Legal, Regulatory and Compliance Forum on

Over the Counter Drugs

A comprehensive guide to the latest developments affecting non-prescription drug products

Tuesday, October 29 to Wednesday, October 30, 2013
The Carlton on Madison, New York, NY

Understand how the FDA’s NSURE Initiative Will Reshape the Tenants of the Current OTC Paradigm of Self Diagnosis and Self Care

FDA’s NSURE (Nonprescription Safe Use Regulatory Expansion) Initiative which seeks to establish a new paradigm for ‘OTC drugs with conditions of safe use’ will undoubtedly alter existing legal and regulatory protocols and product commercialization in the OTC space. Pharmacist assistance coupled with the use of new technologies and rapid diagnostic testing would in certain instances supplement the current OTC paradigm of self-diagnosis and self-care, thus leading to a multitude of controversies ranging from scope of FDA authority to potential liabilities. Additionally, the granting of OTC status to non-traditional switch candidates such as Oxytrol and the controversy over levonorgestrel also known as Plan B have led to new questions concerning how the NSURE Initiative may also impact the Rx-to- OTC switch mechanism.

Prepare to meet the challenges of the rapidly evolving legal and regulatory landscape of the non-prescription drug industry.

To help you make sense of the NSURE Initiative and in furthering the objectives of our inaugural OTC conference, ACI’s Second Annual Legal, Regulatory and Compliance Forum on Over the Counter Drugs will help you thoroughly comprehend the continuing evolution of the OTC landscape. By attending this event, you will understand how these latest developments will impact the existing legal and regulatory structures which frame the OTC environment.

A distinguished faculty of over two dozen leading legal and regulatory OTC experts — including current and former FDA representatives — will address the intricacies of this new proposal as well as existing challenges affecting such core OTC functions as advertising and promotion; labeling; trademarks, trade names and umbrella branding; and the modernization of the monograph system. They will provide you with the critical information that you now need to:

  • Understand how the NSURE Initiative may accelerate the approval of novel candidates for Rx-to-OTC switches
  • Examine how new technologies may cause new controversies in OTC labeling
  • Analyze how the use of social media in the OTC space has blurred the boundaries between advertising and promotion and labeling
  • Comprehend why OTC patent protection has implications beyond IP
  • Appreciate the unique legal and regulatory challenges associated with natural OTCs and the homeopathic pharmacopeia
  • Assess product classifications for international OTC launches
  • Overcome regulatory challenges associated with umbrella branding for monograph and NDA OTCs

Prevent and Enforcement Actions and Civil Litigation in the OTC Space by Mastering Critical AER, GMP and Recall Competencies.

This is the only legal and regulatory gathering specifically designed for the OTC drug industry which will address enforcement activity and preventative measures based on real world examples impacting non-prescription pharmaceutical products. Present and former FDA and FTC enforcers, NAD representatives and industry experts will help you:

  • Understand how recent FDA and DOJ — as well as FTC — enforcement in the OTC space will influence future trends and compliance obligations
  • Devise effective recall execution strategies
  • Implement stringent GMP protocols that will help your company avoid fines, violations and enforcement activity
  • Establish compliant protocols for adverse events in the OTC space pursuant to 21 USC §379aa, i.e., Serious Adverse Event Reporting for Nonprescription Drugs

Benefit from Special Training and Strategy Sessions that will Address the Legal and Regulatory Essentials of OTCs and Intricacies of Commercialization.

To enhance and complete your conference and networking experience, attend one or both of the following strategy sessions:

  • Domestic and International OTCs and Consumer Health Care Products 101: Understanding and Re -Evaluating the Essentials of OTC-Ness for An Evolving U.S. and Ex-U.S. Health Care Marketplace will provide an essential overview of the law and regulations governing over the counter pharmaceutical products in the U.S. as well as in other established markets and the developing world; and
  • Rx to OTC Switch Master Class- In-Depth Analysis and Legal and Business Strategies for Bringing Your Product Over the Counter will provide in-depth analysis of one of the most critical legal in regulatory mechanisms in the commercialization of OTC products.

Register Now.

Register today for the industry’s premier and most comprehensive legal and regulatory forum on OTC pharmaceutical products by calling 1-888-224-2480, faxing your registration form to 1-877-927-1563, or logging on to