FDA Regulations for Commercializing OTC Drug Products

Instructor: Karl M. Nobert
Product ID: 706453
Training Level: Basic to Intermediate
  • Duration: 120 Min
The U.S. Food and Drug Administration’s is responsible for regulating the Over-the-Counter Drug market. In this webinar, attendees will learn what is required to market and sell an OTC drug in the U.S. It will provide information on what is an OTC drug, how they are regulated, the different types of products, how to read a Monograph, whether or not a certain ingredient can be used, the parts of a proper label, and a variety of other important requirements needed to be successful.
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Read Frequently Asked Questions

Why Should You Attend:

  • Do you know how to properly market and sell an OTC drug in the U.S.?
  • Are the ingredients in your product safe? Does your label comply with the regulations?
  • If you are already selling OTC drugs, are you ready for an FDA facility inspection?

Areas Covered in the Webinar:

Participants who attend this course will:

  • Gain a comprehensive understanding of how OTC Drug Products are regulated in the U.S.
  • Learn to distinguish between a potential Rx pharmaceutical product and an OTC drug.
  • Recognize the difference between the various pathways for commercializing an OTC Drug Product.
  • Understand how to identify and successfully navigate an OTC Drug Monograph.
  • Recognize when reliance on a Proposed Rule, Final Rule and/or Drug Monograph is appropriate.
  • Understand how to determine whether an Ingredient is considered Safe or GRAS/E for use in an OTC Drug and understand the difference between Category I, II and II Ingredient designations.
  • Identify the required elements of a compliant OTC Drug Label.
  • Take away strategies for marketing and promoting OTC drug products, and for mitigating potential enforcement risks.
  • Possess a working knowledge of the Rx-to-OTC Switch Process.
  • Review and evaluate several of FDA’s current OTC Monographs with a focus on the Cold & Cough and Oral Healthcare monographs.

Who Will Benefit:

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Production supervisors
  • Manufacturing engineers
  • Production engineers
  • Design engineers
  • Labelers and Private Labelers
  • Contract Manufacturers
  • Importers and Custom Agents
  • U.S. Agents of Foreign Corporations
  • Process owners
  • Quality engineers
  • Quality auditors
  • Document control specialists
  • Record retention specialists
  • Medical affairs
  • Legal Professionals
  • Financial Advisors and Institutional Investors
  • Consultants, Inspectors and cGMP Experts

From the following sectors:

  • OTC drugs
  • Pharmaceuticals
  • Drugs
  • Dietary supplements
  • Ingredient manufacturers
  • Distributors
  • Foreign drug companies

Free Materials:

  • Reference documents
  • Rule documents or guidance
  • Checklist
  • SOP template
  • Easy fill in forms
  • Articles
Instructor Profile:
Karl M. Nobert

Karl M. Nobert
President, ReCellerate, Inc.

Karl Nobert, Esq. is an FDA Regulatory Attorney with the law firm of Michael Best in their Washington, DC office.

Karl focuses his practice in FDA Regulatory law, representing U.S. and international clients in the food and drug industries with regard to pharmaceuticals and OTC drugs, biologics, medical devices, food and beverages including dairy products, cosmetics vitamins and dietary supplements; and veterinary products. He has particular experience in the areas of prescription drugs and regenerative medicine, and has counseled numerous clients seeking FDA approval for Rx drugs and cellular-based products to treat both humans and animals.

Karl has significant experience in the areas of understanding FDA product detentions and developing strategic solutions for the removal of companies and products from Import Alerts. He has successfully assisted multiple clients with resolving costly detention issues including a large Canadian food company with multi-national operations, several Japanese drug and ingredient manufacturers, a European beverage maker, an Israel-based pharmaceutical distributor and a start-up pet product company.

Follow us :
Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)
The Use of Drug Master Files & Quality Agreements

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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