Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations (COM)

Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations (COM)

This interactive one-and-a-half-day seminar is intended to educate regulatory and quality professionals regarding the rather complicated regulations that distinguish Non-prescription Drugs from other products such as foods, cosmetics, dietary supplements and prescription drugs that sometimes contain the same ingredients. Recent FDA actions such as the banning of antibacterial soaps and ongoing programs that may impact manufacturers and private label distributors will be discussed. It will explain differences in the way homeopathic and conventional drugs are regulated and update participants on FDA’s application of GMP regulations to manufacturing low risk drugs that could be sold as cosmetics with the same ingredients, but different labeling.

The seminar will address issues such as:
Registering facilities and listing products with FDA.
How the intended use of the product owner defines a product?
Can a drug contain both homeopathic and conventional drug ingredients?
Update on activities following FDA’s 2015 Public Hearing on Homeopathic drugs?
Information that must appear on principal display panels.
Format and type size requirements for label text.
Must you have a contract and/or separate quality agreement with a contract manufacturer?
FDA’s OTC Drug Monograph rules and how they benefit small business.
How an “old drug” can become a “new drug” subject to FDA’s rigorous approval process.
The relationship of OTC Monograph labeling requirements to "drug facts" boxed labeling.
Labeling products that have both OTC drug and cosmetic claims?
What are basic requirements for marketing Homeopathic OTC drugs?
GMP requirements for cosmeceuticals that can be met at lower cost.

While certain discussions will be applicable to solid dose form and other higher risk ingestible OTC drugs, including items recently switched from Rx to OTC status, this program is intended primarily to address topical liquid, suspension, ointment, powder, and emulsion products that have no dosage limitations.

Learning Objectives:
Understand FDA rules and policies regarding manufacturing and labeling of low risk OTC drugs not covered by approved New Drug Applications.
Learn the importance of knowing the legal definitions of FDA regulated products.
Understand how labeling other than labels and advertising can define a product and cause it to be misbranded or considered a new drug.
Differentiate cosmetic “puffery" claims from those that FDA would likely consider drug claims.
Understand the differences between allopathic (conventional) drugs and homeopathic 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) and what to do if you get one.

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.

Day 01(8:30 AM – 5:00 PM)
08.30 AM – 09.00 AM: Registration
09.00 AM: Session Start
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

Day 02(8:30 AM – 12:30 PM)
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

Bill Schwemer

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.”

Please contact the event manager Marilyn below for the following:
– Discounts for registering 5 or more participants.
– If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.

This Event Listing is Promoted by
New York Media Technologies LLC in association

at postal code 94117, United States

San Francisco, United States

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