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.
This course on FDA regulation of OTC drug products is intended to provide attendees 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 :
- Various available options for producing and selling an OTC drug product,
- U.S. Food and Drug Administration’s (“FDA”) regulation of OTC drug products,
- Strategic recommendations for mitigating the risk of enforcement action in the future.
Participants who attend this course on FDA regulation of OTC drugs 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
Facts about OTC Drugs:
- 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.
- Go into any CVS Retail Pharmacy, Wal-Mart, Meijer Grocery Story, Rite Aid Retail Pharmacy or Target in the United States; and you are guaranteed to find store shelves lined with hundreds or even thousands of different OTC Drug products.
Who will Benefit:
This course is designed for people tasked with formulation, manufacturing, labeling, marketing and promotion; and import / export of OCT drug products; and responsible for overseeing a company’s regulatory strategies. The following personnel will find this session valuable:
- 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
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? Anyone who has ever has 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.
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. 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.