ASTM D4267-2007 Standard Specification for Labels for Small-Volume (100 mL or Less) Parenteral Drug Containers《小容积(100毫升或低于100毫升)非肠道药物包装容器用标签的标准规范》.pdf

1、Designation: D 4267 07Standard Specification forLabels for Small-Volume (100 mL or Less) Parenteral DrugContainers1This standard is issued under the fixed designation D 4267; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year

2、 of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) 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 back

3、ground 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:2D 7298 Test Method for Measurement of Comparative Leg-ibility b

4、y 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,

5、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

6、.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 (fo

7、r 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

8、 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 occ

9、ur 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

10、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

11、 (10-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 and Medical Packaging.Current edition approved Oct. 1, 2007. Published October 2007. Originallyapproved in 198

12、3. Last previous edition approved in 2001 as D 4267 95 (2001).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

13、.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 Offic

14、e, Washington, DC20402.5Federal Food, Drug, and Cosmetic Act, Section 201(m); and USP 23/NF 18,1995, p. 11.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.6.1.2 On containers of 2 mL or less, the vertical height ofcapitals and numera

15、ls for these items should be at least 1.5-mm(6-point or larger) type.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

16、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 flu

17、sh 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 angles (perpen-dicular

18、) to the long axis of the container (see Fig. 3).8. Legibility Requirements8.1 ContrastTo enhance legibility, manufacturers shallprovide contrast between the type used for the proprietaryname and established name of drug, and amount of drug perunit (4.1.1, 4.1.2, and 4.1.3) and either the immediate

19、drugcontainer or an added opaque label background sufficient tomeet 9.1. An opaque label background that does not preventinspection of contents is preferred when feasible. Use of pastelshades such as pink, green, brown, or gray for copy, and otherof these shades for background, shall be avoided.8.2

20、Patient Care FacilitiesPatient care facilities shallprovide enhanced lighting and a black-and-white contrastbackground card in areas where drug product labels must beread.9. Legibility Test9.1 The copy for the proprietary name or established nameof drug, and amount of drug per unit (4.1.1 or 4.1.2 a

21、nd 4.1.3)shall be determined to be legible utilizing the preferred methodfor determining legibility as specified in Test Method D 7298.9.2 The alternative method for determining legibility of thecopy for proprietary name or established name of drug, andamount of drug per unit (4.1.1 or 4.1.2 and 4.1

22、.3) shall beconducted by placing the substrate containing the copy in alight of 215 lx (lux) (20-fc (foot candles) at a distance of 500mm (19.7 in.) and having a person with 20/30 unaided orcorrected vision attempt to read this copy. A contrastingbackground may be used.10. Keywords10.1 container; co

23、ntrast; label; label content; legibility;legibility test; parenteral drug; type sizeASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the

24、 validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your

25、 comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments

26、have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multi

27、ple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).FIG. 1 Copy Printed Parallel to Long Axis of ContainerFIG. 2 Copy Printed From Needle End of SyringeFIG. 3 Copy Printed at Right Angles to Long Axis of ContainerD4267072