Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations (Updated to address recent Homeopathic Drug announcements by FDA & FTC)

This interactive one-and-a-half-day seminar is intended to educate regulatory and quality professionals regarding the rather complicated regulations that distinguish Non-prescription Drugs from other products such as foods, cosmetics, dietary supplements and prescription drugs that sometimes contain the same ingredients. Recent FDA actions such as the banning of antibacterial soaps and ongoing programs that may impact manufacturers and private label distributors will be discussed. It will explain differences in the way homeopathic and conventional drugs are regulated and update participants on FDA’s application of GMP regulations to manufacturing low risk drugs that could be sold as cosmetics with the same ingredients, but different labeling.

The seminar will address issues such as:

• Registering facilities and listing products with FDA.
• How the intended use of the product owner defines a product?
• Can a drug contain both homeopathic and conventional drug ingredients?
• Update on activities following FDA’s 2015 Public Hearing on Homeopathic drugs?
• Information that must appear on principal display panels.
• Format and type size requirements for label text.
• Must you have a contract and/or separate quality agreement with a contract manufacturer?
• FDA’s OTC Drug Monograph rules and how they benefit small business.
• How an “old drug” can become a “new drug” subject to FDA’s rigorous approval process.
• The relationship of OTC Monograph labeling requirements to "drug facts" boxed labeling.
• Labeling products that have both OTC drug and cosmetic claims?
• What are basic requirements for marketing Homeopathic OTC drugs?
• GMP requirements for cosmeceuticals that can be met at lower cost.

While certain discussions will be applicable to solid dose form and other higher risk ingestible OTC drugs, including items recently switched from Rx to OTC status, this program is intended primarily to address topical liquid, suspension, ointment, powder, and emulsion products that have no dosage limitations.

Learning Objectives:

• Understand FDA rules and policies regarding manufacturing and labeling of low risk OTC drugs not covered by approved New Drug Applications.
• Learn the importance of knowing the legal definitions of FDA regulated products.
• Understand how labeling other than labels and advertising can define a product and cause it to be misbranded or considered a new drug.
• Differentiate cosmetic “puffery" claims from those that FDA would likely consider drug claims.
• Understand the differences between allopathic (conventional) drugs and homeopathic drugs.
• Recognize ways to manufacture low health risk products at minimum cost, yet still meet the intent and basic requirements of GMP regulations.
• Learn how to minimize the regulatory risk of a Warning Letter (or other FDA action) and what to do if you get one.