t even think of as drugs. Of course anti-acne products containing benzoil peroxide are OTC drugs, as are aspirin and acetaminophen, ibuprofen, etc. But there are some products that are also OTC drugs that no one would think are regulated by the FDA as drugs at all: These include antiperspirants that are often sold as deodorants as well, sunscreens, and toothpaste, as well as mouthwash. Companies could be refused access for products to the US market unless they comply with FDA regulations regarding OTC drugs for these products as well.

2. You Need Proper Labeling.

The FDA is very strict about what OTC drug labeling should contain. Any deviation could bring an enforcement action and even a recall of the products from the shelves. Common mistakes made involve format of labels (simple issues but issues that are easily missed), product claims that are not approved for OTC drugs by the FDA, and lack of correct ingredient content descriptions (in terms of correct units to be used under the Food and Drug Administration rules for weight and volume, for example). Proper regulatory and legal compliance counseling is essential for labels.

3. You Need Proper Registration of All “Establishments”. 

3.FDA requires registration not only of manufacturers, but also of labelers and distributors, and these have to have proper DUN and Bradstreet identifications.

4. You Need Proper Entry in the FDA OTC Drug Registration System.

You need a specialized computer technician to enter these drugs into the FDA system, without which no OTC drug can be legally sold and marketed in the US.

5. You Need an OTC Drug Quality System.

5.Your OTC drug product has to be produced using good FDA manufacturing practices, including adverse event records even for those who aren’t doing the actual manufacturing. This has to be in the format the Agency wants.

* Information contained on this page is not meant to constitute or substitute for specific legal advice addressing actual legal situations as is meant as general guidelines only. Readers are advised to seek competent legal counsel appropriate and tailored to their particular legal situation.