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Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations (Emphasis on Topical Products): One and a Half Day In-Person Seminar

By:
Bill Schwemer, Principal, Schwemer Consulting and Former Senior FDA & Industry Official
Location 1:-
San Diego, CA

Tuesday, March 17, 2015 | Wednesday, March 18, 2015
Location 2:-
Chicago, IL

Thursday, June 4, 2015 | Friday, June 5, 2015

Course Description:

This interactive one and a half day seminar is intended to help companies understand the legal definitions of cosmetics, drugs, dietary supplements and why certain labeling statements for non-drug products may cause the agency to consider them new drugs without FDA approval.

The instructor, a leading industry expert and former FDA official, will explain differences in the way homeopathic and conventional drugs are regulated and how the risks presented by different types of drug products affect the rigor of FDA enforcement of Good Manufacturing Practices Regulations. A workshop will be held at the finale of the course to emphasize certain issues by having participants review labels of misbranded products and examples of recent FDA Warning Letters.

The seminar will address issues such as:

  • How both labeling and advertising establishes ‘intended use’ which defines a product?
  • When cosmetics, dietary supplements and foods might become drugs requiring FDA approval?
  • How OTC drug monographs can help one to formulate products and design labels?
  • Why are OTC drug/cosmetic combinations (cosmeceuticals) allowed, but not OTC drug/dietary supplement combinations?
  • What are common personal care product ingredients that have both cosmetic and drug uses?
  • The restriction on combining allopathic and homeopathic ingredients in a drug formula.
  • Things that one needs to know when designing labels:
    • Creative product names can cause a product to be misbranded.
    • Proper formatting of Drug Facts boxed panels.
    • Type size requirements and placement of information on principal display panels.
  • Changes FDA now believes may be needed in monograph content and in changing monographs.

Seminar instructor Bill Schwemer is an ex-FDA official with more than 50 years of experience in dealing with FDA compliance matters that include 30 years he spent working with the FDA as a field investigator, director of field investigations, assistant associate commissioner for regulatory affairs, and special assistant to deputy commissioner for policy.




Learning Objectives:

  • Understand FDA regulations and policies regarding manufacturing and labeling of OTC drugs covered by OTC drug monographs (minimal information is provided to contrast the new drug approval process).
  • Learn the definitions of drug, cosmetic, and dietary supplements.
  • Obtain tips on how to research FDA’s OTC drug monograph rulemakings.
  • What labeling other than labels can define a product and cause it to be misbranded as a new drug.
  • Learn that certain ingredients are safe and suitable for use in both drugs and cosmetics.
  • Differentiate cosmetic ‘puffery’ claims from claims that FDA would likely consider drug claims.
  • Learn how to formulate and label cosmeceuticals (cosmetics which are also drugs).
  • Understand the differences in how allopathic (conventional) drugs and homeopathic drugs are regulated.
  • Learn the basic requirements for marketing homeopathic OTC drugs.
  • Recognize ways to manufacture low health risk products at minimum cost, yet still meet the intent and basic requirements of GMP regulations.
  • Learn how to minimize the regulatory risk of a Warning Letter or other FDA action.


Who Will Benefit:

This course is intended for personal care product manufacturers and other businesses that wish to develop and/or market drugs that do not require FDA approval. It will also benefit cosmetic, nutritional, liquid soap and other companies that are considering health related claims for their products, but wish to avoid labeling that would make them new drugs lacking FDA approval. While the emphasis is on topical OTCs, well over half of the presentations are also applicable to OTCs taken internally. It will especially benefit own label distributors and smaller firms that do not have a regulatory professional on their staff. This includes:

  • Senior Managers / Business Owners
  • Product Managers
  • Labeling and Artwork Designers
  • Regulatory and Quality Professionals
  • Sales and Marketing Managers
  • R&D Managers and Staff


Topic Background:

A company may begin to manufacture OTC drug products without any consultation with the FDA or the agency's approval. However, drug registration and listing forms shall be submitted to the FDA when marketing begins. The allopathic or conventional drug products, including cosmeceuticals, need to conform to an OTC drug monograph. Monographs are not established for homeopathic drugs; however, both allopathic and homeopathic drugs need to be manufactured in conformance with FDA's Good Manufacturing Practices (GMPs) regulations. A few GMP requirements are not required for homeopathic drugs and generally the rigor and therefore the cost of implementing adequate GMPs for low risk OTC drug products can be less.





Course Outline:

Day One (8:30 AM - 5:00 PM) Day Two (8:30 AM - 12:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

  • 9:00 AM - 9:15 AM: Introduction
  • 9:15 - 10:15 AM: Overview of Law and Regulations for Drug Products
    • History of legislation
    • Prohibited acts
    • Basic labeling definitions/requirements
  • 10:15 - 10:30 AM: Break
  • 10.30 - 11:15 AM: Labeling Idiosyncrasies - Cosmetics, Drugs, Dietary Supplements
    • Defining personal care products
    • Identifying confusing regulatory issues
  • 11:15 - 12:00 PM: OTC Monographs - Focus on Topical Products
    • How they are established
    • Product categories
    • Requirements
  • 12:00 - 1:00 PM: Lunch
  • 1:00 - 1:45 PM: Cosmeceuticals - Cosmetics that are also Drugs
    • Dominance of drug labeling rules
    • Monographs most applicable to cosmeceuticals
    • Placing cosmetic and drug claims on labels
  • 1:45 - 2:30 PM: More on Monographs
    • Comparing rulemakings
    • Finding your way to useful information in rulemakings
    • FDA seeking changes in monograph process
  • 2:30 - 3:00 PM: OTC Drug Facts Labeling
    • The boxed labeling format
    • Relationship to monographs
  • 3:00 - 3:30 PM: Break
  • 3:30 - 4:15 PM: FDA Policy Regarding Marketing Homeopathic Drugs Understanding CPG 400.400
    • FDA concern about health fraud
    • What is a homeopathic product
    • Labeling requirements
  • 4:15 - 4:45 PM: Reporting Serious Adverse Events to FDA
    • Define reporter, adverse event and responsible person
    • When and how to report
  • 4:45 - 5:00 PM: Q & A

  • 8:30 - 10:00 AM: Complying with Finished Drug CGMPs (for Low Risk Products)
  • 10:00 - 10:30 AM: Break
  • 10:30 - 11:00 AM: FDA Guidance: Contract Manufacturing of Drugs
  • 11:00 - 12:15 AM: Workshop
    • Review labels and comment
    • Review and discuss FDA Warning Letters
  • 12:15 - 12:30 PM: Wrap-up, Hand Out Certificates





Meet Your Instructor

Bill Schwemer
Principal, Schwemer Consulting and Former Senior FDA & Industry Official

Bill Schwemer is an ex-FDA official with more than 50 years’ experience in FDA compliance matters. He was an FDA field investigator and compliance officer in two districts. As director, division of field investigations, he managed the FDA foreign inspection program and his staff supported the district investigations branches. He was a senior official in FDA's Office of the Commissioner in both the Offices of Regulatory Affairs and Policy. His industry experience includes V-P of RA/QA at a personal care products company and consulting for businesses nationwide and in Europe and Asia. His consulting business in recent years has been primarily for pharmaceutical and personal care products companies. He has published more than 125 articles and since becoming a consultant has successfully served as a regulatory compliance expert witness in 22 lawsuits.

In his FDA Office of Regulatory Affairs positions, Mr. Schwemer had insights on all current OTC Drug Compliance Policy Guides (CPGs) and approved either original drafts or revisions on behalf of the office. Recently, he petitioned FDA to revise the CPG “Conditions Under Which Homeopathic Drugs May be Marketed.”





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March 17-18, 2015, San Diego, CA
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San Diego, CA, Local Attractions

Chicago, IL, Local Attractions

The first European to set foot in California was the Spanish explorer Juan Rodriguez Cabrillo, who stepped on shore near this spot in in 1542. He's the guy they made this statue to look like - and named the park after. We don't know if Cabrillo climbed all the way up to the top of this promontory or not, but people who make up here nowadays get some of the best views of San Diego, looking across the Bay and back toward downtown.




Birch Aquarium is north of San Diego in La Jolla. It's not as big as some of the other aquariums in California or as flashy as the big sea-themed park down the road, but instead just right, filled with interesting exhibits and home to leafy sea dragons like the one above, creatures so improbably they look more like something from a children's book than from the ocean.




Legoland theme park takes its inspiration from Lego toys, those cute little bricks that snap together to build all kinds of fun things. It's one of several Legolands worldwide.




The San Diego Zoo's sister park offers a different kind of animal experience. Its name (Safari Park) is the clue and it indeed offers a more safari-like experience. Lots of large animals live in the same big, open areas here - predators kept away from prey, but otherwise much as they would in their natural habitat.




Coronado isn't really an island but a peninsula - a fact that doesn't get in the way of the name most people use for it. Whatever you call it, it's on a slender strip of land between the San Diego Bay and the Pacific Ocean, barely a few blocks wide. What it lacks in size it makes up for in fun, with a beach that's been named among the best in the country, a classic hotel and a compact, lively little downtown. Coronado's laid-back temperament makes a nice break from the busier parts of San Diego across the water.




Originally built for temporary use during the 1915-16 Panama-California Exposition in San Diego, Balboa Park boasts buildings beautiful enough to be considered attractions in themselves, especially if you're a photographer. They're surrounded by trees, lawns and fountains, but that's only the beginning.




In Spanish, La Jolla means "the jewel," an apt name for a pretty, Mediterranean-style seaside town - sitting on cliffs flanking the ocean.
La Jolla visitors like to shop and eat in the nice restaurants, some of them with lovely ocean views. There's a lot for the active visitor, too, including ocean kayaking, tide pool-hopping, surfing at Windansea Beach, biking or running along the waterfront.



One of the more breathtaking scenes on the lake is this tall ship approaching the docks at Navy Pier. The 148-foot four-masted schooner (and its new sister ship, the Windy II ) sets sail for 90-minute cruises two to five times a day, both day and evening. (Because the boats are sometimes booked by groups, the schedule changes each week; call first to confirm sailing times). The boats are at the whims of the wind, so every cruise charts a different course. Passengers are welcome to help raise and trim the sails and occasionally take turns at the ship's helm (with the captain standing close by). The boats are not accessible for people with disabilities.




The building may be historic (it was the first planetarium in the Western Hemisphere), but some of the attractions here will captivate the most jaded video-game addict.

Your first stop should be the modern Sky Pavilion, where the don't-miss experience is the StarRider Theater. Settle down under the massive dome, and you'll take a half-hour interactive virtual-reality trip through the Milky Way and into deep space, featuring a computer-generated 3-D-graphics projection system and controls in the armrest of each seat. Six high-resolution video projectors form a seamless image above your head -- you'll feel as if you're literally floating in space. If you're looking for more entertainment, the Sky Theater shows movies with an astronomical bent; recent shows have included Secrets of Saturn and Mars Now!




With its gleaming-white, palatial, six-story grandstand and lush gardens, this racecourse is one of the most beautiful showcases for thoroughbred horse racing in the world. Its storied history stretches back to 1927, and such equine stars as Citation, Secretariat, and Cigar have graced the track. The annual Arlington Million (the sport's first million-dollar race, held in mid-Aug) attracts top jockeys, trainers, and horses and is part of the World Series Racing Championship, which includes the Breeders Cup races. Arlington's race days are thrilling to behold, with all of racing's time-honored pageantry on display -- from the bugler in traditional dress to the parade of jockeys.




You can't -- and shouldn't -- miss the Art Institute. (You really have no excuse, since it's conveniently located right on Michigan Ave. in the heart of downtown.) No matter what medium or century interests you, the Art Institute has something in its collection to fit the bill. Japanese ukiyo-e prints, ancient Egyptian bronzes, Greek vases, 19th-century British photography, masterpieces by most of the greatest names in 20th-century sculpture, and modern American textiles are just some of the works on display, but for a general overview of the museum's collection, take the free "Highlights of the Art Institute" tour Saturday and Sunday.




A truly grand theater with historic-landmark status, the Auditorium gives visitors a taste of late-19th-century Chicago opulence. Because it's still a working theater -- not a museum -- it's not always open to the public during the day; to make sure you'll get in, schedule a guided tour, which are offered on Mondays at 10am and noon.

Designed and built in 1889 by Louis Sullivan and Dankmar Adler, the 4,000-seat Auditorium was a wonder of the world: the heaviest (110,000 tons) and most massive modern edifice on earth, the most fireproof building ever constructed, and the tallest building in Chicago. It was also the first large-scale building to be lit by electricity, and its theater was the first in the country to install air-conditioning. Originally the home of the Chicago Opera Company, Sullivan and Adler's masterpiece is defined by powerful arches lit by thousands of bulbs and features Sullivan's trademark ornamentation -- in this case, elaborate golden stenciling and gold plaster medallions. It's equally renowned for otherworldly acoustics and unobstructed sightlines.







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