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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 S. Hawana counsels global Mintz clients on regulatory and distribution-related considerations for new FDA-regulated products. She also advises clients on the business impacts of new federal and state actions on food, drugs, cosmetics, electronic nicotine systems, and medical devices.