Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations (Updated to address recent Homeopathic Drug announcements by FDA & FTC): One and a Half Day In-Person Seminar
Bill Schwemer, Principal, Schwemer Consulting and Former Senior FDA & Industry Official
Tuesday, March 1, 2016 | Wednesday, March 2, 2016
San Francisco, CA
Tuesday, August 2, 2016 | Wednesday, August 3, 2016
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.
Note: "Course updated to address recent Homeopathic Drug announcements by FDA & FTC."
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.
This course will also include a discussion on recent FDA Public Hearings aimed at changing the current FDA OTC Monograph System (hearing held February 2014) and Homeopathic Marketing Rules (hearing held April 2015)."
- 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.
Seminar Fee Includes:
USB with seminar presentation
Hard copy of presentation
$100 Gift Cert for next seminar
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
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.
|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
- 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
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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Tampa, FL (Venue to be announced shortly)
March 1-2, 2016
San Francisco, CA(Venue to be announced shortly)
August 2-3, 2016
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Tampa, FL, Local Attractions
San Francisco, CA, Local Attractions
Museum of Science & Industry (MOSI)
More than 450 activities await you at this non-profit facility dedicated to promoting a better understanding of science and technology. The Saunders Planetarium shows you the stars. Step inside the Gulf Coast Hurricane exhibit for a blast of tropical nightmare. At the IMAX Dome Theatre, the world is bigger than life, filled with odd sights and sounds on a huge screen. Souvenirs ranging from totes and T-shirts to puzzles and posters are available at the Science Store. For refreshment, the MOSI Café offers pizzas, salads and sandwiches. In late February, the BARF (Bay Area Renaissance Festival) takes place here.
Salvador Dali Museum
Housing the largest collection of Salvador Dali works in the world, the museum offers a regularly changing exhibit of the legendary surrealist artist's melting-watch canvases and a wide variety of his sculpture and fiber objects that are, at the very least, intriguing. One memorable creation toasts the cocktail party; it is a vest covered with full glasses of creme de menthe. Daily tours seek to explain this complex man and his equally complex art. In the museum store you can select a memento of your surreal experience. Do check the website or call for timings.
Tampa Museum of Art
Established in 1979, this museum houses more than 4,500 objects in its permanent collection and exhibits the largest collection of Greek and Roman antiquities in the Southeast. The Center Gallery displays themed exhibitions from the permanent collection. For a look at 19th and 20th century sculpture set against the backdrop of the Hillsborough River, visit the Terrace Gallery. Stroll through the Outdoor Courtyard featuring contemporary sculptures, fountains and bronze work. For gifts, books, children's items or home accessories, stop by the museum store.
Craftsman House is a gallery that showcases contemporary art works. The lush green lawns and beautiful garden welcome visitors in to this creative space. Owned and managed by Stephanie Schorr, it is a gallery-cum-working studio. Here, you will see umpteen art works displayed; jewelry, glass designs and much more work of local and national artists make for its splendid collection. It also has an on-site café serving delicious short eats and variety of beverages including beer and wines. Apart from the art works, Craftsman House also has a pottery studio that features colorful mugs, pots, vases and other wares that will adorn your living room. The innovative designs and art pieces are truly worth a look; so go ahead and visit the Craftsman House soon.
Located right across the street from Busch Gardens Tampa Bay, Adventure Island’s 30 acres of water-drenched fun in the sun features the ultimate combination of high-speed thrills and tropical, tranquil surroundings for guests of all ages. Within a soothing Key West atmosphere await slides, corkscrews, water falls, a wave pool, children’s water playground and other family attractions.
At Busch Gardens, animals roam free and you are the outsider. You can see the park by monorail, cable car or train. Roller coasters, wild animals, entertaining shows, rides, food, shopping, sightseeing, bird shows, exotic flowers, train rides, Serengeti adventures, river rapids...the list goes merrily on. Wear comfy walking shoes and spend the day at this 300-acre park. You can even taste the Anheuser Busch brew that started it all. Busch Gardens is open year-round with varying schedules. Call or see Web site for details.
Think Escape Party Bus
San Francisco Bay Area
Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line. Planning the perfect night on the town is easy with Think Escape's fleet of luxury buses and extended vehicles, each with different amenities for socializing and transport. Think Escape's Bay Area party bus rentals include free entry into selected exclusive nightclubs, professional hostess and chauffer, in-vehicle coolers stocked with amenities for a perfect night of partying.
Alcatraz Lunch Cruise
The Alcatraz Lunch Cruise is a luxurious way to get to see some of San Francisco’s favorite sights. A gourmet lunch buffet features options like asiago Caesar salad, bay shrimp salad, roasted chicken, garlic-herb roasted new potatoes and more. While guests enjoy lunch, they can take in views of San Francisco Bay’s flora and fauna, Angel Island and Alcatraz, and a live narration explores the history of Alcatraz. Please note that this tour doesn’t stop on Alcatraz Island.
Luxury Catamaran Sailing Cruise
A relaxing way to explore the San Francisco Bay is with the Luxury Catamaran Sailing Cruise. A drink bar and snacks are available for travelers’ enjoyment as they travel under the Golden Gate Bridge, around Alcatraz Island and even past a colony of sea lions. This is a peaceful San Francisco cruise option for families, and children under 5 ride for free.
City Kayak, located on San Francisco's Embarcadero close to the San Francisco Giant's ATT Park, offers a great way to experience San Francisco from Bay level, a point of view and a unique experience you'll not soon forget.
Think Escape Casino Tour
San Francisco Bay Area
San Franciscans may be familiar with Think Escape's party buses that shuttle the late-night crowds to and from various city nightclubs, but the Cache Creek Casino Escape is a little-known gem among Bay Area destinations. With personal charter service on the luxurious Fantasy Limo Bus to Cache Creek Casino and Resort, the Cache Creek Casino Escape tour is a smart choice for San Franciscans looking for a little gaming fun or planning a large group activity