This document discusses the labeling and advertising requirements for drugs. It covers topics such as the definitions of drugs and different drug types (OTC and prescription), labeling requirements, information that must be included on labels, and regulations regarding advertising. It also discusses the roles of regulatory bodies like the FDA and FTC in overseeing drug labeling and advertising.

1. FROM: BINDU
M.PHARM DRA
TO:DR. HARISH DUREJA
ASSOCIATE PROFESSOR
PHARMACEUTICS
MDU,ROHTAK
LABELLING & ADVERTISING
REQUIREMENTS FOR
DRUGS

2. INDEX
 DRUG CLAIMS
 TYPES OF DRUGS
 LABELLING
 INFO ON A LABEL
 ADVERTISING LAWS
 REGULATORY BODIES

3. DRUG (21 U.S.C. § 321(G))
Articles recognized in USP, HPUS, or NF;
and
 Articles intended for use in diagnosis,
cure, mitigation, treatment, or
prevention of disease; and
 Articles (other than food) intended to
affect the structure or function of the
body; and
 Articles intended for use as
components in any of the above
3

4. TYPES OF DRUGS
 Over-the-Counter (OTC) or nonprescription drugs
 Examples: aspirin, acetaminophen, cough medicine
 Prescription drugs
 Examples: blood pressure medicines, blood thinners, antibiotics,
eye drops
For all medicines, you must read and follow the directions!

5. LABELING
 labelling" has been defined' to include the display of
written material
 on the immediate container of a drug presenting
vital prescription information,
 any printed matter on a drug's containers or
wrappers, and
 any promotional or other material "accompanying
such article."'
 Classified as labelling are brochures, mailing
pieces, detailing pieces,
 literature reprints, reference publications containing
manufacturer supplied
 data, and similar literature disseminated to
physicians."
21 CFR 201.56(a)

6. FDA VS FTC
 FTC regulates advertising (cars, home
mortgages, mops, etc.)
 FDA regulates labeling and advertising (drugs,
medical devices, foods)
 Memorandum of Understanding - Ads
 FTC regulates ads for foods, OTC drugs, non-
restricted devices, cosmetics, dietary
supplements
 FDA regulates ads for prescription drugs and
restricted medical devices

7. READING THE OTC DRUG FACT LABEL
 Active Ingredient(s): Chemical compound in the
medicine that works with your body to bring relief
 Uses: This sections tells you the ONLY symptoms
the medicine is approved to treat
 Warnings: This section tells you what to avoid and
who should not use this
 Directions: Recommended daily dosage and
frequency. Follow this strictly
 Other Information: Tells you additional information
such as proper storage
 Inactive Ingredients: A chemical compound that has
no effect on your body

8. Product Name
Identity
Quantity
Manufacturer
Warnings/Caution Statement
Indications
Dosage/Directions
Lot No
Expire
Date
Active Ingred. & Amount

9. DRUG FACT LABEL

10. PRESCRIPTION MEDICATIONS
Dispensed in
limited
amounts by
Registered
Pharmacist
Designed to
protect
consumer
Prescribed by a
physician.

11. PRESCRIPTION LABEL
 Patient name and
address
 Prescriber’s name
 Drug name
 Pharmacy name
and date filled
 Special
Precautions/
Instructions

12. PRECAUTIONS FOR PRESCRIPTION MEDS
 Tell physician of previous
problems/allergies
 Keep list of ALL meds. currently using
 Understand directions
 Discuss side effects / Interactions
 Store properly
 Never take drugs in the dark
 Flush old drugs
 Keep in labeled containers
 Don’t use expired medicines

13. MEDICATION LABEL
A SYSTEM OF INFORMATION
 Primary container labels
(state regulated, FDA requirements)
 Auxiliary Labels (Warning Labels)
(industry-generated, not standardized)
 Consumer Medication Information (CMI)
(industry-generated)
 Medication Guides-Prescription only for providers
(28 developed by FDA)
 Patient Package Information (PPI)-for provider
(written by manufacturer approved by FDA)

14. PATIENT PRODUCT INFORMATION
(PPI)
 Extension of professional labeling for the patient
 Distributed to patients when dispensed and
includes Important information in consumer-
friendly language
 May describe benefits, risks, how to recognize
risks, dosage and administration
 May Include Special Notices (Boxed Warnings)
 Required for certain drugs
 oral contraceptives (21 CFR 310.501)
 estrogens (21 CFR 310.515)
 progestational drug products (21 CFR 310.516)

15. PROFESSIONAL LABEL
 Description
 name, dosage form, ingredients,
sterility, class, structure)
 Animal pharmacology
 Clinical Pharmacology
 Clinical Studies
 Indications and Usage
 Contraindications
 Warnings
 Precautions
 General precautionary information
 Drug interactions; carcinogenicity,
mutagenesis, fertility;
 Pregnancy/ nursing mothers;
 Special Populations – pediatric, geriatrics
Adverse Reactions
Drug Abuse and
Dependence
Overdose
Dosage and
Administration
 How Supplied
 Preparation for use
(shaking)
 Dose
 Route or method of
administration
 Frequency of administration
 Duration of administration
 Time of administration (e.g.,
meals)

16. EXAMPLE PROFESSIONAL LABEL
Professional Labeling: Isotrentinoin

17. ADVERTISING
 “Advertising” is not defined in the FDCA, but it is
commonly understood to include the promotional
materials or statements made for a product that do not
meet the definitions of “label” or “labeling” in the
FDCA. Advertising can include commercials on radio
or TV, or promotional statements that appear in
newspapers, or magazines.
 FDA has primary jurisdiction over advertising for
prescription drugs and a certain, limited category of
medical devices.
 FTC has primary jurisdiction over advertising for OTC
drugs. 17

18. LABELLING VS ADVERTISING
 Labelling regulations
 21 CFR Part 201
 http://www.accessdata.fda.gov/scripts/cdrh/cfdoc
s/cfCFR/CFRSearch.cfm?CFRPart=201
 Advertising regulations
 21 CFR Part 202
 http://www.accessdata.fda.gov/scripts/cdrh/cfdoc
s/cfCFR/CFRSearch.cfm?CFRPart=202

19. WHAT MUST A PRESCRIPTION DRUG
ADVERTISEMENT INCLUDE?
 Under section 502(n) of the FD&C Act,
advertisements must include:
 the established name,
 the brand name (if any),
 the formula showing quantitatively each ingredient, and
 information in brief summary which discusses side
effects, contraindications, and effectiveness. The brief
summary is further discussed in 21 CFR 202.1(e)(1).

20. REQUIREMENTS FOR ADVERTISEMENTS
 Print advertisements: FDA’s regulations require that the
advertisement present a true statement of information in brief
summary relating to the side effects, contraindications and
effectiveness of the prescription drug at issue.(promotional
brochures)
 Broadcast advertisements: FDA’s regulations require (1) that
the advertisement disclose information relating to the major
side effects and contraindications and (2) that either adequate
provision be made for dissemination of the FDA-approved
labeling for the prescription drug or that the advertisement
contain a brief summary of all necessary information related
to side effects and contraindications. (TV,NET,MAIL)
20

21. TYPES OF ADVERTISEMENTS

22. PROCESS FOR PRE-POST APPROVAL
OF ADS
 3.4.1 pre-publication approval of advertising
materials has helped
members achieve a high level of compliance with
both statutory and self regulatory
requirements.
 3.4.2 Specialist staff carry out the pre-publication
approval of advertising materials&
has access to independent medical and legal
expertise to advise
on evidence and matters of interpretation under the
FTC Consumer Code.
 3.4.3 The system of pre-publication approval is as
follows:

23. PRE APPROVAL PROCESS
AMENDMENTS
REQUIRED
FTC GRANTS
APPROVAL
ADD STAMPED
COMPANY READY TO
PROMOTE TO THE PUBLIC

24. POST APPROVAL PROCESS
 A post-publication system relies on a complaints
procedure being applied
after the event
 The global trend is now towards
self-regulatory or co-regulatory methods with
government post-publication
surveillance (i.e., taking action against violations rather
than pre-clearing of adds.
 A post publication system relies on a complaints
procedure being applied after the event

25. 3-25
Agency Effect on Advertising
Federal Trade Commission Regulates credit, labeling, packaging,
www.ftc.gov warranties, and advertising.
Food and Drug Administration Regulates packaging, labeling, and
www.fda.gov manufacturing of food and drug products.
Federal Communications Commission Regulates radio and television stations
www.fcc.gov and networks.
U.S. Postal Service Controls advertising by monitoring materials
www.usps.gov sent through the mail.
Bureau of Alcohol, Tobacco, and Firearms Division of the U.S. Treasury Department
www.aft.treas.gov that regulates advertising for alcoholic
beverages.
U.S. Patent Office Overseas trademark registration to protect
www.uspto.gov against patent infringement.
Library of Congress Provides controls for copyright protection.
www.loc.gov
Table 3.4 Specialized Government Agencies That Affect Advertising

26. ORGANIZATIONS THAT OVERSEE
ADVERTISING
3-20Prentice Hall, © 2009

27. COSMETIC
(1) articles intended to be rubbed, poured, sprinkled,
or sprayed on, introduced into, or otherwise applied
to the human body or any part thereof for cleansing,
beautifying, promoting attractiveness, or altering the
appearance,
(2) articles intended for use as a component of any
such articles; except that such term shall not
include soap.

28. FEDERAL,FOOD,DRUG &
COSMETIC ACT,1938
I. The FFD&C Act prohibits the marketing of
adulterated or misbranded cosmetics in interstate
commerce.
II. Section 601 of the FD&C Act a cosmetic is
adulterated if---
-"it bears or contains any poisonous substance
which may render it injurious to users ,( with an
exception for Hair Dyes)
-container is composed, in whole or in part, of
any poisonous substance.
I. Section 602 of the FD&C Act a cosmetic to be
considered misbranded if:
-False or misleading information,*
-Lack of required information.

29. FAIR PACKAGING & LABELLING
ACT,1966
 Unfair and Deceptive Packaging and
Labeling: Scope of Prohibition.
 labeling is false or misleading
 label does not state
 the name and address of the manufacturer, packer,
or distributor
 the net quantity of contents
 the required information is not stated
prominently, not understood by
consumers
 the container or its fill is misleading

30. LABELING OF COSMETICS
 CLASSIFICATION
 INTENDED USES
 COUNTRY OF ORIGIN
 BATCH NO
 INGREDIENTS
 WARNINGS
 NAME & ADDRESS
OF MANUFACTURER

31. REGULATION REQUIREMENTS
 Cosmetic ingredient declaration regulations apply
only to retail products intended for home use
 Products used exclusively by beauticians in beauty
salons and labeled “For Professional Use Only”
 Cosmetic samples are not required to include the
ingredient declaration. Must state the distributor,
list the content's quantity, and include all necessary
warning statements.

32.  Regulations require ingredients to be listed on
product labels in descending order by quantity
 Based on the amount used, an ingredient such as
water is usually found at the beginning of the
product's ingredient listing
 Color additives and fragrances, used in small
amounts, are normally seen at the end of the
ingredient listing.
 FDA regulates only the labeling that appears on
cosmetic products themselves
 Unfair and deceptive advertising that appears in
magazines, in newspapers, or on television falls
under the authority of the Federal Trade
Commission

33. BIOTECHNOLOGICAL PRODUCTS
 Biotechnology is the use of living systems and
organisms to develop or make useful products, or
"any technological application that uses biological
systems, living organisms or derivatives thereof, to
make or modify products or processes for specific
use"
 BLOOD AND PLASMA DERIVATIVES
 ANTITOXINES
 ANTIBODIES
 ANTIBIOTICS
 BACTERIAL AND VIRAL VACCINES

34. LABEL CONTENT
 Source , ingredients
 Uses: symptoms the medicine is approved to treat
 Warnings: This section tells you what to avoid and who
should not use this
 Directions: Recommended daily dosage and frequency.
Follow this strictly
 Other Information: additional information such as
proper storage
 Storage conditions
 Contraindications
 Drug interaction
 Adverse effects
 Details of manufacturer, distributor

36. REGULATORY AUTHORITIES
 FDA – REGULATES PRE-APPROVAL MARKET
AUTHORISATION AND POST APPROVAL
MONITORING
 CBER ,CDER REVIEW BLA FOR
BIOTECHNOLOGICAL PRODUCTS
 FTC- FEDERAL TRADE COMISSION

37. REFRENCES
 http://ww w.fda.gov/Cosmetics/default.htm
 http://www.fda.gov/oc/promotion
 en.m.wikipedia.org/wiki/biotechnology
 richman_fda_basis_biotech.pdf