ComplianceOnline

OTC Drug Regulations

Instructor: Loren Gelber
Product ID: 705446
Training Level: Intermediate
  • Duration: 60 Min

recorded version

$279.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Sep-2017

Training CD

$379.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

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Email: customercare@complianceonline.com

Read Frequently Asked Questions

This webinar will provide attendees with the knowledge and skills needed to develop and produce an OTC drug product for marketing and sale in the U.S.

Why Should You Attend:

This webinar will discuss U.S. FDA and Consumer Product Safety Commission regulation of OTC drug products and strategic recommendations for mitigating the risk of enforcement action in the future. Attendees will gain an understanding of various available options for producing and selling an OTC drug product.

FDA and CPSC requirements for OTC drugs will be covered. There will also be some discussion of the market differences between Rx and OTC products.

Learning Objectives:

  • 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

Areas Covered in the Webinar:

  • Claims for drugs, devices, medical foods and cosmetics
  • NDA, ANDA and OTC Monographs for OTC Drugs
  • Rx to OTC Switches
  • cGMPs for OTC drugs
  • Tamper Evidence and Poison Control
  • Branded Innovator, Branded Generic and Generics

Who Will Benefit:

  • Regulatory affairs managers, directors and associates
  • Compliance specialists
  • Marketing managers
  • Quality professionals
  • Document control specialists
  • Record retention specialists
Instructor Profile:
Loren Gelber

Loren Gelber
Regulatory Compliance Consultant (Ex-FDA Official)

Dr. Loren Gelber has worked in the pharmaceutical industry for more than 40 years, at both the FDA and in private industry. She has been involved in numerous launches of OTC drugs and in Rx to OTC switches. Her specialty is compliance with US regulatory compliance. She has a BA in Biology, an MS in Chemistry and a Ph.D. in Medicinal Chemistry.

Topic Background:

The Food and Drug Administration and the Consumer Product Safety Commission have regulations pertaining to OTC drugs. The U.S. Food and Drug Administration’s (“FDA”) is responsible for the regulation and oversight of the U.S. OTC drug market. Congress has granted FDA regulatory authority over the formulation, manufacturing, labeling, marketing and promotion; and import / export of OTC drug products into the U.S. Under this current regulatory regime, there are 4 pathways that a company may follow to enter the OTC drug market including (a) following an appropriate Drug Monograph; (b) with an Agency approved New Drug Application (“NDA”); (c) via the currently popular Rx-to-OTC Switch Process or (d) via an ANDA citing a previously-approved product.

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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.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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