Generic Drug Labeling:
Unraveling the Mysteries
2011 USPHS Symposium
Pharmacy Category Day
June 21, 2011
Presented by:
CAPT Lillie D. Golson, MSA, PharmD
Team Leader, Labeling Review Branch
Office of Generic Drugs
Food and Drug Administration
Learning Objectives
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Provide an overview of the labeling review process
in FDA’s Office of Generic Drugs
Describe the types of errors often attributed to
labeling
Present graphic examples highlighting ways
labeling can both contribute to and prevent
medication errors
Provide tips to better understand characteristics
unique to generic labeling
Heighten awareness of the use of labeling
statements to communicate important information
to practitioners
Overview:
Labeling Review Branch
Office of Generic Drugs
(OGD)
Staffing
22 Pharmacists:
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19 Reviewers
3 Team Leaders
Responsibilities
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Ensure that the proposed generic
labeling is the “same as” that of the
branded equivalent or Reference
Listed Drug (RLD)
Ensure that healthcare practitioners
are provided sufficient information to
safely use the product
Review Tools
Primary Focus Areas
of OGD Labeling Reviews
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Labeling Text
Packaging
Pharmacy practice (as related to
safety and the prevention of
medication errors)
Labeling Text Focus:
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Is the generic name correct?
Does font size meet regulatory standards?
Are inappropriate abbreviations used?
Are dyes and coloring agents listed in the
DESCRIPTION section?
Do solid oral dosage forms have unique
identifiers described in the HOW
SUPPLIED section?
Packaging Focus:
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Does the package container differ from the
RLD (e.g., prefilled syringe vs. vial)?
Is the container color appropriate (e.g., cap
color for ophthalmics, potassium chloride)?
Are individual cartons required (e.g., contains
special dosing instructions)?
Is proposed package size mismatched with the
recommended dose?
How will medication guides and patient
information leaflets accompany the product?
Pharmacy Practice Focus:
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Are adequate instructions provided to ensure the
correct use of a product when package differs from
the RLD? Is the difference acceptable from a safety
standpoint?
Are the established name and strength the most
prominent text appearing on the label/labeling?
Is the layout of the labeling cluttered or confusing?
How is the product and labeling being used in the
real world?
Are products sufficiently differentiated?
Labeling and Medication
Errors
2006 IOM Report
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Indicated that major med
error problems involved
drug naming, labeling, and
packaging of products
33% of errors caused by
labeling and packaging
30% of fatalities reported
involved labeling and
packaging
10% of all errors were
attributed to drug name
confusion
Ways The Labeling and
Packaging Cause Confusion
Expression of Strength
 Prominence of Information
 Legibility of Information
 Trade Dress
 Packaging Configurations
 Packaging Design
 Product Design
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Expression of Strength and
Total Drug Content
www.medicalinspection.net/.../02/Figure31.png
Lack of Prominence of Vital
Information
www.medicalinspection.net/.../02/Figure12.png
Poorly Legible Information
Labeling and Packaging
Trade Dress
http://abcnews.go.com/Blotter/slideshow?id=9981722
Poor Packaging Design
Poor Product Design
Ways nomenclature can
cause confusion
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Sound alike – look alike names
Brand name/brand name confusion
Generic name/generic name confusion
Brand to generic name confusion
Generic names lacking unique/brand
identity
Use of abbreviations, acronyms, dose
designations, and various symbols
Brand To Generic Name Confusion
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Established names used more with generic
products.
Branded product frequently uses “fanciful”
terms (e.g., sprinkles, rapidly disintegrating,
caplets, spansules).
RLD slow to change common/usual names to
compendial names.
RLD frequently uses “non-official” dosage
forms in its proprietary names (e.g.,
sustained-release, dispersible, long-acting,
controlled-release).
Brand to Generic Confusion
(LA, CD, SR are not official dosage forms)
RLD
Ritalin
Ritalin LA
Metadate CD
Ritalin SR
Metadate ER
Concerta
Methylin ER
Generic
Methylphenidate HCL Tablets
Methylphenidate HCL
Extended-Release Capsules
Methylphenidate HCL
Extended-Release Tablets
Brand to Generic Confusion
(SR not an official dosage form in USP)
RLD
Generic
Wellbutrin
Bupropion HCL
Tablets
Bupropion HCL
Extended-release
Tablets
Zyban
Wellbutrin SR
Wellbutrin XL
Brainstorming
Ways FDA Tries to Communicate
With
The Pharmacist and Technician
Cross reference common
names with compendial
names
Place important information
on container and carton
labeling
Tall Man Lettering
Color Differentiate Products
Use USP Labeling Statements
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Protect from light
Not for injection
Not for intrathecal use
Must be chewed before swallowing
Must be diluted
Warning: Paralyzing Agent
Use CFR Labeling Statements
21 CFR 201.20
Declaration of presence of FD&C Yellow No. 5 and/or
FD&C Yellow No. 6 in certain drugs for human use
Contains FD&C Yellow #5 (tartrazine)
21 CFR 201.21
Declaration of presence of phenylalanine as a component of aspartame in
over-the-counter and prescription drugs for human use
Phenylketonurics: Contains
phenylalanine (4.5 mg per tablet)
21 CFR 208.24
Distributing and Dispensing a Medication Guide
However…
BOXED STATEMENTS
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Technicians:
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Familiarize yourselves with the general labeling format.
Scan the entire label for alerting statements and inform the
pharmacist before filling the order.
Try not to cover directions for use.
Try not to cover important information before pharmacist sees it.
Never assume.
Useful Links
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The Daily Med:
http://dailymed.nlm.nih.gov/dailymed/about.cfm
Drugs@FDA:
http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/
USP: http://www.usp.org/
Medication Guides:
http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm
Orange Book:
http://www.accessdata.fda.gov/Scripts/cder/ob/default.cfm
Medwatch:
http://www.fda.gov/Safety/MedWatch/default.htm
Thank you!