ASTM_D_6398_-_08_2014.pdf

Designation:D639808(Reapproved 2014)Standard Practice toEnhance Identification of Drug Names on Labels1This standard is issued under the fixed designation D6398;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This practice covers the shape,size,color,layout,typeface,and barcoding on drug container labels intended forprescription product packaging such as might be used inhospitals,pharmacies,and nursing centers.1.1.1 This practice does not apply to bulk product shippingcontainers;in-process transfer containers;or primary,secondary,or tertiary finished goods containers.1.2 This practice does not apply to over-the-counter drugproduct labeling.1.3 This practice does not apply to retail product labeling.1.4 The values stated in SI units are to be regarded asstandard.The values given in parentheses are for informationonly.2.Referenced Documents2.1 ASTM Standards:2D996 Terminology of Packaging and Distribution Environ-mentsD4267 Specification for Labels for Small-Volume(100 mLor Less)Parenteral Drug ContainersD4774 Specification for User Applied Drug Labels in Anes-thesiologyD7298 Test Method for Measurement of Comparative Leg-ibility by Means of Polarizing Filter Instrumentation2.2 Other Documents:21 CFR 429.12 Packaging and Labeling of Insulin321 CFR 201.66 Format and Content Requirements for Over-the-Counter(OTC)Drug Product Labeling3ISO 3864 Safety Colors and Safety Signs43.Terminology3.1 General definitions for packaging and distribution envi-ronments are in accordance with Terminology D996.3.2 Definitions of Terms Specific to This Standard:3.2.1 shape of labelshape of the label wherein is writtenthe name of the drug,the dosage,and the total contents of thedrug in its final form.4.Significance and Use4.1 Medication errors occur when users are confused by thesimilar size,shape,color,typeface,and layout of labels that areused for a range of a manufacturers drugs with widelydissimilar actions or potencies.The human visual system usesshape,size,color,and typeface in the initial recognition of alabeled drug.(See 9.1 9.3.)The use of this human visualsystem has been described in 21 CFR 429.12 for the labeling ofinsulin.Using the similar label design,color,and typefacethroughout a product line makes identifying an individual drugmore difficult.4.2 The objective of this practice is to provide guidance forthe design of drug labels which will enable users to easilydistinguish between drugs of differing action or potency.SeeNote 1.NOTE1For specific requirements for these labels and other features oflabels for OTC human drugs,see 21 CFR 201.66.5.Label RequirementsPanel Shape,Color,andContrast5.1 Differing combinations of label shape and color,withdiffering layouts and text face should be used to provide areadily recognizable combination for each group of drugs withdifferent actions or potency within a manufacturers range ofproducts.(See Fig.1.)5.2 High contrast between the margin of the label and itssurroundings and between the drug name and backgroundshould be provided.1This practice is under the jurisdiction of ASTM Committee D10 on Packagingand is the direct responsibility of Subcommittee D10.32 on Consumer,Pharmaceutical,Medical,and Child Resistant Packaging.Current edition approved April 1,2014.Published April 2014.Originallyapproved in 2001.Last previous edition approved in 2008 as D6398 08.DOI:10.1520/D6398-08R14.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3Available from Standardization Documents Order Desk,DODSSP,Bldg.4,SectionD,700RobbinsAve.,Philadelphia,PA19111-5098,http:/www.dodssp.daps.mil.4Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 6.Color6.1 If applicable,manufacturers should use the colors speci-fied for the specific drug groups in accordance with Specifica-tion D4774 or refer to ISO 3864 for guidance concerning safetycolors.6.2 Pastel colors should not be used for the identification ofdrugs,since approximately 8%of the male population havecongenital X-linked“color blindness”which diminishes theirability to distinguish between pastel shades of red,green,andbeige(see 9.4).6.3 Color contrasts with bright saturated colors contrastingwith the text and the background should be used.6.3.1 Suggested color contrasts are as follows:TextBackgroundBlackWhiteBlueYellowWhiteBlueBlueWhite7.Copy Legibility7.1 Label copy shall be measured in accordance with TestMethod D7298.7.1.1 If the instrumentati