Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations

FDA has authority over the formulation, manufacturing, labeling, marketing, promotion and import and export of OTC drugs in the US, and the Consumer Product Safety Commission also sets rules for them. This 90-minute OTC drug regulation training covers what you need to develop and sell an OTC product.

You'll compare the four pathways to market: following a drug monograph, an approved NDA, the Rx-to-OTC switch process, or an ANDA citing an approved product. You'll also learn how to navigate a monograph, judge ingredient safety categories and tell a potential Rx product from an OTC drug.

The session covers claims, cGMPs, tamper evidence and poison control, compliant labels, branded and generic products, and marketing strategies that limit enforcement risk.

• Explain how OTC drug products are regulated in the US
• Tell a potential Rx product from an OTC drug
• Compare the pathways for commercializing an OTC drug
• Navigate an OTC drug monograph and assess ingredient categories
• Identify the required elements of a compliant OTC label
• Describe the Rx-to-OTC switch process
• Market and promote OTC products while limiting enforcement risk

• Claims for drugs, devices, medical foods and cosmetics
• NDA, ANDA and OTC monograph pathways
• Rx-to-OTC switches
• cGMPs for OTC drugs
• Tamper evidence and poison control
• Branded innovator, branded generic and generic products
• FDA and CPSC requirements for OTC drugs
• Required elements of a compliant OTC label
• Ingredient safety categories and when to rely on proposed or final rules
• Marketing, promotion and reducing enforcement risk

OTC products face both FDA and CPSC requirements, and missteps in pathway, labeling or promotion can lead to enforcement action. This session explains your options and how to reduce that risk, including market differences between Rx and OTC products.

It suits regulatory, compliance, quality, marketing, product, labeling, R&D and document control staff, plus senior managers and business owners.

• Regulatory affairs managers, directors and associates
• Compliance specialists
• Marketing managers
• Quality professionals
• Document control specialists
• Record retention specialists
• Senior Managers / Business Owners
• Product Managers
• Labeling and Artwork Designers
• Regulatory and Quality Professionals
• Sales and Marketing Managers
• R&D Managers and Staff

Dr. Loren Gelber has worked in the pharmaceutical industry for more than 40 years, at both the FDA and in private industry. She has prepared more than 50 submissions to the FDA. Her specialty is compliance with US regulatory requirements. She has a BA in Biology, an MS in Chemistry and a Ph.D. in Medicinal Chemistry.