FDLI's Introduction to Drug Law and Regulation Course

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 
1951
 
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)
 
C. OTC by NDA
 
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