ComplianceOnline

Course Description:

The U.S. Food and Drug Administration (“FDA”) regulates a wide variety of consumer products including prescription drugs (“Rx drugs”), branded and generic drugs, over-the-counter drugs (“OTC drugs”), dietary supplements and cosmetics.

This seminar will provide an introduction to how the FDA regulates each of these products, potential enforcement actions for non-compliance and the various import / export laws applicable to products coming into the country from outside the U.S. Attendees will learn about the FDA’s drug approval process (NDA and BLA) that is necessary to sell a new prescription drug in the U.S.

This course will also provide an introduction to the FDA’s regulation of OTC drug products and the various methods for bringing such a product to market. Participants will learn the various options for marketing an OTC drug, gain an understanding of the FDA’s relevant labeling and promotional rules, and learn strategies for mitigating the potential risk for FDA regulatory enforcement. It will also cover the requirements needed to market and sell homeopathic drugs, dietary supplements and cosmetics in the United States.

Attendees will then learn about the U.S. import and export regulations. Compliance with U.S. import and export customs’ laws requires an understanding of the Customs & Border Patrol’s (“CBP”) regulatory framework and how goods clear CBP into the commerce of the United States. This part of the course summarizes a vast array of customs law topics and focuses on some of the primary customs compliance requirements.



Learning Objective:

Upon completing this course on regulation of pharmaceuticals, OTC drugs and cosmetics participants will understand:

  • FDA’s regulations of pharmaceuticals, OTC drugs, dietary supplements and cosmetics.
  • FDA drug approval process covering branded drugs and generic drugs.
  • Requirements for the marketing and selling of homeopathic drugs and how they must be labelled to comply with the FDA’s regulatory requirements.
  • How to sell OTC drugs in the U.S. and choosing between an NDA approved drug and an OTC monograph drug product.
  • How to avoid FDA enforcement action when labelling and advertising a dietary supplement or vitamin.
  • What one needs to know about the FDA’s rules on selling cosmetic products including shampoo, perfume, skin cream, soaps, wrinkle creams and moisturizers in the U.S.
  • Strategic recommendations for preparing for an FDA facility inspection
  • How to distinguish between the different types of enforcement action.
  • The process for successfully exporting pharmaceuticals, OTC drugs, vitamin and cosmetics to the U.S.; and complying with CBP’s rules.


Who will Benefit:

This course is designed for people tasked with developing a regulatory and business strategy for the marketing and sale of pharmaceuticals, OTC drugs, homeopathic drugs, dietary supplements and/or cosmetics in the United States. This includes individuals who are responsible for ensuring that their company’s products comply with the FDA’s regulatory requirements and obtaining the relevant approval or acceptance needed to market and sell such products, and those tasked with the shipping and exporting drugs, dietary supplements and cosmetics to the U.S. The following personnel will benefit from the course:

  • Brand, Generic and OTC Drug Manufacturers
  • Senior Regulatory Professionals
  • Compliance Professionals
  • OTC Drug Developers
  • Cosmetic Developers
  • Corporate Legal Departments
  • Pharmaceutical, Dietary Supplement and Cosmetic Exporters & Importers
  • Regulatory Consultants
  • Research Analysts
  • Production Supervisors
  • Quality Control Personnel
  • Medical Affairs
  • Regulatory Auditors
  • Customs Brokers
  • Product Labelers, Relabelers and Contract Labelers
  • Contract Manufacturers
  • Governmental Officials
  • Investment Analysts
  • Venture Capitalists
  • M&A Professionals




Day One (8:30 AM – 4:30 PM) Day Two (8:30 AM – 4:30 PM)

Registration Process: 8.30 AM - 9.00 AM

Session Start Time: 9.00 AM
  1. Introduction to the United States Food and Drug Administration (“FDA”)
  2. The Federal Food, Drug & Cosmetic Act (“FDCA”) – Statutory and Regulatory Requirements
  3. FDA’s Regulation of Pharmaceuticals
    1. Definitions
    2. The Investigational New Drug Application (“IND”)
    3. The premarket review and approval process
    4. Substantiating safety and efficacy
    5. Branded drug products or “NDAs”
    6. Generic drug products or “ANDAs”
    7. Current Good Manufacturing Practices (“cGMPs”) for drugs
    8. User Fees, waivers and fee reductions
  4. FDA’s Regulation of Over-The-Counter (“OTC”) Drug Products
    1. OTC NDAs
    2. Drug monographs
      1. Examples of monographs
      2. Elements of the drug facts panel
      3. Ingredients
      4. Labeling and marketing
      5. Revisions and modifications to an existing monograph
    3. Rx-to-OTC switch drugs
      1. Definitions
      2. Procedural requirements
      3. Examples
    4. Enforcement actions
  5. FDA’s Regulation of Homeopathic Drug Products
    1. Definitions
    2. Acceptable ingredients
    3. Labeling and marketing
    4. Enforcement action
      1. “The Zicam Case”

  1. FDA’s Regulation of Dietary Supplements
    1. Selling vitamins and minerals
    2. Product definitions
    3. Using new dietary ingredients
    4. Introduction to the dietary supplement GMPs
    5. Labeling and Marketing Rules and Recommendations
      1. Label and labeling requirements
      2. Structure / function claims
      3. Health claims
      4. Qualified health claims
    6. FDA Enforcement Action
      1. Concerns
      2. Recent Warning Letters and non-compliance
  2. FDA’s Regulation of Cosmetics
    1. Definitions
    2. Examples of cosmetics
    3. Ingredient safety
    4. Labeling and advertising
    5. Facility registration
  3. FDA Facility Compliance Inspections
    1. Preparing for Inspections
    2. Mock inspections
    3. Notice of inspection
    4. The Inspector
    5. The actual inspection
    6. The close-out inspections
    7. The Form FDA 483 and the company’s response
    8. Strategic recommendations for a successful inspections
  4. FDA Enforcement Procedures
    1. The Concepts of “Adulteration” and “Misbranding”
    2. Warning Letters
    3. Seizures
    4. Injunctions
    5. Civil and criminal penalties
    6. “The Park Doctrine”
  5. FDA’s Regulations of Import & Exports
    1. Import Regulations
      1. Legal authority
      2. Prior notice requirements
      3. Import alerts
      4. Import detentions
    2. Export Regulations
      1. Certificates of Free Sale
    3. Product Specific Issues
      1. Pharmaceuticals
      2. APIs
      3. OTC drug products
      4. Homeopathic drug products
      5. dietary supplements
      6. Cosmetics
    4. Customs and Border Protections (“CBP”)
      1. Essentials
      2. Importer’s liability
      3. Tariff classification and product duties
      4. Country of Origin and marking
      5. Customs entry process
      6. Enforcement
      7. Import licenses and tariffs
    5. Strategic Recommendations for FDA Compliance and Successful Imports / Exports





Meet Your Instructor

Karl M. Nobert
Food and Drug Regulatory Attorney, The Nobert Group LLC

Karl M. Nobert is a food and drug regulatory attorney with the Nobert Group LLC. Mr. Nobert provides regulatory advice and counseling to both large and small domestic and international pharmaceutical companies on regulatory issues related to the U.S. Food and Drug Administration’s review and approval of new drug products. This includes counseling clients on FDA’s regulation of prescription branded and generic drugs, and over-the-counter drug products. He also has considerable experience related to the regulation of biologics including cellular and genetic therapies, and veterinary drug products. He frequently presents and has published on such topics.





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