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Course Agenda
Day One (8:00AM - 4:00PM)

8:00 – 8:30 AM: Registration

8:30 –8:50: Needed Regulatory References & Resources

8:50- 10:00AM: Laws and regulations governing OTCs
  •  History & Background to U.S. OTC Regulations
  • FD & C Act Overview
  • U.S. Regulatory Milestone
  • How OTC drugs can be marketed in the U.S.A.

10:00 – 10:20 AM: Break

10: 30 - 12:00 The OTC Review & Monograph Process
  • What is a monograph?
  • Description of Ingredient review/classification and monograph process
  • When is an NDA or ANDA used in the OTC process?
  • What information does a monograph contain & different types of monographs
  • What if you want to deviate from the monograph (innovate)?
  • Future of the monograph process

12:00 – 12:45PM: Lunch

1:00– 2:15PM: OTC Drug Labeling Regulations
  • OTC Drug Labeling requirements/ Fair Packaging & Labeling Act
  • Drug Facts Labeling regulations
  • Tamper Evident Packaging requirements
  •  Drug Current Good Manufacturing Practices
·         Registration of drug facilities & drug listing requirements

2:15 – 2:40AM: Break

2:40 – 3:30PM: Dietary Supplement Health & Education Act (DSHEA) How Dietary Supplements differ from OTC Drugs

3:30 - 4:00  The role and authority of FDA in the U.S. OTC market
  • CDER’s Office of Nonprescription Drug Products
  • The Office of Drug Evaluation IV (ODE IV)
  • Office of New Drugs
  • Nonprescription Drug Advisory Committee
  • FDA Warning Letters & Enforcement Actions

Q & A Session

Workshop on FDA Warning Letters & Enforcement
Day Two (8:30 AM - 4:00PM)

8:30 -9:00 Defining OTC drug products
  • Drugs vs. Cosmetics vs. Supplements
  • Cosmeticeuticals; Nutraceuticals
  • When can a vitamin or cosmetic be considered a drug?

9:00 – 10:00AM: Overview of how an OTC drug comes to market
  • If it’s a new drug - NDA
  • Waxman Hatch- ANDAs and 505(b)(2)provisions
  • Grandfathered Drugs -Pre 1938
  • Rx to OTC switch (US)
  • Time & Extent Applications & NDA deviation
 
10:00 – 10:20 AM: Break

10:20 – 12:00 noon: When is a new drug suitable for OTC usage?
  • EU criteria for OTC vs. Rx usage
  • When must a drug be Rx only?
  • How do you switch a new drug from Rx to OTC?
  • Can a drug be Rx in some forms/dosages/etc., and OTC in others?

12:00 – 12:45PM: Lunch

12:45 – 2:15PM: FDA Adverse Event reporting & New Proposed Legislation
  • FDA Adverse Event Reporting requirements for OTC Drugs & Dietary Supplements
  • New Proposed Legislation for Personal Care products
  • FDA Compliance & Enforcement
 
2:15 – 2:30AM: Break

2:30 –3:30: OTC Advertising and Promotion
  • The role of the FTC in the U.S. & FDA vs. FTC
  • Labeling vs. Advertising and types of promotional claims
  • Advertising & Promotion of OTC Drugs - What's acceptable vs. What's not
 
3:30–4:00: Hands on Product Label & Warning Letter Review Workshop