Date: Oct 24-25, 2022.

Time: 10 AM ET to 2 PM ET

Duration: 2 day - 8 total hours, 4 hrs./ day.

Group Packages: Please contact ben@complyrules.com

FDA Regulations of OTC drugs Course Overview

This 2 day course online is intended to provide participants with the knowledge and skills needed to develop and produce an OTC Drug Product for marketing and sale in the U.S. Attendees will gain an understanding of the various available options for producing and selling an OTC Drug Product, will leave the workshop with an understanding of the U.S. Food and Drug Administration’s (“FDA”) regulation of such products, and will be provided with strategic recommendations for mitigating the risk of enforcement action in the future.

Have a Headache? Back from lunch and now experiencing mild occasional Heart Burn? Suffer from Allergies? Been stuck in bed with a Cough, Sore Throat, Nasal Congestion and a Fever you just can’t shake? Pitched the tent in Poison Ivy on last weekend’s family camping trip by mistake? Use Deodorant?

Over-the-Counter Drug Products or “OTC Drugs” include many of the well-known products that we use to treat or control the symptoms of occasional and moderate health conditions. Available without a prescription and for purchase directly off-the-shelf, OTC drug products currently represent nearly 60% of all drug products sold in the United States.

Anyone who has ever suffered from these or similar occasional symptoms and conditions has likely relied upon an Over-the-Counter Drug Product or “OTC Drug” to feel better. Go into any CVS Retail Pharmacy, Wal-Mart, Meijer Grocery Story, Rite Aid Retail Pharmacy or Target in the United States; you are guaranteed to find store shelves lined with hundreds or even thousands of different OTC Drug products. Some of the most recognized OTC drug products include ibuprofen tablets, anti-itch creams, nasal decongestant sprays, cough syrups, antacids, allergy medicines and topical pain relievers. Available without a prescription and bought right off the store shelf, OTC drugs are safe and effective when properly labeled and used as intended.

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 OCT drug products into the U.S. Under this current regulatory regime, there are 3 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”); or (c) via the currently popular Rx-to-OTC Switch Process.

Market studies suggest that there are currently over 300,000 OTC Drugs being marketed and sold in the U.S. today and that number is growing daily. This amounts to almost 60% of the total U.S. drug market (by purchases) and this number is expected to grow in the future. Based on these predictions alone, this is a profitable market and growth potential that drug and health product companies cannot afford to ignore.

If you can cook and follow a recipe; then you can make an OTC Drug Product with access to the necessary resources and an appropriate facility.

Training Agenda Day 1

• Overview of Drug Regulation in the United States
• Structure of FDA: Specifics of CDER
• Intro to the FDCA, Regulations, and Guidance Documents
• OTC drugs v. Rx Drugs
• History of Regulation of OTC Drugs in the US
• OTC Drug Review Process
• OTC Drug Monographs
• Final OTC monograph establishes the acceptable:
• Marketing the OTC drug product when the Monograph is not final.

Training Agenda Day 2

• 2020 Changes to the OTC Monograph System Under the CARES Act
• OMUFA and the Coronavirus Aid, Relief, and Economic Security (CARES) Act
• What to do about the Changes?
• Status of specific OTC Monographs, their included Regulatory Requirements and Strategies for Commercialization
• OTC Drug Ingredients
• Marketing a drug product that deviates from a final monograph
• OTC Drug Labels, Labeling, Marketing and Advertising Issues
• Definitions of the terms “label” and “labeling”
• Labeling includes the Immediate Container, Outer Packaging, Package Insert, Client Information Sheet, Shipping Label
• Elements of an OTC Drug compliant labelPromotional MaterialsStrategies for Regulatory Compliance
• FDA Enforcement Actions
• Park Doctrine – Corporate Official Liability under FDCA
• Overlapping Agency Jurisdiction – FDA, DOJ, FTC, USDA, and State Agencies

Learning Objectives:

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.

Who Will Benefit

This includes individuals responsible for overseeing regulatory affairs, developing strategies for obtaining drug product approvals and those tasked with ensuring corporate compliance. Among others, this includes:

• 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

Additional service: (Personalized session)

We also do various similar customized events for our clients and it is specially tailored as per the client's requirement. We arrange calls between clients and our course instructors to better understand the training requirement and accordingly a training program is designed. The course duration ranges between 90 Mins and 12 hours. Most 6 hours and 12 hours of classes are split into 2 to 3 days considering customer convenience.

We have 500+ consultants who are associated with us and each have their own specialization example GxP, GMP,GLP, 21 CFR, Computer system validation, FDA Audit & Inspection, Bioassays, Design Control, Data Integrity, FDA regulation, Clinical compliance, and almost everything that falls under Risk, Quality and Compliance arena in the Life Science industry

If you think that your team needs some kind of boost, update or refresher in Risk management and Regulatory compliance then let me know and we can design a highly cost efficient program for you.