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ON-DEMAND FDA Compliance

Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations

Learn how FDA and CPSC regulate OTC drugs, the pathways to market from monographs to Rx-to-OTC switches, labeling and cGMP rules, and how to reduce enforcement risk.

FormatRecorded sessionWatch any time
Length90 minutes
Dr. Loren Gelber Speaker Dr. Loren Gelber Pharmaceutical regulatory consultant · 40+ years in pharma and at FDA
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Overview

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.

Why attend: 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.

What’s covered

  • 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

Who should attend

Regulatory affairs managers, directors and associatesCompliance specialistsMarketing managersQuality professionalsDocument control specialistsRecord retention specialistsSenior Managers / Business OwnersProduct ManagersLabeling and Artwork DesignersRegulatory and Quality ProfessionalsSales and Marketing ManagersR&D Managers and Staff

What you get

CertificateEmailed to each attendee after the session.
HandoutsSlides and checklists to reuse with your team.

About the speaker

Dr. Loren Gelber
Dr. Loren Gelber
Pharmaceutical regulatory consultant

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.

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