ASTM_D_4267_-_07_2015.pdf

Designation:D426707(Reapproved 2015)Standard Specification forLabels for Small-Volume(100 mL or Less)Parenteral DrugContainers1This standard is issued under the fixed designation D4267;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 specification covers the orientation,the size of typeused,and the contrast of the copy with the label background onimmediate drug containers having a volume of 100 mL or less.1.2 The values stated in SI units are to be regarded as thestandard.The values given in parentheses are for informationonly.2.Referenced Documents2.1 ASTM Standards:2D7298 Test Method for Measurement of Comparative Leg-ibility by Means of Polarizing Filter Instrumentation3.Terminology3.1 Definitions:3.1.1 established namethe designated name or officialname(commonly referred to as generic name).3.1.2 immediate containerthat which is in direct contactwith the article at all times.33.1.3 labela display of written,printed,or graphic matterupon the immediate container of any article.43.1.4 labelingall labels and other written,printed,orgraphic matter(1)upon any article or any of its containers orwrappers,or(2)accompanying such article53.1.5 proprietary namemanufacturers trade or brandname.4.Label Requirements4.1 Contents of LabelThe label shall consist of the fol-lowing:4.1.1 Proprietary name of drug(optional).4.1.2 Established name of drug(required).Printing theactive moiety of the established name in accordance with 6.1shall suffice,example,GENTAMICIN Sulfate Inj).4.1.3 Amount of drug per unit(for example,milligrams permillilitre(mg per mL)or quantity of drug per container asappropriate).4.1.4 For liquids,the total volume of the contents shall bemarked in a legible manner.4.1.5 Other information as required by regulation and themanufacturer.4.2 GeneralManufacturers are encouraged to use accept-able abbreviations(for example,HCl for hydrochloride)andminimize the use or size of other copy(for example,brand of,USP solution,injection)or unrequired punctuation(such asmg.versus mg)where label space is critical.5.Significance and Use5.1 Medication errors by users sometimes occur due todifficulty in reading or understanding drug container labels.The objective of this specification is to facilitate correct drugproduct identification.It does not absolve the user from theduty to read the label and correctly identify the drug productprior to use.6.Type Size Requirements6.1 The type size of the print used for the proprietary nameor established name of the drug and the numerals indicating theamount of drug per unit shall be as large as possible.6.1.1 On containers larger than 2 mL,the vertical height ofcapitals and numerals used for these items should be at least2.5-mm(10-point or larger)type.6.1.2 On containers of 2 mL or less,the vertical height ofcapitals and numerals for these items should be at least 1.5-mm(6-point or larger)type.1This specification is under the jurisdiction of ASTM Committee D10 onPackaging and is the direct responsibility of Subcommittee D10.32 on Consumer,Pharmaceutical,Medical,and Child Resistant Packaging.Current edition approved Oct.1,2015.Published October 2015.Originallyapproved in 1983.Last previous edition approved in 2007 as D4267 07.DOI:10.1520/D4267-07R15.2For 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.3United States Pharmacopeia,U.S.Pharmaceutical Convention,Inc.(USPC),Order Processing Dept.,12601 Twinbrook Parkway,Rockville,MD,20852,USP23/NF 18,1995,p.10.4Federal Food,Drug,and Cosmetic Act,Section 201(k);and USP 23/NF 18,1995,p.11.Available from U.S.Government Printing Office,Washington,DC20402.5Federal Food,Drug,and Cosmetic Act,Section 201(m);and USP 23/NF 18,1995,p.11.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 6.2 LegibilityIn all cases the type used for these itemsshall be bold enough to satisfy the legibility test(see 9.1).7.Orientation Requirements7.1 The copy required for proprietary name,or establishedname of drug,and amount of drug per unit(4.1.1,4.1.2,and4.1.3)shall be printed parallel to the long axis of the container.The left-hand margin of the copy shall start from the base endof the container so that it can be read while the top is held inthe right hand(see Fig.1).In prefilled syringes,the copy shallstart flush with,and read from,the needle end(see Fig.2).7.2 Alternatively,if the proprietary name and establishedname of drug,and amount of drug per unit(4.1.1,4.1.2,and4.1.3)can be printed within 180 around the circumference ofthe container,the copy may be printed at right