The Basics- FDA OTC Drug Applications

FDA OTC Drug application

Over the Counter (OTC) or non-prescription drugs are therapeutic products considered to be safe and effective to be used by consumers without treatment from a health professional. There are currently more than 300,000 OTC drugs on the market in the U.S. Due to the sheer volume of products, the FDA reviews therapeutic classes of drugs, rather than the individual products. There are over 80 classes of OTC drugs (for example analgesics and antacids), and each category has an OTC Drug Monograph that outlines acceptable ingredients, doses, formulations, and labelling.

Once the final monograph is in place, OTC drugs can be produced and marketed without FDA pre-approval or review if they conform to the monograph. Products than do not conform have to submit a New Drug Application. The manufacturer can also request that the final monograph be updated to include additional ingredients or modified labelling.

Additional data for OTC monographs can be submitted by drug companies, health professionals, consumers, or citizen groups. If it is a request to amend an existing drug monograph or an opinion on a monograph, it needs to be submitted as a citizen petition or correspondence to an established monograph ticket.

There is a standardised format and content requirements for OTC drug product labelling. This covers the name, quantity per dosage unit and sometimes the proportion of each active ingredient. This makes it easier for consumers to read and understand product labels.

Manufacturers, packagers, or distributors can request an exemption or deferral of labelling requirements, for example due to trade secrets or commercial information that is privileged or confidential.

A request for an exemption or deferral should include:

  1. Cover letter outlining NDA or ANDA for approved drug products, a description of the products and shelf keeping units
  2. Table of Contents/index
  3. Copy of most recent marketed product label (for those under a monograph) and most recent approved labelling (for those marketed under an NDA or ANDA)
  4. Complete listing of all requested exemptions
  5. Explanation as to why the particular requirement is inapplicable, impractical, or contrary to public health and safety. The sponsor should also provide annotated labeling in the Drug Facts format indicating parts of the label where exemptions are requested
  6. Representation of proposed labeling including outserts, panel extensions, graphical or package techniques
  7. Information on the formatting, text style, and text size of the proposed labelling

 

A submission for labelling changes should include:

  1. Cover letter stating inclusion of new labelling in the Drug Facts for the product
  2. Table of Contents/index
  3. Most recent approved labelling
  4. Representation of proposed labeling including outserts, panel extensions, graphical or package techniques
  5. Information on the formatting, text style, and text size of the proposed labelling

 

If you require any assistance with OTC Drug Applications including NDAs and ANDAs, please contact Focal Point Research Inc.  We are industry leading U.S. Drug & FDA Regulatory Consultants that you can trust to help guide your company in the right direction.