FDA's Regulation of OTC Drug Products
Karl M. Nobert, Food and Drug Regulatory Attorney, The Nobert Group LLC
Coming soon.. Please contact customer care for new schedule
||Course "FDA's Regulation of OTC Drug Products" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
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 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.
Event Tags: OTC Drug Products, FDA regulations: formulation, manufacturing, labeling, marketing and promotion, import / export, New Drug Application (“NDA”), Rx-to-OTC Switch Process, GRAS/E, CFSAN, CDER, CBER, CDRH, CVM, ORA, Seizures, Injunctions, 21 USC §§ 303 and 307, FDA, DOJ, FTC, USDA, and State Agencies
Who will Benefit:
This course is designed for people tasked with formulation, manufacturing, labeling, marketing and promotion; and import / export of OTC 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.
|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
- Overview of Drug Regulation in the United States
- Role and function of FDA generally
- FDA’s purpose and mission
- FDA’s jurisdiction
- FDA’s six “product centers”
- Center for Food Safety and Applied Nutrition (CFSAN)
- Center for Drug Evaluation and Research (CDER)
- Center for Biologics Evaluation and Research (CBER)
- Center for Devices and Radiological Health (CDRH)
- Center for Tobacco Products
- Center for Veterinary Medicine (CVM)
- FDA’s operation
- Structure of FDA: Specifics of CDER
- CDER’s mission
- CDER’s jurisdiction
- CDER’s organization (discuss divisions and duties within each office)
- Introduction to the FDCA, Regulations, and Guidance Documents
- Overview of FDCA and regulations
- Introduction to FDA guidance
- OTC drugs v. Rx Drugs
- Differences between the two
- How to distinguish
- History of Regulation of OTC Drugs in the US
- Statutory and Regulatory Authority for OTC Drugs
- 1938: Federal Food Drug Cosmetic Act (FFDCA) drug safety requirement.
- 1951: Durham-Humphrey Amendments to Federal Food, Drug and Cosmetic Act (FFDCA) designated drugs that cannot be used safely without professional supervision as prescription drugs and all other drugs as OTC.
- In order for an OTC drug active ingredient to be included in an OTC monograph it must have been marked prior to May 11, 1972.
- Two legal pathways for OTC drug marketing post 1938.
- Marketing in compliance with drug monograph
- Marketing under the authority of an approved New drug application (NDA).
- OTC Drug Review Process
- New Drug Approval Process
- Rare for a company to pursue an approved NDA for a non-prescription drug because of the expense and effort involved with obtaining FDA approval.
- 1. The Rx-to-OTC Switch regulatory pathway is becoming increasingly popular as companies look for ways to extend the life cycle of their branded prescription products but similar to the option above, an Rx-to-OTC Switch requires FDA’s approval of an NDA.
- OTC Drug Monograph System
- Developed in the 1970’s in response to a whole class of marketed non-prescription drug products that existed in the market that had never been reviewed for safety and effectiveness.
- Attempt to “clean up” the market
- Development of the monograph process (or “OTC Drug Review”)
- OTC drugs as Generally Recognized as Safe & Effective (“GRAS&E”).
- OTC Drug Monographs
- Notice of Proposed Monograph
- Proposed Final Monograph
- Final Monograph
- Final OTC monograph establishes the acceptable:
- active ingredients
- concentration of the active ingredients
- therapeutic claims
- labeling/warning requirements
- directions for use
- Marketing the OTC drug product when the Monograph is not final
- Policy Reasons Behind the Monograph Process
- Status of specific OTC Monographs, their included Regulatory Requirements and Strategies for Commercialization
- Cold & Cough
- External Analgesic
- Internal Analgesic
- Nasal Decongestant
- Skinning Bleaching
- Skin Protectants
- Other Monographs as appropriate.
- OTC Drug Ingredients
- Substantiating the safety and efficacy of a proposed new ingredient
- Showing why an Ingredient should be included in the Monograph
- The concept of GRAS
- Marketing a drug product that deviates from a final monograph
- Suitability Petitions
- OTC Drug Labels, Labeling, Marketing and Advertising Issues
- An OTC product's indications are limited to (a) those approved by FDA in the case of an OTC application or an Rx to OTC Switch product, or (b) the uses and indications included in the relevant monograph.
- Beyond those indications, other labeled uses and indications are not permitted.
- 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 label
- Active Ingredient
- Inactive Ingredients
- Other Information
- Promotional Materials
- Brochures, Press Releases, Flyers, Audio and Advertising
- Written Media, Broadcast Media, Internet Media, Social Media
- Strategies for Regulatory Compliance
- FDA Enforcement Actions
- Noncompliance and Enforcement
- FDA Enforcement Authority over Development, Manufacture, Marketing, and Distribution
- FDA’s Office of Regulatory Affairs (ORA): Responsible for field activities, imports, inspections, and enforcement policy
- Local, State, and Tribal governments
- Types of Enforcement Actions
- Warning Letters and Untitled Letters
- Monetary Penalties (21 USC §§ 303 and 307)
- Criminal Prosecution
- Park Doctrine – Corporate Official Liability under FDCA
- Overlapping Agency Jurisdiction – FDA, DOJ, FTC, USDA, and State Agencies
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.
Register by P.O. / Check
Yes, I want to attend "FDA's Regulation of OTC Drug Products".
Click here to download P.O. form
If you are paying by check:
Checks should be payable to MetricStream Inc. (our parent company) and mailed to:
2479 East Bayshore Road
Palo Alto, CA 94303
Send your team for maximum benefit.
Get your team up to speed!
Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount.
||Get 10% off
|3 to 6 Attendees
||Get 20% off
|7 to 10 Attendees
||Get 25% off
||Get 30% off
Call toll free on +1-888-717-2436 if you have any queries.
Register by Wire Transfer
If you wish to pay by wire transfer, please call us toll free on +1-888-717-2436
Terms & Conditions to register for the Seminar/Conference/Event
Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ email@example.com
Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)
Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future ComplianceOnline event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.
In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
Attendance confirmation and Documents to carry to the seminar venue:
After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.
Conference photograph / video:
By registering and attending ComplianceOnline conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by ComplianceOnline for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline for any kind of claims arising out of copyright or privacy violations.
If you wish to partner with us for this event
contact us: firstname.lastname@example.org
call us: +1-888-717-2436.
Media Partner Benefits
- Logo and company data on the event website.
- Logo on the conference material distributed during the conference.
- Media Partner’s brochure distributed along with conference material.
- Logo on all the mailings before and after the event.
- 10% discount to media partner's subscribers.
Media Partner to do
- Banner (min 728x90 or 468x60) on the Media Partner website.
- Insertion of the event in the event calendar, both printed and/or online.
- Announcement article of the conference on the Magazine and/or Website.
- Dedicated email blast to all subscribers of Media Partner.
- Article on the Magazine and/or Website after the conference.
If you wish to sponsor this event
contact Cruise Webster: email@example.com
call us: (207) 576-4173
South Beach is the most popular tourist attractions in Miami Florida located at east of Miami city, proper between Biscayne Bay and the Atlantic Ocean. The beach is the ideal place for a breath of fresh air beach style. It is perfect place for sunbathing, shopping or just watching people passing by on the beach.When the sun sets on South Beach, daytime shoppers become nighttime club-hoppers at a diverse array of nightspots.
It is a 38-acre (15 ha) oceanarium (oldest in the US) located on the island of Virginia Key in Biscayne Bay. In addition to marine mammals, it houses fish, sharks, sea turtles, birds, reptiles, and manatees. The park offers daily presentations and hosts overnight camps, events for boy scouts, and group programs.
Zoo Miami is the largest and oldest zoological garden in Florida, and the only tropical zoo in the United States. It houses over 2,000 animals on 740 acres (299 ha), 324 acres (131 ha) of which are developed.
Miami Science Museum
The Miami Science Museum is a great learning place. The museum itself also contains the Space-Transit Planetarium, Weintraub Observatory and a wildlife center. Those interested in galaxies, stars, planets and the intricate workings of the universe can quench their thirst for knowledge here.
Coral Castle is a stone structure created by the Latvian American eccentric Edward Leedskalnin (1887-1951 in Miami-Dade County at the intersection of South Dixie Highway (U.S. 1) and SW 157th Avenue. The structure comprises numerous megalithic stones (mostly limestone formed from coral), each weighing several tons. It currently serves as a privately-operated tourist attraction. Coral Castle is noted for legends surrounding its creation that claim it was built single-handedly by Leedskalnin using magnetism and/or supernatural abilities.
Oleta River State Park
The Oleta River State Park is a 1,043-acre (4.22 km2) Florida State Park on Biscayne Bay. Although it offers a variety of recreation, it is best known for its miles of off-road bicycling trails, ranging from novice trails to more than 10 miles challenging trails for experienced mountain bikers.
Jungle Island (formerly Parrot Jungle) is an interactive zoological park in Watson Island, Miami. It offers visitors a fun, educational opportunity to get an up-close look at tropical birds in replicas of their natural habitats. The attraction routinely hosts field trips and offers frequent educational programs. Jungle Island is home to animal wonders like Hercules, a 900-pound liger and Peanut and Pumpkin, our twin orangutans.
No visit to Miami is complete without a stop at the historical 50-acre Vizcaya estate. This European-style mansion offers a glimpse at life in turn-of-the-century South Florida. It's also an extremely popular venue for galas, weddings and other entertainment events.