Understand how to compliantly market, label and promote OTC drugs in U.S.

1. FDA Regulations for Marketing OTC Drugs in the U.S
Presenter
Norma Skolnik
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It is important to understand how to market, label and promote OTC
drugs in the U.S. to be compliant with FDA requirements.

2. PRESENTATION OUTLINE
1. OTC Drug Regulations Background: Basic
rules promulgated under the FD & C Act and
the FP&L Act.
• How OTC drugs can be Marketed in the U.S.
• OTC Monographs and their importance to
Drug Labeling
2. FDA Requirements for Marketing OTC Drugs
3. Drug Facts Labeling Regulations
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3. Needed References & Resources
• Federal Food, Drug and Cosmetic Act (FD&CA)
• Fair Packaging and Labeling Act (FPLA)
• Federal Registers re: Monographs and OTC
regulations
• Title 21 Code of Federal Regulations (CFR)
Parts 200-299 and 300-499.
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4. 1. Food, Drug & Cosmetic Act (FD&C)
Basic Requirements
• Requires drugs to be shown safe before marketing. Must be
NDA approved or comply with an OTC Monograph.
• Requires GMP compliance and authorizes FDA inspections
• Drug misbranded if labeling is false or fails to bear name &
place of business and accurate quantity of contents. Must
bear established name and statement of identity and state
active ingredients.
• Must have adequate directions for use and bear adequate
warnings.
• Quantity, kind & proportion of alcohol must be listed.
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5. OTC Drug Labeling Rules Background:
Fair Packaging & Labeling Act
• Requires labels of all consumer products to bear:
1. the identity of the product
2. Name and place of business of the manufacturer,
packer or distributor
3. the net quantity of contents
• Such requirements similar to those of FD&C Act
A 1994 amendment requires contents to be stated in
metric and U.S. customary units
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6. Principal Display Panel (PDP)
Requirements
• Statement of Identity must be on PDP
• When one exists, include established name followed by
pharmacologic category or main intended action, e.g. antacid.
Example: Ibuprofen Tablets, 200 mg.
Pain Reliever/ Fever Reducer
• State prominently in bold face type, parallel to the base –
Size to be reasonably related to prominent printed matter.
• Net Quantity of Contents: Express in bottom 30% of PDP as
weight, measure, numerical count or combination thereof
(e.g. 20 tablets, 10 mg. each). Fluid measure used for liquids.
Quantity of Contents must be distinct and separate.
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7. To see the complete presentation check the
below link:
http://www.audioeducator.com/pharma-biotech/fda-regulations-otc-drugs-
09-18-2014.html