Skip to main content

FDLI's Introduction to Drug Law and Regulation Course

Regulation of Over-the-Counter OTC Drugs


Date: February 6, 2019

Time: 5:45AM - 6:30AM

Location: Lake County, Illinois

Joanne Hawana will serve as an Instructor for a session entitled "Regulation of Over-the-Counter (OTC) Drugs" at FDLI's Introduction to Drug Law and Regulation Course.

FDLI will present a customized version of their popular Introduction to Drug Law and Regulation course. The company Abbvie is interested in training employees and introducing new members of their team to the field.

The session will have the following agenda:
A. Rx vs. OTC Status
1. Statutory Definition
2. Office of Prescription Drug Promotion (OPDP), Office of Medical Durham- Humphrey Amendment of 
B. The OTC Review and the Monograph Process
1. Legal Nature and Basis
2. Scope of Review
3. Completing and Amending the Monograph
a. Requirements pending monograph completion
b. Updating the monographs
4. Monography Requirements
a. Ingredients
b. Labeling Claims
5. Marketing New Dosage Forms under the OTC Review
6. New OTC Drug Labeling Requirements
7. Time and Extent Application (TEA)
D. Rx-to-OTC Switches
1. By Monograph
2. By NDA
3. The Switch Regulation
4. Non-Patent Exclusivity
5. “Forced” OTC Switches
6. Partial OTC Switches, e.g. Plan “B”
E. “Behind-the-Counter” OTC Drugs


Joanne counsels global clients on the regulatory and distribution-related implications when bringing a new FDA-regulated product to market and how to ensure continued compliance after a product is commercialized.