FROM: BINDUM.PHARM DRA

TO:DR. HARISH DUREJAASSOCIATE PROFESSORPHARMACEUTICSMDU,ROHTAK

LABELLING & ADVERTISING REQUIREMENTS FOR DRUGS

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

DRUG (21 U.S.C. § 321(G))Articles recognized in USP, HPUS,

or NF; andArticles 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 above3

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!

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)

FDA VS FTC

FTC regulates advertising (cars, home mortgages, mops, etc.)

FDA regulates labeling and advertising (drugs, medical devices, foods)

Memorandum of Understanding - AdsFTC regulates ads for foods, OTC

drugs, non-restricted devices, cosmetics, dietary supplements

FDA regulates ads for prescription drugs and restricted medical devices

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

Product Name

Identity

Quantity

Manufacturer

Warnings/Caution Statement

Indications

Dosage/Directions

Lot No.

ExpireDate

Active Ingred. & Amount

DRUG FACT LABEL

PRESCRIPTION MEDICATIONSDispensed in

limited amounts by Registered Pharmacist

Designed to protect consumer

Prescribed by a physician.

PRESCRIPTION LABEL Patient name

and address Prescriber’s

name Drug name Pharmacy name

and date filled Special

Precautions/ Instructions

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

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)

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)

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 ReactionsDrug Abuse and DependenceOverdoseDosage 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)

EXAMPLE PROFESSIONAL LABEL

Professional Labeling: Isotrentinoin

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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.

LABELLING VS ADVERTISING Labelling regulations

21 CFR Part 201http://www.accessdata.fda.gov/scripts/cdrh

/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=201

Advertising regulations21 CFR Part 202http://www.accessdata.fda.gov/scripts/cdrh

/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=202

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).

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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)

TYPES OF ADVERTISEMENTS

PROCESS FOR PRE-POST APPROVAL OF ADS

3.4.1 pre-publication approval of advertising materials has helpedmembers achieve a high level of compliance with both statutory and self regulatoryrequirements.

3.4.2 Specialist staff carry out the pre-publication approval of advertising materials&has access to independent medical and legal expertise to adviseon evidence and matters of interpretation under the FTC Consumer Code.

3.4.3 The system of pre-publication approval is as follows:

PRE APPROVAL PROCESS

company conceives the advertisement

FTC

FTC CODE

AMENDMENTS REQUIRED

FTC GRANTS APPROVALADD STAMPED

COMPANY READY TO PROMOTE TO THE PUBLIC

POST APPROVAL PROCESS A post-publication system relies on a complaints

procedure being appliedafter the event

The global trend is now towardsself-regulatory or co-regulatory methods with government post-publicationsurveillance (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

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, andwww.fda.gov manufacturing of food and drug products.

Federal Communications Commission Regulates radio and television stationswww.fcc.gov and networks.

U.S. Postal Service Controls advertising by monitoring materialswww.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 alcoholicbeverages.

U.S. Patent Office Overseas trademark registration to protectwww.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

ORGANIZATIONS THAT OVERSEE ADVERTISING

3-20Prentice Hall, © 2009

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.

FEDERAL,FOOD,DRUG & COSMETIC ACT,1938I. 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.

III. Section 602 of the FD&C Act a cosmetic to be considered misbranded if:

-False or misleading information,* -Lack of required information.

FAIR PACKAGING & LABELLING ACT,1966Unfair 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

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

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.

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

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

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

REGULATORY AUTHORITIES FDA – REGULATES PRE-APPROVAL

MARKET AUTHORISATION AND POST APPROVAL MONITORING

CBER ,CDER REVIEW BLA FOR BIOTECHNOLOGICAL PRODUCTS

FTC- FEDERAL TRADE COMISSION

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